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Advance Innovation Group

2013
QMS Essentials v 0.2
ISO 9001
Pranay, Shishir
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Document Revision History
Date Document Version
Document
Revision
Comments
Prepared By Approved By
12 April 0.1 Draft Only Shishir Singh Under Review
12 November 0.2 Shishir Singh Pranay Kumar
Distribution List
Document Sent To Purpose
All QMS Students For Information
References
Reference Document Name Description Page No.
N/A N/A N/A
Disclaimer
This document is prepared, reviewed and approved by the AIG Principal Consultant. All changes to this
Document shall be reviewed and approved by AIG Principal Consultant.
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Contents
1.0 PURPOSE______________________________________________________________________________5
2.0 AUDIENCE_____________________________________________________________________________5
3.0 GLOSSARY_____________________________________________________________________________5
4.0 HISTORY ______________________________________________________________________________5
4.1 Introduction _____________________________________________________________ 5
4.2 A Brief History of ISO_______________________________________________________ 6
4.3 The ISO Standardization Process _____________________________________________ 6
5.0 The eight principles of quality management _________________________________________________7
5.1 Customer focus ___________________________________________________________ 7
5.2 Leadership_______________________________________________________________ 7
5.3 Involvement of people _____________________________________________________ 8
5.4 Process approach _________________________________________________________ 8
5.5 System approach to management ____________________________________________ 8
5.6 Continual improvement ____________________________________________________ 8
5.7 Factual approach to decision making __________________________________________ 9
5.8 Mutually beneficial supplier relationships ______________________________________ 9
6.0 ISO 9000 Family of Documents ____________________________________________________________9
6.1 ISO 9000:2005, Quality management systems - Fundamentals and vocabulary _________ 9
6.2 ISO 9001:2008, Quality management systems - Requirements _____________________ 10
6.3 ISO 9004:2009, Managing for the sustained success of an organisation A quality
management approach__________________________________________________________ 10
6.4 ISO 19011, Guidelines on Quality and/or Environmental Management Systems Auditing
(currently under development) ___________________________________________________ 10
7.0 Non conformity _______________________________________________________________________10
7.1 Types of Non conformity __________________________________________________ 10
7.2 Major Non conformity ____________________________________________________ 11
7.3 Minor Non Conformity ____________________________________________________ 11
7.4 Observation_____________________________________________________________ 11
8.0 QMS Essentials________________________________________________________________________11
8.1 Guidance on Clause 4.2 of ISO 9001:2008 _____________________________________ 12
Documented statements of a quality policy and objectives________________________ 12
Quality Manual __________________________________________________________ 12
Documented procedures __________________________________________________ 12
Documents needed by the organization to ensure the effective planning, operation and
control of its processes ________________________________________________________ 13
Records ________________________________________________________________ 13
8.2 Records required by ISO 9001:2008 __________________________________________ 14
8.3 Process Design Methodology _______________________________________________ 14
8.4 Another model saying the same thing ________________________________________ 15
8.5 Typical Quality Pyramid in Organizations ______________________________________ 16
8.6 Ensuring Process Maturity Model Example ___________________________________ 16
8.7 Salient Feature of a sound Quality Management System _________________________ 17
Management Commitment ________________________________________________ 17
Internal Audit & Independence of Internal Auditors _____________________________ 18
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Corrective & Preventive Action______________________________________________ 18
Continual Improvement ___________________________________________________ 18
Documented Process _____________________________________________________ 18
Test of Design ___________________________________________________________ 18
Awareness Program: ______________________________________________________ 18
Implementation & Test of its Effectiveness ____________________________________ 18
Management Involvement in Audit and Audit outcome __________________________ 19
Documentation Hierarchy__________________________________________________ 19
8.8 Service Performance Metrics _______________________________________________ 19
Understand customer requirement & determine the measure of success ____________ 19
Define the operational definition& the defect definition__________________________ 20
Prepare Data Collection Plan _______________________________________________ 20
Validate the data_________________________________________________________ 20
Report Out _____________________________________________________________ 20
9.0 Audit Process _________________________________________________________________________21
9.1 Sample Nonconformance Report ____________________________________________ 24
9.2 Sample Audit Checklist ____________________________________________________ 25
10.0 Best Practices for Implementing and Utilizing a Standards-based QMS __________________________26
10.1 Why implement a Quality Management System ________________________________ 26
10.2 Effective Utilization of a QMS _______________________________________________ 27
10.3 Management Responsibility ________________________________________________ 27
10.4 Resource Management____________________________________________________ 27
10.5 Product Realization_______________________________________________________ 28
10.6 Measurement, Analysis, and Improvement ____________________________________ 28
11.0 Frequently Asked Questions (FAQ's) ______________________________________________________29
11.1 ISO____________________________________________________________________ 30
11.2 ISO 9000 Family of standards _______________________________________________ 30
11.3 ISO 9001:2008___________________________________________________________ 40
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1.0 PURPOSE
The purpose of this document is to serve as a reading material for all students of Advance Innovation Group.
This document intends to be a quick reference guide to all students @AIG in their pursuit to QMS
Implementation.
2.0 AUDIENCE
The QMS Essential Doc is intended for all the students of Advance Innovation Group.
3.0 GLOSSARY
Terms / Acronyms / Abbreviations Description
4.0 HISTORY
4.1 Introduction
The ISO 14000 series of environmental management standards are intended to assist organizations manage
the environmental effect of their business practices. The ISO 14000 series is similar to the ISO 9000 series
published in 1987. The purpose of the ISO 9000 series is to encourage organizations to institute quality
assurance management programs. Although ISO 9000 deals with the overall management of an organization
and ISO 14000 deals with the management of the environmental effects of an organization, both standards are
concerned with processes, and there is talk of combining the two series into one.
Both series of standards were published by ISO, the International Organization for Standardization. The
purpose of ISO is to facilitate international trade and cooperation in commercial, intellectual, scientific and
economic endeavors by developing international standards. ISO originally focused on industrial and
mechanical engineering standards. Now, it has ventured into setting standards for an organization's processes,
policies, and practices.
Both series of standards stemmed from concerns about international trade. One of the issues of the 1986
GATT negotiations in Uruguay was the removal of non-tariff trade barriers. Standards fall into this category.
The ISO 9000 standard was published about a year after the Uruguay GATT negotiations. The ISO 14000
standards are a response to both the GATT negotiations and to the growing global concern for the
environment as evidenced by the 1992 Rio Conference on the environment.
Both the ISO 9000 and the ISO 14000 series have critics and proponents. The critics of the standards point out
that quality management policies proposed by ISO 9000 do not necessarily result in quality products. Critics
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also project that the environmental management policies of ISO 14000 will not guarantee that an organization
is not damaging the environment. Both series require third-party certification, and the certification business is
booming, thanks in part to these two standards. Questions have risen regarding the fairness of the certification
process. Both series are heavy in their documentation requirements and demand a significant amount of time
and personnel.
The proponents of the series point to the economic benefits that can be gained by putting the standards into
practice. These benefits include the opening of new markets and the development of streamlined procedures,
which can lead to increased profits. There are also non-tangible benefits of ISO 14000 certification, such as
improved employee morale, improved corporate image, and the feeling of "doing the right thing".
Because of the strong similarities between the two standards, it is almost impossible to discuss ISO 14000
without including a discussion of ISO 9000 and the ISO standards-setting process. In addition, the experiences
that organizations have had with the ISO 9000 series have raised questions that many people want resolved
before they wholeheartedly embrace the ISO 14000 series. The reader will gain the most information from this
paper by reading the following sections in the order in which they are listed below:
4.2 A Brief History of ISO
Standards are important in international trade because incongruent standards can be barriers to trade, giving
some organizations advantages in certain areas of the world. Standards provide clear identifiable references
that are recognized internationally and encourage fair competition in free-market economies. Standards
facilitate trade through enhanced product quality and reliability, greater interoperability and compatibility,
greater ease of maintenance and reduced costs. ISO covers a wide variety of standards with the exception of
electrical and electronic engineering standards covered by the International Electrotechnical Commission (IEC),
telecommunication standards covered by the International Telegraph Union (ITU) and information technology
cov ered by JTC 1 (a joint committee between ISO and IEC).
The organization which today is known as ISO began in 1926 as the International Federation of the National
Standardizing Associations (ISA). This organization focused heavily on mechanical engineering. It was
disbanded in 1942 during the second World War but was re-organized under the current name, ISO, in 1946.
Even the name of the organization is standardized. The name, "ISO" is not an acronym but was derived from
the Greek word "isos" meaning "equal". (The relation to standards is that if two objects meet the same
standard, they should be equal.) This name eliminates any confusion that could result from the translation of
"International Organization For Standardization" into different languages which would lead to different
acronyms.
ISO is a voluntary organization whose members are recognized standard authorities, each one representing
one country. The bulk of the work of ISO is done by the 2700 technical committees, subcommittees and
working groups. Each committee and subcommittee is headed by a Secretariat from one of the member
organizations. The American National Standards Institute (ANSI) is the United States representative to ISO. The
ANSI ASC Z-1/ASQ Standards Group coordinates the United States representation in the ISO Technical
Committees 176 and 207 which are concerned with the ISO 9000 and ISO 14000 standards respectively.
4.3 The ISO Standardization Process
Each member body who has an interest in the work of a committee is entitled to be a member of that
committee. Standards are reached by consensus with each member organization representing the interests of
the vendors, manufacturers, consumers, profession als, and government of it's country.
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Each standard goes through a six stage process before being published as an ISO standard. The first stage is the
proposal stage in which a need for a standard is determined and members are identified who are willing to
work on it. The standards then ent ers the preparatory stage where a working draft of the standard is
developed. When the working draft is completed, it enters the committee stage and is sent out for comments
until a consensus is reached. The output of this stage is the Draft Internation al Standard (DIS). The DIS then
enters the enquiry stage where it is circulated among all member bodies and then voted upon. If a DIS does
not receive 75% of the vote, it returns to lower stages and work on it continues. If it passes the enquiry stage ,
it becomes a Final Draft International Standard and enters the approval stage. During this stage it will again
circulate through all member bodies for a final vote and again it must pass this stage with 75% of the vote. If
the standard passes this sta ge, it enters the publication stage and is sent to the ISO Central Secretariat for
publication.
Because certain technologies are changing so rapidly, ISO has instituted a Fast Track procedure that allows a
standard which has been proven in the market to enter the approval process at the enquiry stage.
5.0 The eight principles of quality management
Quality - That is the quality of processes and results is and will continue to be an essential competitive
factor, if not the most decisive one. When it comes to achieving ones own objectives as well as fulfilling
customer requirements, a reliable quality management system is indispensable.
The eight principles of quality management reflect the experience of leading top managers. They provide
assistance in focusing on objec-tives, on systematic leadership and on the con-tinual improvement of
performance.
5.1 Customer focus
Consistent customer focus is the single most essential factor of every business success. Being Best in
Class means predicting and exceeding customer expectations. The whole company organisation needs to
be aligned accordingly.
Your customersneeds are understood throughout the company.
Your internal company is directly linked to customer expectations.
You improve your companys ability to fulfill customer needs in day-to-day activities.
You ensure that your employees have the necessary knowledge and skills to satisfy your customers.
5.2 Leadership
The degree to which the purpose, focus and internal environment of an organization fit together is a
question of leadership. Managers create the internal environment in which people develop their skills and
apply them for the benefit of the entire organization. Important tools to achieve this are management by
example, the consider-ation of involved stakeholders inside and outside the organization and the
development of a clear vision of the organizations future.
You develop and communicate a clear vision of your organizations future.
You translate your vision into measurable goals for the organization.
You involve your employees in the realization of your company goals.
You have a motivated, competent and stable staff.
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5.3 Involvement of people
Every organization is only as good as its employ-ees. To allow them to apply their abilities and release their
potential, it is necessary to involve them in the decision-making process. Doing that requires promoting
commitment and problem-solving skills on all levels and to encourage the employees to take the initiative in
seeking op-portunities for improvement.
Your employees contribute actively to the improvement of your business strategy.
Your employees adopt the organizations goals as their own goals.
Your employees are involved in decision-making and the improvement of processes.
Your employees are more satisfied with their work and devote their individual development potential to
the service of your organization.
5.4 Process approach
Results can be achieved more efficiently if necessary activities and resources are bundled and managed as
a process. For this purpose, individual process steps need to be defined, inputs and outputs determined
and the interfaces with the organizations function identified. Finally, in order to ensure the smooth
running of orga-nizational processes, possible error causes need to be identified and responsibilities
determined.
Your processes ensure achievement of planned results and efficient use of resources.
You take advantage of improvement potentials because you are aware of the essential success factors.
Consistent emphasis on process orientation helps you to reduce costs and prevent errors.
You take advantage of improvement potential because you are familiar with the essential success factors.
5.5 System approach to management
Each organization is a complex entity; that is why it is important to identify, manage and understand
individual pro-cesses and their interactions within the organizational workflow. This is the only way for
organizations to establish objec-tives effectively and efficiently.
You develop extensive and ambitious business plans, which combine functional and process
aspects.
Sub-goals of individual processes become aligned with the main goals of your organization.
Monitoring the effectiveness of individual processes allows you to better identify error causes and
improvement potential.
You coordinate competencies and responsibilities for superordinate goals, avoid any overlapping of
competencies and stimulate teamwork.
5.6 Continual improvement
If you cease to improve, you cease to be good. Behind this simple statement lies the realization that
competence and quality are not static, but dynamic values; that applies to organizations as well as to the
people working there. That is why it is important for the success of an organization that continuous
improvement of products and systems becomes the ultimate goal of each employee.
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You combine continuous improvement and strategic planning for more competitive business plans.
You set realistic, measurable and ambitious goals for improve-ment and provide any necessary resources.
Your employees become involved in the process of continual improvement.
All employees of your organization are capable of improving products, processes and systems
5.7 Factual approach to decision making
Efficient decisions are based on the analysis of data and information. Ap-propriate decisions, based on
experi-ence and entrepreneurial intuition, can only be reached when these data and information are
reviewed and verified continuously.
You develop your company strategies based on facts and information.
Taking into account relevant comparative data, you pursue more realistic and more ambitious goals.
You make use of recognized methods for data analysis, making results available where appropriate. You
optimize your companys processes and system performance, taking into account data and information,
manage improvement processes and prevent future problems.
