A Review ISO 9001:2015

Draft
Whats Important to Know Now

Prepared by
Rand E Winters, Jr.
Senior ASR Lead Auditor
March 2014

ISO 9001 Under Revision

Review based on ISO Working Draft 9001
6/13.
Further revisions likely to occur.
Firms may wish to consider these changes
and plan accordingly .
New revisions slated for release Sept 2015
with full implementation Sept 2018.
Draft revisions now 21 pages of
requirements compared to 9 pages in the

Objective of Revisions
Enhance an organizations ability to
satisfy customers.
Maintain relevance, provide
integrated approach to
organizational management, and
integrate with other management
systems.
Reflect needs of all user groups and
increasingly complex operating
environments.

Whats New?
Risk management is being added with focus on
risk-based thinking. Identification of risk and risk
control now a requirement.
Standardized core text, structure, definitions
enable organizations with multiple management
systems to achieve improved integration &
implementation.
Major focus on achieving value for organization
and its customers.
Revisions allow ISO 9001 to be more applicable
by service-based organizations.
Primary focus remains on Customers!

What Prompted Revisions?

Business and industry has changed.
Greater diversity of ISO 9001 users
and broader interests of users.
Knowledge and technology
developments.

QMS Structure Re-organized

4. Context of Organization addresses needs
and expectations of interested parties, scope of
QMS
5. Leadership addresses management
commitment, policy, roles, responsibility & authority
6. Planning includes risks, opportunities,
objectives and plans to achieve them, the planning
of changes
7. Support includes resources, competence,
awareness, communication, documented
information

Structure Re-organized
8. Operation includes planning & control,
determine market needs, interaction w/customers,
planning process, control of external provisions of
goods/services, production of goods, provision of
services, release of goods/services, non-conforming
goods/services
9. Performance Evaluation includes monitoring,
measurement, analysis & evaluation, internal audit,
management review

Structure Outlined
10. Improvement addresses non-conformity &
corrective action, improvement

Timeline to Revision Release

and
2013
Client2014
Transition2015
June 2013 CD
(Committee Draft)
April 2014 DIS
(Draft International
Standard)
July 2015 FDIS
(Final Draft International
Standard)
September 2015
(Published International
Standard)

Timeline to Revision Release

and
2015
2016
2017
Client
Transition
2018
September 2015
Published International
Standard

September 2015 start of 3

years transition period to
September 2018

What Should an
Organization do Now?
Nothing at this time

( well almost

nothing).
Still too early in the 2015 revision process of ISO 9001 to make
any significant changes to an existing QMS.
Some issues drafted may change or disappear in upcoming
drafts or with final version.
Looking aheadexisting registered system documentation
should conform with some small adjustments. In most cases,
existing registered organizations should have enough
documentation and records.
Since risk is documented in most sections of proposed
revision to ISO 9001, consider starting your risk management

Considering Risk
Risk is very detailed in this revision to the
standard as compared to ISO 13485, Food
Safety, or Aerospace.
Think about adding/using words that are
typical in the risk process such as risk
determination, risk control, risk mitigation,
acceptable level of risk.
Next slide outlines the four phases of
managing risk, and maybe helpful as an
organization addresses risk to their
business.

4 Fases para la Gestion de

Riesgos

Analisis del Riesgo

Riesgo

Identificacion del Uso INTENSIONADO

Identificacion HAZARD
Estiamar el RISK

Evaluacin del

Decision de acepatacion del

RIESGO

EVALUACION DEL RIESGO

Control Risk

OPTION analysis

Implementation of
measures
RESIDUAL RISK evaluation
Overall RISK acceptance

Inforacion
PostProduction
Post-production experience
Review of RISK MANAGEMENT
experience- customer use
Take appropriate actions

Where Risk is Addressed in

2013 Draft
3.09 Risk - effect of uncertainty (definition)
4.1 Organization shall take account of these
issues for determining risk.
4.4 QMS - determine risk if unintended output
produced.
5.1 Leadership - ensuring risks that could affect
meeting product requirements managed.
6.1 Actions to address risk and opportunities.

Risk Continued
6.3 Planning and Controlling Changes
a) identification of risk and
control measures associated with product
8.4 Control of External Processes or Productsevaluation based on risks and risk control
8.5.1 Design and Development, define c) risk
8.5.3 Implement c) risk control measures
8.6 Execution/Implementation 8.6.1h)
implementation of risk controls
9.3 Management Review b) determined risks

Related Information &

Once ISO 9001Updates
is revised, expect to see
changes to industry-specific standards and
other supporting documents.

Monitor ASRs newsletter and website for

future releases of the revisions to ISO
9001.

If you have any questions, please

contact ASR
888-891-9002
info@asrworldwide.com