ISO 9001 2015 Presentation ASQ Monthly Dinner Meeting

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

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

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

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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

ISO 9001: 2015 Presentation Quality Progress, August 2016 “Prepare for Landing” - AS 9100 (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

ISO 9001: 2015 Presentation (1)Develop Transition Plan with your Registrar (2)Learn the revised Standard (3)Apply Learnings to your QMS Processes (4)Internal Gap Analysis (5)Registrar Gap Analysis Jay Stahan September 13, 2016

ISO 9001: 2015 Presentation QMed Corp Hi-level Process Flow Chart Asses s Risks Jay Stahan September 13, 2016

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

ISO 9001: 2015 Presentation Terminology Changes ISO 9001: 2008 ISO 9001: 2015 Products Exclusions Not Used (refer Clause A. 5) Management Rep Not Used Documentation, Quality Manual, Procedures, Records Documented Information (QManual, Specific Procedures not identified) Work Environment for the operation of processes Monitoring and Measuring Equipment Monitoring and measuring resources Purchased Product Externally provided products and services Supplier External Provider (Not Used) Jay Stahan September 13, 2016 Products and Services Interested Party Preventive Action Not Used

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

ISO 9001: 2015 Presentation 4. Context of the Organization – Interested Parties “Interested Party” Examples of (not in standard) “Needs and Expectations” Examples of (not in standard) Customers (and their Customers) Product/Service Quality; Price; On-Time Delivery Owners/Share Holders Sustained Profitability; ROI Employees Safe and pleasant work environment; Job security; Competitive compensation External Provider ( Vendor, Personnel Agency, ISO Registrar) Continuous Operations; Sustainable markets and business Competitors Be more competitive/innovative; Ethical behavior (impacts all in the industry) Society; Regulators Ethical behavior; Compliance with regulations Jay Stahan September 13, 2016 Credit to QSG 2015

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

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

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

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” Jay Stahan September 13, 2016 • No requirement for a Quality Manual nor any specific Quality Procedures are identified

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

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

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

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

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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

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

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

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 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

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

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 Jay Stahan September 13, 2016 Company Objectives Department Objectives Individual Objectives Assess Risk

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

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

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

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

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

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

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

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

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

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

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

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

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

ISO 9001: 2015 Presentation A

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

lan… a. P ve ISO 9001: 2015 Presentation Ha Progress, August 2016 Quality “Prepare for Landing” - AS 9100 (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

ugh thro lan loy P onnel… Dep pers KEY ISO 9001: 2015 Presentation • • Sr. Management • Met with ISO Team (Dept heads) • Jay Stahan January 12, 2016 President and VP Ops (Annual Management Review - April) Worked with Registrar on timing for audit, and on understanding ‘ 2015 Std. requirements (interpretations)

ISO 9001: 2015 f. Presentation act o Imp upon agement ocus p Man AF to To 2015 ‘ • President and VP’s Jay Stahan January 12, 2016

ISO 9001: 2015 Presentation its Impa Aud rnal Inte ct to Internal Audit Checklist now includes “Risk Assessment” n la Strat P d e Focus Internal Audit Checklist Jay Stahan January 12, 2016

ISO 9001: 2015 Presentation If you have 3 rd-party QMS software, check for updates… Risk Modules ities rtun ppo O ols… for k t. To Mg Loo Risk iver del to New Modules Jay Stahan January 12, 2016

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ISO 9001: 2015 Presentation nal catio Edu nce… ista Ass FOR ADDITONAL INFORMATION, CHECK OUT ASQ NATIONAL’S WEBSITE Jay Stahan September 13, 2016

nal atio duc E ce… istan Ass ISO 9001: 2015 Presentation le ab ail v ll A ti S Jay Stahan September 13, 2016 ASQ e-Publications

ISO 9001: 2015 Presentation That’s ALL Folks!! Thank You for your time… Jay Stahan September 13, 2016