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ISO 9001:2015

Clause title Clause number


IATF 16949 :2016
Clause number Clause title
IAT
ISO 9001 / IATF 16949
Requirment From Clause
of the Organization
erstanding the Organization and its Context

anization determined external and internal issues relevant to its purpose and strategic direction? If yes, how?

nfo:
ation shall determine external and internal issues that are relevant to its purpose and its strategic direction and that a
hieve the intended result(s) of its quality management system.
erstanding the Organization and its Context

ues affect the ability to achieve the intended result of the QMS? If yes, how so?

nfo:
ation shall determine external and internal issues that are relevant to its purpose and its strategic direction and that a
hieve the intended result(s) of its quality management system.
rstanding the Organization and its Context
itor and review information about these internal and external issues? If so, how are they monitored?

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ation shall monitor and review the information about these external and internal issues.

erstanding the external context can be facilitated by considering issues arising from legal, technological, competitive,
ial, and economic environments, whether international, national, regional or local.
erstanding the internal context can be facilitated by considering issues related to values, culture knowledge and perf
tion.
erstanding the Needs and Expectations of Interested Parties

termined what interested parties are relevant to the QMS? How have you determined these?

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impact or potential impact on the organization’s ability to consistently provide products and services that meet custo
tatutory and regulatory requirements, the organization shall determine:
sted parties that are relevant to the quality management system;
rements of these interested parties that are relevant to the quality management system.
erstanding the Needs and Expectations of Interested Parties
termined what requirements those parties have that are relevant to the QMS? How have you determined these?

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impact or potential impact on the organization’s ability to consistently provide products and services that meet custo
tatutory and regulatory requirements, the organization shall determine:
sted parties that are relevant to the quality management system;
rements of these interested parties that are relevant to the quality management system.
erstanding the Needs and Expectations of Interested Parties

or potential impact been determined? How has it been determined?

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impact or potential impact on the organization’s ability to consistently provide products and services that meet custo
tatutory and regulatory requirements, the organization shall determine:
sted parties that are relevant to the quality management system;
rements of these interested parties that are relevant to the quality management system.
rstanding the Needs and Expectations of Interested Parties

itor and review the information about interested parties and their relevant requirements? How do you monitor this
?

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ation shall monitor and review the information about these interested parties and their relevant requirements.
mining the Scope of the Quality Management System
undaries and applicability of the QMS been used to establish the scope of the organization? How have they been use

nfo:
ation shall determine the boundaries and applicability of the quality management system to establish its scope.

ting functions, whether on-site or remote (such as design centres, corporate headquarters, and distribution centres),
the Quality Management System (QMS)? The only permitted exclusion for this Automotive QMS Standard relates to
ign and development requirements within ISO 9001, Section 8.3. Is the exclusion justified and maintained as docume
(see ISO 9001, Section 7.5)? Permitted exclusions do not include manufacturing process design.
mining the Scope of the Quality Management System

xternal and internal issues; The requirements of relevant interested parties and; The products and services of the org
ered when determining the scope of the organization? How have they been considered?

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mining this scope, the organization shall consider:
nal and internal issues referred to in 4.1;
rements of relevant interested parties referred to in 4.2;
cts and services of the organization.
er - specific requirements evaluated and included in the scope of the organization's quality management system?
mining the Scope of the Quality Management System
lication of the International Standard within the scope been determined? How has it been determined and how has
he organization?

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uirement of this International Standard within the determined scope can be applied, then
pplied by the organization.
mining the Scope of the Quality Management System

quirements of the International Standard been determined as not applicable? How were they determined as not app
onformity of products and services are not affected by this.

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ement(s) of this International Standard cannot be applied, this shall not affect the organization’s ability or responsibi
ormity of products and services.
mining the Scope of the Quality Management System

e scope available? Where is it maintained as documented information?


what products and services are covered by the QMS? Does it justify how instances of requirements of the QMS cann

nfo:
hall be available and be maintained as documented information stating the:
nd services covered by the quality management system;
n for any instance where a requirement of this International Standard cannot be applied.
y Management System and its Processes
e QMS been established? Show how this is implemented. How is it maintained and continually improved? How
ocesses been determined and how do they interact?

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ation shall establish, implement, maintain and continually improve a quality management system, including the proce
their interactions, in accordance with the requirements of this International Standard.
y Management System and its Processes

he processes been determined


?
e inputs and outputs for those

sequence and interaction of the

e criteria, methods,
nt and related performance
eeded to operate and control
sses? What resources are needed and how are
available? How are responsibilities and authorities
those processes? How are risks and opportunities considered and what plans are made to implement actions to add
ods are used to monitor, measure and evaluate processes and, if needed, what changes are made to achieve intended
portunities to improve the processes and the QMS determined?
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ation shall determine the processes needed for the quality management system and their application throughout the
and shall determine:
s required and the outputs expected from these processes;
ence and interaction of these processes;
a, methods, including measurements and related performance indicators needed to ensure the effective operation, a
cesses;
rces needed and ensure their availability;
nment of the responsibilities and authorities for these processes;
nd opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to ad
ods for monitoring, measuring, as appropriate, and evaluation of processes and, if needed, the changes to processes
hieve intended results;
ities for improvement of the processes and the quality management system.
y Management System and its Processes

mented information exists to support the operation of processes? How is this documented information retained? How
hat the processes are being carried out as planned determined?

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ation shall maintain documented information to the extent necessary to support the operation of processes and reta
d information to the extent necessary to have confidence that the processes are being carried out as planned.
nformance of Products and Processes
anization ensured conformance of all products and processes, including service parts and those that are outsourced,
ustomer, statutory, and regulatory requirements (see Section 8.4.2.2)?
duct Safety

ganization have documented processes for the management of product-safety related products and manufacturing p
nclude but not be limited to the following, where applicable?: a) identification by the organization of statutory and r
fety requirements; b) customer notification of requirements in item a); c) special approvals for design FMEA; d) identi
ety - related characteristics; e) identification and controls of safety - related characteristics of product and at the poin
e; f) special approval of control plans and process FMEAs; g) reaction plans (see Section 9.1.1.1); h) defined responsib
escalation process and flow of information, including top management, and customer notification; i) training identifi
or customer for personnel involved in product - safety related products and associated manufacturing processes; j) c
process shall be approved prior to implementation, including evaluation of potential effects on product safety from pr
nges (see ISO 9001, Section 8.3.6); k) transfer of requirements with regard to product safety throughout the supply c
stomer - designated sources (see Section 8.4.3.1); l) product traceability by manufactured lot (at a minimum) through
n (see Section 8.5.2.1); m) lessons learned for new product introduction.

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al approval is an additional approval by the function (typically the customer) that is responsible to approve such docu
ed content.

ip
dership and Commitment for the Quality Management System
op management
es leadership and commitment
MS by taking accountability of
eness of the QMS.
quality policy and objectives
for the QMS and how are they
with the strategic direction and
tional context?
quality policy communicated
rganization? Show how this
d and applied.
requirements of the QMS
nto the business processes?
promote awareness of the
roach?
ensure that resources needed
are available?

communicate the importance


quality management?
communicate the importance of conforming to the QMS requirements? How do you ensure that the QMS achieves i
w do you engage, direct and support people to contribute to the effectiveness of the QMS?
promote continual improvement? How do you support other relevant management roles to demonstrate leadership
ponsibility?
nfo:
ment shall demonstrate leadership and commitment with respect to the quality management system by:
countability of the effectiveness of the quality management system;
that the quality policy and quality objectives are established for the quality management system and are compatible
ection and the context of the organization;
hat the quality policy is communicated, understood and applied within the organization;
the integration of the quality management system requirements into the organization’s business processes;
g awareness of the process approach; f) ensuring that the resources needed for the quality management system are
cating the importance of effective quality management and of conforming to the quality management system require
that the quality management system achieves its intended results;
directing and supporting persons to contribute to the effectiveness of the quality management system;
continual improvement;
g other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

ence to “business” in this International Standard can be interpreted broadly to mean those activities that are core to
the organization’s existence; whether the organization is public, private, for profit or not for profit.

anization defined and implemented corporate responsibility policies, including at a minimum an anti-bribery policy, a
duct, and an ethics escalation policy ("whistle - blowing policy")?
ess Effectiveness and Efficiency
nagement reviewed the product realization processes and support processes to evaluate and improve their effectiven
Are the results of the process review activities included as input to the management review (see Section 9.3.2.1)?

ess owners
nagement identified process owners who are responsible for managing the organization's processes and related outp
ners understand their roles and are they competent to perform those roles (see ISO 9001, Section 7.2)?
tomer Focus

op management demonstrates leadership and commitment w.r.t. customer focus ensuring requirements and applica
d regulatory requirements are determined
w are risks and opportunities that can affect conformity of products and services determined? How is the ability to e
tisfaction determined and addressed? How is the focus on consistently providing products and services that meet cu
tatutory and regulatory requirements maintained? How is customer satisfaction maintained?

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ment shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
requirements and applicable statutory and regulatory requirements are determined and met;
and opportunities that can affect conformity of products and services and the ability to enhance customer satisfactio
and addressed;
on consistently providing products and services that meet customer and applicable statutory and regulatory requirem

on enhancing customer satisfaction is maintained.


lity Policy
op management establish,
maintain a quality policy?
termined to be appropriate to
and context of the
?
ide a framework for setting and
uality objectives?
ain a commitment to satisfy
equirements?
de a commitment to continual
nt of the QMS?
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ment shall establish, review and maintain a quality policy that:
riate to the purpose and context of the organization;
a framework for setting and reviewing quality objectives;
commitment to satisfy applicable requirements;
a commitment to continual improvement of the quality management system.

lity Policy
e quality policy available as
d information?
mmunicated?
w it is understood and applied
rganization.
ou made it available to relevant
arties?

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policy shall:
ble as documented information;
unicated, understood and applied within the organization;
le to relevant interested parties, as appropriate.
izational Roles, Responsibility and Authorities

op management ensure that


ties and authorities for relevant
igned, communicated and
within the organization?

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ment shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and unders
tion.
izational Roles, Responsibility and Authorities
at the QMS conforms to the
l standard?
ocesses are delivering their
tputs?
performance of the QMS,
es for improvement and the
ange or innovation reported to
ment?
omer focus promoted within the
?
ntegrity of the QMS maintained
es to the QMS are planned and
d?

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ment shall assign the responsibility and authority for:
that the quality management system conforms to the requirements of this International Standard;
that the processes are delivering their intended outputs;
on the performance of the quality management system, on opportunities for improvement and on the need for chan
and especially for reporting to top management;
the promotion of customer focus throughout the organization;
that the integrity of the quality management system is maintained when changes to the quality management system
d implemented.
zational Roles, Responsibilities, and Authorities - Supplemental

nagement assigned personnel with the responsibility and authority to ensure that customer requirements are met? H
been documented? This includes but is not limited to the selection of special characteristics, setting quality objectiv
ing, corrective and preventive actions, product design and development, capacity analysis, logistics information, cust
and customer portals.
nsibility and Authority for Product Requirements and Corrective Actions
nagement ensured that: a) personnel responsible for conformity to product requirements have the authority to stop
oduction to correct quality problems?; NOTE: Due to the process design in some industries, it might not always be po
tion immediately. In this case, the affected batch must be contained and shipment to the customer prevented. b) per
d responsibility for corrective action are promptly informed of products or processes that do not conform to require
nonconforming product is not shipped to the customer and that all potential nonconforming product is identified an
) production operations across all shifts are staffed with personel in charge of, or delegated responsibility for, ensurin
o product requirements.

for the Quality Management System


ons to Address Risks and Opportunities
internal and external issues
ed parties considered when
the QMS?
ks and opportunities determined
ed so that the QMS can::
s intended results;
r reduce undesired effects;
ontinual improvement?

