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Requirements – V1.6 © 2015-2016 Whittington & Associates, LLC

ISO 9001:2015

Version 1.6: 02/01/16 © 2015-2016 Whittington & Associates, LLC Slide 1

Transition to

ISO 9001:2015

Whittington & Associates, LLC 6175 Hickory Flat Highway, Suite 110-303, Canton, GA 30115

www.WhittingtonAssociates.com

770-862-1766


Introduction

Prepare for your transition to ISO 9001:2015:

• Annex SL high level clause structure

• Common requirements and definitions

• New and changed requirements

• Word counts show shift in emphasis

• Guidance on transition activities

• Suggestions for transition timing


ISO 9001:2015


ISO 9001 History

1947 – ISO Founded

1979 – BS 5750 Introduction

1980 – TC 176 Formed

1987 – ISO 9001 Introduction

1994 – ISO 9001 Revision

2000 – ISO 9001 Major Revision

2008 – ISO 9001 Revision

2015 – ISO 9001 Major Revision


Reasons for Revision

Standards reviewed every 5 years for relevance.

ISO 9001:2008 needed update for:

• Changing e-business, global economy, and risks

• More applicability for service organizations

• Use of the revised quality management principles

• Improved application of the process approach

• Adoption of the new Annex SL clause structure

• Integration with other management system standards

ISO 9001:2015 will replace ISO 9001:2008.


ISO 9001:2015


Annex SL

High level structure developed by JTCG

(Joint Technical Coordination Group)

• For use by all management system standards

• Aligns format, text, terms, and definitions

• Standards can still add unique requirements

New clause structure is for stating requirements

rather than model for documenting your quality

management system.

Version 1.6 - 02/01/16 © 2015-2016 Whittington & Associates, LLC Slide 6

Dates for Related Standards

ISO 27001:2013 – Issued 9/2013 (using Annex SL)

ISO 9000:2015 – Released 9/2015

ISO/TS 9002:201x – CD level

ISO 14001:2015 – Released 9/2015

AS9100:2016 – 4/2016 (and AS9110, AS9120)

TL 9000, R6.0 – Release 2Q 2016; Effective 9/15/16

ISO 45001:2016 – DIS Stage; Anticipated 10/2016

ISO/TS 16949:2016 – Projected as 12/2016

ISO 13485:2016 – In Publication (not Annex SL)


ISO 9001:2015


Clause Structure

0. Introduction

1. Scope

2. Normative References

3. Terms and Definitions

4. Context of the Organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance Evaluation

10. Improvement

Annex A – Clarification of New Structure, Terminology, and Concepts

Annex B – Other International Standards on Quality Management and Quality

Management Systems Developed by ISO/TC 176

Requirement Grouping


PLAN

4. Context

of the

Organization

5. Leadership

6.

Planning

7. Support

DO

8. Operation

*

CHECK

9. Performance

Evaluation

ACT

10. Improvement

* Most of the unique ISO 9001 requirements are in clause 8.


ISO 9001:2015


Key Changes

• Revised clause structure, core text, common

definitions, and new concepts

• Same core Annex SL requirements across

multiple management system standards

• Much easier to implement and audit an

integrated management system

• Retained ISO 9001:2008 requirements are

moved to new clauses, mostly in clause 8

(Read Introduction and Annex A before Requirement clauses)


Terminology Changes

ISO 9001:2008 ISO 9001:2015

Products Products and services

Exclusions Not used (as applicable; as necessary)

Management representative Not used (responsibilities still covered)

Documented procedures [Maintain] Documented information

Records [Retain] Documented information

Work environment Environment for operation of processes

Purchased product Externally provided products & services

Supplier External provider


ISO 9001:2015


Standard Comparisons - Part 1

Counts 2008 Edition 2015 Edition

Requirement Pages 13 18

Definitions (ISO 9000) 84 146

Shall 136 132

Procedure 10 0

Documented Procedure 6 0

Process 35 57

Record 29 0

Documented Information 0 41


Standard Comparisons - Part 2

Counts 2008 Edition 2015 Edition

Strategic Direction 0 4

Risk 0 16

Knowledge 0 12

Performance 4 16

Output 9 21

Change 13 27

Issues 0 8

Resources 7 15


ISO 9001:2015


Requirement Changes

Context of Organization (4.1) • Understand your business environment

• Determine and monitor internal and external issues

Interested Parties (4.2, A.3) • Determine relevant needs of relevant interested parties

Scope of Quality Management System (4.3) • Focus on scope and applicable requirements

• Scope available as documented information

Applicability (4.3, A.5) … No “exclusions” term • Apply all requirements if applicable within scope

• Maintain as documented information


Additional Changes

Products and Services (A.2) • Most outputs include both products and services

• Service output realized at interface with customer

Process Approach (4.4, 5.1.1.d) • Moved from Introduction to Requirements

• Management must promote process approach

Organizational Knowledge (7.1.6, A.7) • Determine knowledge for operation and conformity

