Feb 20, 2019
1.0 Purpose & Scope
1.0 The purpose of this procedure is to define the actions to be taken when JANAAC examines the participation and performance of a Conformity Assessment Body in proficiency testing and other interlaboratory comparisons.
2.0 This procedure shall apply to all CABs (where applicable) that are accredited by JANAAC or CABs seeking to be accredited in accordance with the requirements of the relevant standard.
For the purposes of this document, the terms and definitions given in ISO/IEC 17000, ISO/IEC 17011 and ISO 9000.
3.1 Use of Proficiency Testing and Interlaboratory Comparisons
3.1.1 JANAAC recognizes the importance of PT as a tool to demonstrate the competence of laboratories and where applicable, inspection bodies, to assist in maintaining the quality of their performance. Accredited CABs are therefore required to participate in proficiency testing when applicable and available, at least once every two (2) years.
3.1.2 JANAAC requires laboratories and IBs to develop and maintain a PT participation plan. This plan should be reviewed in response to changes in staffing, methodology, instrumentation or any other major changes in operations.
3.1.3 JANAAC establishes and maintains a list of appropriate proficiency testing providers
3.1.4 JANAAC utilizes test and calibration comparisons, as far as possible and appropriate, as a means of determining the competence of laboratories and IBs (where applicable) and their accreditation status both in initial assessments and recurrent assessment visits.
3.1.5 During these visits, JANAAC follows up on the results of participation in test and calibration comparisons by the laboratories or IBs, as well as any corrective actions taken by these CABs in response to the results of the comparisons.
3.1.6 PT participation and performance is considered in the decision process in the granting of accreditation. Successive poor performance in PT could have a negative impact on the laboratory’s or IBs’ prospect for accreditation.
3.1.7 For initial assessments, in arriving at the decision regarding the granting of accreditation, greater emphasis is placed on the level of participation, where relevant, and the effectiveness of the corrective actions taken by the applicant CAB than on its performance Where PT participation is mandated by regulatory, industry or professional sector, the CAB shall comply with such requirements
3.2 Requirements for Testing and Medical Laboratories
3.2.1 For each accredited laboratory, JANAAC requires participation in proficiency testing programmes when available to reasonably cover the laboratory's scope of accreditation during the four year period between accreditation and reassessment, or between two reassessments.
3.2.2 In cases where no suitable comparison programmes exist, JANAAC encourages the laboratories concerned to arrange comparisons with their colleagues. Discussion and agreement are required between JANAAC and the CAB on the suitability of the selected alternative. (See ILAC P9)
3.2.3 Where JANAAC deems it necessary, a laboratory may be required to test a 'known' object under the eye of the assessor.
3.3 Requirements for Calibration Laboratories
3.3.1 For calibration laboratories, JANAAC requires participation in a calibration comparison for each function/concept for which they are accredited, at least once every two years. These comparisons may be either national calibration comparisons or other international comparisons.
3.3.2 Where JANAAC deems it necessary, a laboratory may be required to calibrate a 'known' object under the eye of the assessor.
3.3.3 Wherever possible, JANAAC also arranges for the calibration laboratories to perform what are known as limited comparisons, in which the item to be calibrated is matched to the needs of the particular laboratory. Limited calibration comparisons mean that the abilities of a laboratory are measured only against the standards held by the national standards body or some other reference standard. Limited comparisons are generally carried out in connection with an accreditation or surveillance visit, in order to provide JANAAC with an opportunity for observing and assessing the laboratory's handling of the entire calibration process.
3.4 Requirements for Inspection bodies
3.4.1 If an inspection body conducts activities that involve measurements, and such measurements are sub-contracted, the subcontractor shall be accredited to ISO/IEC 17025 for the specific activity, or deemed competent by a national legislation/regulation and must meet the requirements for proficiency testing as stipulated in ISO/IEC 17025. In such cases, the requirements for impartiality and independence, as indicated in ISO/IEC 17020 shall apply.
3.4.2 If the inspection body conducts measurement activities as part of the inspection for which accreditation is sought, such measurements shall be conducted in accordance with the requirements in ISO/IEC 17025 and the requirements for proficiency testing as indicated in the ISO/IEC 17025 standard must be satisfied. Note, however, that the inspection as a whole is still performed under accreditation to ISO/IEC 17020.
Further guidance is provided in ILAC G27:06/2017 on the applicability of the requirements ISO/IEC 17025 or ISO/IEC 17020, with regards, to traceability of measurement results, validation of methods, and quality assurance, including proficiency testing.
3.5 Collaboration with other Agencies
CABs are requiredto purchase their own test comparisons from external providers as JANAAC does not provide these products. Neither will JANAAC make any arrangements for such comparisons to be done. However, JANAAC may provide assistance and support in formulating the CABs’ PTP needs and plans.
3.6 Assessing the Providers of Comparison Programmes
JANAAC does not provide the service of accreditation of Proficiency Testing providers. JANAAC strongly recommends the use of accredited PT providers, but where the provider is not accredited, that an assessment of the credentials and credibility of this provider be carried out by the CAB.