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ISO 9001:2015 Revision Review Presentation

Learn about the changes in ISO 9001 from 2008 to 2015, examples of implementation, and the impact on sector ISO QMS standards.

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ISO 9001:2015 Revision Review Presentation

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  1. ISO 9001:2015 Presentation ASQ Monthly Dinner Meeting Sections 1510, 1515 January 12, 2016 Topic: ISO 9001:2015 Revision Review Jay Stahan January 12, 2016

  2. ISO 9001:2015 Presentation AGENDA • Quick Summary Review of ISO 9001 through the years • Compare change from 2008 Revision to 2015 Revision • Some Examples of how changes can be implemented • Quick Review of Impact to Sector ISO QMS Standards Jay Stahan January 12, 2016

  3. ISO 9001:2015 Presentation • Source Materials: • READ Lots of Articles • ATTENDED Many Webinars Jay Stahan January 12, 2016

  4. ISO 9001:2015 Presentation • ISO 9001 Through the Years • Foundation Mil Std 9858, BS5750 • 1987 (20 Elements; 3 Models (Design/Mfgr; Mfgr; Final Test/Insp)) • 1994 (20 Elements; Some Clarifications; ease-up Docs) • 2000 (1 Model; Process Approach; 20 Elements Gone) • 2008 (Minor Clarifications) • 2015 (New focus areas eg., Risk Based Thinking and Context of the Organization, but many facets of 2008 still apply; 2015 “less prescriptive standard” overall) • Compare/Contrast Evolution to Baldrige Award Criteria Jay Stahan January 12, 2016

  5. ISO 9001:2015 Presentation What does ISO Leadership say about the 2015 Revision https://youtu.be/UrVIVoDq7Sg VIDEO Jay Stahan January 12, 2016

  6. ISO 9001:2015 Presentation Standard Clauses • ISO 9001:2008 • 0. Introduction • 1. Scope • 2. Normative Reference • 3. Terms and Definitions • 4. Quality Management Systems • 5. Management Responsibility • 6. Resource Management • 7. Product Realization • 8. Measurement, Analysis & Improvement • ISO 9001:2015 • 0. Introduction • 1. Scope • 2. Normative Reference • 3. Terms and Definitions • 4. Context of the Organization • 5. Leadership • 6. Planning for the Q M S • 7. Support • 8. Operation • 9. Performance Evaluation • 10. Improvement ISO 9001:2015 format design per ISO Joint Technical Coordination Group’s Requirements, as per ISO Guide 83. ISO 9001 and 14001 now revised. Some Rearranging, however, some NEW requirements Jay Stahan January 12, 2016

  7. ISO 9001:2015 Presentation Terminology Changes Jay Stahan January 12, 2016

  8. ISO 9001:2015 Presentation • 4. Context of the Organization – High Level – Strategic • New Section with New Requirements • Organizations must determine external and internal issues impacting its purpose and strategic direction • Consider external context issues: legal, technological, competitive, market, cultural, social, and economic environments • Consider internal context issues: values, culture, knowledge, and performance of the organization • Organization shall determine a)interested parties (aka Stakeholders ?), and b) needs/expectations of the interested parties (“Customer Req’mts” Not used) • Must “demonstrate with evidence” all the above… Jay Stahan January 12, 2016

  9. ISO 9001:2015 Presentation 4. Context of the Organization – Interested Parties Jay Stahan January 12, 2016 Credit to QSG 2015

  10. ISO 9001:2015 Presentation • 5. Leadership and Commitment • Greater accountability for Top Mgt. re: Q M S… • Top Management shall demonstrate Leadership: • Ensure integration of QMS requirements into the organization’s business processes • Promoting awareness of the Process Approach • Assuring the QMS achieves its intended results (PDCA) • Supporting other management roles to demonstrate Leadership Jay Stahan January 12, 2016

  11. ISO 9001:2015 Presentation • 5. Leadership and Commitment • Top Management shall demonstrate Leadership… • Ensuring Q-Policy and Q-Objectives are compatible with Strategic Direction and the Context of the Organization • Promote Process Approach and Risk Based Thinking • Promoting Continual Improvement • No more Management Rep • From my Registrar: • “The requirement for increased Leadership oversight for an organization’s Q M S could be the biggest challenge.” • How to assess Risks … more later… Jay Stahan January 12, 2016

