H) correlation of results for different characteristics of an item G) retesting or recalibration of retained items This monitoring shall be planned and reviewed and shall include, where appropriate, but not be limited to:Ī) use of reference materials or quality control materials ī) use of alternative instrumentation that has been calibrated to provide traceable results Ĭ) functional check(s) of measuring and testing equipment ĭ) use of check or working standards with control charts, where applicable Į) intermediate checks on measuring equipment į) replicate tests or calibrations using the same or different methods The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to review the results. The laboratory shall have a procedure for monitoring the validity of results. Handling instructions provided with the item shall be followed. Precautions shall be taken to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for testing or calibration. The laboratory shall have a procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer. The laboratory shall retain the following records of validation: The laboratory shall use appropriate methods and procedures for all laboratory activities and, where appropriate, for evaluation of the measurement uncertainty as well as statistical techniques for analysis of data. The procedure shall ensure that:Ī) the requirements are adequately defined, documented and understood ī) the laboratory has the capability and resources to meet the requirements Ĭ) where external providers are used, the requirements of 6.6 are applied and the laboratory advises the customer of the specific laboratory activities to be performed by the external provider and gains the customer's approval ĭ) the appropriate methods or procedures are selected and are capable of meeting the customers' requirements. The laboratory shall have a procedure for the review of requests, tenders and contracts. The laboratory shall have a procedure and retain records for:Ī) defining, reviewing and approving the laboratory’s requirements for externally provided products and services ī) defining the criteria for evaluation, selection, monitoring of performance and re-evaluation of the external providers Ĭ) ensuring that externally provided products and services conform to the laboratory’s established requirements, or when applicable, to the relevant requirements of this document, before they are used or directly provided to the customer ĭ) taking any actions arising from evaluations, monitoring of performance and re-evaluations of the external providers. When intermediate checks are necessary to maintain confidence in the performance of the equipment, these checks shall be carried out according to a procedure. The laboratory shall have a procedure for handling, transport, storage, use and planned maintenance of equipment in order to ensure proper functioning and to prevent contamination or deterioration. The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities shall be documented. The laboratory shall have procedure(s) and retain records for:Ī) determining the competence requirements The laboratory shall document the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience. Ĭ) document its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results. The laboratory shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis. The laboratory shall define and document the range of laboratory activities for which it conforms with this document.
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