A Review ISO 9001:2015 Draft What`s Important to Know Now

A Review ISO 9001:2015 Draft
What’s 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 2008 revised standard
Objective of Revisions
• Enhance an organization’s ability to satisfy
• 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.
• Set a consistent foundation for next 10 years.
What’s New?
• Risk management is being added with focus on risk-based
thinking. Identification of risk and risk control now a
• 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
• Revisions allow ISO 9001 to be more applicable by “servicebased” 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
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
Client Transition
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
Client Transition
September 2015
Published International Standard
September 2015 start of 3 years
transition period to September 2018
What Should an Organization do
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
Looking ahead…existing 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 plan, if you don’t have one. Begin
thinking how to address risk in your business.
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.
Four Phases of Risk
Risk Analysis
 INTENDED USE Identification
 HAZARD identification
 RISK estimation
Risk Control
 OPTION analysis
Implementation of measures
RESIDUAL RISK evaluation
Overall RISK acceptance
Risk Evaluation
 RISK acceptability decisions
Post Production
 Post-production experience
experience- customer use
 Take appropriate actions
Where Risk is Addressed in 2013
• 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
• 8.4 Control of External Processes or Products- evaluation
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 & Updates
• Once ISO 9001 is revised, expect to see changes to
industry-specific standards and other supporting
• Monitor ASR’s newsletter and website for future
releases of the revisions to ISO 9001.
• If you have any questions, please contact ASR
– 888-891-9002
[email protected]
Thank you

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