1. So You Want to Know All About the Changes to ISO 9001 …
Sandford Liebesman, Ph.D.
Member US TAG to ISO/TC 176
Present
Recipient of Honorary Lifetime Achievement Award
ISO 9001 was just approved by the ISO/TC 176
The US Tag has some problems with it
Will discuss them later

2. ISO 9001 Evolution US TAG began1984
First two issues of the standard in 1987 & 1994
Check-list structure
Twenty (20) requirements
Check them off
Big changes came in year 2000
All standards go through periodic updates & improvement

3. What Happened in year 2000? No longer a check-list structure
Major additions:
Organizational structure
Process approach
Continual improvement
Measurable objectives
Note: the 2008 revision contained only minor changes
. Process Approach :Since ISO 9001:2000 the standard has defined a system of processes. It stopped being a check list standard in What is a process? It takes inputs from suppliers and converts them to outputs for customers. Suppliers and customers can be internal, external or both. Now in order to operate effectively a process must be managed by a single person or a team with a team leader. In any case it must have a process owner. All processes have constraints (stated or subtle) and use resources. All organizations operate using a set of processes. A major problem is getting them to work together. This is a simple, direct view of the process approach. Are there any comments

4. Annex SL Published in 2012
New or revised MSS are required to use Annex SL
Goal is to standardize all MSS
Prescribed structure
Identical requirements/text
Common terms & core definitions
Facilitates integration of multiple MSSs
Identical requirements/ identical text
Annex SL goal MSS having the same structure work better together

5. 9001 Restructured in 2015 Uses the Process Approach
Plan the processes & their tnteraction
More emphasis on risk
What are the risk factors?
Identify actions to address risks
Changed the clause structure of the standard
From 8 clauses to 10 because of Annex SL
Applicability of requirements
Replaced “exclusions”
Process approach: systematic definition Using PDCA for structure (See Sections & 0.3.2)
Use risk-based Thinking enables use of preventive controls (See Sections & A.4)
What are the risk factors?
Taking action to prevent re-occurrence
Annex A Clarification

6. Restructured (Cont.) The Context of the Organization (Clause 4.1)
External & internal issues relevant to purpose & strategy
Needs & expectations of interested parties (Clause 4.2)
Scope of the QMS (Clause 4.3) considering:
External & internal issues
Needs & expectations of interested parties
Products & services of the organization
Scope maintained as documented information
This part of the standard is very important & not well written!!

7. Address Risk & Opportunities
Determine the risks & opportunities to achieve intended results
Plan actions to address these risks & opportunities
Enhance desirable effects & achieve improvement
Prevent or reduce undesired effects
ISO is a guide to “risk-based thinking”
Section 6.1 “specifies the Org shall plan actions to address risks.”
But no requirements for risk management
See Section A.4 (Risk-based thinking)

8. Types of Risks Strategic: loss from pursuing poor business plan
Compliance: legal or regulatory
Organizational: external or internal
Operational: 7 sub-risks

9. Operational Risks Management system risks Customer satisfaction risks
Supply chain risks
Revenue recognition risks
Information security risks
Logistics risks
Natural disaster risks

10. Terminology Changes Products becomes “Products & Services”
“Exclusions” omitted
No requirements for:
Management representative *
Quality Manual*
* I recommend continuing to maintain them
Not a change in requirements, only in terminology

11. ISO 9001:2008 Clauses 1. Scope 2. Application 3. Terms & Definitions
4. Quality Management System
5. Management Responsibilities
6. Human Resources
7. Product Realization
8. Measurement, Analysis & Improvement
9001:2015 increased the number clauses from 8 to 10.

12. ISO 9001:2015 1. Scope 2. Normative References 3. Terms & Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operations
9. Performance Evaluation
10. Improvement
9001:2015 increased the number clauses from 8 to 10 because of requirements in Annex SL created to align existing & future ISO MSSs

13. Leadership A very important addition to the standard
11 requirements to ensure commitment
Includes
Assuring effectiveness of the QMS
Communication of the quality policy
Linking the QMS with business processes
Promoting process approach & continual improvement
Other leadership commitments
See article in this month’s Quality Progress by Paul Palmes

14. Interpretations Clauses 0.1to 0.3 Introduction
Process approach
Risk-based thinking
Quality management principles
Plan-do-check-act cycle
Relation with other standards
Need review and agreement with auditors

15. More Interpretations Annex A contains Important Information
Clarification of new structure, terminology & concepts
Most requirements apply to products & services
Improve alignment with other standards (Annex SL)
Risk-based thinking
Applicability used instead of exclusions
Documented information
Again: need review and agreement with auditors

16. Where do you begin?
Study the risks affecting your organization & develop methods of handling each
Provide training on ISO 9001:2015 factors
New terminology
Process Approach (Clause 0.3.1)
Risk prevention
Assure that objectives are measurable
Assure your interpretations agree with your auditor’s
Read ISO 9001 articles in Quality Progress September 2015
PDCA cycle for all processes
0,2) Quality Management Principles

17. You Have Until 2018 to Comply
Don’t wait until the final months to comply
The changes are wide-spread and effect the entire quality management system
Create a compliance organization
Provide training for your organization
Get help from your auditor and/or your quality consultant as needed
Your auditor should help with interpretations

18. References
8 authors, “Keep Calm and Prepare for ISO 9001:2015,” Quality Progress, September 2015,
Dan Reid, “Open to Change, How Expected Revisions to ISO 9001:2015 may affect Sector Specific Standards,” Quality Progress, July 2015,
Sandford Liebesman, “Brought into Focus, Quality Progress, September 2014,
Paul Palmes, “15 things you must know about the upcoming ISO 9001 revision,” Quality Progress, September 2014,
Debra M. Hay Hampton, “A Step Forward,” Quality Progress, March 2014,
Sandford Liebesman, “Risk Management is a Must in Today’s Global Economy, “Quality Progress, May 2013,