5.8 Mutually beneficial supplier relationships
All things are interdependent; organizations particularly depend on good business relationships with their
suppliers. This is the only way for both parties to make the maximum contribution to the creation of
mutual value. Indispensable to that end is transparent communication, agreement on com-mon goals
while taking account of the customers interests, and cooperation in the development and improvement
of products.
You increase your competitive advantage through the develop-ment of strategic partnerships with
suppliers.
You develop more ambitious goals by including your suppliers in your planning at an early stage.
Through improved relationships with suppliers, you ensure reliability, punctuality and error free
compliance of incoming goods.
You develop and strengthen the performance capability of your suppliers through training activities and
joint efforts towards continuous improvement.
6.0 ISO 9000 Family of Documents
6.1 ISO 9000:2005, Quality management systems - Fundamentals and
vocabulary
Establishes a starting point for understanding the standards and defines the fundamental
terms and definitions used in the ISO 9000 family which you need to avoid misunderstandings in their
use.
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6.2 ISO 9001:2008, Quality management systems - Requirements
This is the requirement standard you use to assess your ability to meet customer and applicable
regulatory requirements and thereby address customer satisfaction.
It is now the only standard in the ISO 9000 family against which third-party certification can be
carried.
6.3 ISO 9004:2009, Managing for the sustained success of an
organisation A quality management approach
ISO 9004 now gives guidance to the management of an organization on how to achieve sustained
success by use of a quality management approach. It helps an organization to move its management system
beyond the basic requirements of ISO 9001, to meet the needs and expectations of its all relevant interested
parties, and guides management in assessing their organizations strengths and weaknesses.
ISO 9004:2009 gives guidance to an organization on the steps it should take for improving its quality
maturity beyond that achieved from the implementation of an ISO 9001 based QMS. Taken together, the
standards form a consistent pair of standards, as both are based on the 8 quality management principles and
the Process approach model.
6.4 ISO 19011, Guidelines on Quality and/or Environmental
Management Systems Auditing (currently under development)
Provides you with guidelines for verifying the system's ability to achieve defined quality objectives.
You can use this standard internally or for auditing your suppliers.
7.0 Non conformity
Nonconformity refers to a failure to comply with requirements. A requirement is a need, expectation,
or obligation. It can be stated or implied by an organization, its customers, or other interested parties.
There are many types of requirements. Some of these include quality requirements, customer
requirements, management requirements, product requirements, and legal requirements. Whenever
your organization fails to meet one of these requirements, non-conformity occurs. ISO 9001
lists quality management systemrequirements. When your organization deviates from these
requirements, nonconformity occurs.
7.1 Types of Non conformity
Major Non conformity
Minor Non Conformity
Observation
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7.2 Major Non conformity
The absence or total breakdown of a system to meet the ISO 9000 requirement.
A number of minor nonconformities against one requirement can represent a total breakdown of the
system and thus be considered a major nonconformity.
Any noncompliance that would result in the probable shipment of nonconforming product.
A condition that may result in the failure or materially reduce the usability of the products or services
for their intended purpose.
A noncompliance that judgment and experience indicate is likely either to result in the failure of the
quality system or to materially reduce its ability to assure controlled processes or products
7.3 Minor Non Conformity
An ISO 9000 nonconformance to that judgment and experience indicate is not likely to result in the
failure of the quality system or reduce its ability to assure controlled processes or products.
A failure in some part of the supplier's documented quality system relative to ISO 9000, or
A single observed lapse in following one item of the company's quality system.
7.4 Observation
An observation is essentially an OPINION.
Some say you can ignore it while others expect the Observation to be addressed in some manner -
such as through the corrective action system
8.0 QMS Essentials
ISO 9001:2008 clause 4.1 General requirements requires an organization to establish, document,
implement, and maintain a quality management system and continually improve its effectiveness in
accordance with the requirements of this International Standard
Clause 4.2.1 General explains that the quality management system documentation shall include:
Documented statements of a quality policy and quality objectives;
A quality manual
Documented procedures required by this International Standard
Documents needed by the organization to ensure the effective planning, operation and control of its
processes, and
Records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a documented
procedure, the procedure has to be established, documented, implemented and maintained. It also
emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
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The size of organization and type of activities;
The complexity of processes and their interactions, and
The competence of personnel.

All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO
9001:2008, or, for the particular case of records, according to clause 4.2.4.
8.1 Guidance on Clause 4.2 of ISO 9001:2008
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the
general documentation requirements of the International Standard.
Documented statements of a quality policy and objectives
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented
quality policy has to be controlled according to the requirements of clause 4.2.3.
Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended
requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented
quality objectives are also subject to the document control requirements of clause 4.2.3.
Quality Manual
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and
structure of the manual is a decision for each organization, and will depend on the organizations size,
culture and complexity. Some organizations may choose to use the quality manual for other purposes
besides that of simply documenting the QMS.
A small organization may find it appropriate to include the description of its entire QMS within a
single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level,
and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of
clause 4.2.3.
Documented procedures
ISO 9001:2008 specifically requires the organization to have documented procedures for the
following six activities:
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
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These documented procedures have to be controlled in accordance with the requirements of clause
4.2.3
Some organizations may find it convenient to combine the procedure for several activities into a
single documented procedure (for example, corrective action and preventive action). Others may
choose to document a given activity by using more than one documented procedure (for example,
internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may
require additional documented procedures (particularly those relating to product realization
processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the
organization could enable these to be effectively implemented without necessarily being
documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has
to be able to provide objective evidence (not necessarily documented) that its QMS has been
effectively implemented.
Documents needed by the organization to ensure the effective planning,
operation and control of its processes
In order for an organization to demonstrate the effective implementation of its QMS, it may be
necessary to develop documents other than documented procedures. However, the only documents
specifically mentioned in ISO 9001:2008 are:
- Quality policy (clause 4.2.1.a)
- Quality objectives (clause 4.2.1.a)
- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS
and demonstrate conformity by the preparation of other documents, even though the standard does
not specifically require them. Examples may include:
- Process maps, process flow charts and/or process descriptions
- Organization charts
- Specifications
- Work and/or test instructions
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or
4.2.4, as applicable
Records
To see examples of records specifically required by ISO 9001:2008,
Organizations are free to develop other records that may be needed to demonstrate conformity of
their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records
have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.
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8.2 Records required by ISO 9001:2008
Clause Record required
5.6.1 Management reviews
6.2.2 e) Education, training, skills and experience
7.1 d) Evidence that the realization processes and resulting product fulfill requirements
7.2.2 Results of the review of requirements related to the product and actions arising from the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions
7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
7.5.2 d)
As required by the organization to demonstrate the validation of processes where the resulting
output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
7.6 a)
Basis used for calibration or verification of measuring equipment where no international or national
measurement standards exist
7.6
Validity of the previous measuring results when the measuring equipment is found not to conform to
requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3
Nature of the product nonconformities and any subsequent actions taken, including concessions
obtained
8.5.2 e) Results of corrective action
8.5.3 d) Results of preventive action
8.3 Process Design Methodology
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8.4 Another model saying the same thing
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8.5 Typical Quality Pyramid in Organizations
8.6 Ensuring Process Maturity Model Example
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8.7 Salient Feature of a sound Quality Management System
Management Commitment
At every step of QMS development & implementation the management of the organization should
be actively involved.
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Internal Audit & Independence of Internal Auditors
To ensure that the QMS remains effective and the documented processes are being adhered to,
quarterly audits are being performed by independent auditors. (The periodicity may differ from organization
to organization depending on the organizational maturity etc. One should keep in mind that audit is a cost
hence overdoing audit is never advisable unless it is a new system, and /or it is critical to organizational
success or customer satisfaction).
Organization should ensure independence of the Internal Audit process by getting the quality
function to report to the highest office of the organization.
Corrective & Preventive Action
For all process or product non conformities, the process of RCA should be in place and for all non
conformities a formally documented Corrective Action Plan is mandatory.
Continual Improvement
Organization should aim at continual improvement of processes as part of our endeavor for
operational excellence. As an auditor, one should spend time with the process owners to understand what
endeavors have been made to improve the system.
Documented Process
All processes in the organization are formally documented and communicated to all employees. They
should be adequately version controlled, review process defined and availability, integrity & confidentiality of
information be ensured. Organization may choose to have central repository that ensures availability of the
documents on a need to know basis, while ensuring suitable controls of availability, integrity & confidentiality
of information.
Test of Design
All processes created should be tested for their design intent (if they meet all the CTQ that
have been identified, all process handshakes provisioned for etc.). While auditing or implementing
processes one should do due diligence to understand the needs of various stakeholders and process
bottlenecks.
Awareness Program:
There should be an awareness program mandated for all processes with defined set of audience.
To monitor the design and effectiveness of these programs there should be a well defined audit process
in place.
Implementation & Test of its Effectiveness
All processes implemented should be verified through internal & external audit process for their
effectiveness.
Periodicity of Audits and their scope should be pre-defined.
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Management Involvement in Audit and Audit outcome
Management and the leadership team of the organization is actively involved at every step of the
process design ,review, review of the review of the audit results, non-conformities and their closure resulting
out of corrective & preventive actions.
Documentation Hierarchy
The Organization should have a 3 tier process documentation approach.
Level 1 Constitutes of the Organizational Quality Policy, Manual and organizational objectives.
Level 2 Documents are specific to departments and constitutes of department manuals, department
objectives, SOP, Work Instructions, standards and guidelines etc.
Level 3 Should constitute of the templates, checklist etc. The diagrammatic representation of the same is
given above (See Typical Quality Pyramid in Organizations)
8.8 Service Performance Metrics
At XXXX we should make adequate provisions to establish an organization driven by numbers. Metrics play a
key role in our decision making process and understanding of the areas of improvement. Metrics should form
the basis of our process of measuring success to anything that we do.
There should be a defined way of creating metrics at the company. Essentially all such endeavor starts with the
customer and his definition of the measure of success.
Understand customer requirement & determine the measure of success
Your initiative of metrics creation should always start with understanding the customer
requirement. Determine the measure of success based on the customer requirement.
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Measure of success determined is validated by the customer to avoid expectation mismatch at a
later stage.
Define the operational definition& the defect definition
Operational definition and defect definition are defined in advance to ensure that all the people
involved have the common understanding of the process.
Prepare Data Collection Plan
Data collection plan should be prepared to establish framework for data collection. Individuals are
identified within the organization and assigned roles and responsibilities to collect data.
The entire data collection process should be designed in an organized manner to identify
bottlenecks if any, and put effective controls to efficiently collect data. Data collection plan helps us identify
what data needs to be collected and from where.
P.S. Data Validity is an important concern for the customer.
Validate the data
Once the data is collected, the same is validated by review process to ensure its completeness and
correctness.
Report Out
Timely report should be sent to all stakeholders to ensure effective monitoring. It helps to know the
current state of affairs, identify areas of improvement, if any; take corrective and preventive steps for
eradication of defects and continual improvement.
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9.0 Audit Process
Y
N
Require a sign off
from GE GDC
Program Office
Define Audit Methodology
(including Sampling techniques)
Conduct internal audit based
on TOD/TOE
A
Audit Reporting
(Comply with the reporting
guidelines published by GE GDC
Program.)
Submit the action plan for
closure of audit findings.
On quarterly
basis covering at
least 3 quarters
Conducted annually by GE approved
External Auditors
(Audit will be based in TOD/TOE)
Any
Exception to
this schedule
Publish schedule
on the first
quarter of the
year
Internal
External
CnS Audit
START
END
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Audit Process Flow 2
Sample Audit Flow Chart
Prepare and publish Internal Audit
Plan
Prepare and publish Internal Audit
Schedule
Identify Audit Methodology
Conduct Internal Audits
Audit Reporting
CAPA Logging
Follow-up Audit
Any open NC
Audit Process Closed
Yes
START
END
Management
Review
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END
CAPA Closing
Audit Reporting
(Comply with the reporting
guidelines published by GE GDC
Program.)
A
CAPA
Reporting
Any Open
NC
Management
Review
Meeting
Follow Up
Audit
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9.1 Sample Nonconformance Report
.
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9.2 Sample Audit Checklist
Section ISO Guide Line Sub-section Sub-Guideline Count of Shall Documentation Required Records Required
4.1 General Requirement 5
4.2
Documentation
requirement
4.2.1 General 1
4.2.2 Quality Manual 1
4.2.3 Control Of Document 3 Yes
4.2.4 Control Of Records 2 Yes
5.1
Management
Commitment 1
5.2 Customer focus 1
5.3 Quality Policy 1
5.4 Planning
5.4.1 Quality Objective 2
5.4.2 QMS Planning 1
5.5
Responsibility, Athority
and Communication
5.5.1 Responsibility & Authority 1
5.5.2 Management Representative 2
5.5.3 Internal Communication 1
5.6 Management Review
5.6.1 General 1 Yes
5.6.2 Review Input 1
5.6.3 Review Output 1
6.1 Provisions of resources 1
6.2 Human Resources
6.2.1 General 1
6.2.2
Competence awareness and
training 1 Yes
6.3 Infrastructure 1
6.4 Work Environment 1
7.1
Planning of Product
Realization 3 Yes
7.2
Customer related
Processes
7.2.1
Determination of requirements
related to the product 1
7.2.2
Review of Requirements related to
the product 6 Yes
7.2.3 Customer Communication 1
7.3 Design & Devolpment
7.3.1 Design and devolopment planning 4
7.3.2 Design and devolopment inputs 4 Yes
7.3.3 Design and devolopment outputs 3
7.3.4 Design and devolopment review 3 Yes
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10.0 Best Practices for Implementing and Utilizing a Standards-
based QMS
As industries grow increasingly competitive, it is important for companies, large and small, to
certify to certain quality standards, such as ISO 9001 or sector-specific standards. As companies consider
registering to these standards, the challenge becomes how to best implement and utilize a quality
management system.
A few general questions need to be asked when undertaking what could be a complex, and
somewhat costly, effort. Why does a company need to implement a quality standard?
How will this standard fit that companys particular business? What type of return on
investment can be expected?
