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Introduction to ISO 15189 New and modified requirements.

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Presentation on theme: "Introduction to ISO 15189 New and modified requirements."— Presentation transcript:

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 & 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: 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: 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

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