Introduction to ISO 15189 Overview and mapping to current CPA Standards

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Introduction to ISO 15189
Overview and mapping to current CPA Standards
Ben Courtney
Introduction
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• Implementation of change – Transition Steering Groups
• Structure of CPA Standards
• Structure of ISO 15189
• Steering Group 2 - Gap analysis
Steering Group 1
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• 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
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Unique alphanumeric and title
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Explanatory text
Unique alphanumeric and clause
Explanatory notes
Cross reference to ISO 15189
CPA Standards as a process model
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Current CPA structure
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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
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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
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ISO 15189:2012 structure
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• 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)
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Steering Group 2 - Gap analysis
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• 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
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Questions?
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