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

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

3. Steering Group 1 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

4. Current CPA structure

5. Unique alphanumeric and title Unique alphanumeric and clause
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
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

9. ISO 15189:2012 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

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)

12. 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

13. Help with the process Roadshows
Simplified gap analysis presented and provided
New and modified requirements described
Assessments are to ISO and CPA Standards

14. Questions?