  12. ISO 9001:2015 Presentation • 6. Planning the Q M S • Quality Objectives: shall establish quality objectives at relevant functions, levels, processes; be monitored; maintain documented information • Actions to address risks and opportunities • Integrate/implement Actions into Q M S • Evaluate the effectiveness of these Actions (PDCA) • Risk Based Thinking, Risk Assessment: • Notation (from the standard): Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision. • “Preventive Actions” has been removed Jay Stahan January 12, 2016

  13. ISO 9001:2015 Presentation • 7. Support • Resources, People (Competence, Training), Infrastructure, Monitoring and Measuring activities basically unchanged • Communication/Awareness now in this section (from Management Responsibility Section) • Documentation: now “Documented Information” • Documented Information: • “The Organization shall maintain documented information to the extent necessary to support the operation of processes and retain documentation to the extent necessary to have confidence that the processes are being carried out as planned” • No requirement for a Quality Manual nor any specific Quality Procedures are identified Jay Stahan January 12, 2016

  14. ISO 9001:2015 Presentation • 8. Operation • (The current Product Realization section) • Products and “Services” • “Design” process remains, but sections on “Verification and Validation” removed • Section has few Impactful changes: same overall flow remains: Customer Requirements > Design > Externally Provided Products and Services (Purchasing) > Production/Service Controls > ID Traceability > Preservation > Non-Conformances ID’d and Controlled Jay Stahan January 12, 2016

  15. ISO 9001:2015 Presentation • 9. Performance Evaluation • Performance Evaluation: • “The Organization shall determine what needs to be monitored/measured” • Includes… • Customer Satisfaction Information • Process Performance • External Provider Performance • Internal Audits • Management Review, including checking the QMS for alignment with the strategic direction of the organization – this is NEW!! Jay Stahan January 12, 2016

  16. ISO 9001:2015 Presentation • 10. Improvement • - Determine and Select Opportunities for Improvement… • “Examples of Improvement can include Correction, Corrective Action, Continual Improvement, Breakthrough Change, Innovation, and Re-organization.” • “Corrective Action” is in this section • “Retain Documented Information” as evidence results of Corrective Action • NOTE**: Improvement can be effected • Reactively (e.g. corrective action), • Incrementally (e.g. continual improvement) • Step-by-step (e.g. breakthrough) • Creatively (e.g. innovation) • Re-organization (e.g. transformation) • ** - “bullets” for emphasis Jay Stahan January 12, 2016

  17. ISO 9001:2015 Presentation Term: “Documented Information” Jay Stahan January 12, 2016

  18. ISO 9001:2015 Presentation • Risk Based Thinking • No “Preventive Action sub-clause”. P/A is expressed through a Risk-Based Approach to formulating Q M S requirements • Risk-based approach has facilitated some reduction in prescriptive requirements and their replacement by performance-based requirements • There is no requirement for formal Risk Management or a documented Risk Management Process • Actions taken to address Risks and Opportunities shall be proportionate to the potential impact on the conformity of products and services Jay Stahan January 12, 2016

  19. ISO 9001:2015 Presentation • Risk Based Thinking • From my Registrar: • Misconception: Risk assessment replaces Preventive Action • Truth: Risk Assessment is the initiating process and preventive action is the result • Root Cause of Preventive Action is Risk Assessment • ISO 31000 (Risk Management Principles and Guidelines) a useful reference • So now what ???? Jay Stahan January 12, 2016

  20. ISO 9001:2015 Presentation • Risk Based Thinking • Remember from the Planning Section… • Quality Objectives: shall establish quality objectives at relevant functions, levels, processes • Develop Actions to address Risks • “Retain” documented information (Records) • Plan Do Check Act (PDCA) • “Waterfall Effect” / Cascading Objectives Stated Objectives Assess Risk Company Objectives Department Objectives Individual Objectives Jay Stahan January 12, 2016

  21. ISO 9001:2015 Presentation • ‘WaterFall”: Example of Goals/Obj. Functional Level

  22. ISO 9001:2015 Presentation • Risk Based Thinking: Tools… Failure Mode and Effects Analysis (FMEA)

  23. ISO 9001:2015 Presentation • Risk Based Thinking: Tools… RISK MATRIX S E R I O U S N E S S Jay Stahan January 12, 2016 PROBABILITY

