Introduction to ISO 15189

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1 Introduction to ISO New and modified requirements

2 Introduction Identification of the differences Key differences (not exhaustive) How this might be assessed Lessons learned

3 Scope of session 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

4 Basic principles of assessment 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

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

6 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

7 Information management 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

8 Service agreements 4.4.1: Each request shall be considered an agreement Agreement shall specify the information needed to ensure appropriate examination and result interpretation

9 Service agreements 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

10 Clinical staff competence Clause: 5.1 On-going competency assessment programme Acceptance criteria for performance Records of qualifications, experience and training

11 Clinical staff competence Evidence of incorporation into management system Coverage by internal audit Links to: 4.7; 4.12; 4.14; 5.6

12 Purchasing Clause: 4.6 Equipment, reagents, consumables and services Acceptance criteria Evaluation

13 Purchasing Monitoring of performance Collaborate with other departments, if necessary Links to: ; 4.13, 5.3, 5.6

14 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

15 Verification Clause: mainly but mentioned in 13 clauses e.g Equipment acceptance testing: The laboratory shall verify upon installation. Can manufacturer's specifications be met?

16 Verification 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

17 Validation Clause: Defined acceptance criteria Documented procedure as detailed as required? Critical evaluation of manufacturer s validation, including traceability

18 Validation 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

19 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

20 Traceability

21 Traceability 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

22 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

23 EQA Clause: Proficiency testing (external quality assurance) and interlaboratory comparisons important in demonstrating competence Documented procedure responsibilities, plan, participation

24 EQA 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

25 EQA TPS 47 excerpt 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.

26 EQA

27 EQA https://www.eptis.bam.de/en/index.htm

28 IQC Clause: On-going monitoring of performance by IQC required

29 IQC 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?

30 IQC Documented procedure responsibilities, participation Links to 4.14; 5.1; 5.5

31 Staff competence Clause: 5.1.4; 5.1.6; 5.1.8; Staff competence - objective evidence Separate from training Across scope of activities and staff On-going reassessment against predefined criteria

32 Staff competence Continuing education and proof of effectiveness Personnel records to include accidents, work experience Links to: 4.1; 5.5; 5.6

33 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?

34 Evidence requirements Where is the evidence that this is implemented? Is the evidence objective? What does the evidence tell you? Does it work?

35 Rationale Individual components of ISO 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

36 Rationale Holistic assessment Designed to facilitate continual improvement Not a new concept

37 Summary Changes are in specific areas but impact on the whole of ISO Different types of changes New Revised expectations Performance should be evaluated at management review, including review of suppliers

38 Summary Health and Safety assessment - much reduced Objective evidence critical

39 Introduction to ISO New and modified requirements

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