• Maintain knowledge and make available as needed

• Know how to acquire, access, update knowledge


ISO 9001:2015


More Changes

Leadership (5) • Top management more accountable for system

• Policy and objectives compatible with strategy

Documented Information (7.5, A.6) • Less emphasis on documentation

• No mention of documented procedures or records

• Documents and records = documented information

• Documents if “maintain” documented information

• Records if “retain” documented information


Even More Changes

Externally Provided Processes, Products, and

Services (8.4) • Replaces section on Purchasing

• Addresses all forms of external provision

– purchasing from a supplier

– arrangement with associate company

– outsourcing of processes

Control of Changes (8.5.6) • Review and control production or service changes

• Retain documented information on review; actions


ISO 9001:2015


Further Changes

Monitoring and Measuring Resources (7.1.5) • Replaces section on calibration of equipment

• Introduces use of term “resources”

• Adds verification of conformity of services

• Humans may carry out activity without equipment

Improvement (10) • Expansion of different types of improvement

– correction, corrective action,

– continual improvement, breakthrough change,

– innovation, and re-organization.


Other Changes

Risk-Based Thinking (6.1, A.4) • Not really new; Informally do it already

• Determine and address risks and opportunities

• Use planning events to identify and analyze risks

• Increase likelihood of reaching quality objectives

• Reduce probability of negative results

• Don’t want to say “we should’ve seen that coming”

• Replaces the Preventive Action requirements

• Risk only mentioned in ISO 9001:2008, clause 0.1

• Now mentioned 16 times in Requirements


ISO 9001:2015


… And These Changes

Quality Manual - Not Required • Some of its requirements are now in 4.3 and 4.4

• Must maintain “documented information”

• Could decide to keep a revised policy manual

• Any contractual requirements for documents?

• Will potential customers still request a copy?

Management Representative - Not Required • Old requirements are now in 5.3

(Organizational Roles, Responsibilities, and Authorities)

• MR unnecessary if system is embedded in business

• Could retain role, but more done by top management


Transition to ISO 9001:2015

• Synchronize with your external audit schedule

• Complete transition prior to September 2018

• Obtain funding for your transition activities

• Arrange for training on ISO 9001:2015

• Understand “context of organization”

• Determine internal and external issues

• Determine relevant interested parties

• Document QMS scope and any “exclusions”


ISO 9001:2015


Transition to Risk-based Thinking

• Promote risk-based thinking as a preventive tool

• Determine risks and opportunities

• Plan actions to address risks and opportunities

• Understand your options for dealing with risks

• Plan how to integrate actions into processes

• Evaluate effectiveness of the actions on risks

• Review effectiveness of these actions on risks

• See ISO 31000 for risk management guidance

• Consider ISO 22301 for business continuity


Transition Guidance

• Advise top management of new responsibilities

• Ensure visible leadership and accountability

• Align quality policy and objectives with strategy

• Make policy available to interested parties?

• Apply process approach to all key processes

• Integrate requirements into business processes

• Decide on Management Representative role

• Keep or disburse requirements to Management

• Perform gap analysis against new requirements


ISO 9001:2015


More Transition Guidance

• Review transition guidance from your registrar

• Develop your ISO 9001:2015 transition plan

• How communicate plan to your organization?

• How will you mobilize staff for implementation?

• Keep required procedures until transitioned

• Conduct more frequent management reviews

• Conform to ISO 9001:2008 planning (5.4.2, 5.6)

• Update existing system for new requirements

(Identify specific evidence to prove conformity)


Additional Transition Guidance

• Keep your current documents if working well

• Will you restructure and renumber documents?

• Remove references to old standard and clauses

• Consider adding new requirements in phases

• Decide changes needing change management

• Assess new requirements using internal audits

• Be aware that more audit time will be needed

• Use transition to improve quality and business

• Consider integration of management systems


ISO 9001:2015


Transition Timing

• Plan transition audit for next recertification

• Use of recertification audit will add fewer days

• Recertify to ISO 9001:2008 if date is too soon

• Skip to next surveillance for transition audit

• Surveillance will become new recertification

• Move to annual surveillance for more prep time

• Can add special audit for transition, if preferred

• Could use pre-assessment to ensure readiness

• Don’t get caught part in 2008 and part in 2015


Summary of Changes

• Annex SL clause structure and common text

• Expanded applicability to service organizations

• Organizational issues and interested parties

• Alignment of QMS and business strategy

• Focus on risk planning, actions, and monitoring

• Expanded focus on process approach

• Emphasis on outputs and performance

• Demonstration of management leadership


ISO 9001:2015


Summary of Changes

• Maintenance of organizational knowledge

• Purchasing covers all external provision

• More planning and control of changes

• Removal of old requirements: QM, MR, and PA

• Ensuring product and service claims can be met

• Improvement for future needs and expectations

What do you think are other significant changes?

Which changes most impact your organization?


Presentation Handouts

Clause Maps

1. ISO 9001:2008 > ISO 9001:2015 (2 pages)

2. ISO 9001:2015 > ISO 9001:2008 (3 pages)

3. Annex SL Appendix 2 (11 pages)

4. Clause Quick Reference (2 pages)

5. Required Documented Information (3 pages)

6. Quality Management Principles (4 pages)

7. Risk Assessment Worksheets (4 pages)


ISO 9001:2015


Questions

If you have questions about ISO 9001:2015,

contact Larry Whittington at 770-862-1766,

or email [email protected].