  24. ISO 9001:2015 Presentation • Risk Based Approach: Tools… Risk Register Ranking Matrix Probability Seriousness Jay Stahan January 12, 2016

  25. ISO 9001:2015 Presentation • Risk Based Thinking: Tools… Jay Stahan January 12, 2016

  26. ISO 9001:2015 Presentation If you have 3rd-party QMS software, check for updates… Risk Modules New Jay Stahan January 12, 2016

  27. ISO 9001:2015 Presentation Use Flowcharts for Risk Assessment • QMed Corp • Hi-level Process Flow Chart • Assess Risks Jay Stahan January 12, 2016

  28. ISO 9001:2015 Presentation Baldrige Criteria Enterprise Risk Mgt. QMS Risk Mgt. Jay Stahan January 12, 2016

  29. ISO 9001:2015 Presentation • Other Sector ISO QMS Standards… • ISO/TS 16949:2009 – Automotive (US, German, French, Italian) • Follows Section format of ISO 9001:2008 with additions Supplemental Engineering Specs, APQP, PPAP, MSA, Error Proofing, FMEA. • No timeline for Revision – under study by the IATF (Int’l Automotive Task Force) Jay Stahan January 12, 2016

  30. ISO 9001:2015 Presentation • Other Sector ISO QMS Standards… • ISO 13485:2003 – Medical Device Manufacturing • Follows format of ISO 9001:2008 with • Additions – Cleanliness/contamination, Batch Records, Production Validations, Installations, Servicing, Sterility, Implantables, less emphasis upon Continual Improvement and Customer Satisfaction compared to • Regulatory Compliance • Revision 2014 not approved; postponed • Revision 2016 (3rdedition Final Draft Vote (10/15 – 12/15)). • ISO 13485:2016 – future European regulations and 21CFR820 come into force (implications for software controls enhanced, documentation requirements; validations for pre-clinical and clinical evaluations; validation of packaging and distribution requirements; Customer communications and complaint handling) Jay Stahan January 12, 2016

  31. ISO 9001:2015 Presentation • Other Sector ISO QMS Standards… • ISO AS9100:2009 – Aerospace • Follows format of ISO 9001:2008 with Additions – • Revision due 2016 2nd quarter • Will follow ISO 9001:2015 format • Will consider emerging International requirements, Product Safety, Counterfeit Parts, and Configuration Management Jay Stahan January 12, 2016

  32. ISO 9001:2015 Presentation • Other Sector ISO QMS Standards… • ISO TL9000:2008 – Telecommunications • Includes Release 5.5 Handbook • Complaint Tracking and reporting via U of Texas (Dallas) • Published for benchmarking • No timetable for updating to ISO:2015 format Jay Stahan January 12, 2016

  33. ISO 9001:2015 Presentation • Other Sector ISO QMS Standards… • ISO 14001:2015 – Environmental Standards • Now released/published • Follows format of ISO 9001:2015 Jay Stahan January 12, 2016

  34. ISO 9001:2015 Presentation • SUMMARY of changes 9001:2008 > 9001:2015… • Top Management Involvement • Context of the Organization • Risk Based Thinking • Optional Changes to current documentation: • Retain Q-Manual? • Retain Management Representative? • Revise Vocabulary? Jay Stahan January 12, 2016

  35. ISO 9001:2015 Presentation • SUMMARY of changes 9001:2008 > 9001:2015… • My Registrar’s Summary: • No need to change numbering of your documents – create a cross-reference table • Must incorporate Risk Analysis • Determine Controls for External providers • Reduced documentation requirements • Increased focus on Leadership being actively involved Jay Stahan January 12, 2016

  36. ISO 9001:2015 Presentation • FINAL THOUGHTS on Conversion Plan: From my Registrar: • Involve your Registrar • Gap Analysis • Update existing Q M S • Develop Implementation Plan & Timetable • 3 years for Recertification (by Sept. 2018) Jay Stahan January 12, 2016

  37. ISO 9001:2015 Presentation FOR ADDITONAL INFORMATION, CHECK OUT ASQ NATIONAL’S WEBSITE Jay Stahan January 12, 2016

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