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ing for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirem
n 4.2 and determine the risks and opportunities that
addressed to:
ance that the quality management system can achieve its intended result(s);
or reduce, undesired effects;
ontinual improvement.
ons to Address Risks and Opportunities
tions planned to address risks
unities?
tions integrated and
d into the QMS processes?
evaluate the effectiveness of

nfo:
ation shall plan:
address these risks and opportunities;

and implement the actions into its quality management system processes (see 4.4);
the effectiveness of these actions.
ons to Address Risks and Opportunities

tions taken to address risks and


es determined as being
to the potential impact on the
of products and services?

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n to address risks and opportunities shall be proportionate to the potential impact on the conformity of products an
Analysis
anization included in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field return
plaints, scrap, and rework? Has the organization retained documented information as evidence of the results of risk
entive Actions

anization determined and implemented action(s) to eliminate the causes of potential nonconformities in order to pre
Are preventive actions appropriate to the severity of the potential issues? Has the organization established a proces
of negative effects of risk including the following: a) determining potential nonconformities and their causes; b) evalu
tion to prevent occurrence of nonconformities; c) determining and implementing action needed; d) documented info
; e) reviewing the effectiveness of the preventive action taken; f) utilizing lessons learned to prevent recurrence in si
ee ISO 9001, Section 7.1.6)?
tingency Plans

anization: a) identified and evaluated internal and external risks to all manufacturing processes and infrastructure equ
maintain production output and to ensure that customer requirements are met; b) defined contingency plans accord
to the customer; c) prepared contingency plans for continuity of supply in the event of any of the following: key equip
o see Section 8.5.6.1.1); interruption from externally provided products, processes, and services; recurring natural dis
uptions; labor shortages; or infrastructure disruptions; d) included, as a supplement to the contingency plans, a notifi
he customer and other interested parties for the extent and duration of any situation impacting customer operations
tested the contingency plans for effectiveness (e.g. simulations, as appropriate); f) conducted contingency plan revie
nnually) using a multidisciplincary team including top management, and updated as required; g) documented the con
tained documented information describing any revision(s), including the person(s) who authorized the change(s). Do
plans include provisions to validate that the manufactured product continues to meet customer specifications after
n following an emergency in which production was stopped and if the regular shutdown processes were not followe
lity Objectives and Planning to Achieve Them
he quality objectives and are these at all relevant functions, levels and processes?
nsistent with the quality policy?
asureable?
sider applicable requirements?
evant to the conformity of products and services and do they enhance customer satisfaction?
nitored? How? How often?
y communicated? How are they updated? Where is the documented information on the quality objectives?

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ation shall establish quality objectives at relevant functions, levels and processes.
objectives shall:
tent with the quality policy, b) be measurable;
account applicable requirements; d) be relevant to conformity of products and services and the enhancement of cust

ored;
unicated;
ed as appropriate.
ation shall retain documented information on the quality objectives.

lity Objectives and Planning to Achieve Them


he organization determine what
, with what resources, when
and how will results be
r quality objectives?

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ing how to achieve its quality objectives, the organization shall determine: a) what will be done;
ources will be required;
be responsible;
will be completed;
esults will be evaluated.
oduct Design Skills

determine that personnel with


ign responsibility are competent
esign requirements? How do
ne skills required in applicable
chniques? How do you identify
ools and techniques?

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ation shall ensure that personnel with product design responsibility are competent to achieve design requirements an
plicable tools and techniques.
ools and techniques shall be identified by the organization.
ity Objectives and Planning to Achieve Them - Supplemental
nagement ensured that quality objectives to meet customer requirements are defined, established, and maintained f
rocesses, and levels throughout the organization? Are the results of the organization's review regarding interested pa
nt requirements considered when the organization establishes its annual (at a minimum) quality objectives and relate
e targets (internal and external)?

ng of Changes

anges to the QMS planned


ly?
e the purpose and potential
es of changes;
e the integrity of the QMS;
e how resources are made

e how responsibility and


allocated or reallocated.

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organization determines the need for change to the quality management system (see
nge shall be carried out in a planned and systematic manner.
ation shall consider:
ose of the change and any of its potential consequences;
ity of the quality management system;
bility of resources;
tion or reallocation of responsibilities and authorities.
ources: General

e how resources are


for the establishment,
tion, maintenance and continual
nt of the QMS.
w the capabilities and
on internal resources are

w needs from external


e considered.

nfo:
ation shall determine and provide the resources needed for the establishment, implementation, maintenance and co
nt of the quality management system. The organization shall consider:
ilities of, and constraints on, existing internal resources;
ds to be obtained from external providers.
ources: People
provide persons necessary to
meet customer, applicable
d regulatory requirements for
luding the necessary

nfo:
at the organization can consistently meet customer and applicable statutory and regulatory requirements, the organ
persons necessary for the effective operation of the quality management system, including the processes needed.
ources: Infrastructure
determine, provide and
e infrastructure for the operation
s to achieve products and
ormity?

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ation shall determine, provide and maintain the infrastructure for the operation of its processes to achieve conformit
d services.

product realization change affecting customer requirements requires notification to, and agreement from, the custom

t, Facility, and Equipment Planning


anization used a multidisciplinary approach including risk identification and risk mitigation methods for developing an
lant, facility, and equipment plans? In designing plant layouts, has the organization: a) optimized material flow, mater
d value-added use of floor space including control of nonconforming product, and b) facilitated synchronous materia
Are methods developed and implemented to evaluate manufacturing feasibility for new product or new operations?
ng feasibility assessments include capacity planning? Are these methods also applicable for evaluating proposed cha
rations? Has the organization maintained process effectiveness, including periodic re-evaluation relative to risk, to in
made during process approval, control plan maintenance (see Section 8.5.1.1), and verification of job set-ups (see S
e assessments of manufacturing feasibility and evaluation of capacity planning inputs to management reviews (see IS
?

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se requirements should include the application of lean manufacturing principles. Note 2: These requirements should
lier activities, as applicable.
ources: Environment for the Operation of Processes
determine, provide and
e environment for the operation
s to achieve products and
ormity?

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ation shall determine, provide and maintain the environment necessary for the operation of its processes and to achi
of products and services.

nment for the operation of processes can include physical, social, psychological, environmental and other factors (su
e, humidity, ergonomics and cleanliness).
onment for the Operation of Processes - Supplemental
anization maintained its premises in a state of order, cleanliness, and repair that is consistent with the product and
ng process needs?
ources: Monitoring and Measuring Processes

resources determined for


id and reliable monitoring and
esults, where used?

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itoring or measuring is used for evidence of conformity of products and services to specified requirements the organ
he resources needed to ensure valid and reliable monitoring and measuring results.
ources: Monitoring and Measuring Processes
ensure that resources
e suitable for the specific
and measurement activities and
ned to ensure continued fitness
?

nfo:
ation shall ensure that the resources provided:
le for the specific type of monitoring and measurement activities being undertaken;
ained to ensure their continued fitness for their purpose.
ources: Monitoring and Measuring Processes

ocumented information
dence of fitness for purpose of
and measurement resources.

nfo:
ation shall retain appropriate documented information as evidence of fitness for purpose of monitoring and measure

ources: Monitoring and Measuring Processes


cable, show how
nt instruments are:
alibrated at specified intervals
onal or international
nt standards;
no standards, show me the
d information which is used as
ed for calibration or verification.
w measurement instruments
d to determine their calibration

w they are safeguarded from


.
w they are safeguarded from
deterioration.
nfo:
surement traceability is: a statutory or regulatory requirement; a customer or relevant interested party expectation; o
by the organization to be an essential part of providing confidence in the validity of measurement results; measuring
shall be:
calibrated at specified intervals or prior to use against measurement standards traceable to international or national
nt standards. Where no such standards exist, the basis used for calibration or verification shall be retained as docume
;
n order to determine their calibration status;
d from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurem
ources: Monitoring and Measuring Processes

determine the validity of previous measurements if you find an instrument to be defective during verification or cali
priate actions can you take?

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ation shall determine if the validity of previous measurement results has been adversely affected when an instrumen
tive during its planned verification or calibration, or during its use, and take appropriate corrective action as necessar
easurement Systems Analysis
cal studies been conducted to analyse the variation present in the results of each type of inspection, measurement, a
system identified in the control plan? Do the analytical methods and acceptance criteria used conform to those in ref
measurement systems analysis? Other analytical methods and acceptance criteria may be used if approved by the cu
of customer acceptance of alternative methods retained along with results from alternative measurement systems a
1.1)?

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tization of MSA studies should focus on critical or special product or process characteristics.
ibration / Verification Records

ganization have a documented process for managing calibration / verification records? Are records of the calibration
activity for all gauges and measuring and test equipment (including employee - owned equipment relevant for measu
wned equipment, or on-site supplier-owned equipment) needed to provide evidence of conformity to internal requir
nd regulatory requirements, and customer -defined requirements retained? Has the organization ensured that calibra
activities and records include the following details: a) revisions following engineering changes that impact measurem
any out-of-specification readings as received for calibration / verification; c) an assessment of the risk of the intended
sed by the out-of-specification condition; d) when a piece of inspection measurement and test equipment is found to
r defective during its planned verification or calibration or during its use, documented information on the validity of
nt results obtained with this piece of inspection measurement and test equipment shall be retained, including the as
ast calibration date and the next due date on the calibration report; e) notification to the customer if suspect product
ipped; f) statements of conformity to specification after calibration / verification; g) verification that the software ver
and process controls is as specified; h) records of the calibration and maintenance activities for all gauging (including
pment, customer-owned equipment, or on-site supplier-owned equipment); i) production-related software verificati
process control (including software installed on employee-owned equipment, customer-owned equipment, or on-si
pment).
boratory Requirements: Internal Laboratory

ganization's internal laboratory facility have a defined scope that includes its capability to perform the required inspe
n services? Is this laboratory scope included in the quality management system documentation? Has the laboratory s
ented, as a minimum, requirements for: a) adequacy of the laboratory technical procedures; b) competency of the la
) testing of the product; d) capability to perform these services correctly, traceable to the relevant process standard
tc.); when no national or international standard(s) is available, has the organization defined and implemented a meth
urement system capability; e) customer requirements, if any; f) review of the related records?

nfo:
-party accreditation to ISO / IEC 17025 (or equivalent) may be used to demonstrate the organization's in-house labor
o this requirement.
boratory Requirements: External Laboratory
/commercial/independent laboratory facilities used for inspection, test, or calibration services by the organization ha
oratory scope that includes the capability to perform the required inspection, test, or calibration, and either: - the lab
o ISO / IEC 17025 or national equivalent and includes the relevant inspection, test, or calibration service in the scope
n (certificate); the certificate of calibration or test report includes the mark of a national accreditation body; or - ther
at the external laboratory is acceptable to the customer?