10.1 Why implement a Quality Management System
Most often, a company needs to implement a quality management system (QMS) based on a
recognized standard, such as ISO 9001, because customers have begun to require it or have asked about a
companys plan to implement such a standard. To become a preferred supplier, or even bid on contracts, many
companies are required to be certified to ISO 9001 or similar standards. In these situations, the business case
for a QMS is straight forward. Rather than lose the business of a valuable customer, the better choice often is
to determine how the standard applies to overall business operations and implement it.
Benefits go beyond retaining existing customers or qualifying for new contracts.
Implementing a quality management system that is ISO 9001 compliant also provides discipline, improves
processes and increases the productivity and effectiveness of a companys operations. Consistent, reliable,
well-documented management systems result in reduced scrap and waste, less human errors, and as a result,
increased profitability and customer satisfaction.
One way to determine the value of a quality management system is to learn from those that
have successfully implemented and certified their own systems. Over 20,000 companies have gone through
the process and will openly discuss the results with suppliers and customers, as well as in user forums.
Similarly, companies that are certified can answer important questions regarding measurable benefits, costs,
timing, and challenges. In support of quality management systems, those that have undergone the process
often will point out the following:
QMS certification demonstrates a commitment to customers and stakeholders by top management.
It increases customer satisfaction through improved responsiveness and product/service reliability.
QMS certification forms a strong, recognized foundation for meeting regulatory requirements.
It enhances the image of an organization through proactive quality-focused leadership and
international credentials.
It reduces operating costs through error prevention, clear work instructions, consistent practices, and
lower overall liability.
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QMS certification improves communications between employees, customers, and suppliers.
QMS certification identifies opportunities for improvement through best practices process metrics,
and customer feedback.
10.2 Effective Utilization of a QMS
How a company implements a management system should be consistent with the companys
existing objectives, business operations, and tasks performed, which ISO 9000 refers to as processes.
Companies have found that particular processes they have defined, or built the company around, are part of
their competitive advantage, whether a manufacturing or service delivery process. ISO 9000 does not
prescribe how a company operates but instead, identifies four processes (listed below) that all companies
must perform. The standard instructs, Document what you do, and do what you document. Often,
companies have implemented requirements but have not associated those requirements with the particular
requirements of a standard, such as ISO 9001:2008. The level of success and return for companies that
implement and certify QMS comes from how well they do the following four clauses identified by ISO 9001.
10.3 Management Responsibility
Every business needs to know how it is performing in order to stay in business and preempt
any problems with operations or customer dissatisfaction. Whether analyzing financial information, piece
counts, yield data, shipment and return information, labor hours, machine hours, prompt payment, repeated
service request, warranty claims, customer interviews, surveys, or other forms of customer feedback,
measures will need to be set and monitored as to whether or not they are satisfactory or unsatisfactory. The
monitoring may be referred to as management review under ISO 9000. In most cases, the unsatisfactory
aspects will need to be fixed through some form of corrective action and likewise, the satisfactory aspects
improved upon through some form of continual improvement procedure or program. Preventative action also
will need to be taken to avoid the satisfactory from becoming unsatisfactory.
10.4 Resource Management
When managing its resources, a company must identify each of its business operations and
place it in one of the following categories:
Key processes (a task directly related to satisfying the customer)
Support processes (necessary to operate key processes)
Management processes (used to help manage, measure, or report about the key Process).
Organizing existing information under these processes will facilitate an understanding of and ideally,
the implementation of the process approach. Many companies find it extremely beneficial to form a team and
have each team member read the standard several times. This will ensure an overall understanding of the
intent of the standard and the process approach.
After a company identifies its processes, it must take a general look at its business operations
by mapping the processes in the logical sequence in which they occur. Processes that rely on an input and
output from one operation to another must be connected in sequence, relating the processes to key support
and management processes previously identified. It also is important to show how each of your existing
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records, procedures, work instructions and documents relate to one another. This will help to ensure each of
the processes is followed and the company is meeting the requirements of the chosen standard.
Once operations have been mapped, the system must be tested by completing audits in the
process approach. Interview those implementing the requirements and observe each process and
requirement. Revisit, revise, improve or supplement those processes that do not meet the standard and those
that are not flexible, fluent, feasible or efficient, given the nature of the particular business.
10.5 Product Realization
A major part of implementing and maintaining a successful quality management system is
product realization, or the process by which products are developed, designed, produced, marketed, and
disposed. This will require a close look at the customers needs as they relate to the strategies and products
of the certifying company.
Prior to accepting an order from a customer, a review of what the customer has ordered will
need to be performed, deciding such factors as whether or not the product can be manufactured or the
service provided as expected, what the terms of the offer will be, and what are the associated costs. This is a
typical customer-related process per ISO 9001:2008.
In conjunction with this customer-related process, a company also will select a supplier of
material or other commodity, train employees, and discover the best methods to administer and implement
the process in order to obtain the desired results. Along this path, companies maintain records of customer
orders, invoices, purchases, and schedules.
These activities may meet ISO 9001:2008 requirements, when formalized, for competence,
awareness and training, control of records, and purchasing information. Following receipt of a customer
order, the realization of the product must be planned. In other words, plan the design of the product, the
purchasing of materials or other commodities, and verify that the item meets what has been ordered. Other
points to consider include the manufacture of material, component, or part to specific criteria and
requirements that will provide a product acceptable to the customer, including identifying, tracking,
preserving, packaging, measuring, testing, delivering and orrecting any work in progress.
10.6 Measurement, Analysis, and Improvement
What is the Return on Investment (ROI)? This is a question that should always be asked by
Senior Management, where resources, cost and/or capital are involved. The first and most obvious
measurement of ROI is the retention and hit rate with customers who have required or inquired about a
companys ISO 9001 or ISO/TS 16949 certified or compliant quality management system.
Objectives and targets should be set for other ROI measures, such as levels of scrap, rework, and
customer rejects (spills in automotive). The objectives and targets should be reviewed periodically for
adequacy, suitability, and effectiveness. Adjustments, redefinition and changes should be made where the
targets or overall objectives are not consistent with the business environment. Likewise, corrective and
preventive actions should be taken where expectations are not met or do not progress at a pace that meets
the schedule for achievement.
Once targets are met and progress is satisfactory, continual improvement of the process should
begin. The objectives and targets may need to be redefined or moved and additional objectives and targets
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identified. In the overall picture, a companys ROI should be consistent and correlate with the effect of quality
management on its financial performance, and internal and external customer satisfaction levels.
Success is a matter of discovering where a companys policies, requirements, and processes
best fit the clauses of the standard. Defining, monitoring, measuring, redefining, adjusting and changing the
processes will lead to achievement of the financial goals of the business.
11.0 Frequently Asked Questions (FAQ's)
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This list of Frequently Asked Questions (FAQs) has been prepared by ISO/TC 176/SC 2 to support
the publication of ISO 9001:2008 and of ISO 9004:2009. Input has been obtained from experts
and users of the ISO 9000 standards, expressed during seminars and presentations around the
world.
The list will be reviewed and updated on a regular basis to maintain its accuracy, and to include
new questions where appropriate. It is intended that this list will also provide a good source of
information for new users of the standards.
The FAQs given below have been categorized as follows:
1. ISO
2. ISO 9000 Family of standards
3. ISO 9001
4. ISO 9004
11.1 ISO
What is ISO?
The International Organization for Standardization (ISO) was established in 1947 and is
(currently) an association of approximately 160 National Standards Bodies, which each
represent their own country. ISO employs a system of Technical Committees, Sub-committees
and Working Groups to develop International Standards. Besides the National Standards Bodies,
ISO permits other international organizations that develop standards to participate in its work,
by accepting them as Liaison members. ISO works in accordance with an agreed set of rules of
procedure, the ISO/IEC Directives, which also include requirements on the presentation of
standards.
Who are the National Standards Bodies, and who represents my country at
ISO?
Please use the link on ISO's web site that gives details, including contact information, of the
National Standards Bodies:
www.iso.org/iso/about/iso_members.htm
Is there any way I can participate in the development of standards?
Yes. If you are interested you should contact your National Standards Body for further details.
11.2 ISO 9000 Family of standards
What are the ISO 9000 standards ?
The ISO 9000 standards are a collection of formal International Standards, Technical
Specifications, Technical Reports, Handbooks and web based documents on Quality
Management. There are approximately 25 documents in the collection altogether, with new or
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revised documents being developed on an ongoing basis.
(It should be noted that many of the International Standards in the ISO 9000 family are
numbered in the ISO 10000 range.)
Who is responsible for developing the ISO 9000 standards?
ISO Technical Committee (TC) number 176 (ISO/TC 176), and its Sub-committees, are
responsible for the development of the standards. The work is conducted on the basis of
"consensus" among quality and industry experts nominated by the National Standards Bodies,
representing a wide range of interested parties.
Where can copies of the standards be obtained?
Copies of the standards may be purchased from your National Standards Body, or from ISO
itself. Many National Standards Bodies have them available in local-language versions.
Where can copies of the supporting ISO 9000 guidance notes or other
documents be found ?
Copies of the ISO 9000 Introduction and Support Package modules:
- Guidance on ISO 9001:2008 Sub-clause 1.2 'Application'
- Guidance on the Documentation requirements of ISO 9001:2008
- Guidance on the Terminology used in ISO 9001 and ISO 9004
- Guidance on the Concept and Use of the Process Approach for management systems
- Guidance on 'Outsourced Processes'
Where can information be obtained on the ISO 9000 standards?
There are a number of sources of information on the ISO 9000 quality management system
standards, including ISO's web site (www.iso.org), which carry information on the standards.
Your National Standards Body should be able to provide copies of the standards, and
registrars/certification bodies will be able to provide guidance on registration arrangements.
Why are standards revised?
ISOs formal review process:
Requires continual review to keep standards up to date. Must be initiated within 3 years of
publication of a standard.
User inputs from:
o Global user questionnaires/surveys
o Market Justification Studies
o Suggestions arising from the interpretation process
o Opportunities for increased compatibility with ISO 14001
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o The need for greater clarity, ease of use, and improved translation
Current trends:
o Keeping up with recent developments in management system practices.
Who is responsible for revising ISO 9001 and ISO 9004?
The revision process is the responsibility of ISO Technical Committee no.176, Sub-committee
no.2 (ISO/TC 176/SC 2) and is conducted on the basis of consensus among quality and industry
experts nominated by ISO Member bodies, and representing all interested parties.
Where can I obtain information on the standards?
ISO maintains a web site at http://www.iso.org/ that carries general information on the
standards. Your National Standards Body can give you additional information about national
versions.
Are the standards available in my national language?
The active participation of experts from around the world in the preparation of the new
standards facilitates their translation into many different languages.
ISO itself publishes standards in English and French.
You should contact your National Standards Body to see if they have your national language
translations of the standards.
Where can my organization go if it needs additional clarification or
interpretation of the standards?
The starting point for any individual request for an interpretation should be with the enquirer's
National Standards Body. ISO Central Secretariat and ISO/TC 176/SC 2 cannot accept direct
requests from individuals for interpretations of the ISO 9000 standards. ISO/TC 176 has a
Working Group that only accepts formal requests for interpretations from the National
Standards Bodies.
Do the standards address financial issues?
Financial issues are not addressed in ISO 9001:2008, which is a requirements standard.
The ISO 10014:2006 and ISO 9004:2009 guidance standards emphasize the financial resources
needed for the implementation and improvement of a quality management system.
What are the benefits of ISO 9001:2008 and ISO 9004:2009?
For ISO 9001:2008 the major benefits are:
- Simple to use
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- Clear in language
- Readily translatable and easily understandable
- Compatibility with other management systems such as ISO 14001.
For ISO 9004:
- Facilitates improvement in users quality management systems.
- Provides guidance to an organization for the creation of a quality management system
that:
o creates value for its customers, via the products it provides
o creates value for all other interested parties
o balances all interested-party viewpoints.
- Provides guidance for managers on leading their organization towards sustained success.
- Forward compatibility to allow organizations to build on existing quality management
systems.
What are the main benefits to be derived from implementing an ISO 9000
quality management system?
The ISO 9000 standards give organizations an opportunity to increase value to their activities
and to improve their performance continually, by focusing on their major processes. The
standards place great emphasis on making quality management systems closer to the processes
of organizations and on continual improvement. As a result, they direct users to the
achievement of business results, including the satisfaction of customers and other interested
parties.
The management of an organization should be able to view the adoption of the quality
management system standards as a profitable business investment, not just as a required
certification issue.
Among the perceived benefits of using the standards are:
- The connection of quality management systems to organizational processes
- The encouragement of a natural progression towards improved organizational
performance, via:
o the use of the Quality Management Principles
o the adoption of a "process approach"
o emphasis of the role of top management
o requirements for the establishment of measurable objectives at relevant functions
and levels
o being orientated toward "continual improvement" and "customer satisfaction",
including the monitoring of information on "customer satisfaction" as a measure of
system performance.
o measurement of the quality management system, processes, and product
o consideration of statutory and regulatory requirements.
o attention to resource availability
Are the standards compatible with national quality award criteria?
The standards are based on 8 Quality Management Principles, which are aligned with the
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philosophy and objectives of most quality award programs.
These principles are
- Customer focus,
- Leadership,
- Involvement of people,
- Process approach,
- System approach to management,
- Continual improvement,
- Factual approach to decision making, and
- Mutually beneficial supplier relationships.
ISO 9004 recommends that organizations perform self-assessments as part of their
management of systems and processes, and includes an annex giving guidance on this
approach. This is similar to many quality awards programmes.
Why is the monitoring of "customer satisfaction" included in the standards?
"Customer satisfaction" is recognized as one of the driving criteria for any organization. In order
to evaluate if a product meets customer needs and expectations, it is necessary to monitor the
extent of customer satisfaction. Improvements can be made by taking action to address any
identified issues and concerns.
Can the standards improve "customer satisfaction"?
The quality management system details that are described in the standards are based on
Quality Management Principles that include the "process approach" and "customer focus". The
adoption of these principles should provide customers with a higher level of confidence that
products will meet their needs and increase their satisfaction.
What is meant by "continual improvement"?
Continual improvement is the process focused on continually increasing the effectiveness
and/or efficiency of the organization to fulfil its policies and objectives. Continual improvement
(where "continual" highlights that an improvement process requires progressive consolidation
steps) responds to the growing needs and expectations of the customers and ensures a
dynamic evolution of the quality management system.
What is a process?
Any activity or operation, which receives inputs and converts them to outputs, can be
considered as a process. Almost all activities and operations involved in generating a product or
providing a service are processes.
