Страница 2: ДСТУ EN ISO/IEC 17043:2014. Conformity assessment - General requirements for proficiency testing (61382)

NOTE It is advisable to consider the need to retrain staff periodically. Staff training policies can take account of technological change, the need to demonstrate ongoing competence and aim at continual skills upgrading.

NOTE Objective measures can be used to assess the attainment of competence.

NOTE Conditions can include, for example, biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibrations levels, as appropriate to the technical activities concerned.

NOTE Stakeholders' interests can be considered in developing a plan and relevant information.

NOTE The proficiency testing provider can utilize advice or assistance from any advisors, experts or steering group (see 4.4.1.4).

1. the name and address of the proficiency testing provider;

2. the name, address and affiliation of the coordinator and other personnel involved in the design and operation of the proficiency testing scheme;

3. the activities to be subcontracted and the names and addresses of subcontractors involved in the operation of the proficiency testing scheme;

4. criteria to be met for participation;

5. the number and type of expected participants in the proficiency testing scheme;

6. selection of the measurand(s) or characteristic(s) of interest, including information on what the participants are to identify, measure, or test for in the specific proficiency testing round;

7. a description of the range of values or characteristics, or both, to be expected for the proficiency test items;

8. the potential major sources of errors involved in the area of proficiency testing offered;

9. requirements for the production, quality control, storage and distribution of proficiency test items;

10. reasonable precautions to prevent collusion between participants or falsification of results, and procedures to be employed if collusion or falsification of results is suspected;

11. a description of the information which is to be supplied to participants and the time schedule for the various phases of the proficiency testing scheme;

12. for continuous proficiency testing schemes, the frequency or dates upon which proficiency test items are to be distributed to participants, the deadlines for the return of results by participants and, where appropriate, the dates on which testing or measurement is to be carried out by participants;

13. any information on methods or procedures which participants need to use to prepare the test material and perform the tests or measurements;

n) procedures for the test or measurement methods to be used for the homogeneity and stability testing of proficiency test items and, where applicable, to determine their biological viability;

15. preparation of any standardized reporting formats to be used by participants;

16. a detailed description of the statistical analysis to be used;

17. the origin, metrological traceability and measurement uncertainty of any assigned values;

18. criteria for the evaluation of performance of participants;

19. a description of the data, interim reports or information to be returned to participants;

20. a description of the extent to which participant results, and the conclusions that will be based on the outcome of the proficiency testing scheme, are to be made public; and

21. actions to be taken in the case of lost or damaged proficiency test items.

1. planning requirements as listed in 4.4.1.3;

2. identification and resolution of any difficulties expected in the preparation and maintenance of homogeneous proficiency test items, or in the provision of a stable assigned value for a proficiency test item;

3. preparation of detailed instructions for participants;

4. comments on any technical difficulties or other remarks raised by participants in previous proficiency testing rounds;

5. provision of advice in evaluating the performance of participants;

6. comments on the results and performance of participants as a whole and, where appropriate, groups of participants or individual participants;

7. provision of advice for participants (within limits of confidentiality), either individually or within the report;

8. responding to feedback from participants; and

9. planning or participating in technical meetings with participants.

NOTE It is advisable that the proficiency testing provider give due consideration to the preparation of sufficient numbers of proficiency test items, in order to allow for the need to replace any such proficiency test items lost or damaged during distribution, or intended to be provided for use after the results of the proficiency testing scheme have been evaluated. Such uses can include training aids for participants or use as a reference material.

and manipulate, the proficiency test item and submit it to the proficiency testing provider, the proficiency testing provider shall issue instructions for preparation, packaging and transport of the proficiency test item.

NOTE 1 The requirements in this subclause are intended to ensure that every participant receives comparable proficiency test items, and that these proficiency test items remain stable throughout the proficiency testing. Careful planning, manufacture and shipping are necessary to achieve this, and testing is usually needed to confirm it.

NOTE 2 In some cases, it is not feasible for proficiency test items to be subjected to homogeneity and stability testing. Such cases would include, for example, when limited material is available to prepare proficiency testing items.

NOTE 3 In some cases, materials that are not sufficiently homogeneous or stable are the best available; in such cases, they can still be useful as proficiency test items, provided that the uncertainties of the assigned values or the evaluation of results take due account of this (see B.3.1.3 and ISO 13528:2005, Annex B).

NOTE 4 Considerations for homogeneity and stability are further discussed in ISO Guide 34, ISO Guide 35 and ISO 13528.

