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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 2008 revised standard

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.

Set a consistent foundation for next 10 years.

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 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
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


Client Transition
2013

2014

2015

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
2015

2016

2017

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 plan, if you dont 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

RISK ASSESSMENT

Post Production
Information

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 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
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

Thank you