1 / 53

ASQ Monthly Dinner Meeting Sections 1510, 1515 September 13, 2016 Topic: ISO 9001:2015

ISO 9001:2015 Presentation. ASQ Monthly Dinner Meeting Sections 1510, 1515 September 13, 2016 Topic: ISO 9001:2015 Transition – Lessons Learned. ISO 9001:2015 Presentation. AGENDA. Brief Review of the 2015 Revision The “Plan” to execute the change

powelldavid
Télécharger la présentation

ASQ Monthly Dinner Meeting Sections 1510, 1515 September 13, 2016 Topic: ISO 9001:2015

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ISO 9001:2015 Presentation ASQ Monthly Dinner Meeting Sections 1510, 1515 September 13, 2016 Topic: ISO 9001:2015 Transition – Lessons Learned Jay Stahan September 13, 2016

  2. ISO 9001:2015 Presentation AGENDA • Brief Review of the 2015 Revision • The “Plan” to execute the change • Some Examples of how changes were implemented • Lessons Learned from the Transition Jay Stahan September 13, 2016

  3. ISO 9001:2015 Presentation • Source Materials: • READ Lots of Articles both hard copy and downloads from internet • ATTENDED Many Webinars Jay Stahan September 13, 2016

  4. Re-Certification Audit Result

  5. ISO 9001:2015 Presentation Re-Certification Report Summary: • “0” Nonconformances (Major or Minor) • - 1 OFI: Vendor Rating System could be more robust (consider more attributes, such as on-time delivery) Jay Stahan September 13, 2016

  6. ISO 9001:2015 Presentation • Quality Progress, August 2016 • “Prepare for Landing” - AS9100 (LL “Buddy” Cressionnie) • Develop a Plan and schedule for your transition • Perform a Gap Assessment • Revise Plan as necessary based upon Gap Report • Make changes to documented information • Perform Internal Audit(s) using ‘2015 standard • Perform Manage Review to ‘2015 standard • Coordinate with Registrar the Transition Plan Jay Stahan September 13, 2016

  7. ISO 9001:2015 Presentation • Develop Transition Plan with your Registrar • Learn the revised Standard • Apply Learnings to your QMS Processes • Internal Gap Analysis • Registrar Gap Analysis Jay Stahan September 13, 2016

  8. ISO 9001: 2015 Presentation • QMed Corp • Hi-level Process Flow Chart • Assess Risks Jay Stahan September 13, 2016

  9. 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. Mostly Rearranging, however, some NEW requirements Jay Stahan September 13, 2016

  10. ISO 9001:2015 Presentation Terminology Changes Jay Stahan September 13, 2016

  11. 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 September 13, 2016

  12. ISO 9001:2015 Presentation 4. Context of the Organization – Interested Parties Jay Stahan September 13, 2016 Credit to QSG 2015

  13. 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 September 13, 2016

  14. 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 September 13, 2016

  15. 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 September 13, 2016

  16. 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 September 13, 2016

  17. 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 September 13, 2016

  18. 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 September 13, 2016

  19. 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) Jay Stahan September 13, 2016

  20. 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 September 13, 2016

  21. ISO 9001:2015 Presentation My Registrar’s Gap Assessment A Jay Stahan September 13, 2016

  22. ISO 9001:2015 Presentation Example from Delta (Gap) Audit… A Ja Stahan January 12, 2016 Jay Stahan September 13, 2016

  23. ISO 9001:2015 Presentation Dialogue with Auditor A Jay Stahan September 13, 2016

  24. ISO 9001:2015 Presentation • Prior to the on-site Re-Certification Audit: • Must have completed Internal QMS Audit to ‘2015 standard • Must have completed a Management Review to ‘2015 standard Jay Stahan September 13, 2016

  25. ISO 9001:2015 Presentation • Since ISO 9001:2008 Requirements were basically in place, focused upon changes from ‘2008 > ’2015. • That essentially meant focusing upon Risk Assessment Requirements: • Context of the Organization (External and Int.factors • Top Mgt. Risk Factors (Strat. Plans, marketing/sales plans) • Operations Risk Factors Jay Stahan September 13, 2016

  26. 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 Procedures, incl. numbering? Jay Stahan September 13, 2016

  27. 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. But “OK” to retain P/A procedure, list • 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 September 13, 2016