For organizations to function, they have to define and manage numerous inter-linked
processes. Often the output from one process will directly form the input into the next process.
The systematic identification and management of the various processes employed within an
organization, and particularly the interactions between such processes, may be referred to as
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the process approach to management.
What is the "process approach"?
The "process approach" is a way of obtaining a desired result, by managing activities and
related resources as a process. The "process approach" is a key element of the ISO 9000
standards. For further guidance, please refer to the ISO 9000 Introduction and Support Package
module: Guidance on the Concept and Use of the Process Approach for management systems.
Can the "process approach" be applied to other management systems?
Yes. The "process approach" is a generic management principle, which can enhance an
organizations effectiveness and efficiency in achieving defined objectives.
How can the PDCA cycle be used in the "process approach"?
The PDCA cycle is an established, logical, method that can be used to improve a process.
This requires:
- (P) planning (what to do and how to do it),
- (D) executing the plan (do what was planned),
- (C) checking the results (did things happened according to plan) and
- (A) act to improve the process (how to improve next time).
The PDCA cycle can be applied within an individual process, or across a group of processes.
Can any organization apply the "process approach"?
Yes. Many organizations already apply a "process approach" without recognizing it. They could
achieve additional benefits by understanding and controlling it.
Why should an organization apply the "process approach"?
By applying the "process approach" an organization should be able to obtain the following types
of benefits:
The integration and alignment of its processes to enable the achievement of its planned
results.
An ability to focus effort on process effectiveness and efficiency.
An increase in the confidence of customers and other interested parties as to the
consistent performance of the organization.
Transparency of operations within the organization.
Lower costs and shorter cycle times through effective and efficient use of resources.
Improved, consistent and predictable results.
The identification of opportunities for focused and prioritized improvement initiatives.
The encouragement and involvement of people, and the clarification of their
responsibilities.
The elimination of barriers between different functional units and the unification of their
focus to the objectives of the organization.
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Improved management of process interfaces.
What is meant by the sequence of processes and their "interactions"?
The "sequence" of processes shows how the processes follow, or link, to each other to result in
a final output.
For example, the output from one process may become the input of the next process or
processes.
The "interactions" show how each process affects or influences one or more of the other
processes. For example, the monitoring or controlling of a process may be established in a
separate process.
How can the processes in an organization be determined?
Identify the organization's intended outputs, and the processes needed for achieving them.
These will need to include processes for Management, Resources, Realization and
Measurement and Improvement.
- Identify all process inputs and outputs, along with the suppliers and customers, who may
be internal or external.
- Identify the sequence and interactions of the processes.
Should an organization define and document all its processes?
The main purpose of documentation is to enable the consistent and stable operation of an
organization's processes.
Although statutory, standards' or customer requirements may require certain documentation,
there is no defined catalogue, or list of processes that has to be documented in ISO 9001,
apart from the 6 indicated ones.
The organization should determine which processes are to be documented on the basis of:
- The size of the organization and type of its activities,
- The complexity of its processes and their interactions,
- The criticality of the processes and
- Availability of competent personnel.
A number of different methods can be used to document processes, such as graphical
representations, written instructions, checklists, flow charts, visual media, or electronic
methods.
How much detail is required in process documentation?
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The extent of detail is likely to depend upon factors such as:
- the size of an organisation and its types of activities,
- the complexity of its processes and their interactions, and
- the competence (level of education, training, skills and experience) of its personnel.
Is there a standard way of describing a process?
No, there is no standard way to describe a process. It depends on the culture, management
style, staff literacy, personal attributes and their interactions.
A process may be described using a flow chart, block diagram, responsibility matrix, written
procedures or pictures.
Process flowcharts or block diagrams can show how policies, objectives, influential factors, job
functions, activities, material, equipment, resources, information, people and decision making
interact and/or interrelate in a logical order.
What should an organization do to adopt the "process approach"?
To adopt the "process approach" an organization should apply the following steps:
- Identify the processes of the organization,
- Plan the processes,
- Implement and measure the processes,
- Analyse the processes,
- Improve the processes.
What is a "process owner"?
A person who is given the responsibility and authority for managing a particular process is
sometimes referred to as the "process owner".
It may be useful for an organization's Management to appoint individual "process owners" and
to define their roles and responsibilities; these should include the responsibility for ensuring the
implementation, maintenance and improvement of their specific process and its interactions.
It should be noted, however, that ISO 9001:2008 does not specifically require the appointment
of "process owners".
How can a process be measured?
There are various methods of measuring process controls and process performance, ranging
from simple monitoring systems up to sophisticated statistically based systems (e.g. statistical
process control, or SPC, systems). The selection and use of any particular method will be
dependent on the nature and complexity of an organization's processes and products. The
effectiveness of an individual process may be measured by the conformity of its output or
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product to customer requirements. Its efficiency may be measured from its use of resources. In
all cases the measurement of the process determines if its (measurable) objectives have been
achieved. Sometimes it only requires monitoring to confirm process operations.
Typical factors that are useful to consider when identifying measures of process control and
process performance include:
- Conformity with requirements,
- Customer satisfaction,
- Supplier performance,
- On time delivery,
- Lead times,
- Failure rates,
- Waste,
- Process costs.
- Incident frequency
What is the difference between a "process" and a "procedure"?
A "process" may be explained as a set of interacting or interrelated activities, which are
employed to add value. A "procedure" is a method of describing the way or How in which all or
part of that process activities shall/should be performed.
ISO 9000:2005 defines a procedure as a "specified way to carry out an activity or a process",
which does not necessarily have to be documented.
An organization has a well-established set of procedures. Can these
procedures be used to help describe its processes?
Yes, if the procedures describe inputs and outputs, appropriate responsibilities, controls and
resources needed to satisfy customer requirements.
Which standard are organizations registered/certified to?
Organizations have their quality management system registered/certified to ISO 9001:2008. The
scope of registration/ certification will need to reflect precisely and clearly the activities
covered by the organization's quality management system; any exclusion to non-applicable
requirements of the standard (permitted through ISO 9001 clause 1.2 "Application") will need
to be documented and justified in the quality manual (see also the ISO/TC 176/SC2 ISO 9000
Introduction and Support Package module Guidance on ISO 9001:2008 clause 1.2 'Application').
Can an organization be certified/registered to ISO 9004?
ISO 9004 is a guidance standard, which is not intended to be used for third party
registration/certification purposes. A key element of ISO 9004 is the ability to perform self-
assessments. Third party quality management system certifications/ registrations are
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performed to ISO 9001:2008.
What is happening to the other standards and documents in the ISO 9000
family?
The four primary standards of the current ISO 9000 family are ISO 9000:2005, ISO 9001:2008,
ISO 9004:2009 and ISO 19011:2002.
ISO 19011:2002 is currently being revised, with a new version expected in 2011.
The other standards and documents are being reviewed and updated as necessary
What has happened to the ISO handbook ISO 9001 for Small Businesses?
A new edition was published in June 2010, to reflect the changes in ISO 9001:2008.
How are the standards applicable to organizations that provide services. ?
The standards are applicable to all types of organizations, operating in all types of sectors,
including service providers.
(Note: the definition of the term 'product' in ISO 9000:2005 also includes 'services'. ISO
9001:2008 and ISO 9004:2009 have been written to reflect this definition.)
What do quality management practitioners (consultant, auditor, or trainer)
need to know about the standards?
As a minimum, quality management practitioners should familiarize themselves with the
requirements of ISO 9001:2008, and also with the content and philosophies of ISO 9000:2005,
ISO 9004 and the Quality Management Principles.
Practitioners whoa are already familiar with ISO 9001:2000 should become aware of the
clarifications introduced in ISO 9001:2008, and their implications, prior to conducting audits to
that standard, or giving training and consultancy.
They should understand their clients activities and processes, before providing appropriate
interpretations of the requirements of the standards, to add value to the client's operations.
ISO/TC 176 has developed the standard ISO 10019 Guidelines for the selection of quality
management system consultants and use of their services, which may be useful to refer to for
further guidance.
How should regulatory bodies use the standards?
Regulatory bodies should review their regulations currently in effect (or under development)
and identify points where reference to the quality management system standards would be
appropriate, before making recommendations to the legislative body.
What do auditors need to know about the standards?
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Auditors, whether external or internal, should be able to demonstrate their competence on the
structure, content and terminology of the standards, and also on the underlying Quality
Management Principles.
The standards require that auditors are able to understand the organization's activities and
processes and appropriately audit against the requirements of the ISO 9001 in relation to the
organization's objectives. According to joint advice from the International Accreditation Forum
(IAF), ISO's Policy Committee for Conformity Assessment (ISO-CASCO) and ISO TC 176, auditors
should be able to demonstrate competency in:
- The requirements of the ISO 9001:2008.
- The concepts and terminology of the ISO 9000:2005.
- The eight Quality Management Principles
- A general understanding of ISO 9004
- Familiarity with the auditing guidance standard ISO 19011.
11.3 ISO 9001:2008
How much is the implementation of ISO 9001:2008 going to cost?
It is not possible to give a definitive cost for implementing a QMS that meets the requirements
of ISO 9001.
The implementation costs, and associated certification costs, will be dependent on factors such
as:
the size of the organization (a few employees versus many)
its organizational structure (a single division versus multiple ones)
its geographical locations (a single site, versus multiple ones in many countries)
the maturity of its existing QMS (is there an existing functional QMS in the organization
that just needs amending to meet the standard, or does the organization have to start one
from scratch)
the complexity of its products (simple manufacturing or service delivery processes versus
complex ones requiring statistical process controls)
One of the goals of ISO/TC 176/SC 2 is to produce standards that will minimize any
potential costs during a smooth implementation. Any additional costs may be considered as a
value-adding investment. A key factor in the development of ISO 9001:2008 was to limit the
impact of changes on users.
What are the main changes in ISO 9001:2008 as compared to ISO 9001:2000?
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ISO 9001:2008 has been developed in order to introduce clarifications to the existing
requirements of ISO 9001:2000 and changes that are intended to improve compatibility with
ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change
the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an upgrade, and organizations that are certified to ISO
9001:2000 should be afforded the same status as those who have already received a new
certificate to ISO 9001:2008. However, all organizations are expected to have made the
migration to using ISO 9001:2008 by November 2010.
All changes between ISO 9001:2000 and ISO 9001:2008 are detailed in Annex B to ISO
9001:2008.
How will the implementation of ISO 9001:2008 help my organization to
improve its efficiency?
ISO 9001:2008 aims at guaranteeing the effectiveness (but not necessarily the efficiency) of the
organization. For improved organizational efficiency, however, the best results can be obtained
by using ISO 9004:2009 in addition to ISO 9001:2008. The guiding quality management
principles are intended to assist an organization in continual improvement, which should lead
to efficiencies throughout the organization.
Is an organization's ISO 9001 certificate applicable to all of its products ?
When an organization seeks to have its quality management system registered/certified to ISO
9001:2008, it is required to agree a "scope of certification" with its registrar/certification body.
This will define the products to which the organization's quality management system is
applicable, and against which it will be assessed. An organization is not obliged to include within
its "scope of certification" all the products that it provides (note that the ISO 9000:2005
definition of "Product" includes "services"), but may be selective about those that are included.
All applicable requirements of ISO 9001:2008 will need to be addressed by the organization's
quality management system that covers those products that are included in the "scope of
certification".
Customers should ensure that a potential supplier's "scope of certification" covers the products
that they wish to order. Caveat Emptor!
What can an organization do if it is not able to comply with all of the
requirements of ISO 9001?
ISO 9001 allows for the exclusion of some of its requirements (via clause 1.2 Application), but
only if it can be shown that these requirements are not applicable to the organization.
Exclusions are limited to the requirements given in Section 7 ("Product Realization"), where
individual requirements may only be excluded if it can be shown that they do not affect the
organization's ability to provide product that meets customer and applicable statutory or
regulatory requirements. Justification for such exclusions is also required to be detailed within
the organization's quality manual.
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For example, if design activities are not required by an organization to demonstrate its
capability to meet customer and applicable statutory /regulatory requirements, or if its product
is provided on the basis of established design, then it may be able to exclude some of the
"design" requirements but still be able to be registered/certified to ISO 9001:2008.
For further guidance, see the ISO 9000 Introduction and Support Package module: Guidance on
ISO 9001:2008 clause 1.2 'Application'.
How will a small organization be able to adapt the requirements of ISO 9001?
What flexibility will be allowed?
The requirements of the amended ISO 9001:2008 remain applicable to small, medium, and
large organizations alike, and such organizations should acquaint themselves with the
clarifications in ISO 9001:2008. ISO/TC 176 has published a handbook ISO 9001 for Small
Businesses What to do ? giving specific advice to small businesses.
The requirements of ISO 9001 are applicable to small, medium, and large organizations alike.
ISO 9001:2008 provides some flexibility, through clause 1.2 Application, on the exclusion of
certain requirements for specific processes that may not be performed by the organization.
If, for example, the nature of your products does not require you to perform design activities, or
if your product is provided on the basis of established design, you could discuss and justify the
exclusion of these requirements with your certification/registration body (see also the ISO 9000
Introduction and Support Package module Guidance on ISO 9001:2008 clause 1.2 'Application').
However, individual organizations will still need to be able demonstrate their capability to meet
customer and applicable statutory or regulatory requirements for their products, and will need
to consider this when determining the complexity of their quality management systems.
Further guidance for small businesses may be found in the ISO handbook: ISO 9001 for Small
Businesses What to do, Advice from ISO/TC 176
Whats the relationship between the revised ISO 9001 and ISO 14001?
Compatibility with ISO 14001:2004 has been maintained and enhanced. Compatibility means
that common elements of the standards can be implemented by organizations in a shared
manner, in whole or in part, without unnecessary duplication or the imposition of conflicting
requirements.
Are there any guidelines covering joint implementation of ISO 9001 and ISO
14001?
The two standards are compatible. It is not expected that an ISO guideline will be prepared on
this subject at the present time. If the need for such a document arises, ISO will consider the
request as a new project. However, both ISO 9001 and ISO 14001 include an annex to show the
correspondence between the two standards.
Is there a common guideline standard for auditing QMS and EMS according to
ISO 9001 and 14001?