nfo:
evidence may be demonstrated by customer assessment, for example, or by customer-approved second-party assess
ry meets the intent of ISO/IEC 17025 or national equivalent. The second-party assessment may be performed by the
assessing the laboratory using a customer-approved method of assessment. Calibration services mayb be performed
manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases, the organizati
the requirements listed in Section 7.1.5.3.1 have been met. Use of calibration services, other than by qualified (or cu
boratories, may be subject to government regulatory confirmation, if required.
ources: Organizational Knowledge

determine necessary knowledge for the operation of processes? How do you determine necessary knowledge to ach
of products and services?

nfo:
ation shall determine the knowledge necessary for the operation of its processes and to achieve conformity of produ

ources: Organizational Knowledge


maintain this knowledge and how do you make it available to the extent necessary?
nfo:
dge shall be maintained, and made available to the extent necessary.
ources: Organizational Knowledge

consider current knowledge and how do you acquire additional knowledge when addressing changing needs and tre

nfo:
ssing changing needs and trends, the organization shall consider its current knowledge and determine how to acquir
ry additional knowledge.

anizational knowledge can include information such as intellectual property and lessons learned.
btain the knowledge required, the organization can consider:
ources (e.g. learning from failures and successful projects, capturing undocumented knowledge and experience of to
hin the organization);
ources (e.g. standards, academia, conferences, gathering knowledge with customers or providers).
etence

You determine the necessary competence of people doing work under your control that affects quality performance;
ne competence on the basis of appropriate education, training or
How do you take actions to acquire necessary competence where applicable and how do you evaluate the effectiven
s? Show documented information where appropriate of competence.
nfo:
ation shall:
e the necessary competence of
oing work under its control that affects
erformance;
at these persons are competent on the
ropriate education, training, or

plicable, take actions to acquire the


ompetence, and evaluate the
s of the actions taken;
propriate documented information as
competence.

able actions can include, for example, the provision of training to, the mentoring of, or the re- assignment of current
ersons; or the hiring or contracting of competent persons.

etence - Supplemental
anization established and maintained a documented process(es) for identifying training needs including awareness (s
chieving competence of all personnel performing activities affecting conformity to product and process requirements
erforming specific assigned tasks qualified, as required, with particular attention to the satisfaction of customer requ

etence - On-The-Job Training


ganization provide on-the-job training (which shall include customer requirements training) for personnel in any new
sponsibilities affecting conformity to quality requirements, internal requirements, regulatory or legislative requireme
contract or agency personnel? Is the level of detail required for on-the-job training commensurate with the level of
el possess and the complexity of the task(s) they are required to perform for their daily work? Are persons whose wo
y informed about the consequences of nonconformity to customer requirements?
al Auditor Competency

ganization have a documented process(es) to verify that internal auditors are competent, taking into account any cus
uirements? For additional guidance on auditor competencies, refer to ISO 19011. Does the organization maintain a lis
ernal auditors? Are quality management system auditors, manufacturing process auditors, and product auditors all a
e the following minimum competencies: a) understanding of the automotive process approach for auditing, including
understanding of applicable customer-specific requirements; c) understanding of applicable ISO 9001 and IATF 16949
ts related to the scope of the audit; d) understanding of applicable core tool requirements related to the scope of the
ng how to plan, conduct, report, and close out audit findings. Additionally, do manufacturing process auditors demon
derstanding of the relevant manufacturing process(es) to be audited, including process risk analysis (such as PFMEA)
? Do product auditors demonstrate competence in understanding product requirements and use of relevant measuri
o verify product conformity? Where training is provided to achieve competency, is documented information retained
e the trainer's competency with the above requirements? Is maintenance of and improvement in internal auditor com
ed through: f) executing a minimum number of audits per year, as defined by the organization; and g) maintaining kn
uirements based on internal changes (e.g. process technology, product technology) and external changes (e.g. ISO 90
tools, and customer specific requirements)?
d-Party Auditor Competency
ganization demonstrate the competence of the auditors undertaking the second-party audits? Do second-party audit
ecific requirements for auditor qualification and demonstrate the minimum following core competencies, including
ng of: a) the automotive process approach to auditing, including risk based thinking; b) applicable customer and orga
uirements; c) applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit; d) applicable manu
to be audited, including PFMEA and control plan; e) applicable core tool requirements related to the scope of the aud
duct, prepare audit reports, and close out audit findings?
eness

ople aware of: The quality policy? Relevant quality objectives? Their contribution to the effectiveness of the QMS? Th
performance? The implications of not conforming with the QMS requirements?

nfo:
ng work under the organization’s control shall be aware of:
y policy;
quality objectives;
ribution to the effectiveness of the quality management system, including the benefits of improved quality performa
cations of not conforming with the quality management system requirements.
ness - Supplemental
ganization maintain documented information that demonstrates that all employees are aware of their impact on prod
ortance of the activities in achieving, maintaining, and improving quality, including customer requirements and the r
the customer with non-conforming product?
ness - Employee Motivation and Empowerment
ganization maintain a documented process(es) to motivate employees to achieve quality objectives, to make continu
nts, and to create an environment that promotes innovation? Does the process include the promotion of quality and
al awareness throughout the whole organization?
munication

determine internal and


mmunications relevant to the
do you determine: What? When? With Whom? How?

nfo:
ation shall determine the internal and external communications relevant to the quality management system including
t will communicate;
communicate;
m to communicate;
ommunicate.
umented Information: General
mented information do you have as required by this standard? What documented information do you have as being n
tiveness of your QMS?

nfo:
ation’s quality management system shall include:
ted information required by this
l Standard;
ted information determined by the organization as being necessary for the effectiveness of the quality management

xtent of documented information for a quality management system can differ from one organization to another due t
f organization and its type of activities, processes, products and services;
lexity of processes and their interactions;
etence of persons.

umented Information: Quality Management System Documentation


zation's quality management system documented and includes a quality manual, which can be a series of document
or hard copy)? Is the format and structure of the quality manual at the discretion of the organization and does it depe
's size, culture, and complexity? If a series of documents is used, is a list retained of the documents that comprise th
he organization? Does the quality manual include, at a minimum, the following: a) the scope of the quality managem
uding details of and justification for any exclusions; b) documented processes established for the quality managemen
them; c) the organization's processes and their sequence and interactions (inputs and outputs), including type and e
ny outsourced processes; d) a document (ie. matrix) indicating where within the organization's quality management s
ecific requirements are addressed?

nfo:
trix of how the requirements of this Automotive QMS standard are addressed by the organizatoin's processes may be
nkages of the organization's processes and this Automotive QMS.
umented Information: Creating and Updating

our documented information contains: Identification; Description; In what media format? Show how the documente
is reviewed and approved for suitability and adequacy.

nfo:
ng and updating documented information the organization shall ensure appropriate:
tion and description (e.g. a title, date, author, or reference number);
.g. language, software version, graphics) and media (e.g. paper, electronic); c) review and approval for suitability and
ocumented Information: Control of Documented Information
ou control documented information. Show how you make it available and suitable for use. How do you protect your
d information?

nfo:
d information required by the quality management system and by this International Standard shall be controlled to e
ble and suitable for use, where and when it is needed;
uately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
ocumented Information: Control of Documented Information

olling documented information, how do you address:


; Access; Retrieval; Use;
preservation; Legibility;
hanges; Retention and disposition.

nfo:
rol of documented information, the organization shall address the following activities, as applicable:
on, access, retrieval and use; b) storage and preservation, including preservation of legibility;
changes (e.g. version control);
and disposition.
ocumented Information: Control of Documented Information
identify as appropriate and control documented information of external origin which you have determined as neces

nfo:
d information of external origin determined by the organization to be necessary for the planning and operation of the
nt system shall be identified as appropriate, and controlled.

s can imply a decision regarding the permission to view the documented information only, or the
and authority to view and change the documented information.
ntrol of Documented Information: Record Retention

ganization define, document, and implement a record retention policy? Do the control of records satisfy statutory, re
al, and customer requirements? Are production part approvals, tooling records (including maintenance and ownersh
process design records, purchase orders (if applicable), or contracts and amendments retained for the length of tim
ctive for production and service requirements, plus one calendar year, unless otherwise specified by the customer or

nfo:
uction part approval documented information may include approved product, applicable test equipment records, or a

ntrol of Documented Information: Engineering Specifications


ganization have a documented process describing the review, distribution, and implementation of all customer engin
pecifications and related revisions based on customer schedules, as required? When an engineering standard/specifi
lts in a product design change, refer to the requirements in ISO 9001, Section 8.3.6. When an engineering standard/s
lts in a product realization process change, refer to the requirements in Section 8.5.6.1. Does the organization retain
which each change is implemented in production? Does implementation include updated documents? Is review com
orking days of receipt of notification of engineering standards/specification changes?

nfo:
nge in these standards / specifications may require an updated record of customer production part approval when th
ns are referenced on the design record or if they affect documents of the production part approval process, such as co
(such as FMEAs), etc.
n
tional Planning and Control
cesses needed to meet requirements for provision of products and services planned, implemented and controlled? H
ts for products and services determined? How is criteria for processes and acceptance for products and services dete
ources determined? How is process control implemented? Show me the documented information that shows confid
es have been carried out as planned and can demonstrate conformity of products and services.

nfo:
ation shall plan, implement and control the processes, as outlined in 4.4, needed to meet requirements for the provis
d services and to implement the actions determined in 6.1, by:
ng requirements for the product and services;
ng criteria for the processes and for the acceptance of products and services;
ng the resources needed to achieve conformity to product and service requirements; d) implementing control of the
ce with the criteria;
documented information to the extent necessary to have confidence that the processes have been carried out as pla
ate conformity of products and services to requirements.
tional Planning and Control

ou determined that the output from the planning process is suitable for your operations?

nfo:
of this planning shall be suitable for the organization's operations.
tional Planning and Control
control planned changes? How do you review the consequences of unintended changes? What action is taken to mi
cts?

nfo:
ation shall control planned changes and review the consequences of unintended changes, taking action to mitigate an
ecessary.
tional Planning and Control

control outsourced processes?

nfo:
ation shall ensure that outsourced processes are controlled in accordance with 8.4.
tional Planning and Control - Supplemental

ing for product realization, are the following topics included: a) customer product requirements and technical specifi
uirements; c) manufacturing feasibility; d) project planning (refer to ISO 9001, Section 8.3.2); e) acceptance criteria?
entified in ISO 9001, Section 8.1 c), refer to the required verification, validation, monitoring, measurement, inspectio
ecific to the product and the criteria for product acceptance.
entiality
anization ensured the confidentiality of customer-contracted products and projects under development, including rel
rmation?
ermination of Requirements for Products and Services: Customer Communication
ur processes for communicating with customers? How do you communicate information relating to: Products;
quiries; Contracts; Order handling; Customer views, perceptions and complaints; Handling or treatment of customer
ecific requirements for contingency actions?

