1.01k likes | 3.33k Views
Introduction to ISO 15189. Overview and mapping to current CPA Standards. Introduction. Implementation of change – Transition Steering Groups Steering Group – Aims & remit Structure of CPA Standards Structure of ISO 15189 Steering Group - Gap analysis. Steering Group 1.
E N D
Introduction to ISO 15189 Overview and mapping to current CPA Standards
Introduction • Implementation of change – Transition Steering Groups • Steering Group – Aims & remit • Structure of CPA Standards • Structure of ISO 15189 • Steering Group - Gap analysis
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
Unique alphanumeric and title Explanatory text Unique alphanumeric and clause Explanatory notes Cross reference to ISO 15189
ISO 15189:2012 structure 4 Management requirements
ISO 15189:2012 structure 5 Technical requirements
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)
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
Help with the process • Seminars • Simplified gap analysis presented and provided • New and modified requirements described • Assessments are to ISO 15189 and CPA Standards
Introduction to ISO 15189 Overview and mapping to current CPA Standards