Introduction to ISO 15189

1. Introduction to ISO 15189 New and modified requirements

2. Introduction • 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

3. 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

4. Identifying the differences • 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

5. Early assessments – key findings • 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

6. Scope • Aim: • Communicate the gaps (not exhaustive) • Not: • To advise on how to achieve conformity • Laboratory responsible for identifying and addressing gaps

7. Evaluation & Risk management Information management Equipment records Service agreements Staff suggestions New Modified Staff competence EQA/IQC Validation/ Verification Uncertainty Traceability Laboratory director & clinical staff competence Purchasing

8. Information management • 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

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

10. 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

11. 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

12. Clinical staff competence • 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

13. Equipment and Reagents • 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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?

24. 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

25. 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

26. Introduction to ISO 15189 New and modified requirements