nfo:
ation shall establish the processes for communicating with customers in relation to:
on relating to products and services;
, contracts or order handling, including changes;
customer views and perceptions, including customer complaints;
ing or treatment of customer property, if applicable;
equirements for contingency actions, when relevant.
uirements for Products and Services: Customer Communication - Supplemental
verbal communication in the language agreed with the customer? Does the organization have the ability to commun
formation, including data in a customer-specified computer language and format (e.g. computer-aided design data, e
ange)?

ermination of Requirements for Products and Services: Determination of Requirements Related to Products and Serv

r process to determine the requirements for products and services to be offered to potential customers? How do
h, implement and maintain this process?

nfo:
ation shall establish, implement and maintain a process to determine the requirements for the products and services
otential customers.

ermination of Requirements for Products and Services: Determination of Requirements Related to Products and Serv
define product and service requirements including statutory and regulatory requirements? How do you ensure that
o meet the defined requirements and substantiate any claims for your products and services?

nfo:
ation shall ensure that:
nd service requirements (including those considered necessary by the organization), and applicable statutory and reg
ts, are defined;
ability to meet the defined requirements and substantiate the claims for the products and services it offers.
uirements for Products and Services: Determining the Requirements for Products and Services - Supplemental

quirements include recycling, environmental impact, and characteristics identified as a result of the organization's kn
and manufacturing processes? Does compliance to ISO 9001, Section 8.2.2 item a) 1), include but not limited to the
e government, safety, and environmental regulations related to acquisiton, storage, handling, recycling, elimination, o

ermination of Requirements for Products and Services: Review of Requirements Related to Products and Services
review: Customer requirements for delivery and post-delivery? Requirements necessary for customers’ specified or i
known; Additional statutory and regulatory requirements applicable to products and services; Any other contract or o
ts.

nfo:
ation shall review, as applicable: a) requirements specified by the customer, including the requirements for delivery a
vities;
ents not stated by the customer, but necessary for the customers' specified or intended use, when known;
statutory and regulatory requirements applicable to the products and services;
or order requirements differing from those previously expressed.

rements can also include those arising from relevant interested parties.

ermination of Requirements for Products and Services: Review of Requirements Related to Products and Services

at the review is conducted prior to your commitment to supply products and services to your customers. How do you
order requirements which differ from those previously defined?

nfo:
shall be conducted prior to the organization’s commitment to supply products and services to the customer and shal
order requirements differing from those previously defined are resolved.
ermination of Requirements for Products and Services: Review of Requirements Related to Products and Services
confirm customer
ts where the customer does not provide a documented statement?

nfo:
ustomer does not provide a documented statement of their requirements, the customer requirements shall be confi
tion before acceptance.
ermination of Requirements for Products and Services: Review of Requirements Related to Products and Services

here you retain documented information which describes results of the review including any new or changed require

nfo:
d information describing the results of the review, including any new or changed requirements for the products and s
ined.
ermination of Requirements for Products and Services: Review of Requirements Related to Products and Services

e documented information containing changes to products and services. How do you ensure that relevant personnel
ose changes?

nfo:
irements for products and services are changed, the organization shall ensure that relevant documented information
nd that relevant personnel are made aware of the changed requirements.
quirements for Products and Services: Review of the Requirements for Products and Services - Supplemental
ganization retain documented evidence of a customer-authorized waiver for the requirements stated in ISO 9001, Sec
a formal review?
quirements for Products and Services: Customer-Designated Special Characteristics
ganization conform to customer requirements for designation, approval documentation, and control of special charac
quirements for Products and Services: Organization Manufacturing Feasibility
ganization utilize a multidisciplinary approach to conduct an analysis to determine if it is feasible that the organization
ng processes are capable of consistently producing product that meets all of the engineering and capacity requireme
the customer? Does the organization conduct this feasibility analysis for any manufacturing or product technology n
and for any changed manufacturing process or product design? Additionally, does the organization validate through
marking studies, or other appropriate methods, their ability to make product to specifications at the required rate?

gn and Development of Products and Services: General

establish, implement and maintain a design and development process (where detailed requirements of your produc
not already established or defined by the customer or other parties).

nfo:
detailed requirements of the organization’s products and services are not already established or not defined by the cu
erested parties, such that they are adequate for subsequent production or service provision, the organization shall es
and maintain a design and
nt process.

organization can also apply the requirements given in 8.5 to the development of processes for
and services provision.
services, design and development planning can address the whole service delivery process.
ation can therefore choose to consider the requirements of clauses 8.3 and 8.5 together.
gn and Development of Products and Services - Supplemental
irements of ISO 9001, Section 8.3.1, apply to product and manufacturing process design and development and focus
ather than detection? Does the organization document the design and development process?
gn and Development of Products and Services: Design and Development Planning

mining the stages and control for design and development, show how you consider: The nature, duration and comple
equirements that specify particular process stages including applicable reviews; Required verification and validation;
ties and authorities; How interfaces are controlled between individuals and parties;
r involvement of customer and user groups. Show documented information that confirms design and development
ts have been met.

nfo:
ng the stages and controls for design and development, the organization shall consider: a) the nature, duration and c
n and development activities;
ents that specify particular process stages, including applicable design and development reviews;
ed design and development verification and validation;
nsibilities and authorities involved in the design and development process;
to control interfaces between individuals and parties involved in the design and development process;
or involvement of customer and user groups in the design and development process; g) the necessary documented i
hat design and development requirements have been met.
gn and Development Planning - Supplemental
ganization ensure that design and development planning includes all affected stakeholders within the organization an
its supply chain? Examples of areas for using such a multidisciplinary approach include but are not limited to the fol
agement (for example, APQP or VDA - RGA); b) product and manufacturing process design activities (for example, DF
s consideration of the use of alternative designs and manufacturing processes; c) development and review of produc
(FMEAs), including actions to reduce potential risks; d) development and review of manufacturing process risk analy
MEAs, process flows, control plans, and standard work instructions).

nfo:
ltidisciplinary approach typically includes the organization's design, manufacturing, engineering, quality, production,
intenance, and other appropriate functions.
uct Design Skills

ganization ensure that personnel with product design responsibilty are competent to achieve design requirements an
plicable product design tools and techniques? Are applicable tools and techniques identified by the organization?

nfo:
ample of product design skills is the application of digitized mathematically based data.
elopment of Products with Embedded Software

ganization use a process for quality assurance for their products with internally developed embedded software? Is a s
nt assessment methodology utilized to assess the organization's software development process? Using prioritization b
ential impact to the customer, does the organization retain documented information of a software development capa
? Does the organization include software development within the scope of their internal audit programme (see Sectio
gn and Development of Products and Services: Design and Development Inputs
w how you determine:
ts essential for the type of
d services being designed and
ncluding as applicable:
& performance requirements; Statutory and regulatory requirements; Standards or codes of practice where there is a
t to implement; Internal and external resources needed for the design and development of products and services; Po
es of failure; Level of control expected of the design and development process by customers and other relevant parti

nfo:
ation shall determine:
ents essential for the specific type of products and services being designed and developed, including, as applicable, f
mance requirements;
e statutory and regulatory requirements;
or codes of practice that the organization has committed to implement;
nd external resource needs for the design and development of products and services; e) the potential consequences
ature of the products and services;
of control expected of the design and development process by customers and other relevant interested parties.
gn and Development of Products and Services: Design and Development Inputs

determine that inputs are adequate, complete and unambiguous for design and development? How do you
flicts among inputs?

nfo:
be adequate for design and development purposes, complete, and unambiguous. Conflicts among inputs shall be res
uct Design Output

ganization identify, document, and review product design input requirements as a result of contract review? Do prod
ements include but not limited to the following: a) product specifications including but not limited to special characte
3.3); b) boundary and interface requirements; c) identification, traceability, and packaging; d) consideration of design
e) assessment of risks with the input requirements and the organization's ability to mitigate / manage the risks, inclu
y analysis; f) targets for conformity to product requirements including preservation, reliability, durability, serviceabilit
onmental, development timing, and cost; g) applicable statutory and regulatory requirements of the customer-identi
estination, if provided; h) embedded software requirements? Does the organization have a process to deploy inform
previous design projects, competitive product analysis (benchmarking), supplier feedback, internal input, field data,
rces for current and future projects of a similar nature?

nfo:
approach for considering design alternatives is the use of trade-off curves.
ufacturing Process Design Input

ganization identify, document, and review manufacturing process design input requirements including but not limited
product design output data including special characteristics; b) targets for productivity, process capability, timing, an
ng technology alternatives; d) customer requirements, if any; e) experience from previous developments; f) new ma
dling and ergonomic requirements; and h) design for manufacturing and design for assembly? Does the manufacturi
de the use of error-proofing methods to a degree appropriate to the magnitude of the problem(s) and commensurat
ntered?
ial Characteristics
ganization use a multidisciplinary approach to establish, document, and implement its process(es) to identify special
cs, including those determined by the customer and the risk analysis performed by the organization, and does it incl
documentation of all special characteristics in the drawings (as required), risk analysis (such as FMEA), control plans
rk/operator instructions; special characteristics identified with specific markings and cascaded through each of these
b) development of control and monitoring strategies for special characteristics of products and production processe
ecified approvals, when required; d) compliance with customer-specified definitions and symbols or the organization
ymbols or notations, as defined in a symbol conversion table? Is the symbol conversion table submitted to the custom

gn and Development of Products and Services: Design and Development Controls


trols that are applied to the design and development process ensure: Results achieved by design and development a
ed? Design and development reviews are conducted as planned? Outputs meet the input requirements by verificatio
conducted to ensure that the
oducts and services are capable of meeting the requirements for the specified application or intended use (when kno

nfo:
applied to the design and development process shall ensure that:
s to be achieved by the design and development activities are clearly defined;
d development reviews are conducted as planned;
n is conducted to ensure that the design and development outputs have met the design and development input req
is conducted to ensure that the resulting products and services are capable of meeting the requirements for the spe
or intended use (when known).

itoring
ements at specified stages during the design and development of products and processes defined, analysed, and repo
sults as an input to management review (see Section 9.3.2.1)? When required by the customer, are measurements o
process development activity reported to the customer at stages specified, or agreed to, by the customer?

nfo:
n appropriate, these measurements may include quality risks, costs, lead times, critical paths, and other measuremen

gn and Development Validation

d development validation performed in accordance with customer requirements, including any applicable industry an
al agency-issued regulatory standards? Is the timing of design and development validation planned in alignment with
ming, as applicable? Where contractually agreed with the customer, does this include evaluation of the interaction of
's product, including embedded software, within the system of the final customer's product?
otype Programme

red by the customer, does the organization have a prototype programme and control plan? Does the organization use
e same suppliers, tooling, and manufacturing processes as used in production? Are all performance-testing activities
ompletion and conformity to requirements? When services are outsourced, does the organization include the type an
e scope of its quality management sytem to ensure that outsourced services conform to requirements (see ISO 9001

uct Approval Process


ganization establish, implement, and maintain a product and manufacturing approval process conforming to requirem
he customer(s)? Does the organization approve externally provided products and services per ISO 9001, Section 8.4.3
of their part approval to the customer? Does the organization obtain documented product approval prior to shipmen
the customer? Are records of such approval retained?

