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ISO 9001:2015 Efficient Transition to an Effective System

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Step-by-step "how to" transition to ISO 9001:2015 with senior leaders, process owners, and internal auditors working concurrently.

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ISO 9001:2015 Efficient Transition to an Effective System

  1. 1. ISO 9001:2015 Efficient Transition to an Effective System Kristin Case, PE 61st EOQ Quality Congress October 2017
  2. 2. The Intent (Optimizing the Transition) • Minimize redundancy • Minimize rework • Involve key players in the QMS • Instill ownership • Eliminate “signature-only” approvals • Maximize understanding of ISO 9001 requirements • Avoid the unnecessary full-system gap analysis
  3. 3. Who is involved in an efficient transition? • Facilitator – Keeps senior leaders, process owners, internal auditors on task • Senior leaders 1. Define the context of the organization 2. Determine how to evaluate system effectiveness 3. Involved in the risk mitigation process 4. Ensure they meet “Leadership requirements” from ISO 9001 • Process owners - Define process inputs, outputs, methods, criteria, resources, responsibilities… • Internal auditors – Small scale gap analyses
  4. 4. Clause 4 Context Clauses 9.1 and 6.2 Objectives Clause 6.1 Risk mitigation Clause 5 Leadership Process definitions Clause 4.4.1 a, b, c, d, e, f, g, h Internal audit / Corrective action cycle (Gap analysis of all other clauses) Senior Leadership Process Owners Internal Auditors
  5. 5. TIME
  6. 6. Clause 4 Context Clauses 9.1 and 6.2 Objectives Clause 6.1 Risk mitigation Clause 5 Leadership Process definitions Clause 4.4.1 a, b, c, d, e, f, g, h Internal audit / Corrective action cycle (Gap analysis of all other clauses)
  7. 7. Clause 4, Context Senior Leadership • Given the organization’s purpose and strategy, what are its “issues”? And who monitors what, with what frequency? Make sure updates are reported in management review (9.3.2(b)). • For purposes of the system, who are the stakeholders and what are their needs? And who monitors what, with what frequency? • Determine system boundaries. What is included? Excluded? • What are the QMS processes? What is their sequence and interaction?
  8. 8. Clauses 9.1 & 6.2, Evaluation and Objectives Senior Leadership • Q: Why does Senior Leadership need to be involved in determining how the organization measures the effectiveness of the quality management system? • A1: Leadership is accountable for it (5.1.1(a)). • A2: A management system is a set of interrelated processes that work together to achieve objectives. (All of the activities required by ISO 9001 should assist the organization in meeting its objectives.) • Review / update organizational objectives.
  9. 9. Clause 6.1, Risk Mitigation Senior Leadership + • Determine the risks that need to be addressed. • Plan action; take action; evaluate for effectiveness.
  10. 10. Clause 5, Leadership Senior Leadership • HOW DO Senior Leaders… • Ensure the integration of QMS requirements into the business processes? • Promote the use of process-based thinking? • Promote the use of risk-based thinking? • Promote improvement? • Support other managers to demonstrate leadership as it applies to their scope of responsibility? • Ensure customer focus?
  11. 11. Clause 4 Context Clauses 9.1 and 6.2 Objectives Clause 6.1 Risk mitigation Clause 5 Leadership Process definitions Clause 4.4.1 a, b, c, d, e, f, g, h Internal audit / Corrective action cycle (Gap analysis of all other clauses)
  12. 12. Clause 4.4.1 Process Owners For each key process identified as part of the QMS, a) Determine expected inputs and outputs c) Determine (and apply) criteria and methods d) Determine and provide resources e) Assign responsibilities and authorities f) Address risks and opportunities g) Evaluate process; ensure processes meet intended results h) Improve processes (and therefore the QMS)
  13. 13. Clauses 9.2 and 10.2 Internal Auditors & C/A assignees Corrective action Internal audits
  14. 14. Clauses 9.2 and 10.2 Internal Auditors & C/A assignees • Internal audits and corrective action (1st) • Planning of changes (2nd) • All of the support processes (clause 7), including “document and records control” • Management review • All of the operations processes (clause 8) • Continual improvement (and improvement, gen.) • QMS documents and records (clause 4.4.2)
  15. 15. Benefits • Avoids wasteful full-system gap analysis • Minimizes redundancy • Involves multiple functions throughout the organization (including senior leaders) • Provides activity-based or workshop-style training (not a 1-hour PowerPoint overview of ISO 9001:2015) for leadership, process owners and their teams, internal auditors, and those assigned corrective actions
  16. 16. Questions? Kristin Case, PE CaseConsults www.caseconsults.com +1 (918) 200-4446 kristin.case@cox.net www.linkedin.com/in/kristincase

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