CPA is a UKAS company Introduction to ISO 15189 New and modified requirements

CPA is a UKAS company

Introduction to ISO 15189

New and modified requirements


• Identification of the differences

• Outputs of the gap analysis

• Outputs of the pilot and early assessments

• Key differences (not exhaustive)

• How this might be assessed

Introduction


• Unchanged

• Multiple ways of meeting requirements

• As before, not an audit, but an assessment

• Holistic approach to add value

• Assessment Team looking for conformity

Basic principles of assessment


• Project Steering Groups: Gap analysis performed between

CPA Standards and ISO 15189

• Reviewed the differences as well as the implementation

and application of respective Standards

• Additional requirements of ISO 15189

• Approach to the assessment and expectations

• Differences in focus

• Possible areas of inconsistency

• May be assessed now but certainly under ISO 15189

Identifying the differences


• Initial application documentation was not sufficiently

detailed

• Steering group gap analysis was confirmed – high

numbers of findings around verification, traceability,

uncertainty

• Unable to offer accreditation to 20% of labs

• Some labs clearly under prepared for assessment

Early assessments – key findings


• Aim:

• Communicate the gaps (not exhaustive)

• Not:

• To advise on how to achieve conformity

• Laboratory responsible for identifying and addressing

gaps

Scope


New

Modified

Information management

Validation/Verification

Uncertainty Traceability

EQA/IQCStaff

competence

Evaluation & Risk management Equipment

records

Laboratory director & clinical staff competence

Service agreements

Staff suggestions

Purchasing


• 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

• 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


• Clause: 4.14

• Emphasises the need for regular reflection

• Evaluate work process impact and potential failures to

reduce risk

• Established TATs that are reviewed

• Reviews by external organisations

• Links to: 4.10; 4.11; 4.12; 4.15

Evaluation


• 4.14.4 & 4.1.2.6

• Communication processes – effective

• Staff to be encouraged to make suggestions to improve

• Evaluated

• Implemented, as appropriate

• Feedback

• Records maintained

• Links to: 4.11, 4.12

Staff suggestions


• 4.4.1: Each request shall be considered an agreement

• Agreement shall specify the information needed on

request to ensure appropriate examination and result

interpretation

• Following conditions shall be met:

• Requirements of customers, users and provider (lab)

must be understood - evidence

• 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


• Clause: 5.1

• On-going competency assessment programme

• Acceptance criteria for performance

• Records of qualifications, experience and training

• Evidence of incorporation into management system

• Coverage by internal audit

• Links to: 4.7; 4.12; 4.14; 5.6

Clinical staff competence


• Clause: 5.3.1.7 / 5.3.2

• Expanded requirements – records maintained

• Acceptance testing: new lot verification of performance

• Inventory and instructions for use

• Agreements with manufacturer to be informed of

changes?

• Records: identity, condition, instruction, performance

verification

• Links to: 4.13; 5.5.1; 5.6

Equipment and Reagents


• Clause: 4.6

• Equipment, reagents, consumables and services

• Acceptance criteria

• Evaluation

• Monitoring of performance

• Collaborate with other departments, if necessary

• Links to: 4.1.1.4; 4.13, 5.3, 5.6

Purchasing


• 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


• Clause: 5.5.1.2 but mentioned in 13 clauses

• Documented procedure to verify competence

• Can manufacturer's specifications be met?

• Use of kit limited to manufacturer’s specified scope or

requirement to validate?

• Have representative staff been involved?

• Authorisation by competent personnel

• When change reagents

• Links to: 4.12; 4.14; 5.6

Verification


• Clause: 5.5.1.3

• Defined acceptance criteria

• Documented procedure – as detailed as required?

• Critical evaluation of manufacturer’s validation, including

traceability

• Suitable for use within the lab for user demographic

• Validation supplemented where necessary?

• Changes to methods captured for impact on validation

• Suitable authorisation

• Links to: 4.12; 4.14; 5.6

Validation


• 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

• 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


• 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


• Clause: 5.6.3

• Proficiency testing and interlaboratory comparisons

critical in demonstrating competence

• Documented procedure – responsibilities, participation

• Acceptance criteria for the scheme

• Acceptance criteria for the results

• TPS 47 and ILAC P9

• Links to 4.14; 5.1; 5.5

EQA


• Clause: 5.6.2

• On-going monitoring of performance by IQC required

• 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?

• Documented procedure – responsibilities, participation

• Links to 4.14; 5.1; 5.5

IQC


• Clause: 5.1.4; 5.1.6; 5.1.8; 5.1.9

• Staff competence - objective evidence

• Specifies list

• Across scope of testing?

• Across scope of staff?

• On-going assessment against pre-defined criteria

• Continuing education and proof of effectiveness

• Personnel records to include accidents, work experience

• Links to: 4.1; 5.5; 5.6

Staff competence


• 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?

• Where is the evidence that this is implemented?

• Is the evidence objective?

• What does the evidence tell you?

• Does it work?

Evidence requirements


• Individual components of Standard 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

• Holistic assessment

• Designed to facilitate continual improvement

• Not a new concept

Rationale


• Changes are in specific areas but impact on the whole

Standard

• Different types of changes

• New

• Revised expectations

• Performance should be evaluated at management review,

including review of suppliers

• Health and Safety assessment - much reduced

• Objective evidence critical

Summary


Introduction to ISO 15189

New and modified requirements

Documents

CPA is a UKAS company Introduction to ISO 15189 New and modified requirements