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Yes, ISO 19011:2002 provides guidelines for quality and/or environmental management
systems auditing. Note that a project to revise ISO 19011 was started in 2008, to make it
applicable to all of ISOs management system standards, and is expected to be completed in
2011.
My organization provides services. Is ISO 9001:2008 applicable to us?
ISO 9001 is equally appropriate to all sectors, including service providers. The standard is
applicable to all types of organizations.
How does ISO 9001:2008 relate to the needs of specific business sectors?
ISO 9001:2008 is compatible with the existing management systems standards for specific
business sectors such as ISO/TS 16949, AS 9000/EN 9100 and TL 9000.
Users of a specific sector scheme are recommended to refer to the organization that is
responsible for that sector scheme, e.g. for:
- ISO/TS 16 949 refer to the IATF,
- TL 9000 refer to the QuEST Forum
- For AS 9000/EN 9100 refer to the IAQG
What documentation is required by ISO 9001?
ISO 9001:2008 refers specifically to only 6 documented procedures; however, other
documentation (including more documented procedures not specifically mentioned in ISO
9001:2008) may be required by an organization, in order to manage the processes that are
necessary for the effective operation of the quality management system. This will vary
depending on the size of the organization, the kind of activities in which it is involved and their
complexity. For further guidance, please also refer to the ISO 9000 Introduction and Support
Package module "Guidance on the Documentation Requirements of ISO 9001:2008"
What does an organization need to do to comply with ISO 9001?
When initially starting to use ISO 9001, an organization should familiarize its personnel with the
Quality Management Principles, analyze the standards (especially ISO 9000 and ISO 9004), and
consider how their guidance and requirements may affect your activities and related processes.
If it then wishes to proceed to registration/certification, it should perform a gap analysis against
the requirements of ISO 9001 to determine where its current quality management system does
not address the applicable ISO 9001:2008 requirements, before developing and implementing
additional processes to ensure that compliance will be achieved.
ISO 9004
What benefits are there to an organization implementing ISO 9004 ?
If a quality management system is appropriately implemented, utilizing the eight Quality
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Management Principles, and in accordance with ISO 9004, all of an organization's interested
parties should benefit. For example:
Customers and users will benefit by receiving the products (see ISO 9000:2005) that are:
- Conforming to the requirements
- Dependable and reliable
- Available when needed
- Maintainable
People in the organization will benefit by:
- Better working conditions
- Increased job satisfaction
- Improved health and safety
- Improved morale
- Improved stability of employment
Owners and investors will benefit by:
- Increased return on investment
- Improved operational results
- Increased market share
- Increased profits
Suppliers and partners will benefit by:
- Stability
- Growth
- Partnership and mutual understanding
Society will benefit by:
- Fulfilment of legal and regulatory requirements
- Improved health and safety
- Reduced environmental impact
- Increased security
What was the need to update ISO 9004:2000?
The standards have to be kept up to date and they are regularly reviewed (at least every five
years under ISOs rules) and revised as necessary. Also the feedback from users showed that
some changes and improvements were needed.
If a product is not meeting its requirements or the expectations of its users, then it should be
withdrawn, changed or improved. ISO/TC 176/SC2 received information which indicated that
ISO 9004:2000 was not meeting expectations, so decided to take action to change and improve
the product.
How was ISO 9004:2009 specified and developed?
In 2004 ISO/TC 176/SC2 conducted a formal review of ISO 9004:2000, in parallel with one for
ISO 9001:2000; this review led to a decision to revise the standard (and to amend ISO 9001).
Next followed the development and approval of a Design Specification in 2005, followed by
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the start of the drafting process. The drafting of an ISO standard involves the achievement of
several different successive levels of drafts; at all but the last stage, verification processes were
employed to check the drafts against the Design Specification, and during the last but one
stage, a validation process involving external reviews by potential users was employed. Most of
the drafts were circulated for ballot amongst ISOs member national standards bodies, leading
to their approval, and ultimately to publication of the revised standard.
What are the most important changes in ISO 9004:2009?
a) It has a new direction, giving advice on how to manage an organization for sustained
success. It includes guidance on the development and deployment of an organizations
strategy, as well as emphasizing innovation and learning.
b) It introduces two new, user-friendly, self-assessment tools; these describe possible situations
in the organization and give comparisons against each element of the standard, before rating
these by 5 different levels of maturity.
What are the differences between ISO 9004:2000 and this new version?
ISO 9004:2000 was based closely on ISO 9001:2000. The new 2009 edition of ISO 9004 has a
separate focus on the sustained success of an organization over the long term.
There is much greater emphasis on: balancing the needs of all relevant interested parties; long-
term planning; strategic issues; resources; risks; innovation; learning; and the use of self-
assessment tools.
Sustained success what does it mean?
The sustained success of an organization refers to its ability to consistently meet the needs and
expectations of its customers and other interested parties (e.g. shareholders, regulators,
employees or society), in a balanced way, in order to remain a viable entity over the long term.
What are the main features of ISO 9004:2009?
Guidance to managers on processes for an organization to create and follow its own path
towards sustained success, including two powerful self-assessment tools (one on strategic
issues and the other on operational issues).
What are the main benefits to users of ISO 9004:2009?
It will help them to ensure the success of their organization over the long term, by achieving
higher levels of effectiveness and efficiency in their organizations processes, in turn resulting in
higher satisfaction levels for all of its relevant interested parties.
Is ISO 9004:2009 useful for Small and Medium Enterprises (SMEs) or only for
large organizations?
ISO 9004:2009 is applicable to any organization, regardless of its size, type and activity. ISO
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9004:2009 is particularly suitable for SMEs, because of the strategy related aspects covered in
it.
We have a QMS based on ISO 9001. Why should we apply ISO 9004:2009?
ISO 9004 will help you to take your organization forward to its next stage of quality maturity, by
enhancing its effectiveness and efficiency, and by re-orienting the organization to focus on all
its relevant interested parties, with the aim of achieving high levels of satisfaction of their needs
and expectations.
What organizations can use ISO 9004:2009?
All organizations can use ISO 9004, regardless of their size, products, activities, or type (profit,
not-for-profit, governmental body etc.).
When should ISO 9004:2009 be applied?
In all situations where improvement is needed, or when important changes occur, such as:
To improve customer satisfaction;
To reduce costs or to increase profits;
In case of an acquisition or a merger;
In case of changes in the management of an organization;
To improve relations with suppliers;
To increase the speed of processes.
Could we get our quality management system certified against ISO
9004:2009?
This new standard is a guideline standard, not a requirement standard; it is not suitable, or
intended, for certification purposes.
Why has the title of ISO 9004 changed?
ISO 9004:2009 now gives guidance on how to remain successful in the future, so the title had to
be changed to reflect this new direction. In turbulent and constantly changing situations,
organizations can no longer just rely on better performance against their current business
models to survive and be successful; instead they have to anticipate, be proactive and monitor,
predict, and react to the ever changing needs and expectations of their interested parties, in
order to remain successful in the future.
What is the scope of ISO 9004:2009?
This standard provides guidance to organizations to support the achievement of sustained
success by a quality management approach. It is applicable to any organization, regardless of its
size, type, products or activity.
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What is the purpose of ISO 9004:2009?
ISO 9004 now gives guidance to the management of an organization on how to achieve
sustained success by use of a quality management approach. It helps an organization to move
its management system beyond the basic requirements of ISO 9001, to meet the needs and
expectations of its all relevant interested parties, and guides management in assessing their
organizations strengths and weaknesses.
What are the changes in the structure of ISO 9004:2009?
ISO 9004 no longer has the same clause by clause structure as ISO 9001 (which was the case for
ISO 9004:2000). Instead the standard now starts with a clause on managing an organization
towards sustained success, followed by clauses on:
strategy,
resources,
processes,
monitoring, measurement, analysis and review; and closing with,
improvement, innovation and learning.
Why has the structure been changed?
The new structure is related to the question: How do you manage an organization for success in
the long term? The previous edition was more related to the question: How do you extend the
quality management system to incorporate all interested parties and support the achievement
of higher performance?
In ISO 9004:2009 the term partner is used. How do partners differ from
suppliers?
Partners can be either suppliers, or other types of bodies. Partners can be selected
suppliers that an organization chooses to have a strategic relationship with, or which are
strategically important, for its future success. Partners can also be other types of bodies other
than suppliers, e.g. some of its customers, universities/academic institutions or research
organizations, or even in some cases competitors (e.g. when there is a need to agree to
standardize products or technologies).
What are the differences between the process approach model used in ISO
9001 and the one used in ISO 9004?
ISO 9004 contains a more extensive process model than the one given in ISO 9001. While it
covers all of the elements of the ISO 9001 model, it also addresses some of the additional issues
from ISO 9004 itself, such as the needs of interested parties, strategy and policy, resource
management (extended), process management, innovation and learning.
What is the meaning of innovation in ISO 9004, and what should be
innovated?
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Innovation refers to the development of new products, processes, organizational structures,
interfaces and strategy, in contrast to the improvement of the existing ones.
What is the meaning of learning in ISO 9004, and what should be covered by
learning?
Learning refers to an organization implementing processes to capture the results of experiences
and lessons learned by people, both individually and collectively, and to then apply that
knowledge to new situations, to achieve beneficial results. The learning processes should cover
elements such as: products, processes and their interfaces, organizational structures,
management systems, human aspects and culture, infrastructure, work environment,
technology, and relationships with relevant interested parties.
What should be the main steps to take when implementing ISO 9004:2009?
These will depend on the organizations current situation, its ambitions, its present level of
maturity, and its organizations environment (i.e. its business environment, but relating to
not-for-profit type businesses, governmental bodies etc.). In general, the mains steps should
be:
a review of the organizations strategy,
conducting a self-assessment at a strategic (key elements) level,
refinement of its strategy (as a result of the self-assessment),
conducting a self-assessment at an operational (detailed) level, to identify improvement
opportunities
developing a management agenda and action plans for the medium term horizon (e.g. for
the next 2 to 3 years)
deployment and translation of the action plans into requirements for the organizations
processes, interfaces and resources (especially human resources),
execution of any improvements or change programmes,
evaluating and reviewing what has been achieved,
going back to the first step (above) to adapt and improve the whole approach (i.e. closing
one cycle of a P-D-C-A loop and starting the next one).
What should be the first steps to take when implementing ISO 9004:2009?
If the organization has a clear strategy in place, the first step should be a strategic (key element)
level self-assessment, to enable the organization to develop a management agenda and action
plans for the medium term horizon (e.g. for the next 2 - 3 years). If the strategy is not available
or is not up-to-date, the first step should be a review of the organizations strategy, policies and
associated objectives, and to use these as an input to self-assessments that should be
conducted at both a strategic (key elements) and operational (detailed) levels.
What should be the role of top management during the implementation of
ISO 9004:2009?
The top management of an organization should take the role of the most important supporter
and sponsor of such an implementation program. Implementing ISO 9004 will change the way
an organization thinks and behaves, and how it communicates both internally and externally.
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What should be the path towards sustained success, when starting with an
ISO 9001 based QMS?
Such a path will develop in two main directions:
a) extending the coverage of the processes in the organization towards all aspects of its
activities and towards all relevant interested parties, and
b) improving each individual process with respect to its effectiveness and its efficiency, for
lasting improvement in its performance.
The rate at which an organization should extend its process coverage, and the rate at which it
should improve its processes, will be dependent on its own ambitions and its competitive
position.
What could be the costs of an improvement project or programme?
It is impossible to give an indication of the exact costs, as these will be specific to an
organization and its current situation; however, a well known rule of the thumb is that the
costs of waste reduction are often between 10% and 20% of the value of that waste. Another
well known figure is that waste in industrial organizations is on average between 7% and 15% of
turnover, and in service industries is between 15% and 30%.
What should be done differently when applying ISO 9004 in a not-for-profit
organization?
About the only difference for a not-for-profit organization when compared to a for-profit
organization is the terminology that is sometimes used for management issues, while the issues
remain the same for both. However, it is recognized that not-for-profit organizations often
have more complex patterns of dealing with, and influencing, their interested parties, than the
usual contractual approach of for-profit organizations.
What are the most critical risks for failure when applying ISO 9004 :2009?
The most critical risk is people aspects. This includes the behaviour of top management as a key
component.
What is the relationship between ISO 9004:2009 and the ISO 26000 Social
responsibility standard?
It is frequently said that the three key pillars of sustainability are sustained
economic/business (including not-for-profit business) success, environmental protection and
social responsibility, and that an organization has to find the right balance between each of
these pillars in order to survive. ISO 9004:2009 (as well as the other standards in the ISO 9000
family) relates to the first of these, the ISO 14000 series of standards to the second, and ISO
26000 to the third. For organizations that are familiar with the quality management standards,
but not yet familiar with the issues relating to social responsibility, then implementing ISO
9004:2009 could be a useful step in helping an organization towards its adaptation of ISO
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26000, through its recommendations on balancing the needs and expectations of interested
parties.
What is the relationship between ISO 9004:2009 and the Excellence / Award
models such as EFQM and Deming Award Prize?
It is not competing with them but gives complementary guidance on the path towards
excellence. ISO 9004:2009 is compatible with the main international and national
Excellence/Award models.
What is the relationship between ISO 9004:2009 and the ISO 14000 series of
standards?
ISO 9004:2009 refers to ISO 14001 under the clauses 6.5. Infrastructure, 6.8 Natural resources
and 8.3.3 Internal audit. ISO 9004:2009 all but demands the use of the ISO 14000 series of
standards, especially when an organization is aiming to satisfy all of its relevant interested
parties. This is particularly the case in the areas of strategy and policies, resources, processes,
products (and their life-cycles), innovation and learning. Overall the relation between these
standards is extremely important.
What is the relationship between ISO 9004:2009 and ISO 9001:2008?
ISO 9004:2009 gives guidance to an organization on the steps it should take for improving its
quality maturity beyond that achieved from the implementation of an ISO 9001 based QMS.
Taken together, the standards form a consistent pair of standards, as both are based on the 8
quality management principles and the Process approach model.
What is the relationship between ISO 9004:2009 and other ISO standards?
ISO 9004:2009 is compatible with many other management system standards. It makes
reference to some of the ISO 14000 standards (environmental management); ISO 31000 (risk
management) and ISO 10000 series of standards (belonging to the ISO 9000 family of
standards).
What is ISO 9004:2009 NOT for?
ISO 9004 is not a guideline for implementing a quality management system based on ISO 9001.
