1. Requirements for the Competence of Providers of Proficiency Testing Schemes ILAC Guide 13:2000 – supplementing ISO Guides 43-1 and 43-2

2. ILAC Guide 13:20002 ILAC Guide 13:2000 Preamble –directed to the providers of PT schemes (voluntary basis), formal compliance with –a basis for recognising the competence of providers of PT schemes by formal compliance with a set of internationally acceptable requirements for PT planning and implementation, characterisation, homogeneity stablility –based on ISO Guide 43-1 and on relevant elements of ISO/IEC 17025:2000,  applicable to the characterisation, homogeneity and stablility of the PT test material, compentent performance –the responsible organisation for coordinating and providing a PT scheme should ensure compentent performance (whether carried out by itself or by collaborators).

3. ILAC Guide 13:20003 Relevant elements of ISO 9000 are included (to eliminate the need for separate recognition for compliance with ISO 9000), accordingly comprising: –Management System Requirements –Technical Requirements but: ILAC Guide 13:2000 is applicable only for interlaboratory comparisons for the purpose of PT ILAC Guide 13:2000 Preamble

4. ILAC Guide 13:20004 Management System Requirements 4 The provider of a PT scheme shall: QM system appropriate to its scope of activities –establish, implement and maintain a QM system appropriate to its scope of activities (incl. type, range, volume of PT schemes provided); policy, objectives, commitment –define and document policy, objectives, commitment to ensuring and maintaining the quality of all PT aspects, i.e.: homogeneity, stability, equipment calibration, method validation, statistical procedures, performance evaluation, storage & transport, reporting...

5. ILAC Guide 13:20005 Management System Requirements 4 The provider of a PT scheme shall have a Quality System covering: –aims, scope statistical design, format; –operational procedures, preparation and issuing of reports; –policies on confidential and ethical procedures, handling of complaints; –computing and information systems; –collaboration & subcontracting; –participation fees; –use of scheme results; –role and responsibilities of Technical & Quality Manager & PT coordinator.

6. ILAC Guide 13:20006 Organisation and Management 4 Requirements for providers of PT schemes: –managerial & technical personnel with the resources needed; –management and personnel free from commercial or other pressures; –policies and procedures to ensure the protection of confidential information and proprietary rights; –policies and procedures to avoid involvement in activities that might diminish confidence in competence, impartiality, judgement, integrity.

7. ILAC Guide 13:20007 Organisation and Management 4 Requirements for providers of PT schemes: –define organisation and management structure, inter-institutional relations, etc.; –specify responsibilities, authorities, have a technical management, appointed Quality & Technical Manager (deputy, if applicable)

8. ILAC Guide 13:20008 Document Control 4 establish and maintain procedures to control all documents: –approval and issue; –unique identification; –authorised editions available where essential; –periodical document review and withdrawal of obsolete documents –review of document changes; –request, tender, contract review; –records of reviews

9. ILAC Guide 13:20009 Use of collaborators 4 PT provider shall have procedures for evaluating and selecting collaborators. Procurement of services and supplies 4 PT provider shall have procedures for the selection of services and supplies; 4 to use adequate services and supplies; 4 equipment, consumables not to be used until inspected, calibrated, verified for compliance.

10. ILAC Guide 13:200010 Control of non-conforming activities 4 procedures shall ensure: –designated responsibilities; –actions in case of nonconformities; –evaluation of significance; –work halted, if necessary; –remedial action; –complete records maintenance of nonconformities; –corrective actions promptly followed.

11. ILAC Guide 13:200011 Corrective actions 4 policies and procedures shall ensure: –appropriate personnel for implementing corrective actions; –appropriate corrective actions to eliminate causes; –document and implement any required changes to operational procedures.

12. ILAC Guide 13:200012 Corrective actions 4 identification of QM system problems: –client complaints, –quality control, –test material checking, –statistical evaluation, –observations / supervision, –management reviews, –internal / external audits,

13. ILAC Guide 13:200013 Corrective actions 4 should include: –cause analysis, –monitoring of corrective actions, –protective action to reduce the likelihood of nonconformances.

14. ILAC Guide 13:200014 Records 4 PT provider shall establish and maintain procedures for: –identification, collection, indexing, access, storage, maintenance, disposal, retention, quality and technical records, including: –legibility, retrievability, suitable environment for storage, prevention of damage, deterioration, loss.

