CPA is a UKAS company Introduction to ISO 15189 Overview and mapping to current CPA Standards Ben...

CPA is a UKAS company

Introduction to ISO 15189

Overview and mapping to current CPA Standards

Ben Courtney


• Implementation of change – Transition Steering Groups

• Structure of CPA Standards

• Structure of ISO 15189

• Steering Group 2 - Gap analysis

Introduction


• 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


Current CPA structure


Unique alphanumeric and title

Explanatory text

Unique alphanumeric and clause

Explanatory notes

Cross reference to ISO 15189


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


Current CPA structure


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



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


• 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)



• 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


• Roadshows

• Simplified gap analysis presented and provided

• New and modified requirements described

• Assessments are to ISO 15189 and CPA Standards

Help with the process


Questions?

CPA is a UKAS company Introduction to ISO 15189 Overview and mapping to current CPA Standards Ben...

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