ISO 9004 is not a competitor to the business excellence awards
ISO 9004 is not for certification.
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12.0 Sample Documents
12.1 Quality Manual
XYZ SOLUTIONS LTD
Quality Manual
QUALITY MANAGEMENT SYSTEM
DOC. NO: XYZ-QM-01
Issued By: MR Approved By: CEO
Issue Date: 01/04/2008 Approved Date:
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CHAPTER TITLE PAGE
00
TABLE OF CONTENT Total Pages -7
Organization Profile (1.1) 2 of 7
XYZ & its services(1.2) 2 of 7
Scope of ISO 9001:2000 & Exclusion(1.3) 4 of 7
Manual Distribution Control(1.4) 4 of 7
Amendment Sheet(1.5) 5 of 7
Organization Chart(1.6) 6 of 7
Definition & Abbreviation(1.7) 7 of 7
1
QUALITY MANAGEMENT SYSTEM (4.0) Total Pages-5
General requirements (4.1) 2 of 5
Documentation requirements (4.2) 2 of 5
General (4.2.1) 3 of 5
Quality Manual (4.2.2) 3 of 5
Structure of Manual(4.2.2.1) 3 of 5
Method of Issue(4.2.2.2) 4 of 5
Revision Updating and Amendment Procedure(4.2.2.3) 4 of 5
Amendment Sheet(4.2.2.4) 5 of 5
Distribution List(4.2.2.5) 5 of 5
Control of Document(4.2.3) 5 of 5
Control of Record(4.2.4) 5 of 5
2
MANAGEMENT RESPONSIBILITY(5.0) Total Pages-6
Management Commitment(5.1) 2 of 6
Customer Focus(5.2) 2 of 6
Customer Relationship Development(5.2.1) 2 of 6
Customer Communication Method(5.2.2) 2 of 6
Customer Input(5.2.3) 3 of 6
Supplier Input(5.2.4) 3 of 6
Quality Policy(5.3) 3 of 6
Planning(5.4) 3 of 6
Quality Objective(5.4.1) 3 of 6
Quality Management System Planning(5.4.2) 3 of 6
Responsibility Authority & Communication(5.5) 4 of 6
Responsibility & Authority(5.5.1) 4 of 6
Management Representative(5.5.2) 4 of 6
Internal Communication(5.5.3) 5 of 6
Management Review(5.6) 5 of 6
General(5.6.1) 5 of 6
Review Input(5.6.2) 6 of 6
Review Output(5.6.3) 6 of 6
3
RESOURCE MANAGEMENMT(6.0) Total Pages 2
Provision of Resource(6.1) 2 of 2
Human Resource(6.2) 2 of 2
General(6.2.1) 2 of 2
Competence Awareness & Training(6.2.2) 2 of 2
Infrastructure(6.3) 2 of 2
Work Environment(6.4) 2 of 2
4
PRODUCT REALIZATION (7.0) Total Pages 6
Planning For Product Realization(7.1) 2 of 6
Customer Related Process(7.2) 2 of 6
Requirement related to Product(7.2.1) 2 of 6
Review of requirement related to product(7.2.2) 2 of 6
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Customer Communication(7.2.3) 2 of 6
Design & Development(7.3) 2 of 6
Design & Development planning(7.3.1) 3 of 6
Design & Development Input(7.3.2) 3 of 6
Design & Development Output(7.3.3) 3 of 6
Design & Development Review(7.3.4) 3 of 6
Design & Development Verification(7.3.5) 3 of 6
Design & Development Validation(7.3.6) 3 of 6
Design & Development changes(7.3.7) 4 of 6
Purchasing(7.4) 4 of 6
Purchasing process(7.4.1) 4 of 6
Purchasing Information(7.4.2) 4 of 6
Verification of purchased product(7.4.3) 4 of 6
Production & Service provision(7.5) 5 of 6
Control of production & Service provision(7.5.1) 5 of 6
Validation of processes for production & service provision(7.5.2) 5 of 6
Identification & traceability(7.5.3) 5 of 6
Customer property(7.5.4) 5 of 6
Preservation of product(7.5.5) 6 of 6
Control of monitoring & measuring device(7.6) 6 of 6
5
MEASUREMENT ANALYSIS AND IMPROVEMENT Total Pages 5
General(8.1) 2 of 5
Monitoring & Measurement(8.2) 2 of 5
Customer Satisfaction (8.2.1) 2 of 5
Internal Audit(8.2.2) 2 of 5
Monitoring & Measurement of Process(8.2.3) 3 of 5
Monitoring & Measurement of Product(8.2.4) 3 of 5
Control of Non -conforming product(8.3) 3 of 5
Analysis of data(8.4) 3 of 5
Trend Analysis of Nonconforming product(8.4.1) 4 of 5
Service performance data(8.4.2) 4 of 5
Improvement(8.5) 4 of 5
Continual improvement(8.5.1) 4 of 5
Corrective Action & Preventive Action (8.5.2& 8.5.3) 4 of 5 & 5 of 5
Annexure1 Interaction of Key Processes 2 of 2
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CHAPTER ZERO
TABLE OF CONTENT
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1.1 Organization profile:
XYZ is a next-generation end-to-end enabler of mobile value added services for mobile operators, media
companies, content providers enterprises and others.
A subsidiary of the US$ 500 million Escorts Group and a leading provider for mobile connectivity, applications,
solutions, content and services.
XYZ was established in year 2000-01 and works with all major Telecom Operators and Large Enterprises like
Airtel, Idea, Reliance, American Express, LIC, UTI Bank, ICICI Bank, Citibank enabling all the players in the value
chain to deploy value added services quickly and cost effectively.
XYZ has expertise across Telecom Connectivity bearers like SMS, IVR, MMS, and GPRS and has available range
of mobile applications, mobile services, content aggregation etc to be deployed on such bearers.
Established : Year 2000-2001
Customer Base : Enterprises & Telecom Operator
1.2 XYZ and its Service:
India based XYZ Solutions LTD. is a dynamic and forward thinking Company providing Value Added Services on
the mobility domain, focused on increasing revenues across all areas of mobile data value chain. With the
product repertoire customized for Operators, Enterprises and Consumers, XYZ translates market needs and
requirements into innovative wireless solutions Striving towards unlocking the true potential of Mobile VAS in
India, XYZ aims to cut across barriers to ensure development of solutions and products to cater to all
segments, greater rationality in revenue sharing between Telcos & content developers and also develop
higher quality content
Service Platform:
XYZ has a very array of technology platform and software for the mobile VAS market. The key strength of the
company is that its own technology platform, software across the value chain from the various messaging
platform and gateway to content management and billing system to device based application.
This allows for quick deployment, integration and in this very fast moving market and ability to make
immediate change and updates gives customers an edge on innovation. A holistic approach is taken to ensure
that all products developed and Marketed by XYZ will encompass not just current requirement but future
requirement also dependable and lasting relationship.
Challenges are addressed through innovative software architectures, best in class software engineering
processes, innovative and fair business models and 24x7 customer support.
Value offerings:
1. Time to Market: The major part of the application is already developed, tested and is in operation. The
client is only required to plug into a proven platform, saving time spent in gathering, software development,
testing and deployment.
2. Low cost for the Client: The client does not have to invest in basic infrastructure like hardware and
bandwidth. The client also does not have to invest in setting up an infrastructure for operational activities such
as people, data structure, power back up, security, 24x7 monitoring & support and much more.
Our Service Lines:
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1. Messaging
Cellpush: It allows high volume outgoing messages.
Cellxpress short code platform: It captures incoming messages on short access numbers and mobile
content sale. This also covers managing operators STK services including DP5/ DP6.
GME: It also captures incoming messages and focuses on providing low cost access numbers to the
end users.
2. IVR:
IVR premium content services platform on short access numbers for mobile content sale
3. Celldial:
It enables large number of automated out dial calls for enterprises.
4. Mobile Commerce:
Mobile commerce refers to transactions using a wireless device and data connection that result in the transfer
of value in exchange for information, services, or goods. Mobile commerce, facilitated generally by mobile
phones, includes services such as banking, payment, and ticketing.
XYZ provides a set of integrated product suite for supporting companies in following categories to mobile
operators, banks and merchants. Also XYZ supports Commerce over SMS, IVR, and handset application
connected over GPRS or SMS.
5. Mobile Authentication:
A platform for banks and cash card operators for securely authenticating the account holder in interaction with
him over mobile.
6. Merchant M-Commerce:
Enables merchants to securely accept payment for goods and services for their customers over mobile. It also
facilitates the merchant to showcase their merchandise (tickets, bill payments, card recharge and much more).
7. Cellworld Mobile Mall:
It allows user to access, search and discover commodities offered by merchants in a convenient and secure
GUI format.
8. Multimedia over Media:
Cellpaper: Cellpaper is an MMS based platform that provides a new idea to publish rich content on
mobile. The subscribers of these services receive a packaged Multimedia Message (MMS) with
presentation that includes Text, Audio, Images and Video with presentation.
Media Center: This platform delivers rich audio and video content over mobile such as full length
songs, music albums & videos, TV serials, news capsules and much more.
9. Enterprise Business Processes:
Celltrust, product authentication and mobile CRM platform: A new unique product authentication
service from XYZ, targeted to consumer facing industry such as FMCG, Pharmaceuticals, automotives
& spare parts, industrial commodities (bearings, welding rods, consumables etc.)
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Cellmonitor: An application that allows monitoring of critical information processes using wireless
phones.
Mobile sales tracker: It supports logistics of retail distribution.
1.3 Scope of ISO 9001:2008 & Exclusion:
Scope of ISO-9001: 2008:-
The scope of ISO 9001:2008 Quality Management System is PROVIDING MOBILE VALUE ADDED
SERVICES & MOBILE DATA SERVICES.
Exclusions:-
There are no exclusions from the ISO 9001:2000 Quality Management System of XYZ Solutions Ltd.
1.4 Manual Distribution Control:
ISSUE NO. 01
IS THIS A CONTROLLED COPY?
YES NO
COPY NO. 01
Distribution list:
COPY NO. DISTRIBUTED TO
01 (Master Copy) Management Representative
02 Chief Executive Officer
03 Employees of XYZ
04 Certification Body
COPY APPROVED BY Signature Date
COPY ISSUED BY Signature Date
1.5 Amendment Sheet:
Sr.
No.
Section
Page
No.
Amendment details Rev. No. Rev. Date
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1.6 Organization Chart:
1.7 Definitions and Abbreviation:
S.No Description Acronym
1 International Organization for Standardization ISO
2 Quality Management System QMS
3 Procedure P
4 Quality Objective QO
5 Chief Executive Officer CEO
6 Project Manager PM
7 Head Sales & Marketing HEAD S&M
8 Change Request Form CRF
9 Purchase Order PO
10 Customer Feedback Form CFF
11 Customer Support Center CSC
12 Release Note RN
13 Minutes Of Meeting MOM
14 Audit Summary Report ASR
15 Technical Change Request Form TCR
16 Purchase Requisition Form PRF
17 Quality Check Report QCR
18 Visual Source Safe VSS
19 Management Representative MR
20 Management Review Meeting MRM
21 Internal Quality Auditor IQA
22 Human Resources HR
23 Network Operation NOP
24 Sales & Marketing S&M
25 Data Management Group DMG
26 Requirement Document RD
27 Installation Document ID
28 Estimation Document ED
29 Test Plan TP
30 Test Case TC
31 Audit Report AR
32 Configuration Management Policy CMP
33 Roles &Responsibility R&R
34 Order Processing & Billing Advice OPBA
35 Business Development Executive BDE
36 Program Manager PM
37 Work Instruction W
38 Quality Policy QP
39 Testing TES
40 Service Level Agreement SLA
41 Operation Level Agreement OLA
41 Problem Detail Form PDF
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CHAPTER ONE
QUALITY MANAGEMENT SYSTEM
4 Quality Management Systems:
4.1 General Requirements:
The company has established and implemented a documented Quality System conforming to the requirements
of the International Quality System Standard ISO-9001: 2000 to ensure that all the services provided meet or
exceed customers requirement. The Quality System show that the company operations are in accordance with
the companys Quality Policy and organizational structure The Quality System is documented Structure, given
below.
Level I: Quality Manual
Level II: Procedures
Level III: W.I
Level IV: Formats
And Record
Level - I: Quality Manual (QM):
This Document outlines our policies regarding the requirements of ISO 9001:2000 define the scope and
exclusions, This Quality Manuals defines the manner in which the company has implemented a QMS in order
to provide assurance of the high standards of Quality that we strive to achieve.
Level - II: Procedure (P):
Procedure are documented to the adequate level i.e. (Process-I to Process- X) for ease of implementation of
the policies stated in QM
Process I - Customer Support Center
Process II Network Operations
Process III Engineering
Process IV Sales & Marketing
Process V - Data Management Group
Process VI- Administration & Purchase
Process VII- Human Resource
Process IX- Quality Assurance
Process X- Testing
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Level - III: Work Instructions (W):
Work Instructions, required at the operational level are documented to ensure that the activities are done as
per the requirements. These Work Instructions are based on the applicable codes / contract / standard
practices / specifications / product quality requirements.
Level - IV: Formats and Records:
Forms/templates are used in Different areas for recording information regarding action to be taken/results
obtained. Records provided evidence of conformity to requirements and effective operation of the QMS.
The Department Head of various departments are responsible to implement the QMS in Respective
department.
4.2. Documentation Requirements:
4.2.1 General:
XYZ Solutions Limited has identified the documentation requirements for each activity at various
stages which is given below:
The QMS is a four level of documentation structure consisting of: Quality Manual, Quality Standard
Procedures, Work Instructions and Formats & Records.
QM is prepared, controlled and issued by MR. It is approved and authorized for issue by CEO.
4.2.2 Quality Manual: 3
This Quality Manual describes the Quality Management System adopted by XYZ SOLUTIONS LTD. The manual
lists down Resources, Processes, Procedures, Monitoring and Measurement System for the Quality
Management System that has been formulated on the basis of ISO-9001: 2000 that is primarily of Plan, Do,
Check & Act [PDCA] Cycle.
The Manual and the information incorporated herein is the property of XYZ SOLUTIONS LTD., it must not be re-
produced in any form in whole or in part or otherwise without prior consent in writing from CELLENXT
SOLUTIONS LTD. This quality manual has been effective from April 01, 2008.