nfo:
uct approval should be subsequent to the verification of the manufacturing process.
gn and Development of Products and Services: Design and Development Outputs

ensure that design and development outputs: Meet the input requirements for design and development? Are adequ

r the provision of products and services? Include or reference monitoring and measuring requirements, and accepta
e?
ucts to be produced, or services to be provided, are fit for intended purpose and their safe and proper use?

nfo:
ation shall ensure that design and development outputs:
input requirements for design and development;
uate for the subsequent processes for the provision of products and services;
reference monitoring and measuring requirements, and acceptance criteria, as applicable;
oducts to be produced, or services to be provided, are fit for intended purpose and their safe and proper use.
gn and Development of Products and Services: Design and Development Outputs

e documented information which results from the design and development process.

nfo:
ation shall retain the documented information resulting from the design and development process.
gn and Development Outputs - Supplemental

ct design output expressed in terms that can be verified and validated against product design input requirements? D
ign output include but is not limited to the following, as applicable: a) design risk analysis (FMEA); b) reliability study
cial characteristics; d) results of product design error-proofing, such as DFSS, DFMA, and FTA; e) product definition in
hincal data packages, product manufacturing information, and geometric dimensioning & tolerancing (GD & T); g) pro
w results; h) service diagnostic guidelines and repair and serviceability instructions; i) service part requirements; j) pa
requirements for shipping.

nfo:
m design outputs should include any engineering problems being resolved through a trade-off process.
ufacturing Process Design Output

ganization document the manufacturing process design output in a manner that enables verification against the man
gn inputs? Does the organization verify the outputs against manufacturing process design input requirements? Does
ng process design output include but is not limited to the following: a) specifications and drawings; b) special charac
manufacturing process; c) identification of process input variables that impact characteristics; d) tooling and equipm
and control, including capability studies of equipment and process(es); e) manufacturing process flow charts / layout
oduct, process, and tooling; f) capacity analysis; g) manufacturing process FMEA; h) maintenance plans and instructi
(see Annex A); j) standard work and work instructions; k) process approval acceptance criteria; l) data for quality, rel
ity, and measurability; m) results of error-proofing identification and verification, as appropriate; n) methods of rapid
nd correction of product/manufacturing process nonconformities?
gn and Development of Products and Services: Design and Development Changes
review, control and identify changes made to the design inputs and outputs during design and development of prod
uring no impact on conformity to requirements?

nfo:
ation shall review, control and identify changes made to design inputs and design outputs during the design and deve
d services or subsequently, to the extent that there is no adverse impact on conformity to requirements.
gn and Development of Products and Services: Design and Development Changes

ocumented information for design and development changes.

nfo:
d information on design and development changes shall be retained.
gn and Development Changes - Supplemental

ganization evaluate all design changes after initial product approval, including those proposed by the organization or
r potential impact on fit, form, function, performance, and/or durability? Are these changes validated against custom
ts and approved internally, prior to production implementation? If required by the customer, does the organization o
d approval, or a documented waiver, from the customer prior to production implementation? For products with emb
oes the organization document the revision level of software and hardware as part of the change record?
trol of Externally Provided Products and Services: General

ensure externally provided processes, products and services conform to specified requirements?

nfo:
ation shall ensure that externally provided processes, products, and services conform to specified requirements.
trol of Externally Provided Products and Services: General
ou apply specified requirements for the control of externally provided products and services when: Products and ser
external providers for incorporation into your own products and services; You provide products and services directly
y external providers on your behalf;
part-process is provided by an external provider as a result of a decision to outsource a process or function.

nfo:
ation shall apply the specified requirements for the control of externally provided products and services when:
and services are provided by external providers for incorporation into the organization’s own products and services;
and services are provided directly to the customer(s) by external providers on behalf of the organization;
or part of a process is provided by an external provider as a result of a decision by the organization to outsource a pr

trol of Externally Provided Products and Services: General

ou establish and apply criteria for evaluation, selection, monitoring of performance and re-evaluation of external pro
assess
to provide processes or products and services in accordance with specified requirements?

nfo:
ation shall establish and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of e
sed on their ability to provide processes or products and services in accordance with specified requirements.
trol of Externally Provided Products and Services: General
mented information do you have of the results of evaluations, monitoring of performance and re- evaluations of exter

nfo:
ation shall retain appropriate documented information of the results of the evaluations, monitoring of the performan
of the external providers.
eral - Supplemental

ganization include all products and services that affect customer requirements such as sub- assembly, sequencing, so
calibration services in the scope of their definition of externally provided products, processes, and services?
plier Selection Process

ganization have a documented supplier selection process? Does the selection process include: a) an assessment of th
sk to product conformity and uninterrupted supply of the organization's product to the customers; b) relevant quality
formance; c) an evaluation of the supplier's quality management system; d) multidisciplinary decision making; and e)
of software development capabilities, if applicable? Are other supplier selection criteria considered including the foll
utomotive business (absolute and as a percentage of total business); - financial stability; - purchased product, materi
plexity; - required technology (product or process); - adequacy of available resources (e.g. people, infrastructure); - d
nt capabilities (including project management); - manufacturing capability; - change management process; - business
g. disaster preparedness, contingency planning); - logistics process; - customer service
omer-Directed Sources (also known as "Directed-Buy")

fied by the customer, does the organization purchase products, materials, or services from customer-directed source
ts of Section 8.4 (except the requirements in IATF 16949, Section 8.4.1.2) applicable to the organization's control of c
rces unless specific agreements are otherwise defined by the contract between the organization and the customer?
trol of Externally Provided Products and Services: Type and Extent of Control of External Provision

determine the controls applied to the external provision of processes, products and services and take into considera
pact of the externally provided processes, products and services on the ability to consistently meet customer and ap
d regulatory requirements? b) The perceived effectiveness of the controls applied by the external provider?

nfo:
ng the type and extent of controls to be applied to the external provision of processes, products and services, the or
to consideration:
tial impact of the externally provided processes, products and services on the organization’s ability to consistently m
nd applicable statutory and regulatory requirements;
ived effectiveness of the controls applied by the external provider.
trol of Externally Provided Products and Services: Type and Extent of Control of External Provision

ation or other activities do you have to ensure externally provided processes, products and services do not adversely
nsistently deliver conforming products and services to your customers?

nfo:
ation shall establish and implement verification or other activities necessary to ensure the externally provided proces
d services do not adversely affect the organization's ability to consistently deliver conforming products and services t

trol of Externally Provided Products and Services: Type and Extent of Control of External Provision
sses or functions have been outsourced to external providers, how do you consider a) and b) in 8.4.1 and how do yo
intended to be applied to the external provider and to the resulting process output?

nfo:
r functions of the organization which have been outsourced to an external provider remain within the scope of the
’s quality management system; accordingly, the organization shall consider a) and b) above and define both the cont
pply to the external provider and those it intends to apply to the resulting process output.
and Extent of Control - Supplemental

ganization have a documented process to identify outsourced processes and to select the types and extent of control
rmity of externally provided products, processes, and services to internal (organizational) and external customer requ
ocess include the criteria and actions to escalate or reduce the types and extent of controls and development activite
formance and assessment of product, material, or service risks?
utory and Regulatory Requirements

ganization document their process to ensure that purchased products, processes, and services conform to the curren
d regulatory requirements in the country of receipt, the country of shipment, and the customer-identified country of
if provided? If the customer defines special controls for certain products with statutory and regulatory requirements
ensure they are implemented and maintained as defined, including at suppliers?
plier Quality Management System Development
ganization require their suppliers of automotive products and services to develop, implement, and improve a quality
nt sytem certified to ISO 9001, unless otherwise authorized by the customer (e.g. item a) below), with the ultimate ob
ertified to this Automotive QMS Standard? Unless otherwise specified by the customer, is the following sequence app
requirement: a) compliance to ISO 9001 through second-party audits; b) certification to ISO 9001 through third-part
wise specified by the customer, do suppliers to the organization demonstrate conformity to ISO 9001 by maintaining
cation issued by a certification body bearing the accreditation mark of a recognized IAF MLA (International Accreditati
Recognition Arrangement) member and where the accreditation body's main scope includes management system ce
17021; c) certification to ISO 9001 with compliance to other customer-defined QMS requirements (such as Minimum
Quality Management System Requirements for Sub-Tier Suppliers [MAQMSR] or equivalent) through second-party a
to ISO 9001 with compliance to IATF 16949 through second-party audits; e) certification to 16949 through third-part
party certification of the supplier to IATF 16949 by an IATF-recognized certification body)?
tomotive product-related software or automotive products with embedded software

ganization require their suppliers of automotive product-related software, or automotive products with embedded so
and maintain a process for software quality assurance for their products? Is a software development assessment met
ssess the supplier's software development process? Using prioritization based on risk and potential impact to the cus
ganization require the supplier to retain documented information of a software development capability self-assessme
plier Monitoring
ganization have a documented process and criteria to evaluate supplier performance in order to ensure conformity o
oducts, processes, and services to internal and external customer requirements? At a minimum, are the following sup
e indicators monitored: a) delivered product conformity to requirements; b) customer disruptions at the receiving pla
rd holds and stop ships; c) delivery schedule performance; d) number of occurrences of premium freight? If provided
oes the organization also include the following, as appropriate, in their supplier performance monitoring: e) special s
otifications related to quality or delivery issues; f) dealer returns, warranty, field actions, and recalls?
cond-party audits

ganization include a second-party audit process in their supplier management approach? Second-party audits may be
g: a) supplier risk assessment; b) supplier monitoring; c) supplier QMS development; d) product audits; e) process au
alysis, including product safety/regulatory requirements, performance of the supplier, and QMS certification level, at
oes the organization document the criteria for determining the need, type, frequency, and scope of second-party au
tion retain records of the second-party audit reports? If the scope of the second-party audit is to assess the supplier
nt system, is the approach consistent with the automotive process approach?

nfo:
ance may be found in the IATF Auditor Guide and ISO 19011.
plier Development

ganization determine the priority, type, extent, and timing of required supplier development actions for its active sup
on inputs include but are not limited to the following: a) performance issues identified through supplier monitoring (
econd-party audit findings (see Section 8.4.2.4.1); c) third-party quality management system certification status; d) r
es the organization implement actions necessary to resolve open (unsatisfactory) performance issues and pursue op
l improvement?
trol of Externally Provided Products and Services: Information for External Providers
w you communicate to
viders, applicable requirements for:
d services to be provided or the processes to be performed on behalf of the organization;
release of products and services, methods, processes or equipment;
e of personnel, including necessary qualification;
ctions with the organization's quality management system;
and monitoring of the external provider’s performance to be applied by the organization;
activities that the organization, or its customer, intends to perform at the external provider’s premises.

nfo:
ation shall communicate to external providers applicable requirements for the following:
cts and services to be provided or the processes to be performed on behalf of the organization;
or release of products and services, methods, processes or equipment;
nce of personnel, including necessary qualification;
ractions with the organization's quality management system;
ol and monitoring of the external provider’s performance to be applied by the organization;
n activities that the organization, or its customer, intends to perform at the external provider’s premises.

trol of Externally Provided Products and Services: Information for External Providers

ommunicate with external


ow do you ensure the
specified requirements?