  28. 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 September 13, 2016

  29. 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 September 13, 2016

  30. ISO 9001:2015 Presentation • Researched Risk Assessment Tools… • Two Risk Assessment Tools Selected: • Risk Ranking Matrix: • President • VP’s • FMEA (Failure Mode Effects Analysis): • Distribution Operations Processes Jay Stahan September 13, 2016

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

  32. ISO 9001:2015 Presentation • Risk Based Approach: Tools… Risk Register Ranking Matrix Probability Seriousness Jay Stahan September 13, 2016

  33. ISO 9001:2015 Presentation • Risk Based Thinking: Tools… Generate 1 new procedure to include all Tool types

  34. ISO 9001:2015 Presentation • Risk Based Thinking: Tools… Generated 1 new Procedure to include both Tool types

  35. ISO 9001:2015 Presentation • Risk Based Thinking: Tools… Generate 1 new procedure to include all Tool types

  36. ISO 9001:2015 Presentation • Risk Based Thinking • Aligned Goals/Objectives C A S C A D I N G STRATEGIC PLAN SR. MANAGEMENT OPERATIONS MGT … PRESIDENT … VP’s … ISO Team Mgrs STERLING/BALDRIGE LIKE Progression?? Jay Stahan January 12, 2016

  37. ISO 9001:2015 Presentation • Met with President and VP Ops (Annual Management Review - April) • Met with Sr. Mgt – VP’s • Met with ISO Team (Dept heads) Jay Stahan January 12, 2016

  38. ISO 9001:2015 Presentation • Annual Mgt. Review • Addressed regular mangement review agenda items • Allowed for one-on-one Re-Certification audit preparation with the President (re: Strategic Plan and Risk Assessment) • Required 2-days, 2.5 hours each day Jay Stahan January 12, 2016

  39. ISO 9001:2015 Presentation • Meeting Sr. Management • Sr. Mgt. = VP’s • Developed Risk Matrix to address elements key to meeting/exceeding Account success • Risk Matrix based upon Strat Plan (example: New Customer initiative impacts IT-VP, Dist. Ops-VP, Quality-VP, etc..) Jay Stahan January 12, 2016

  40. ISO 9001:2015 Presentation • Risk Based Thinking: Tools… RISK Register Example: Sr. Mgt Acct. Mgr. Jay Stahan January 12, 2016

  41. ISO 9001:2015 Presentation • ISO Team Dept Heads Mtg • “Business” as usual • Operations Processes • Incorporate “Risk Based Thinking to Operations Processes Jay Stahan September 13, 2016

  42. ISO 9001:2015 Presentation • Risk Based Thinking: Tools… RISK Matrix: FMEA – Operations – ISO Team Mgt. Jay Stahan January 12, 2016

  43. ISO 9001:2015 Presentation A

  44. ISO 9001:2015 Presentation Lessons Learned… Jay Stahan September 13, 2016

  45. ISO 9001:2015 Presentation Have a Plan… • Quality Progress, August 2016 • “Prepare for Landing” - AS9100 (LL “Buddy” Cressionnie) • Develop a Plan and schedule for your transition • Coordinate with Registrar the Transition Plan • Perform a Gap Assessment • Revise Plan as necessary based upon Gap Report • Involve “Key” Personnel (Mgt. decision-makers) • Make changes to documented information • Perform Internal Audit(s) using ‘2015 standard • Perform Manage Review to ‘2015 standard Jay Stahan September 13, 2016

  46. ISO 9001:2015 Presentation Deploy Plan through KEY personnel… • President and VP Ops (Annual Management Review - April) • Sr. Management • Met with ISO Team (Dept heads) • Worked with Registrar on timing for audit, and on understanding ‘2015 Std. requirements (interpretations) Jay Stahan January 12, 2016

  47. ISO 9001:2015 Presentation A Focus upon Impact of ‘2015 to Top Management • President and VP’s Jay Stahan January 12, 2016

  48. ISO 9001:2015 Presentation Impact to Internal Audits Internal Audit Checklist now includes “Risk Assessment” Strat Plan Focused Internal Audit Checklist Jay Stahan January 12, 2016

  49. ISO 9001:2015 Presentation If you have 3rd-party QMS software, check for updates… Risk Modules Look for Opportunities to deliver Risk Mgt. Tools… New Modules Jay Stahan January 12, 2016

  50. ISO 9001:2015 Presentation Don’t overlook hard copy materials… Save Expenses Jay Stahan September 13, 2016

More Related