So You Want to Know All About the Changes to ISO 9001 … Sandford Liebesman, Ph.D. Member US TAG to ISO/TC 176 1984 --- 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

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

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 2000. 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

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

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 0.3.1 & 0.3.2) Use risk-based Thinking enables use of preventive controls (See Sections 0.3.3 & A.4) What are the risk factors? Taking action to prevent re-occurrence Annex A Clarification

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!!

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 31000 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)

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

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

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

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.

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

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

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

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

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

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

References 8 authors, “Keep Calm and Prepare for ISO 9001:2015,” Quality Progress, September 2015, 18-28. Dan Reid, “Open to Change, How Expected Revisions to ISO 9001:2015 may affect Sector Specific Standards,” Quality Progress, July 2015, 16-23. Sandford Liebesman, “Brought into Focus, Quality Progress, September 2014, 22-29. Paul Palmes, “15 things you must know about the upcoming ISO 9001 revision,” Quality Progress, September 2014, 18-21. Debra M. Hay Hampton, “A Step Forward,” Quality Progress, March 2014, 38-43. Sandford Liebesman, “Risk Management is a Must in Today’s Global Economy, “Quality Progress, May 2013, 46-47.