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CPA is a UKAS company
Introduction to ISO 15189
Overview and mapping to current CPA Standards
Ben Courtney
CPA is a UKAS company
• Implementation of change – Transition Steering Groups
• Structure of CPA Standards
• Structure of ISO 15189
• Steering Group 2 - Gap analysis
Introduction
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
Steering Group 1
CPA is a UKAS company
Current CPA structure
CPA is a UKAS company
Unique alphanumeric and title
Explanatory text
Unique alphanumeric and clause
Explanatory notes
Cross reference to ISO 15189
CPA is a UKAS company
CPA Standards as a process model
Input Output
B Personnel
C Premises and environment
D Equipment, information systems and materials
H Evaluation andquality
assurance
A Organisation and quality management system
Report USER
Satisfaction ordissatisfaction
USER
Request
E Pre examination process
F Examination process
G Post examination process
Requirements
CPA is a UKAS company
Current CPA structure
CPA is a UKAS company
ISO 15189:2012 structure
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
4 Management requirements
CPA is a UKAS company
ISO 15189:2012 structure
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
5 Technical requirements
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)
ISO 15189:2012 structure
CPA is a UKAS company
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
Steering Group 2 - Gap analysis
CPA is a UKAS company
• Roadshows
• Simplified gap analysis presented and provided
• New and modified requirements described
• Assessments are to ISO 15189 and CPA Standards
Help with the process
CPA is a UKAS company
Questions?