15. ILAC Guide 13:200015 Technical records 4 PT provider shall establish and maintain a records system for: –measurent observations, –appropriate calculations, –derived data (statistical treatments, uncertainty budgets), –results from participants, –scheme reports.

16. ILAC Guide 13:200016 Internal audits 4 PT provider shall conduct internal audits: –with a predetermined schedule and procedure, –addressing all elements of the QM system, including the test item preparation, –at the responsibility of the technical manager to plan and organise, independent of the activity to be audited –by trained and qualified personnel who are independent of the activity to be audited (if ever feasible).

17. ILAC Guide 13:200017 Management reviews 4 Senior management shall periodically conduct a review of the PT provider‘s QM system and PT scheme procedures. 4 The review should take account of: –reports of management and supervisory personnel, –outcome of recent internal audits and assessments by external bodies, –feedback from participants, –other relevant factors.

18. ILAC Guide 13:200018 Technical requirements - Management, Staffing, Training experience –coordination and conduct of PT schemes only be undertaken if respective experience in interlaboratory comparisons and the type of test items is in place, –competence –competence in the measurement of the properties to be determined (assignment of values, homogeneity, stability). 4 Note: –laboratory accreditation –laboratory accreditation to ISO/IEC 17025 for appropriate tests will satisfy the requirement of competence, –if no laboratory accreditation is in place other factors should be considered (e.g. own laboratory performance in appropriate PT schemes).

19. ILAC Guide 13:200019 Technical requirements - Management, Staffing, Training –appropriate managerial personnel, –measurement of the properties of interest to be supervised by a technically competent manager, –levels of qualification for the key positions defined, –sufficient personnel with the necessary education, training, experience, –staff be sufficiently trained, –maintenance of up-to-date training records.

20. ILAC Guide 13:200020 Technical requirements - collaborators / subcontractors: PT provider 4 the PT provider is required: –to demonstrate that the collaborators technical competence is sufficient for the assigned tasks, –that work be placed with a competent laboratory, –that the competence of the collaborator is assessed, –that details of the methodology, results, outcomes of monitoring are available and appropriately maintained.

21. ILAC Guide 13:200021 Organisation and design - planning : 4 before commencement, a documented plan should be in place, including: –name and address of the PT provider, coordinator, collaborators and other personnel involved, –nature and purpose of the scheme, –procedure for selection (if applicable) and the number and identity of expected participants, –the manner in which test items are to be obtained, checked, distributed,

22. ILAC Guide 13:200022 Organisation and design - planning : 4 before commencement, a documented plan should be in place, including: –description of the information to be supplied to participants (pre-notification) and the time schedule for the various phases, –target dates / deadlines, –frequency / dates upon which test items are to be distributed (for ongoing schemes), –information on methods / procedures needed to perform the tests, –outline of the statistical analysis to be used, including determination of assigned values and outlier detection techniques,

23. ILAC Guide 13:200023 Organisation and design - planning : 4 before commencement, a documented plan should be in place, including: –a description of the data or information to be returned by the participants, –the basis of performance evaluation, –the extent to which test results / conclusions based on the outcome of the scheme are to be made public.

24. ILAC Guide 13:200024 Organisation and design - planning : 4 The PT provider should: advisory group –establish an advisory group of technical specialists with detailed experience in the relevant field; the responsibilities should include the complete design and arrangements of the PT scheme, statistician –have (or have access to) a statistician to design and implement a PT scheme and analyse submitted results.

25. ILAC Guide 13:200025 Organisation and design – preparation of test items : 4 The PT provider should provide procedures and resources for: –material selection, –maintaining a suitable environment for preparation and testing of test material, –material preparation, measuring, testing, equipment calibration, measurement methods, –assessing material homogeneity / stability, –adequate storage facilities and conditions, –adequate packaging / labelling / transport / distribution,

26. ILAC Guide 13:200026 Organisation and design - preparation of test items 4 The PT provider should provide procedures and resources for: –statistical analysis of test results and assigning values of measurands / associated uncertainties, –adequate reporting service to participants.

