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
Trying to stress that there’s not too much to worry about

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
How we arrived at this presentation (likely to be covered by Phil but no harm in reiterating). Stresses that there are various types of differences

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
How we arrived at this presentation (likely to be covered by Phil but no harm in reiterating). Stresses that there are various types of differences

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

7. Laboratory director & clinical staff competence
Evaluation &
Risk management
Information management
Equipment records
Staff suggestions
Service agreements
New
Modified
Staff competence
EQA/IQC
Pretty graph to break it up a bit and summarise the main areas
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
In addition to SLAs

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: / 5.3.2
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
The performance records referred to in j) shall include copies of reports/certificates of all calibrations and/or verifications including dates, times and results, adjustments, the acceptance criteria and due date of the next calibration and/or verification, to fulfil part or all of this requirement.

14. Purchasing Clause: 4.6 Equipment, reagents, consumables and services
Acceptance criteria
Evaluation
Monitoring of performance
Collaborate with other departments, if necessary
Links to: ; 4.13, 5.3, 5.6

15. Validation and verification
ISO 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:
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
CPA – programme of calibration that is traceable to SI or ref material

19. Measurement Uncertainty
Clause:
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
CPA Standards: lab shall determine uncertainty, where relevant and possible

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