Страница 3: ДСТУ EN ISO/IEC 17043:2014. Conformity assessment - General requirements for proficiency testing (61382)

NOTE The proper distribution of proficiency test items can present severe problems for some types of material, e g. those which require uninterrupted storage in cold conditions or which should not be exposed to X-rays, shock or vibration. Most types of chemical materials would benefit from air-tight packaging to avoid contamination by atmospheric contaminants, e.g. fuel vapours or engine exhaust gases which can be encountered during transport.

individual proficiency test items and are designed to remain legible and intact throughout the proficiency testing round.

NOTE This could be achieved in accordance with 4.6.1.1 by asking participants to inform the proficiency testing provider if proficiency test items have not been received in line with the schedule of dates provided.

test results that may be inappropriate for statistical evaluation, e.g. miscalculations, transpositions and other gross errors.

provider shall provide expert commentary on the performance of participants with regard to the following:

1. overall performance against prior expectations, taking measurement uncertainties into account;

2. variation within and between participants, and comparisons with any previous proficiency testing rounds, similar proficiency testing schemes, or published precision data;

3. variation between methods or procedures;

4. possible sources of error (with reference to outliers) and suggestions for improving performance;

5. advice and educational feedback to participants as part of the continual improvement procedures of participants;

6. situations where unusual factors make evaluation of results and commentary on performance impossible;

7. any other suggestions, recommendations or general comments; and

8. conclusions.

NOTE It can be useful to provide individual summary sheets for participants periodically during or after completion of a particular proficiency testing scheme. These can include updated summaries of performance for individual participants over successive proficiency testing rounds of a continuous proficiency testing scheme. Such summaries can be further analysed and trends highlighted, if required,

NOTE Where all original data cannot be reported to participants, a summary of the results, e g. in tabulated or graphical form, can be supplied.

1. the name and contact details for the proficiency testing provider;

2. the name and contact details for the coordinator;

3. the name(s), function(s), and signature(s) or equivalent identification of person(s) authorizing the report;

4. an indication of which activities are subcontracted by the proficiency testing provider;

5. the date of issue and status (e.g. preliminary, interim, or final) of the report;

6. page numbers and a clear indication of the end of the report;

7. a statement of the extent to which results are confidential;

8. the report number and clear identification of the proficiency testing scheme;

9. a clear description of the proficiency test items used, including necessary details of the proficiency test item's preparation and homogeneity and stability assessment;

10. the participants' results;

11. statistical data and summaries, including assigned values and range of acceptable results and graphical displays;

12. procedures used to establish any assigned value;

13. details of the metrological traceability and measurement uncertainty of any assigned value;

n) procedures used to establish the standard deviation for proficiency assessment, or other criteria for evaluation;

15. assigned values and summary statistics for test methods/procedures used by each group of participants (if different methods are used by different groups of participants);

16. comments on participants' performance by the proficiency testing provider and technical advisers;

17. information about the design and implementation of the proficiency testing scheme;

18. procedures used to statistically analyse the data;

19. advice on the interpretation of the statistical analysis; and

20. comments or recommendations, based on the outcomes of the proficiency testing round.

NOTE For continuous proficiency testing schemes, it can be sufficient to have simpler reports, such that many of the elements in this clause could be excluded from routine reports, but included in proficiency testing scheme protocols or in periodic summary reports that are available to participants.

NOTE This allows for early investigation of possible error.

1. a unique identification;

2. a reference to the original report that it replaces or amends; and

3. a statement concerning the reason for the amendment or re-issue.

1. relevant details of the scope of the proficiency testing scheme;

2. any fees for participation;

3. documented eligibility criteria for participation;

4. confidentiality arrangements; and

5. details of how to apply.

NOTE Participants can elect to waive confidentiality within the proficiency testing scheme for the purposes of discussion and mutual assistance, e.g. to improve performance. Confidentiality can also be waived by the participant for regulatory or recognition purposes. In most instances, the proficiency testing results can be provided to the relevant authority by the participants themselves.

