Introduction to ISO 15189 Overview and mapping to current CPA Standards
CPA is a UKAS company Introduction to ISO 15189 Overview and mapping to current CPA Standards Ben Courtney Introduction CPA is a UKAS company • Implementation of change – Transition Steering Groups • Structure of CPA Standards • Structure of ISO 15189 • Steering Group 2 - Gap analysis Steering Group 1 CPA is a UKAS company • Old CPA STEG • Steering Group Lead: Cheryl Blair • 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 Current CPA structure CPA is a UKAS company Unique alphanumeric and title CPA is a UKAS company Explanatory text Unique alphanumeric and clause Explanatory notes Cross reference to ISO 15189 CPA Standards as a process model CPA is a UKAS company Current CPA structure CPA is a UKAS company ISO 15189:2012 structure 4 Management requirements 4.1 Organisation and management responsibility 4.8 Resolution of complaints 4.2 Quality management system 4.9 Identification and control of nonconformities 4.3 Document control 4.10 Corrective action 4.4 Service agreements 4.11 Preventive action 4.5 Examination by referral laboratories 4.12 Continual improvement 4.6 External services and supplies 4.7 Advisory services 4.13 Control of records 4.14 Evaluation and audits 4.15 Management review CPA is a UKAS company ISO 15189:2012 structure 5 Technical requirements 5.1 Personnel 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment, reagents and consumables 5.6 Ensuring quality of examination results 5.7 Post-examination processes 5.8 Reporting of results 5.4 Pre-examination processes 5.9 Release of results 5.5 Examination processes 5.10 Laboratory information management CPA is a UKAS company ISO 15189:2012 structure CPA is a UKAS company • 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) CPA is a UKAS company Steering Group 2 - Gap analysis CPA is a UKAS company • 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 • Roadshows • Simplified gap analysis presented and provided • New and modified requirements described • Assessments are to ISO 15189 and CPA Standards CPA is a UKAS company Questions? CPA is a UKAS company
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