NOTE In some cases, the use of a random stratified or systematic selection of proficiency test items from the whole batch is more appropriate.

been packaged in the final form and before distribution to participants unless, for example, stability studies indicate that they should be stored in bulk form.

NOTE 1 Homogeneity can be demonstrated prior to packaging where no influence of packaging is reasonably expected.

NOTE 2 On some occasions, homogeneity testing cannot be carried out prior to distribution for practical, technical or logistical reasons.

NOTE 1 Statistical design covers the process of planning, collection, analysis and reporting of the proficiency testing scheme data. Statistical designs are often based on stated objectives for the proficiency testing scheme, such as detection of certain types of errors with specified power or determination of assigned values with specified measurement uncertainty.

NOTE 2 Data analysis methods could vary from the very simple (e.g. descriptive statistics) to the complex, using statistical models with probabilistic assumptions or combinations of results for different proficiency test items.

NOTE 3 In cases where the proficiency testing scheme design is mandated by a specification given by, for example, a customer, regulatory authority or accreditation body, the statistical design and data analysis methods can be taken directly from the specification.

NOTE 4 In the absence of reliable information needed to produce a statistical design, a preliminary interlaboratory comparison can be used.

to the following:

1. the accuracy (trueness and precision) as well as the measurement uncertainty required or expected for each measurand or characteristic in the proficiency testing;

2. the minimum number of participants in the proficiency testing scheme needed to meet the objectives of the statistical design; in cases where there is an insufficient number of participants to meet these objectives or to produce statistically meaningful analysis of results, the proficiency testing provider shall document, and provide to participants, details of the alternative approaches used to assess participant performance;

3. the relevance of significant figures to the reported result, including the number of decimal places;

4. the number of proficiency test items to be tested or measured and the number of repeat tests, calibrations or measurements to be conducted on each proficiency test item or for each determination;

5. the procedures used to establish the standard deviation for proficiency assessment or other evaluation criteria;

6. procedures to be used to identify or handle outliers, or both;

7. where relevant, the procedures for the evaluation of values excluded from statistical analysis; and

8. where appropriate, the objectives to be met for the design and the frequency of proficiency testing rounds.

NOTE Metrological traceability is not always possible or appropriate.

metrological traceability, including measurement uncertainty.

NOTE The required metrological traceability chain can differ depending on the type of proficiency test item, the measurand or characteristic, and the availability of traceable calibrations and reference materials.

1. have a policy and follow a procedure regarding comparison of results obtained by different test or measurement methods;

2. be aware of which different test or measurement methods for any measurand are technically equivalent, and take steps to assess participants' results using these methods accordingly.

Instructions to participants shall include:

1. the necessity to treat proficiency test items in the same manner as the majority of routinely tested samples (unless there are particular requirements of the proficiency testing scheme which require departure from this principle);

2. details of factors which could influence the testing or calibration of the proficiency test items, e.g. the nature of the proficiency test items, conditions of storage, whether the proficiency testing scheme is limited to selected test methods, and the timing of the testing or measurement;

3. detailed procedure for preparing or conditioning, or both preparing and conditioning, of the proficiency test items before conducting the tests or calibrations;

4. any appropriate instructions on handling the proficiency test items, including any safety requirements;

5. any specific environmental conditions for the participant to conduct tests or calibrations, or both, and, if relevant, any requirement for the participants to report relevant environmental conditions during the time of the measurement;

6. specific and detailed instructions on the manner of recording and reporting test or measurement results and associated uncertainties. If the instructions include reporting of the uncertainty of the reported result or measurement, this shall include the coverage factor and, whenever practicable, the coverage probability;

NOTE This instruction usually includes parameters such as the units of measurement, the number of significant figures or decimal places and reporting basis (e.g. on dry weight, or “as received”).

7. the latest date for the provider to receive the proficiency testing or measurement results for analysis;

8. information on the contact details of the proficiency testing provider for enquiries; and

9. instructions on return of the proficiency test items, when applicable.

and segregated and cannot become contaminated or degraded, from the time of preparation to their distribution to participants.

prevent damage or deterioration of any proficiency test item between preparation and distribution. Appropriate procedures for authorizing despatch to, and receipt from, such areas shall be defined.

materials shall be assessed at specified intervals during their storage life in order to detect possible deterioration.

shall be available to ensure their safe handling, decontamination and disposal.