27. ILAC Guide 13:200027 Organisation and design - homogeneity and stability testing 4 The PT provider shall: –use a random selection of samples to assess the homogeneity of the PT material, –have a documented assessment procedure in accordance with an acceptable statistical design (e.g. analysis of variance under repeatability conditions), –assess homogeneity after the test material has been packed, and before distribution to participants (as far as applicable), –determine PT values periodically (over a range of applicable storage conditions), –demonstrate that test material is sufficiently stable without significant changes throughout the PT scheme.

28. ILAC Guide 13:200028 Organisation and design - statistical design : 4 The PT provider shall: –document the statistical model and data analysis techniques to be used, –describe the reasons for the model selection,, –ensure that the statistical treatment is carried out in accordance with the prescribed procedures (i.e. ISO Guide 43-1), –give careful consideration to: trueness, precision, assigned value, confidence level, outliers, homogeneity, stability.

29. ILAC Guide 13:200029 Organisation and design - choice of method / procedure : test method of their choice 4 The PT participants shall normally be permitted to use the test method of their choice (consistent with routine procedures). 4 Details of the methods used should be requested from the participants, to permit comparisons and comments on the results obtained by different test methods.

30. ILAC Guide 13:200030 Conduct of PT schemes - instruction to the participants 4 The PT provider shall: –inform participants in due time about the intention to conduct a PT scheme, –give detailed documented instructions to all participants (influencing factors, storage conditions, test procedure, timing, etc.), –give specific instructions on recording and reporting of results (units, number of significant figures, e.g. based on dry weight or as received, etc.), –instruct participants to treat PT samples in the same manner as routine samples.

31. ILAC Guide 13:200031 Conduct of PT schemes - materials handling and storage 4 The PT provider / collaborator shall: –identify, preserve, segregate all test material and test items to avoid contamination, –ensure adequate packaging and secure storage, –assess conditions of stored / stocked items and materials at specified intervals during storage.

32. ILAC Guide 13:200032 Conduct of PT schemes - packaging, labelling, distribution 4 The PT provider shall: –control packaging and marking processes, –ensure that labels are securely attached to the packaging and remain legible and intact within the period of use.

33. ILAC Guide 13:200033 Data analysis and interpretation of PT scheme results 4 Appropriate data analysis and records require: –adequate data processing equipment, –a description of all data processing equipment established and maintained, –the role and responsibility of a person designated for the effective operation of the data processing system, –data processing equipment and software be validated according to documented procedures before use,

34. ILAC Guide 13:200034 Data analysis and interpretation of PT scheme results 4 Appropriate data analysis and records require: –received results be promptly recorded and analysed by appropriate documented statistical procedures, –documented criteria and procedures for dealing with results inappropriate for statistical evaluation, –documented criteria for determining whether test items are not suitable for evaluation (inhomogeneity, instability, contamination).

35. ILAC Guide 13:200035 Data analysis and interpretation of PT scheme results 4 Evaluation of performance (if required): –overall performance against prior expectation, –variation within and between laboratories, –comparison with previous schemes or published precision data, –variation between methods / procedures, –possible sources of errors, –suggestions for improving performance, –comments, recommendations, conclusions.

36. ILAC Guide 13:200036 PT scheme reports 4 A PT report shall be comprehensive, clear with data on the distribution of the results of all participants, including: –name and address of the provider, persons involved in the design and conduct of the scheme, –date of issue of the report, –clear identifcation of the report, –description of items, materials, details of sample preparation, homogeneity testing, –participation codes and test results, –statistical data and summaries, assigned values, acceptability ranges, graphical displays, –traceability, uncertainty of assigned values.

37. ILAC Guide 13:200037 PT scheme reports 4 A PT report shall include (where appropriate): –comments on particpants‘ performance by the provider and technical advisers, –details / reference to the scheme protocol, –advice on the interpretation of statistical results. 4 Report shall be made available to the participants within a specified time table.

38. ILAC Guide 13:200038 Communication with participants 4 The PT provider shall provide detailed information to potential partipants (form of scheme protocol, how to apply, scope, fees, policies). 4 Prompt advices in writing in the case of changes in scheme design and operation. 4 Feedback from particpants be encouraged for the active contribution to the development of the scheme.

39. ILAC Guide 13:200039 Confidentiality identity confidential 4 The identity of the PT participants shall be confidential. information supplied confidential 4 All information supplied by the participant to the provider shall be treated as confidential. Note: PT schemes should be designed to ensure that there is little opportunity for collusion and falsification of results.