nfo:
ation shall ensure the adequacy of specified requirements prior to their communication to the external provider.
mation for External Providers - Supplemental

ganization pass down all applicable statutory and regulatory requirements and special product and process character
ers and require the suppliers to cascade all applicable requirements down the supply chain to the point of manufactu
duction and Service Provision: Control of Production and Service Provision

olled conditions do you have for


and service provision, including
post-delivery activities?

nfo:
ation shall implement controlled conditions for production and service provision, including delivery and post-delivery
duction and Service Provision: Control of Production and Service Provision
w controlled conditions for:
bility of documented information defining the characteristics of
s and services;
bility of documented information defining the activities to be
and the results to be achieved;
g and measurement activities at appropriate stages to verify that criteria
f processes and process outputs, and acceptance criteria for
d services, have been met.
nd control of suitable infrastructure and process environment;
bility and use of suitable monitoring and measuring resources;
etence and, where applicable, required qualification of persons;
tion, and periodic revalidation, of the ability to achieve planned results of
for production and service provision where the resulting output cannot
by subsequent monitoring or measurement;
mentation of products and services release, delivery and post-delivery activities.
nfo:
onditions shall include, as applicable: a) the availability of documented information that defines the characteristics o
d services;
bility of documented information that defines the activities to be performed and the results to be achieved;
g and measurement activities at appropriate stages to verify that criteria for control of processes and process output
criteria for products and services, have been met.
nd control of suitable infrastructure and process environment;
bility and use of suitable monitoring and measuring resources;
etence and, where applicable, required qualification of persons;
tion, and periodic revalidation, of the ability to achieve planned results of any process for production and service pro
esulting output cannot be verified by subsequent monitoring or measurement;
mentation of products and services release, delivery and post-delivery activities.

rol Plan
ganization develop control plans (in accordance with Annex A) at the system, subsystem, component, and / or materi
manufacturing site and all product supplied, including those for processes producing bulk materials as well as parts?
s acceptable for bulk material and similar parts using a common manufacturing process? Does the organization have
launch and production that shows linkage and incorporates information from the design risk analysis (if provided by
process flow diagram, and manufacturing process risk analysis outputs (such as FMEA)? Does the organization, if requ
rovide measurement and conformity data collected during execution of either the pre-launch or production control p
tion include in the control plan: a) controls used for the manufacturing process control, including verification of job s
t-off part validation, as applicable; c) methods for monitoring of control exercised over special characteristics (see An
both the customer and the organization; d) the customer-required information, if any; e) specified reaction plan (see
nforming product is detected, the process becomes statistically unstable or not statistically capable? Does the organi
rol plans, and update as required, for any of the following: f) the organization determines it has shipped nonconform
mer; g) when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, p
nges, or risk analysis (FMEA) (see Annex A); h) after a customer complaint and implementation of the associated corr
n applicable; i) at a set frequency based on a risk analysis? If required by the customer, does the organization obtain c
er review or revision of the control plan?

dardised Work - Operator Instructions and Visual Standards

ganization ensure that standardised work documents are: a) communicated to and understood by the employees wh
for performing the work; b) legible; c) presented in the language(s) understood by the personnel responsible to follo
or use at the designated work area(s)? Do the standardised work documents also include rules for operator safety?
fication of Job Set-Ups
ganization: a) verify job set-ups when performed, such as an initial run of a job, material changeover, or job change th
p; b) maintain documented information for set-up personnel; c) use statistical methods of verification, where applicab
t-off/last-off part validation, as applicable; where appropriate, are first-off parts retained for comparison with the last
opriate, are last-off parts retained for comparison with first-off parts in subsequent runs; e) retain records of process
roval following set-up and first-off/last-off part validations?
fication After Shutdown
ganization define and implement the necessary actions to ensure product compliance with requirements after a plan
production shutdown period?
Productive Maintenance

ganization develop, implement, and maintain a documented total productive maintenance system? At a minimum, do
de the following: a) identification of process equipment necessary to produce conforming product at the required vo
of replacement parts for the equipment identified in item a); c) provision of resource for machine, equipment, and fa
e; d) packaging and preservation of equipment, tooling, and gauging; e) applicable customer-specific requirements; f
d maintenance objectives, for example: OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failure), a
To Repair), and Preventive Maintenance compliance metrics? Does performance to the maintenance objectives form
ement review (see ISO 9001, Section 9.3); g) regular review of maintenance plan and objectives and a documented ac
orrective actions where objectives are not achieved; h) use of preventive maintenance methods; i) use of predictive
e methods, as applicable; j) periodic overhaul?
agement of Production Tooling and Manufacturing, Test, Inspection Tooling and Equipment
ganization provide resources for tool and gauge design, fabrication, and verification activities for production and serv
d for bulk materials, as applicable? Does the organization establish and implement a system for production tooling
nt, whether owned by the organization or the customer, including: a) maintenance and repair facilities and personnel
y; c) set-up; d) tool-change programmes for perishable tools; e) tool design modification documentation, including en
of the product; f) tool modification and revision to documentation; g) tool identification, such as serial or asset num
as production, repair or disposal; ownership; and location. Does the organization verify that customer-owned tools,
ng equipment, and test/inspection equipment are permanently marked in a visible location so that the ownership an
of each item can be determined? Does the organization implement a system to monitor these activities if any work is
?
uction Scheduling

ganization ensure that production is scheduled in order to meet customer orders/demands such as Just-In-Time (JIT)
y an information system that permits access to production information at key stages of the process and is order drive
tion include relevant planning information during production scheduling, e.g. customer orders, supplier on-time deli
e, capacity, shared loading (multi-part station), lead time, inventory level, preventive maintenance, and calibration?
duction and Service Provision: Identification and Traceability

s do you use to identify process outputs to ensure conformity of products and services?

nfo:
ssary to ensure conformity of products and services, the organization shall use suitable means to identify process ou
duction and Service Provision: Identification and Traceability
identify the status of process outputs?

nfo:
ation shall identify the status of process outputs with respect to monitoring and measurement requirements through
and service provision.
duction and Service Provision: Identification and Traceability

control the unique identification of process outputs, where applicable? What documented information do you retain

nfo:
ability is a requirement, the organization shall control the unique identification of the process outputs, and retain an
d information necessary to maintain traceability.

ss outputs are the results of any activities which are ready for delivery to the organization’s
to an internal customer (e.g. receiver of the inputs to the next process); they can include
rvices, intermediate parts, components, etc.
tification and Traceability - Supplemental
e of traceability is to support identifaction of clear start and stop points for product received by the customer or in th
quality and/or safety-related nonconformities. Therefore, does the organization implement identification and tracea
s described below? Does the organization conduct an analysis of internal, customer, and regulatory traceability requir
ve products, including developing and documenting traceability plans, based on the levels of risk or failure severity fo
customers, and consumers? Do these plans define the appropriate traceability systems, processes, and methods by p
d manufacturing location that: a) enable the organization to identify nonconforming and/or suspect product; b) enab
to segregate nonconforming and/or suspect product; c) ensure the ability to meet the customer and/or regulatory r
ments; d) ensure documented information is retained in the format (electronic, hardcopy, archive) that enables the
to meet the response time requirements; e) ensure serialized identification of individual products, if specified by the
y standards; f) ensure the identification and traceability requirements are extended to externally provided products w
atory characteristics?
duction and Service Provision: Property Belonging to Customers or External Providers

o you provide for customer or external provider’s property while under your control?
identify, verify, protect and safeguard that property which is provided for use or incorporation into your products or

nfo:
ation shall exercise care with property belonging to the customer or external providers while it is under the organizati
eing used by the organization. The organization shall identify, verify, protect and safeguard the customer’s or externa

use or incorporation into the products and services.


duction and Service Provision: Property Belonging to Customers or External Providers
s do you use to report to the customer or external provider if their property is incorrectly used, lost, damaged or foun
or use?

nfo:
erty of the customer or external provider is incorrectly used, lost, damaged or otherwise found to be unsuitable for u
shall report this to the customer or external provider.

mer property can include material, components, tools and equipment, customer premises, intellectual property and

duction and Service Provision: Preservation

ensure preservation of process


ng production and service
maintain conformity to product
ts?

nfo:
ation shall ensure preservation of process outputs during production and service provision, to the extent necessary to
o requirements.

rvation can include identification, handling, packaging, storage, transmission or transportation, and protection.
ervation - Supplemental
vation include identification, handling, contamination control, packaging, storage, transmission or transportation, an
Does preservation apply to materials and components from external and/or internal providers from receipt through
ipment and until delivery to/acceptance by the customer? In order to detect deterioration, does the organization ass
planned intervals the condition of product in stock, the place/type of storage container, and the storage environmen
use an inventory management system to optimize inventory turns over time and ensure stock rotation, such as "first
Does the organization ensure that obsolete product is controlled in a manner similar to that of nonconforming prod
s comply with preservation, packaging, shipping, and labeling requirements as provided by their customers?
duction and Service Provision: Post - Delivery Activities

meet requirements for post- delivery activities associated with products and services?

nfo:
e, the organization shall meet requirements for post-delivery activities associated with the products and services.
duction and Service Provision: Post - Delivery Activities
determine: Risk;
and intended lifetime; Customer feedback;
d Regulatory requirements, when determining the extent of post- delivery activities required with products and serv

nfo:
ng the extent of post-delivery activities that are required, the organization shall consider: a) the risks associated with
d services;
e, use and intended lifetime of the products and services;
feedback;
and regulatory requirements.

elivery activities can include actions under warranty provisions, contractual obligations such as maintenance services
ary services such as recycling or final disposal.
back of Information from Service

ganization ensure that a process for communication of information on service concerns to manufacturing, material h
gineering, and design activities is established, implemented, and maintained?

nfo:
intent of the addition of "service concerns" to this sub-clause is to ensure that the organization is aware of nonconfo
nd material(s) that may be identified at the customer location or in the field. NOTE 2: "Service Concerns" should inclu
ld failure test analysis (see Section 10.2.6) where applicable.
ce Agreement with Customer
is a service agreement with the customer, does the organization: a) verify that the relevant service centres comply w
equirements; b) verify the effectiveness of any special purpose tools or measurement equipment; c) ensure that all se
re trained in applicable requirements?
duction and Service Provision: Control of Changes

review and control unplanned changes to ensure continuing conformity with specified requirements?

nfo:
ation shall review and control unplanned changes essential for production or service provision to the extent necessar
onformity with specified requirements.
duction and Service Provision: Control of Changes

mented information can you show me which describes the results of reviews of changes, the personnel authorizing ch
ry actions?