4.2.2.1 Structure of the Manual:
This Quality Manual is structured as shown in the contents page of the Manual and follows the sequence of
Quality Management System elements according to ISO 9001:2000.
Each page of Quality Manual contains the Revision number of the Manual the Revision number "00" has been
given to the first issue of the section. Only the front page of the manual bears the signatures of the Chief
Executive Officer (Approving Authority of Manual) and the Management Representative (Issuing Authority of
Manual).
In case of a controlled copy manual in the physical / paper form, each page of the manual is stamped
CONTROLLED COPY at specified location on each page. The Obsolete Copy of the Manual of previous issues
are identified and stamped as OBSOLETE COPY is to be kept in archives along with records of amendments.
Manual without CONTROLLED COPY stamp is considered as uncontrolled.
In case of a controlled copy manual in the soft / electronic form, the manual is converted into a PDF file and
watermarked as CONTROLLED COPY. The obsolete copies of the manual are kept in a separate folder named
as Obsolete Documents. Manuals in the non PDF version (Except the one with Management Representative
which will be in word format) are considered as uncontrolled manuals.
4.2.2.2 Method of Issue:
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The Management Representative is authorized by the CEO to carry out the activities of preparing, issuing,
maintaining and updation of this Quality Manual. The distribution of the Manual and the amendment(s) are
controlled and are carried out by the Management Representative. The controlled copies issued to copy
holders bear a rubber stamp "CONTROLLED COPY" on each page at specified location if the manual i s in
physical / paper copy. Controlled Soft / Electronic copies are issued after converting the manual in the PDF
form.
Any additional copies of the Manual, required for external agencies, are issued by the Management
Representative and such copies of the Manual issued are stamped "UNCONTROLLED' or issued in the non
PDF form. These uncontrolled copies do not come under the purview of document amendment procedure
and they are not updated and are not used within the Organization.
A distribution list of the Quality Manual has been provided in all controlled copies. This list is used as
reference for updation of the respective controlled copies.
The Management Representative maintains a Master copy of the manual.
4.2.2.3 Revision, Updating and Amendment Procedure:
The Quality Manual is reviewed periodically by the Management Representative in consultation with the
related personnel. No revision is implemented unless it has been approved by the CEO / Quality Head and
formally issued. Each revision is introduced formally by the Management Representative by issue of revised
page for each of the copy as per the Distribution list.
When revisions take place, the revisions will be indicated by the revision number and recorded in the
amendment sheet available in the controlled copies of the Manual and indicated at 4.2.2.4 below. If there are
more than 20 amendments in the manual the complete manual is revised and Issue number is changed on the
front page of the manual.
The insertion of the additional / amended section(s) and the removal of the old section(s) in the individual
controlled copies as per the distribution list of the Manual is the responsibility of the person holding the
individual copy. All old section(s) so removed are stamped as "OBSOLETE and returned to the Management
Representative who ensures that the same are destroyed to avoid inadvertent or misuse of document. In case
of manual in electronic format, the obsolete manual is deleted from the computer of the user and new manual
is stored. Management Representative will preserve the copy of the manual in OBSOLETE DOCUMENT FOLDER.
Obsolete master copy of will be retained by Management Representative for a minimum period of three years
from the date of their super session due to revision.
4.2.2.4 Amendment Sheet:
To ensure that each controlled copy of Quality Manual contains a complete record of revision, this amendment
sheet is updated and issued with each set of revised/new chapter(s) of the Quality Management System
Manual. An acknowledgement slip will be included along with for the signature and returned by all holders of
the controlled copies. Amendment sheet is available at the beginning of this manual in section 00
4.2.2.5 Distribution List:
Distribution List is available at the beginning of this manual in Chapter 1
4.2.3 Control of Documents:
The Management Representative is responsible for coordination and enforcing the document control related
activities in accordance with procedure SYS-P-01.
All the documents are developed & controlled in accordance with Process documentation.
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The Unique document Identification for all types of documents in XYZ shall be structured manner which is
defined in procedure for Control of Documentation (Refer SYS-P-01)
4.2.4 Control of Records:
Record has been established and is maintained to provide evidence of conformity to requirement and to the
effective operation of the Quality Management system. Record shall remain legible readlly identifiable and
retrievable a documented procedure is which is defining identifiable storage protection retrievable retention
time and disposition of record (Refer to Procedure control of Record SYS-P-02).
The MR is overall responsible for maintaining the record Matrix.
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CHAPTER TWO
MANAGEMENT RESPONSIBILITY
5 Management Responsibility:
The Top Management shall be overall responsible for making Management Review effective. MR shall assist
the Top Management in carrying out Management Review.
5.1 Management Commitment:
The top management is committed to the development and implementation of the Quality Management
System and continually improving its effectiveness through.
Communicating to the organization the importance of meeting customer as well as statutory and regulatory
requirements,
Establishing the quality policy,
Ensuring that quality objectives are established,
Conducting management reviews.
Ensuring the availability of resources.
The top management drives Organization wide Quality Initiatives through Quality Management System,
Process Audit, and Customer Satisfaction Surveys & Deployment of breakthrough process initiatives.
5.2 Customer Focus:
The top management shall ensure that customer requirements are determined and are met with the aim of
enhancing customer satisfaction. This is defined in the Customer Satisfaction Index. This metric will be
measured once in every six months
CEO and all departmental heads shall ensure that the Organization remains focused on Customer by
understanding;
a] The Market / Industry / Social / Economy Conditions and requirements.
b] The Present and future Customer needs.
c] Identifying the requirements of the customers and fulfilling them with the aim of enhancing Customer
Satisfaction.
d] Global technological advancement in the field of Telecom Value Added Services.
For further details refer Section 7.2.1. and 8.2.1.
5.2.1 Customer Relationship Development:
Customer Relationship development & Management at XYZ Solutions Limited happens at multiple levels.
Top Management ensures that the customer requirement are either converted in to Services or Quality System
inputs as appropriate. These requirement may also be used as an input for New Development.
5.2.2 Customer Communication Method:
Customer communication is a two way process at XYZ Solutions Limited customer can share his issues through
Key Account Manager & helpdesk. Organization ensures that suitable action such as new Quality improvement
initiatives is taken against these requirements which helping developing long-term relation with the
customers.
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5.2.3. Customer Input:
Customer inputs are taken through requirements given to sales Key Accounts Manager by the customer,
customer feed back forms & input provided to the helpdesk through mail/phone call. These inputs are
considered for all business activities
5.2.4 Supplier Input:
Supplier/Partner Inputs are taken during review meetings with the supplier/Partners and these are further
taken into consideration while planning the business plan.
5.3 Quality Policy:
The Quality policy of XYZ Solutions Limited is:
XYZ Solutions Limited is committed to delight customers by providing Superior & innovative services in the
field of mobile & data service
This we shall achieve by:
1. Ensuring continual improvements in our processes & operations
2. Providing growth oriented work environment to the Employees.
3. Establishing & maintaining symbiotic relationship with the stakeholders.
CEO ensures that the quality Policy is made to understand at all levels of the organization by means of
displaying the Quality policy at various locations, setting Quality Objectives in line with the Quality Policy.
5.4 Planning:
5.4.1 Quality Objective:
Top management shall ensure that Quality objectives includes those needed to meet requirement for
product are established at relevant function and levels within the organization the Quality objectives shall
be measurable and consistent with the Quality Policy.
(Refer to List of Quality objectives of different Departments)
5.4.2 Quality Management System Planning:
Quality Head is overall responsible for effective planning, implementation and maintenance of Quality
Management System.
The following criteria will be considered as input to the planning:
Quality policy and objectives.
Customer Feedback.
Need and expectation of the customer.
Standards and requirements of the industry.
Global economy and industry growth
Technological advancement and innovations
Customer suggestion
Perceived opportunities and threats by doing a SWOT analysis if required.
Necessary assessments, measurements, monitoring and analysis
Any changes affecting QMS.
Based on above, the management works on the following parameters:
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Further skill set, training and expertise needed.
Budgetary and personnel needs.
Measurements of progress.
Any additional resource needs.
Need for process improvement if any.
Need for documentation and records.
5.5 Responsibility, Authority and Communication:
5.5.1 Responsibility, and authority:
Management of the company is directed by the managing director and assisted by various functional Heads.
The companys organization structure showing inter office relationship of various functional Heads is defined
in Organization chart.
Responsibilities & Authorities of Key personnel who manage, perform and verify work affecting Quality are
defined in (Roles & Responsibility Matrix).
These Personnel have authority to:
Initiate action to prevent reoccurrence of non-conference relating to the product, process & Quality
system.
Identify and record any problem relating to the product, process and Quality system
Initiate recommended or provided solution through designated Channels
Verify implementation of the solution
Control further processing delivery or installation of nonconforming product until required corrective
action is taken.
5.5.2 Management Representative:
The Managing Director has appointed MR in addition to his normal responsibilities, as Management
Representative who has responsibilities and authority to as defined in Roles & responsibility in detail.
Important responsibilities are given below:
Monitor the establishment, implementation and functioning of the Quality Management System by
monitoring the implementation of the QMS on a day-to-day basis and organizing internal Quality
audits and management review meetings.
Report to the CEO about the status of Quality Management System.
Conduct internal audits, Identify and Analyze non-conformities and results of internal audits and
report to management for review.
Monitor correct implementation of corrective and preventive actions as per quality procedures and
verify effectiveness.
Responsible for the distribution of all controlled documentation.
Promotion of customer requirement throughout the organization.
Ensuring effectiveness of the Q.M.S. in the organization and to implement modifications required in
the documentation from time to time as requested by the user or self identification.
.
5.5.3 Internal Communication:
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The internal Communication will be ensured between various departments and levels, regarding the process of
the Quality Management System and their effectiveness by the following means of Meeting.
Top to Bottom Communication is carried out by the way of informal meeting with the concerned employee
and the Process Owner. Formal top to bottom communication is carried out by the way of scheduled meeting
of the employees with top management at a regular interval.
Bottom to Top communication is carried out on specific request of the employee to the management.
Peer-to-Peer communication is carried out through informal discussions, formal notices, email, chat software
etc.
Internal communication is mainly carried out mainly by one to one communication, phone and emails.
Effectiveness of QMS is communicated through internal quality audit reports and minutes of management
review meetings.
5.6 Management Review:
5.6.1 General:
The management review is done through management review meetings which are chaired by CEO. The M.R.
organizes the management review meetings for reviewing the effectiveness of existing quality systems and
improvements at least once in three months. Management review findings and recommendations are
recorded in minutes of meeting and circulated to all concerned persons by M.R.
The meetings also reviews customer complaints, trends in achieving quality objectives, review training needs,
training imparted, its effectiveness, resources planning, and internal audit report, supplier performance,
customer complaints and feedback, Process performance, corrective and preventive action taken.
The Quality Management System adopted to satisfy the requirements of the International Standard ISO
9001:2000 are reviewed once in three months by the company to ensure its continuing suitability and
effectiveness.
The following people are member of the Management Review Meeting:
Chief Executive officer (CEO)
Head Customer Support
Management Representative (MR)
All Process Owners
Quality-In-charge
Time, date, venue and agenda for Management Review Meeting is prepared and circulated by mail to all
concerned members by the MR in consultation with the Top Manager at least a week before the scheduled
date of the meeting.
During these meeting various aspects of QMS (Audits review of process performance) are discussed and action
plan is done minutes of meeting are maintained by the Management representative.
5.6.2 Review input:
The points for discussion during the Management Review Meeting shall as a minimum, include the following:
Results of Audits and status of various non-conformities.
Achievement Status of Quality Policy and Quality Objectives.
Customer Feedback / Complaint,
Process performance and Product Conformity,
Status of Preventive and Corrective Actions,
Follow-up actions from previous Management Reviews,
Changes that could affect the Quality Management System and
Recommendations for further improvement.
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5.6.3 Review output:
The output of review shall be recorded in the form of Minutes of Meeting, which shall detail the action plan.
After Management review meeting, the following points must be as output of MRM;
Improvement of the effectiveness of the quality management System and its process,
Improvement of product related to customer requirements, and
Resource need
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CHAPTER THREE
RESOURCE MANAGEMENT
6 Resource Management:
6.1 Provision of resources:
The organization shall determine and provide the resources like competent personnel, proper working
environment and adequate infrastructure needed to implement and maintain Quality Management System
and continually improve its effectiveness to enhance customer satisfaction by meeting customer
requirements.
6.2 Human Resource (Refer to HR Manual):
6.2.1 General:
Human Resources are the biggest assets of any organization and that has to be taken care by any organization.
HRD is the major contributor for this activity. XYZ Solutions Limited has laid down a detailed process to provide
manpower to each department. Depending upon their requirements. Individual departments give their
requirements to HRD and the same has been processed (Refer HR Requirement & Training Procedure)
6.2.2 Competence, Awareness and Training:
Performance is a combination for knowledge, skill, experience, attitude and environment. The requisite level
of performance has to be maintained &constantly improved, which determines the need for training & the
type of training, which is to be given
The organization always ensures to provide the required training to all its employees, whose performance may
affect repair quality or effectiveness of the Quality System, whenever required.
Training needs are identified depending on the established procedures and are provided accordingly. (For
Detail Refer to HR & Training Procedure).
6.3 Infrastructure:
The management shall ensure that the employees are provided with the necessary resources to perform their
duties without hindering the product conformity. Based on the project/product all the software and hardware
resources to build the same shall be provided. Transportation for delivery of the product for testing purposes
etc shall also be made available.
All the departments are having their own responsibility defined in their detailed process to control and
monitor the availability of all the required Equipments
(Refer to Infrastructure Assessment and Provision SYS-F-12)
6.4 Work Environment:
A suitable working environment to the extent possible is maintained, where the absence will result in product
quality. The maintenance of work environment is taken care by Admin Department (Refer to Admin Manual
CSL-AM-01)
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CHAPTER FOUR
PRODUCT REALIZATION
7 Product Realizations:
7.1 Planning of Product /Service Realization:
Top management plans processes needed for product / service realization.
The processes required for product realization are described in 4.1 of this Manual.
On the basis of business received from the customer, current load and distribution of work to various and
availability of the in-house resources, planning for delivery of the service is done. On the basis of planning the
customer is informed the proposed Project Start date and also resource management and mobilization
activities are initiated if required for the particular order.
