CPA is a UKAS

company

Introduction to ISO 15189

New and modified requirements

CPA is a UKAS

company

• Identification of the differences

• Key differences (not exhaustive)

• How this might be assessed

• Lessons learned

Introduction

CPA is a UKAS

company

• Aim:

Communicate the gaps (not exhaustive)

• It isn’t….:

To instruct on how to achieve conformity

• Ultimately it is the laboratory’s

responsibility to identify and address the

gaps

Scope of session

CPA is a UKAS

company

• Basically unchanged

• Multiple ways of meeting requirements

• As before, not an audit, but an assessment

• Holistic approach to add value

• Assessment Team looking for conformity

• Much may already have been assessed

under CPA but consistency and depth may

have varied

Basic principles of assessment

CPA is a UKAS

company

New

Modified

Information

management

Validation/

Verification Uncertainty Traceability

EQA/IQC Staff

competence

Evaluation &

Risk management Equipment

records

Laboratory director

& clinical staff

competence

Service

agreements Staff

suggestions

Purchasing

CPA is a UKAS

company

• Clause: 5.10

• Validated by supplier and verified by lab

• Safeguarded against tampering –

authorisations for management,

modification and maintenance of LIMS

• Integrity maintained and system failures

documented

Information management

CPA is a UKAS

company

• Results and records accurately

reproduced

• Contingency plans

• If systems maintained off site,

requirements must still be met –

selection of suppliers

• Links to: 4.1; 4.6; 4.9; 4.13; 5.2; 5.8; 5.9

Information management

CPA is a UKAS

company

• 4.4.1: Each request shall be considered

an agreement

• ‘Agreement’ shall specify the information

needed to ensure appropriate

examination and result interpretation

Service agreements

CPA is a UKAS

company

• Following conditions shall be met:

• Evidence to show that the requirements

of the *customers*, users and provider

(lab) have been understood

• Capability, including skills/expertise

• Methods fit for purpose

• Links to: 4.14; 5.1; 5.4.2; 5.4.3; 5.5.1

Service agreements

CPA is a UKAS

company

• Clause: 5.1

• On-going competency assessment

programme

• Acceptance criteria for performance

• Records of qualifications, experience and

training

Clinical staff competence

CPA is a UKAS

company

• Evidence of incorporation into

management system

• Coverage by internal audit

• Links to: 4.7; 4.12; 4.14; 5.6

Clinical staff competence

CPA is a UKAS

company

• Clause: 4.6

• Equipment, reagents, consumables and

services

• Acceptance criteria

• Evaluation

Purchasing

CPA is a UKAS

company

• Monitoring of performance

• Collaborate with other departments, if

necessary

• Links to: 4.1.1.4; 4.13, 5.3, 5.6

Purchasing

CPA is a UKAS

company

• ISO 15189 definitions:

• Verification – confirmation, through

provision of objective evidence, that

specified requirements have been fulfilled

• Validation – confirmation, through

provision of objective evidence, that the

requirements for a specific intended use

or application have been fulfilled

Validation and verification

CPA is a UKAS

company

• Clause: 5.5.1.2 mainly but mentioned in

13 clauses

• e.g. 5.3.1.2 ‘Equipment acceptance

testing: ‘The laboratory shall verify upon

installation….’

• Can manufacturer's specifications be

met?

Verification

CPA is a UKAS

company

• Use of kit limited to manufacturer’s

specified scope or would need to validate

• Authorisation of outcome by competent

personnel

• Re-verify when the manufacturer or the

composition of reagents change

• Links to: 4.12; 4.14; 5.6

Verification

CPA is a UKAS

company

• Clause: 5.5.1.3

• Defined acceptance criteria

• Documented procedure – as detailed as

required?

• Critical evaluation of manufacturer’s

validation, including traceability

Validation

CPA is a UKAS

company

• Suitable for user demographic

• Validation supplemented where

necessary?