nfo:
ation shall retain documented information describing the results of the review of changes, the personnel authorizing
any necessary actions.
rol of Changes - Supplemental
ganization have a documented process to control and react to changes that impact product realization? Are the effec
uding those changes caused by the organization, the customer, or any supplier, assessed? Does the organization: a) d
and validation activities to ensure compliance with customer requirements; b) validate changes before implementati
he evidence of related risk analysis; d) retain records of verification and validation? Do changes, including those made
quire a production trial run for verification of changes (such as changes to part design, manufacturing location, or
ng process) to validate the impact of any changes on the manufacturing process? When required by the customer, d
: e) notify the customer of any planned product realization changes after the most recent product approval; f) obtain
d approval, prior to implementation of the change; g) complete additional verification or identification requirements,
rial run and new product validation?
mporary Change of Process Controls

ganization identify, document, and maintain a list of the process controls, including inspection, measuring, test, and e
vices, that includes the primary process control and the approved back-up or alternate methods? Does the organizati
he process that manages the use of alternate control methods? Does the organization include in this process, based o
h as FMEA), severity, and the internal approvals to be obtained prior to production implementation of the alternate
fore shipping product that was inspected or tested using the alternate method, if required, does the organization ob
m the customer(s)? Does the organization maintain and periodically review a list of approved alternate process contr
renced in the control plan? Are standard work instructions available for each alternate process control method? Doe
review the operation of alternate process controls on a daily basis, at a minimum, to verify implementation of stand
al to return to the standard process as defined by the control plan as soon as possible? Example methods include but
e following: a) daily quality focused audits (e.g. layered process audits, as applicable); b) daily leadership meetings. Is
documented for a defined period based on severity and confirmation that all features of the error-proofing device or
ly reinstated? Does the organization implement traceability of all product produced while any alternate process cont
s are being used (e.g. verification and retention of first piece and last piece from every shift)?
se of Products and Services

lanned arrangement have been implemented at appropriate stages to verify product and service requirements have
hat evidence you retain.

nfo:
ation shall implement the planned arrangements at appropriate stages to verify that product and service requiremen
vidence of conformity with the acceptance criteria shall be retained.
se of Products and Services

he release of products and services is held until planned arrangements for verification of conformity have been satisf
unless approved
t authority, or the customer if applicable. Show documented information which shows traceability to the person auth
roducts and services.

nfo:
of products and services to the customer shall not proceed until the planned arrangements for verification of confor
ctorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. Document
shall provide traceability to the person(s) authorizing release of products and services for delivery to the customer.
e of Products and Services - Supplemental

ganization ensure that the planned arrangements to verify that the product and service requirements have been met
the control plan and are documented as specified in the control plan (see Annex A)? Does the organization ensure th
angements for the intial release of products and services encompass product or service approval? Does the organizati
t or service approval is accomplished after changes following initial release, according to ISO 9001, Section 8.5.6?
Inspection and Functional Testing
nspection and a functional verification to applicable customer engineering material and performance standards perfo
t as specified in the control plans? Are results available for customer review?

nfo:
out inspection is the complete measurement of all product dimensions shown on the design record(s). NOTE 2: The f
pection is determined by the customer.
rance Items

tions manufacturing parts designated by the customer as "appearance items", does the organization provide the foll
resources, including lighting, for evaluation; b) masters for colour, grain, gloss, metallic brilliance, texture, distinctnes
aptic technology, as appropriate; c) maintenance and control of appearance masters and evaluation equipment; d) v
nel making appearance evaluations are competent and qualified to do so?
ation and Acceptance of Conformity of Externally Provided Products and Services

ganization have a process to ensure the quality of externally provided processes, products, and services utilizing one
g methods: a) receipt and evaluation of statistical data provided by the supplier to the organization; b) receiving insp
ng, such as sampling based on performance; c) second-party or third-party assessments or audits of supplier sites wh
s of acceptable delivered product conformance to requirements; d) part evaluation by a designated laboratory; e) ano
eed with the customer?
ory and Regulatory Conformity

ase of externally provided products into its production flow, does the organization confirm and is it able to provide ev
lly provided processes, products, and services conform to the latest applicable statutory, regulatory, and other requir
s where they are manufactured and in the customer-identified countries of destination, if provided?
ance Criteria
e criteria defined by the organization and, where appropriate or required, approved by the customer? For attributed
the acceptance level zero defects (see Section 9.1.1.1)?
ol of Non-Conforming Process Outputs, Products and Services

identify and control process outputs, products and services that do not conform to requirements and prevent their u
ery?

nfo:
ation shall ensure process outputs, products and services that do not conform to requirements are identified and con
r unintended use or delivery.
ol of Non-Conforming Process Outputs, Products and Services

priate corrective actions are taken based on the nature of the nonconformity and its impact on the conformity of pro
ow do you apply this to nonconformity detected after delivery?

nfo:
ation shall take appropriate corrective action based on the nature of the nonconformity and its impact on the conform
d services. This applies also to nonconforming products and services detected after delivery of
s or during the provision of the service.
ol of Non-Conforming Process Outputs, Products and Services
al with nonconforming process outputs, products and services in terms of: Correction;
, containment, return or suspension of provision of products and services?
e customer?
uthorization for use as-is? Release, continuation or re-provision of the products and service?
under concession?

nfo:
e, the organization shall deal with nonconforming process outputs, products and services in one or more of the follow
n;
on, containment, return or suspension of provision of products and services;
the customer;
authorization for:

ntinuation or re-provision of the products and services;


e under concession.

ol of Non-Conforming Process Outputs, Products and Services

verify conformance where process outputs, products and services are corrected following nonconformance?

nfo:
onforming process outputs, products and services are corrected, conformity to the requirements shall be verified.
ol of Non-Conforming Process Outputs, Products and Services
mented information do you keep following actions taken to address nonconformities, including any concessions obtai
or authority
he decision regarding dealing with the nonconformance.

nfo:
ation shall retain documented information of actions taken on nonconforming process outputs, products and services
essions obtained and on the person or authority that made the decision regarding dealing with the nonconformity.
omer Authorization for Concession

ganization obtain a customer concession or deviation permit prior to further processing whenever the product or ma
fferent from that which is currently approved? Does the organization obtain customer authorization prior to further
s" and rework dispositions of nonconforming product? If sub-components are reused in the manufacturing process, i
reuse clearly communicated to the customer in the concession or deviation permit? Does the organization maintain
on date or quantity authorized under concession? Does the organization also ensure compliance with the original or s
ns and requirements when the authorization expires? Is material shipped under concession properly identified on eac
his applies equally to purchased product)? Does the organization approve any requests from suppliers before submis

rol of Nonconforming Product - Customer - Specified Process


ganization comply with applicable customer-specified controls for nonconforming product(s)?
rol of Suspect Product
ganization ensure that product with unidentified or suspect status is classified and controlled as nonconforming prod
tion ensure that all appropriate manufacturing personnel receive training for containment of suspect and nonconfor

rol of Reworked Product


ganization utilize risk analysis (such as FMEA) methodology to assess risks in the rework process prior to a decision to
equired by the customer, does the organization obtain approval from the customer prior to commencing rework of t
es the organization have a documented process for rework confirmation in accordance with the control plan or othe
d information to verify compliance to original specifications? Are instructions for disassembly or rework, including re-
ility requirements, accessible to and utilized by the appropriate personnel? Does the organization retain documented
on the disposition of reworked product including quantity, disposition, disposition date, and applicable traceability in
rol of Repaired Product

ganization utilize risk analysis (such as FMEA) methodology to assess risks in the repair process prior to a decision to r
es the organization obtain approval from the customer before commencing repair of the product? Does the organiza
d process for repair confirmation in accordance with the control plan or other relevant documented information? Are
for disassembly or repair, including re-inspection and traceability requirements, accessible to and utilized by the app
Does the organization obtain a documented customer authorization for concession for the product to be repaired? D
retain documented information on the disposition of repaired product including quantity, disposition, disposition da
aceability information?
omer Notification
ganization immediately notify the customer(s) in the event that nonconforming product has been shipped? Is initial
tion followed with detailed documentation of the event?
conforming Product Disposition

ganization have a documented process for disposition of nonconforming product not subject to rework or repair? For
requirements, does the organization verify that the product to be scrapped is rendered ununsable prior to disposal?
shall not divert nonconforming product to service or other use without prior customer approval.
ance Evaluation
nitoring, Measurement, Analysis and Evaluation: General
ou determine: What needs to be monitored and measured?
monitoring, measurement, analysis and evaluation to ensure valid results?
rform monitoring and measuring?
s shall be analysed and evaluated?

nfo:
ation shall determine:
ds to be monitored and measured; b) the methods for monitoring, measurement, analysis and evaluation, as applica
results;
monitoring and measuring shall be performed;
results from monitoring and measurement shall be analysed and evaluated.
nitoring, Measurement, Analysis and Evaluation: General

mented information can you show that monitoring and measurement activities have been implemented in accordanc
requirements?

nfo:
ation shall ensure that monitoring and measurement activities are implemented in accordance with the determined
ts and shall retain appropriate documented information as evidence of the results.
nitoring, Measurement, Analysis and Evaluation: General

ou evaluate the quality performance and the effectiveness of the QMS.


nfo:
ation shall evaluate the quality performance and the effectiveness of the quality management system.
itoring and Measurement of Manufacturing Processes
ganization perform process studies on all new manufacturing (including assembly or sequencing) processes to verify
nd to provide additional input for process control, including those for special characteristics?

nfo:
ome manufacturing processes, it may not be possible to demonstrate product compliance through process capability
lternate methods such as batch conformance to specification may be used. The organization shall maintain manufact
ability or performance results as specified by the customer's part approval process requirements. The organization sh
cess flow diagram, PFMEA, and control plan are implemented, including adherence to the following: a) measuremen
b) sampling plans; c) acceptance criteria; d) records of actual measurement values and/or test results for variable da
ns and escalation process when acceptance criteria are not met. Significant process events, such as tool change or m
be recorded and retained as documented information. The organization shall initiate a reaction plan indicated on the
aluated for impact on compliance to specifications for characteristics that are either not statistically capable or are un
on plans shall include containment of product and 100 percent inspection, as appropriate. A corrective action plan sh
nd implemented by the organization indicating specific actions, timing, and assigned responsibilities to ensure that t
able and statistically capable. The plans shall be reviewed with and approved by the customer, when required. The or
in records of effective dates of process changes.
tification of Statistical Tools
ganization determine the appropriate use of statistical tools? Does the organization verify that appropriate statistical
part of the advanced product quality planning (or equivalent) process and included in the design risk analysis (such a
icable), the process risk analysis (such as PFMEA), and the control plan?
ication of Statistical Concepts
al concepts, such as variation, control (stability), process capability, and the consequences of over-adjustment, under
ployees involved in the collection, analysis, and management of statistical data?
nitoring, Measurement, Analysis and Evaluation: Customer Satisfaction
monitor customer perception of the degree to which requirements have been met?

nfo:
ation shall monitor customer perceptions of the degree to which requirements have been met.
nitoring, Measurement, Analysis and Evaluation: Customer Satisfaction

obtain information relating to customer views and opinions of your products and services?

nfo:
ation shall obtain information relating
views and opinions of the organization and its products and services.
nitoring, Measurement, Analysis and Evaluation: Customer Satisfaction

ods for obtaining and using this information do you have?

nfo:
s for obtaining and using this information shall be determined.

mation related to customer views can include customer satisfaction or opinion surveys, customer data on delivered pr
lity, market-share analysis, compliments, warranty claims and dealer reports.
omer Satisfaction - Supplemental
satisfaction with the organization monitored through continual evaluation of internal and external performance indic
pliance to the product and process specifications and other customer requirements? Are performance indicators bas
idence and include but not limited to the following: a) delivered part quality performance; b) customer disruptions; c
alls, and warranty (where applicable); d) delivery schedule performance (including incidents of premium freight); e) c
related to quality or delivery issues, including special status? Does the organization monitor the performance of ma
o demonstrate compliance with customer requirements for product quality and process efficiency? Does the monitor
of customer performance data including online customer portals and customer scorecards, where provided?
nitoring, Measurement, Analysis and Evaluation: Analysis and Evaluation

ou analyse and evaluate data and information arising from monitoring, measurement and other sources.

