4.1 This Practice establishes general criteria for a Quality System that, when followed, helps ensure consistently acceptable data quality from an AETB. The relevant criteria contained in this Practice shall be addressed in the AETB’s Quality Manual, which shall contain or refer to additional specific criteria and requirements where relevant and necessary. The Quality Manual and its implementation (including test protocols, reports, and personnel testing) shall provide the sole basis for determining the conformance of the AETB with this standard.
Note 3: This Practice assesses the overall ability of an AETB to deliver data of known and documented quality on a consistent basis regardless of the test method used. There is no requirement to define a scope of testing. It is a requirement of this Practice that prior to performing a test method for the first time, the AETB has in place resources, training, and QA/QC consistent with this Practice to insure data of acceptable quality are produced.
4.2 This Practice is for use by AETBs in developing the quality, administrative, and technical systems that govern their operations. Clients, regulatory authorities, and accreditation bodies may also use it in confirming or recognizing the competency of AETBs.
Note 4: This Practice is performance-based; that is, it focuses on the actual performance (in other words, consistent generation of data of known and documented quality) of the AETB rather than on an extensive collection of prescriptive criteria that may or may not be relevant to a particular AETB. It also focuses on the education and qualifications of the individual tester.
Note 5: There has been an effort in the development of this Practice to keep the paperwork and administrative burdens on affected AETBs to the minimum required for an effective program.