• System to ensure that changes are

evaluated for any impact on validation

• Suitable authorisation

• Links to: 4.12; 4.14; 5.6

Validation

CPA is a UKAS

company

• Clause: 5.3.1.4

• When equipment directly or indirectly

affects results

• Verification at defined intervals

• Records of metrological traceability of

calibration standards

• Manufacturer data may or may not be

sufficient

Traceability

CPA is a UKAS

company

Traceability

http://www.bipm.org/en/committees/jc/jctlm/

CPA is a UKAS

company

• Provenance of reference materials

• Where traceability not possible/relevant,

other means of providing confidence in the

results required

• Links to: 4.14; 5.5; 5.6

Traceability

CPA is a UKAS

company

• Clause: 5.5.1.4

• Performance requirements for each

measurement procedure to be defined

• Regularly reviewed

• Uncertainty estimates to be readily available

• Requirements cover examinations reporting

measured quantity values and those that

include a measurement step

• Links to: 4.14; 5.1; 5.6

Measurement Uncertainty

CPA is a UKAS

company

• Clause: 5.6.3

• Proficiency testing (external quality

assurance) and interlaboratory

comparisons important in demonstrating

competence

• Documented procedure – responsibilities,

plan, participation

EQA

CPA is a UKAS

company

• Acceptance criteria for the scheme, (internal

acceptance criteria)

• TPS 47 (UKAS Policy on Participation in

Proficiency Testing) and ILAC P9

• Links to 4.14; 5.1; 5.5

EQA

CPA is a UKAS

company

• ‘4.3 Laboratories shall formulate and document a

plan for the level and frequency of participation

in PT, the plan shall be regularly reviewed in

response to changes in staffing, methodology,

instrumentation, scope etc. Laboratories should

refer to the EA Publication EA 4/18 TA Guidance

on the level and frequency of proficiency testing

participation for further guidance on how to

establish a plan.’

EQA TPS 47 excerpt

CPA is a UKAS

company

EQA

CPA is a UKAS

company

EQA

https://www.eptis.bam.de/en/index

.htm

CPA is a UKAS

company

• Clause: 5.6.2

• On-going monitoring of performance by

IQC required

IQC

CPA is a UKAS

company

• Needs to be suitably robust

• What is this based on?

• Define rationale for approach to test

assurance – what is the package?

• Including manufacturer material, is there

sufficient to provide confidence in test

results?

IQC

CPA is a UKAS

company

• Documented procedure – responsibilities,

participation

• Links to 4.14; 5.1; 5.5

IQC

CPA is a UKAS

company

• Clause: 5.1.4; 5.1.6; 5.1.8; 5.1.9

• Staff competence - objective evidence

• Separate from training

• Across scope of activities and staff

• On-going reassessment against pre-

defined criteria

Staff competence

CPA is a UKAS

company

• Continuing education and proof of

effectiveness

• Personnel records to include accidents,

work experience

• Links to: 4.1; 5.5; 5.6

Staff competence

CPA is a UKAS

company

• Where does it say what you do?

• Why is it done that way?

• Do staff know what should be done and

why?

• Where is this implemented?

Evidence requirements

CPA is a UKAS

company

• Where is the evidence that this is

implemented?

• Is the evidence objective?

• What does the evidence tell you?

• Does it work?

Evidence requirements

CPA is a UKAS

company

• Individual components of ISO 15189 are

not assessed in isolation

• Elements link together and will be

assessed as such:

Staff competence, test assurance,

uncertainty, validation

Purchasing, equipment, test

assurance, responsibilities

Rationale

CPA is a UKAS

company

• Holistic assessment

• Designed to facilitate continual

improvement

• Not a new concept

Rationale

CPA is a UKAS

company

• Changes are in specific areas but impact on

the whole of ISO 15189

• Different types of changes

• New

• Revised expectations

• Performance should be evaluated at

management review, including review of

suppliers

Summary

CPA is a UKAS

company

• Health and Safety assessment - much

reduced

• Objective evidence critical

Summary

CPA is a UKAS

company

Introduction to ISO 15189

New and modified requirements