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Introduction to ISO 15189

Introduction to ISO 15189

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Introduction to ISO 15189

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  1. Introduction to ISO 15189 Overview and mapping to current CPA Standards

  2. Introduction • Implementation of change – Transition Steering Groups • Steering Group – Aims & remit • Structure of CPA Standards • Structure of ISO 15189 • Steering Group - Gap analysis

  3. Steering Group 1 • Aims and objectives: To compare and identify the differences in the following standards: • CPA Standards and ISO 15189:2007 • CPA Standards and ISO 15189:2012 • CPA POCT Standards and ISO 22870: 2006 • Output summer 2012: Report on the mapping between standards

  4. Current CPA Standard Structure

  5. Unique alphanumeric and title Explanatory text Unique alphanumeric and clause Explanatory notes Cross reference to ISO 15189

  6. CPA Standards as a process model

  7. Current CPA structure

  8. ISO 15189:2012 structure 4 Management requirements

  9. ISO 15189:2012 structure 5 Technical requirements

  10. ISO 15189:2012 structure • Example: • 4.14: Evaluation and audit [unique numeric clause and title] • 4.14.6: Internal audit [unique numeric sub-clause and title] • Requirement • Notes for guidance (not a requirement)

  11. Steering Group 2 - Gap analysis • Other variables to consider • Full gap analysis • Documentary • Practical – assessment approach • Many areas of concordance • Simple gaps in the order and structure • More complex gaps between requirements – some new, some modified

  12. Help with the process • Seminars • Simplified gap analysis presented and provided • New and modified requirements described • Assessments are to ISO 15189 and CPA Standards

  13. Introduction to ISO 15189 Overview and mapping to current CPA Standards