Introduction to ISO 15189
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Introduction to ISO 15189. New and modified requirements. Ben Courtney. Introduction. Identification of the differences Outputs of the gap analysis Key differences (not exhaustive) How this might be assessed. Basic principles of assessment. Unchanged Multiple ways of meeting requirements

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Introduction to ISO 15189

New and modified requirements

Ben Courtney


Introduction

  • Identification of the differences

  • Outputs of the gap analysis

  • Key differences (not exhaustive)

  • How this might be assessed


Basic principles of assessment

  • Unchanged

  • Multiple ways of meeting requirements

  • As before, not an audit, but an assessment

  • Holistic approach to add value

  • Assessment Team looking for conformity


Identifying the differences

  • 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


Scope

  • Aim:

    • Communicate the gaps (not exhaustive)

  • Not:

    • To advise on how to achieve conformity

  • Laboratory responsible for identifying and addressing gaps


Evaluation &

Risk management

Information management

Equipment records

Service agreements

Staff suggestions

New

Modified

Staff competence

EQA/IQC

Validation/

Verification

Uncertainty

Traceability

Purchasing

Laboratory director responsibilities


Information management

  • Clause: 5.10

  • Specific requirements for laboratory information management

  • Systems validated by supplier and verified by lab (resultant changes will need to be verified again)

  • Authorisation for management of LIMS, including maintenance and modification and for those who use LIMS


Information management (cont)

  • Safeguarded against tampering

  • Environment compliant?

  • 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


Evaluation

  • 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


Staff suggestions

  • 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


Service agreements

  • 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


Laboratory director

  • Clause: 4.1.1.4

  • Lab Director shall (not just have competence to..) lead and be responsible for services, but also:

    • Ensure implementation of Quality Policy

    • Select and monitor lab suppliers

    • Define, implement and monitor standards of performance

  • Links to: 4.7; 4.12; 4.14; 5.6


Equipment records

  • Clause: 5.3.1.7

  • Expanded requirements – records maintained

    • Contact information for the supplier

    • Date of receipt and date into service

    • Condition when received

    • Manufacturer instructions

    • Initial acceptability for use

    • On-going acceptability for use

  • Links to: 4.13; 5.5.1; 5.6


Reagents and consumables

  • Clause: 5.3.2

  • 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


Purchasing

  • 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


Validation and verification

  • 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


Verification

  • Clause: 5.5.1.2

  • 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 all staff been involved?

  • Authorisation by competent personnel

  • When change reagents

  • Links to: 4.12; 4.14; 5.6


Validation

  • 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


Traceability

  • 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


Measurement Uncertainty

  • 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


EQA

  • 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


IQC

  • 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


Staff competence

  • 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


Evidence requirements

  • 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?


Rationale

  • 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


Summary

  • 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



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