5 Management requirements

1. have managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence of departures from the management system or from the procedures for providing proficiency testing schemes, and to initiate actions to prevent or minimize such departures;

2. have arrangements to ensure that its management and personnel are free from any undue internal or external commercial, financial and other pressures that may adversely affect the quality of their work;

3. have policies and procedures to ensure the protection of its participants' confidential information and proprietary rights, including procedures for their protection during electronic storage and transmission;

4. have policies and procedures to avoid involvement in any activities that might diminish confidence in its competence, impartiality, judgement or operational integrity;

5. define the organization and management structure, its place in any parent organization, and the relationships between quality management, technical operations and support services;

6. specify the responsibility, authority, interrelationships and required competence of all personnel who manage, perform or verify work affecting the quality of the operation of proficiency testing schemes;

7. ensure that the personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system;

8. provide adequate supervision of technical staff, including trainees, by persons familiar with procedures for each activity;

9. have technical management which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of proficiency testing schemes, including access to the necessary technical expertise and experience in the relevant field of testing, calibration or inspection, as well as statistics, as indicated in 4.4.1.4;

10. appoint a member of staff as quality manager (named as appropriate) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the management system is implemented and followed at all times; the quality manager shall have direct access to the highest level of management at which decisions are taken on the proficiency testing provider's policies or resources; and

11. appoint deputies for key managerial personnel.

NOTE Where proficiency testing providers have a small number of personnel, individuals can have more than one function and it can be impractical to appoint deputies for all major functions.

NOTE These aspects include, but are not limited to, proficiency test item quality (e.g. homogeneity and stability), characterization (e.g. equipment calibration and method validation), assignment of property values (e.g. use of appropriate statistical procedures), evaluation of participant performance, distribution of proficiency test items, storage and transport procedures, statistical treatment of test results, and reporting.

1. the management's commitment to the quality of its proficiency testing services to participants and other customers;

2. the management's statement of the standard of service;

3. the purpose of the management system related to quality;

4. a requirement that all personnel concerned with the proficiency testing activities familiarize themselves with the quality documentation and implement the policies and procedures in their work; and

5. the management's commitment to comply with this International Standard and to continually improve the effectiveness of the management system.

The proficiency testing provider shall establish and maintain procedures to control all documents that form part of its management system (internally generated, or from external sources), such as regulations, standards, other normative documents, proficiency testing scheme protocols, test or calibration methods, or both test and calibration methods, as well as drawings, software specifications, instructions and manuals.

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5.3.2.2

1. authorized editions of appropriate documents are available at all locations where activities essential to the effective operation of proficiency testing schemes are performed;

2. documents are periodically reviewed and updated, as necessary, to ensure continuing suitability and compliance with applicable requirements;

3. invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use; and

4. obsolete documents retained for either legal or knowledge preservation purposes are suitably marked.

5.3.2.3 Management system documents generated by the proficiency testing provider shall be uniquely identified. Such identification shall include the date of issue or revision identification, or both, page numbering, the total number of pages or a mark to signify the end of a document, and the issuing authority/authorities.

5.3.3 Document changes

original review and approval, unless specifically designated otherwise. The designated personnel shall have access to pertinent background information upon which to base their review and approval.

attachments.

1. the requirements, including those for test and calibration methods, measuring equipment and proficiency test items to be used, are adequately defined, documented and understood;

2. the proficiency testing provider has the capability and resources to meet the requirements; and

3. the proficiency testing scheme is technically appropriate.

NOTE 1 This review is particularly important when a customer requests a proficiency testing scheme to be created for a specific purpose or for a different level or frequency of participation from that normally offered.

NOTE 2 This review can be simplified when the proficiency test scheme is fully described in a catalogue or other notice, and the participant is enrolling for a routine shipment.