nfo:
ation shall analyse and evaluate appropriate data and information arising from monitoring, measurement and other s
nitoring, Measurement, Analysis and Evaluation: Analysis and Evaluation
he output of analysis and evaluation is used to:
e conformity of products and services to requirements?
enhance customer satisfaction?
ormity and effectiveness of the

e that planning has been successfully implemented?


ess performance?
ormance of external providers? Determine the need or opportunities for improvements within the QMS?

nfo:
of analysis and evaluation shall be used to:
ate conformity of products and services to requirements;
d enhance customer satisfaction; c) ensure conformity and effectiveness of the quality management system;
ate that planning has been successfully implemented;
e performance of processes;
performance of external provider(s); g) determine the need or opportunities for improvements within the quality m

nitoring, Measurement, Analysis and Evaluation: Analysis and Evaluation

the results of analysis and evaluation are used to provide inputs to management review.

nfo:
of analysis and evaluation shall also be used to provide inputs to management review.
itization
n quality and operational performance compared with progress toward objectives and lead to action to support prior
mproving customer satisfaction?
rnal Audit

audits being conducted at


ervals? Do they determine
QMS conforms to the
ts of ISO 9001 and to the other
ts established by Organization?
ords to demonstrate
e)
ermine whether the QMS is
mplemented and maintained?
ords)
nfo:
ation shall conduct internal audits at planned intervals to provide information on whether the quality management sy
to:
ization’s own requirements for its quality management system;
rements of this International

ely implemented and maintained.

rnal Audit
w audit programme(s) that takes into consideration the quality
mportance of the processes, customer feedback, changes impacting the organization and the results of previous aud
he audit criteria and scope for each audit?
monstrate that selection of auditors and the conduct of audits are objective and impartial and that auditors
their own work?
dit results reported to relevant management?
monstrate that necessary correction and corrective actions are taken without undue delay?
w documented information of the audit programme and the audit results?

nfo:
ation shall:
blish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning
ts and reporting, which shall take into consideration the quality objectives, the importance of the processes concerne
edback, changes
n the organization, and the results of previous audits;
e audit criteria and scope for each audit;
ditors and conduct audits to ensure objectivity and the impartiality of the audit process; d) ensure that the results of

relevant management;
ssary correction and corrective actions without undue delay;
umented information as evidence of the implementation of the audit programme and the audit results.

O 19011 for guidance.


nal Audit Programme

ganization have a documented internal audit process? Does the process include the development and implementatio
it programme that covers the entire quality management system including quality management system audits, manu
its, and product audits? Is the audit programme prioritized based upon risk, internal and external performance trend
the process(es)? Where the organization is responsible for software development, does the organization include soft
nt capability assessments in their internal audit programme? Is the frequency of audits reviewed and, where appropr
sed on occurrence of process changes, internal and external nonconformities, and/or customer complaints? Is the eff
programme reviewed as a part of management review?
ity Management System Audit

ganization audit all quality management system processes over each three-year calendar period, according to an ann
using the process approach to verify compliance with this Automotive QMS Standard? Integrated with these audits,
sample customer-specific quality management system requirements for effective implementation?
ufacturing Process Audit

ganization audit all manufacturing processes over each three-year calendar period to determine their effectiveness a
ing customer-specified required approaches for process audits? Where not defined by the customer, does the organ
he approach to be used? Within each individual audit plan, is each manufacturer process audited on all shifts where
e appropriate sampling of the shift handover? Does the manufacturing process audit include an audit of the effective
tion of the process risk analysis (such as PFMEA), control plan, and associated documents?
uct Audit

ganization audit products using customer-specific required approaches at appropriate stages of production and delive
o specified requirements? Where not defined by the customer, does the organization define the approach to be used
nagement Review

frequency that top management reviews the organization's QMS? How is the QMS deemed suitable, adequate and e

nfo:
ment shall review the organization's quality management system, at planned intervals, to ensure its continuing suitab
nd effectiveness.
nagement Review

of information are reviewed in management reviews? These must include: actions status of previous reviews;
nternal/external issues relevant to the QMS; issues that affect strategy;
conformities and corrective actions; monitor and measurement of results; audit results; customer satisfaction;
rning external providers; issues concerning other relevant parties; adequacy of resources and effectiveness of QMS;
ormance; conformity of products and services; actions taken to address risks and opportunities and their effectivene
portunities for continual improvement.
nfo:
ment review shall be planned and carried out taking into consideration:
of actions from previous management reviews;
n external and internal issues that are relevant to the quality management system including its strategic direction;
on on the quality performance, including trends and indicators for:
rmities and corrective actions;
ng and measurement results;
ults;
satisfaction;
ncerning external providers and other relevant interested parties;
of resources required for maintaining an effective quality management system;
erformance and conformity of products and services;
tiveness of actions taken to address risks and opportunities (see clause 6.1);
ntial opportunities for continual improvement.

agement Review - Supplemental


ent review conducted at least annually? Is the frequency of management review(s) increased based on risk to compl
quirements resulting from internal or external changes impacting the quality management system and performance-
management reviews include decisions and actions relating to: Continual improvement opportunities;
r changes to the QMS including resource needs.

nfo:
of the management review shall include decisions and actions related to:
improvement opportunities; b) any need for changes to the quality management system, including resource needs.

documented information you have as evidence of management reviews.

nfo:
ation shall retain documented information as evidence of the results of management reviews.
agement Review Inputs - Supplemental

o management review include: a) cost of poor quality (cost of internal and external nonconformance); b) measures o
s; c) measures of process efficiency; d) product conformance; e) assessments of manufacturing feasibility made for c
rations and for new facilities or new product (see Section 7.1.3.1); f) customer satisfaction (see ISO 9001, Section 9.1
rformance against maintenance objectives; h) warranty performance (where applicable); i) review of customer score
icable); j) identification of potential field failures identified through risk analysis (such as FMEA); k) actual field failure
afety or the environment?
agement Review Outputs - Supplemental
anagement document and implement an action plan when customer performance targets are not met?

ement
eral
determine and select opportunities for improvement? What necessary actions have you implemented so that you h
quirements and enhanced customer satisfaction?

nfo:
ation shall determine and select opportunities for improvement and implement necessary actions to meet customer
ts and enhance customer satisfaction.
eral

ou have: Improved processes to prevent nonconformities;


oducts and services to meet known and predicted requirements; Improved QMS results.

nfo:
clude, as appropriate: a) improving processes to prevent nonconformities;
g products and services to meet known and predicted requirements;
quality management system results.

vement can be effected reactively (e.g. corrective action), incrementally (e.g. continual improvement), by step chang
h), creatively (e.g. innovation) or by re-organization (e.g. transformation).
nconformity and Corrective Action
onformities occur, show how;
ake action to control and correct it;
e consequences; Evaluate the need for action to eliminate
that it does not recur or occur elsewhere by:
he nonconformity; Determining the cause of the
ity; Determining if similar nonconformities exist
entially occur; Actions needed are implemented;
effectiveness of corrective actions taken, if any;
sary changes to the QMS.
nfo:
conformity occurs, including those arising from complaints, the organization shall: a) react to the nonconformity, and

n to control and correct it;


the consequences;
the need for action to eliminate the
he nonconformity, in order that it does
occur elsewhere, by:
the nonconformity;
ng the causes of the nonconformity;
ng if similar nonconformities exist, or
tially occur;
nt any action needed;
e effectiveness of any corrective action taken;
nges to the quality management system, if necessary.
nconformity and Corrective Action

orrection actions were appropriate to the effects of the nonconformities encountered.

nfo:
ctions shall be appropriate to the effects of the nonconformities encountered.

ome instances, it can be impossible to eliminate the cause of a nonconformity. NOTE 2 Corrective action can reduce t
recurrence to an acceptable level.

mented information can you


dence of:
of the nonconformities and
actions taken;
of any corrective action.

nfo:
ation shall retain documented information as evidence of:
e of the nonconformities and any subsequent actions taken;
s of any corrective action.
em Solving
ganization have a documented process(es) for problem solving including: a) defined approaches for various types and
.g. new product development, current manufacturing issues, field failures, audit findings); b) containment, interim ac
ities necessary for control of nonconforming outputs (see ISO 9001, Section 8.7); c) root cause analysis, methodolog
d results; d) implementation of systemic corrective actions, including consideration of the impact on similar processe
verification of the effectiveness of implemented corrective actions; f) reviewing and, where necessary, updating the
e documented information (e.g. PFMEA, control plan). Where the customer has specified prescribed processes, tools
solving, does the organization use those processes, tools, or systems, unless otherwise approved by the customer?
-Proofing

ganization have a documented process to determine the use of appropriate error-proofing methodologies? Are detai
d documented in the process risk analysis (such as PFMEA) and are test frequencies documented in the control plan?
ude the testing of error-proofing devices for failure or simulated failure? Are records maintained? Are challenge parts
fied, controlled, verified, and calibrated where feasible? Do error-proofing device failures have a reaction plan?
anty Management Systems

rganization is required to provide warranty for their product(s), does the organization implement a warranty manage
es the organization include in the process a method for warranty part analysis, including NTF (no trouble found)? Wh
the customer, does the organization implement the required warranty management process?
mer Complaints and Field Failure Test Analysis

ganization perform analysis on customer complaints and field failures, including any returned parts, and does it intiat
corrective action to prevent recurrence? Where requested by the customer, does this include analysis of the interacti
oftware of the organization's product within the system of the final customer's product? Does the organization comm
f testing/analysis to the customer and also within the organization?
tinual Improvement
e that you continually improve the suitability, adequacy and effectiveness of the QMS.

nfo:
ation shall continually improve the suitability, adequacy, and effectiveness of the quality management system.
tinual Improvement

e that outputs of analysis and evaluation and the outputs from management review are considered to confirm if ther
formance or opportunities that shall be addressed as part of continual improvement.

nfo:
ation shall consider the outputs of analysis and evaluation, and the outputs from management review, to confirm if th
derperformance or opportunities that shall be addressed as part of continual improvement.
tinual Improvement

able tools and methodologies for investigation of the causes of underperformance and to support continual improve

nfo:
cable, the organization shall select and utilise applicable tools and methodologies for investigation of the causes of
mance and for supporting continual improvement.
nual Improvement - Supplemental
ganization have a documented process for continual improvement? Does the organization include in this process the
tion of the methodology used, objectives, measurement, effectiveness, and documented information; b) a manufactu
rovement action plan with emphasis on the reduction of process variation and waste; c) risk analysis (such as FMEA)?

nfo:
nual improvement is implemented once manufacturing processes are statistically capable and stable or when produc
cs are predictable and meet customer requirements.
PREPARATION FOR DOCUMENTATION
IMS Documentation
Clause no. Procedure SOP WI
S Documentation Requirment
Form / Check Sheet Department - section code
QUESTIONS

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