Planning for product / service realization is carried out by Operations Head in consultation with Training Head
depending upon the customers requirement and existing work load
7.2 Customer related Process:
In certain cases the customer may require XYZ to implement their processes to drive the Project Execution. In
such cases the same shall be followed.
7.2.1 Requirement related to Product:
It is ensured that the product / service requirements are adequately defined, documented and checked
whether feasible and required.
Accuracy level, formatting style and other specifications related to the service delivery are obtained from the
customer in writing either through email or in paper form. In case customer quotes the same verbally the
same is to be confirmed with the customer by sending a confirmation email or suitable communication.
Statutory and regulatory requirements for providing Telecom value added services to the client are addressed
properly and are met with and required license are obtained where ever required
7.2.2 Review of Requirement Related to Product:
Any differences in the offering of the organization and expectations of the customers are suitably reviewed
and are resolved/amended/attended on a case to case basis and it is made sure that no work order is accepted
before detailed discussions with technical and commercial employees are carried out about economical and
technical feasibility of the requirements.
7.2.3 Customer Communication:
Marketing team or respective Process owners or quality head or operations head communicate with the
customers on any operational issues through email or telephone or direct meeting as and when necessary.
Customer Feedback, Customer Complaint etc. are the methodology for reverse customer communication. i.e.
from customer to the organization.
(Refer to Customer Feedback form S&M-F-18)
7.3 Design and development:
The extend of design and development application to the organizations overall processes is limited. It is
limited to the in-house development or up gradation of platforms or Applications used for providing Telecom
Value Added Services. Overall responsibility for design and development is with the Engineering Head.
(Refer to New Application Development Process S&M-P-02)
7.3.1 Design and Development Planning:
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Program Manager will ensure that before starting of any project, design and development plan is prepared
containing the following information.
Inputs specifications required for each of the stages
Responsibility for each of the stages along with scheduled and actual Design and Development
Output.
Review to see the match between design and development input and output.
Proper verifications at various stages is carried out so as to ensure
That product is developed as per the project objective.
Validation of the project before installation to ensure its error free and complete functional as per
the requirement of the organization or the process.
7.3.2 Design and Development Input:
Program Manager ensures that the following details are available depending on the basis of nature of the
project. (Refer to Engineering Procedure ENG-P-01)
All kind of functional and performance requirements/specifications for a project.
Complete operational details that the project/software that it is supposed to deliver should be must
be clearly defined considering applicable statutory and regulatory requirements along with drawings,
formats, work flow etc. wherever required and possible.
Past experience from the similar projects should also be used as an input whenever possible.
7.3.3 Design and Development Output:
Project Manager/ Program Manager / Team Leader will ensure that design and development output is in the
form of a programming code or software application.
Records of design and development output is maintained by the organization for all kind of projects.
7.3.4 Design and development Review:
Engineering Head ensures for suitability and adequacy of design and development input for the design and
development output. The review information is documented.
7.3.5 Design and development verification:
Project Manager / Project Member carry out frequent verifications at various stages of the experiment of
development process so as to ensure desired result and performance of the final product / software
application / code. Result of the verifications is documented.
7.3.6 Design and development validation:
Engineering Head / Project Leader is responsible for validation of the final product / developed application /
generated code before it is installed and made live. Validation is carried out against project requirements,
functionality and performance parameters as mentioned in the specifications.
Result of the validation is documented.
7.3.7 Design and development changes:
Any changes in the design and development process are documented.
(Refer to change request_ Enhancement in existing application ENG-F-05)
7.4 Purchasing:
All purchases are carried out by admin in-charge as per requirements and requests received from various
departments through Purchase Requisition form.
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Purchase covers everything that is required to process the input to generate output.
(Refer Purchase Procedure PUR-P-01)
(Refer Purchase requisition Form PUR-F-06
7.4.1 Purchasing Process:
Purchases are made from the approved suppliers who are registered before purchasing.
A List of approved supplier is prepared.
(Refer List of Approved Supplier PUR-F-03)
7.4.2 Purchasing Information:
Purchasing information clearly states the precise identification of the requirements, specifications and delivery
dates.
The record of approved suppliers is maintained and is continuously updated based on the evaluation of the
performance of suppliers.
The orders are reviewed for adequacy of specified requirements prior to release.
7.4.3 Verification of Purchased Product:
Incoming material / HW/SW / service are inspected by the concerned employee of the organization against the
pre-defined deliverables in order to ensure the highest quality of products / services.
(Refer Quality Check Report PUR-F-04)
Admin Head evaluates performance of the suppliers, to asses their suitability on a continuous basis and
monitors regularly performance of the suppliers.
Records are maintained as detailed in the procedures.
Refer To Given Documents:
Procedure for Purchase PUR-P-01
Supplier Registration Form PUR-F-01
Supplier evaluation form PUR-F-02
List of approved suppliers PUR-F-03
7.5 Production and service provision:
7.5.1 Control of Production & Service Provision:
The Overall responsibility for implementation of the procedure lies with Operations Head and Quality Head.
The organization has planned service provision activities under controlled conditions.
(Refer to Procedure of Network Operation NOP-P-01)
(Refer to Procedure for Incident _Bug Fixing (CSC-P-02)
7.5.2 Validation of processes for production and service provision:
For validation of content uploading we check the alert on registered SIMs so that 2-3 SIMs are registered for
every service.
After sending messages Alerts received on mobile (on testing sim or on in house no. which are already
registered against the keywords). To cross check the efficiency of the task done.
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7.5.3 Identification and Traceability:
The overall responsibility for implementation of this clause lies with the Customer Support Head.
All the cases for processing are given a unique identification number and assign to an employee for processing.
The processing can be traced back for date and time at any point of time because it is identified by a unique
case number and is processed by an employee whose job allocation details are documented. In case of any
complaints of the customers, the cases can be easily traced back to its origin and with all the relevant data
Reference: Support Center tool
7.5.4 Customer Property:
The organization deals with data that are highly critical in nature. The data processed by the organization are
backup of logs for various clients.
In order to ensure that the customer data are protected and not misused by anybody in the organization, a
strict control is exercised.
Access control is in place to ensure only authorized person access to restricted areas.
No USB ports or email or floppy or CD drive are made available on any of the computer systems of the agents.
In order to further augment the organizations commitment towards protection of property of the customer,
ISO 27001 ISMS is being planned by the organization.
Refer to List of Customer Property (NOP-F-26)
7.5.5 Preservation of product:
The input files and processed files are stored on the central servers with adequate data back-up mechanism.
Local data during processing are also backed up to ensure that they are safe in case of any system failure.
7.6 Control of Monitoring & Measuring Device:
For monitoring of services provided by XYZ Solutions Limited we used gateways if the gateway is hanged or
down, the customer support person (CSC person) has to restart the gateway properly. In case, gateway is
working properly and still not received the message, inform Netops immediately and log the case on CRM for
the same.
Further, Netops can check the technical issue to resolve the problem. As soon as, the problem is solved,
Netops contacts the CSC and the content person will send a message only on test SIM to cross check the
service.
The software used for monitoring and measuring of job allocation and process monitoring is calibrated every
six months by using a known sample and validating the software for output. Responsibility of this calibration is
with the Network Operation Head that use this software.
Refer to OP Manager Tool
Refer to Work Instruction for Monitoring of Gateway (CSC-W-12)
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CHAPTER FIVE
MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.0 Measurement, Analysis and Improvement:
8.1 General:
Measurement, analysis and improvement processes are implemented as a means of demonstrating that
products/ services conform to the requirements. Each area of management responsibility defines and records,
measure accordingly to their importance and the results of data analysis, together with improvements are
used as inputs to the management review process.
8.2 Monitoring and Measurement:
8.2.1 Customer Satisfaction:
XYZ Solutions Limited. Collects feedback from the immediate customer at regular intervals. From the
immediate customer feedback is collected minimum once every three months. The feedback addresses Quality
of service.
The records of the customer feedback are maintained.
(Refer to Customer feedback form (S&M-F-18)
The following parameters are measured for customer satisfaction: -
Sl. No Parameters Measured for Customer Satisfaction
1. Understanding of the requirements
2. Adherence to schedule
3. Quality of documentation
4. Promptness
5. Effectiveness of support
6. Internal Audits
8.2.2. Internal Audit:
Management Representative is responsible for ensuring the implementation of this procedure. He is also
responsible for overall coordination of matters related to Internal Audits.
The company has established a procedure for carrying out "Internal Audit". The Internal Quality Audits are
planned and coordinated in such a manner that the entire Quality Management System of the company is
audited at least once in three months by trained auditors independent of their activities.
The Audit Planning carried out by Management Representative, by preparing schedules for audits based on the
status and importance of the activity. Internal audit can also be conducted by external auditors if required.
The procedure requires audit reports to be documented. The reports of the audits form the basis for suitable
and timely corrective actions by the respective sections.
All corrective actions agreed upon as an outcome of the Internal Quality Audits are verified, Implementation
and effectiveness of corrective actions taken are recorded.
The audit findings that need attention of the managing director or top management team are brought to their
attention by Management Representative through Management Review.
In case any significant changes are observed in the system i.e. change in process or in case of special
assignment / Order, then unscheduled audits may be carried out.
The Management Representative maintains the records of the Internal Quality Audits.
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(Refer to Procedure of Internal Audit SYS-P-03)
8.2.3 Monitoring and Measurement of Process:
XYZ Solutions Limited monitors and measures the processes to achieve planned results by:
Internal Audit
Number of customer complaints.
Number of non-conformity arising during product / service realization.
Customer feed backs and supplier performance.
Through SLA & Cases Analysis
The data collected are used to take relevant corrective and preventive action and to enhance the process and
product realization process.
8.2.4 Monitoring and Measurement of Product:
In order to monitor and measure the characteristics of the final output to be uploaded on the server, the same
is monitored for accuracy level at Network Operation. The same is verified again through UAT.
8.3 Control of Non-conforming Product:
The overall responsibility for implementation lies with MR. The responsibility for disposition/rectification of
non-conformities also lies with the MR.
The non-conformity control involves identification, evaluation, segregation of documentation and disposition
of the non-conforming products found in purchased items, during service provision and other Quality
Management System areas. A documented procedure has been developed to deal with the non-conforming
products.
Records pertaining to control of non-conforming products are maintained as detailed in the relevant
procedures.
(Reference: SYS-P-04 Control of Non-conforming Product)
8.4 Analysis of Data:
Relevant and reliable data is collected and is to be reviewed and analyzed for the continual improvement of
the Quality Management System. The data is collected from relevant management information systems
including internal audits, corrective and preventive action, non-conforming product/service, customer
satisfaction reports etc.
Analysis of the data provides information on:
Effectiveness of the Quality Management System
Customer Satisfaction
Suppliers evaluation
Customer Complaints
Process performance
The analysis of data is done in a graphical form wherever possible for clear representation of the results and is
appropriate to the various objectives set by the organization.
8.4.1 Trend Analysis of Nonconforming Product:
The Nonconforming product data is collected by Testing Team & also through Customer complaints. The data
is analyzed and is presented in review meeting of management for necessary action by respective teams,
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8.4.2 Service performance data:
Service performance parameter like SLA, OLA have been tracked on weekly basis to timely resolve the
customer complaints
8.5 Improvement:
8.5.1 Continual Improvement:
Top Management is responsible for implementation and taking decision towards continual management. It is a
process that is undertaken throughout the organization.
The following will be used at the time of Management Review Meeting for continually improving the Quality
Management System and the business of the organization.
Quality Policy
Quality Objectives
Internal Audit Results
Customer Feedback
Analysis of Data relating to i] Corrective Action
ii] Preventive Action
8.5.2 & 8.5.3 Corrective and Preventive Actions:
M.R. is over all responsible for implementation of this procedure.
A procedure has been established for initiating corrective and preventive actions with respect to non-
conformity. Through this procedure, it is ensured that
The actual cause of non-conformity relating to product, process and quality system is investigated.
Potential causes of non-conformity are identified through customer complaints, analysis of work /
operations, quality records, audit results etc.
Determining the need of suitable action.
Identifying and implementing the action.
Record the action taken.
Review the effectiveness of action taken to prevent recurrence and or occurrence of any known
nonconformities.
The company gives utmost importance to the customer complaints and suggestions. The corrective and
preventive actions are attended urgently depending upon the gravity of customer complaint, in the presence
of concerned departmental head, Quality Head, Management Representative and other personnel.
However, the review and analysis of the Corrective and Preventive Action requests, internal audit reports,
customer complaints, production quality related data and supplier related information are carried out in
Management Review Meetings. The concerned functions are then advised on further course of action required
to prevent recurrence of non-conformities and elimination of potential causes of non-conformities.
Reference:
SYS-P-05 Procedure for Corrective and Preventive Action
List of identified preventive actions
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ANNEXURE- 1
INTERACTION OF KEY BUSINESS PROCESS
Interaction of Key Business Process of XYZ Solutions Limited
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Annexure A
Term ISO 9000:2005 Clause Definition
Document 3.7.2 information and its supporting medium
Procedure 3.4.5
specified way to carry out an activity or
a process (Note: Procedures can be
documented or not)
Quality Manual 3.7.4
document specifying the quality
management system of an organization
Quality Plan 3.7.5
document specifying which procedures
and associated resources shall be
applied by whom and when to a specific
project, product, process or contract
Record 3.7.6
document stating results achieved or
providing evidence of activities
performed
Specification 3.7.3 document stating requirements
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Annexure B
Clause Record required
5.6.1 Management reviews
6.2.2 e) Education, training, skills and experience
7.1 d) Evidence that the realization processes and resulting product fulfil requirements
7.2.2
Results of the review of requirements related to the product and actions arising
from the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions
7.4.1
Results of supplier evaluations and any necessary actions arising from the
evaluations
7.5.2 d)
As required by the organization to demonstrate the validation of processes where
the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4
Customer property that is lost, damaged or otherwise found to be unsuitable for
use
7.6 a)
Basis used for calibration or verification of measuring equipment where no
international or national measurement standards exist
7.6
Validity of the previous measuring results when the measuring equipment is found
not to conform to requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3
Nature of the product nonconformities and any subsequent actions taken, including
concessions obtained
8.5.2 e) Results of corrective action
8.5.3 d) Results of preventive action

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