Introduction to ISO 15189

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

• Implementation of change Transition Steering
  Groups
• Steering Group Aims remit
• Structure of CPA Standards
• Structure of ISO 15189
• Steering Group - Gap analysis

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Steering Group 1

• Aims and objectives To compare and identify the
  differences in the following standards
• CPA Standards and ISO 151892007
• CPA Standards and ISO 151892012
• CPA POCT Standards and ISO 22870 2006
• Output summer 2012 Report on the mapping between
  standards

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Current CPA Standard Structure
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Unique alphanumeric and title
Explanatory text
Unique alphanumeric and clause
Explanatory notes
Cross reference to ISO 15189
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• CPA Standards as a process model

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Current CPA structure
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ISO 151892012 structure
4 Management requirements
4.1 Organisation and management responsibility 4.2 Quality management system 4.3 Document control 4.4 Service agreements 4.5 Examination by referral laboratories 4.6 External services and supplies 4.7 Advisory services 4.8 Resolution of complaints 4.9 Identification and control of nonconformities 4.10 Corrective action 4.11 Preventive action 4.12 Continual improvement 4.13 Control of records 4.14 Evaluation and audits 4.15 Management review
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ISO 151892012 structure
5 Technical requirements
5.1 Personnel 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment, reagents and consumables 5.4 Pre-examination processes 5.5 Examination processes 5.6 Ensuring quality of examination results 5.7 Post-examination processes 5.8 Reporting of results 5.9 Release of results 5.10 Laboratory information management
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ISO 151892012 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)

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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

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Help with the process

• Seminars
• Simplified gap analysis presented and provided
• New and modified requirements described
• Assessments are to ISO 15189 and CPA Standards

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Introduction to ISO 15189
Overview and mapping to current CPA Standards