ISO/IE C 17025 – the internationalstandard on laboratories（二） [复制链接]

CLA USE 5—technical requirementsI would recommend that Clause 5.1 (General) be deleted s "KPTV  
from both the proposed testing and calibration laboratorstandards. It appears to be simply a placeholder, and it is very difficult to assess a laboratory to the requirements of 5.1. The measurement uncertainty covered in 5.1.2 could be covered more appropriately in Clauses 5.4, 5.5, and 5.6. In Clause 5.2 on Personnel, the changes required would be simple semantic changes to distinguish between testing and calibration activities. For example, for testing labs, the t>D|1E"  
first sentence in 5.2.1 would read, “The laboratory management shall ensure the competence of all who operate specific equipment, perform tests, evaluate results, and sign test reports.” For calibration labs, it would read “The laboratory management shall ensure the competence of all who operate specific equipment, perform calibrations, evaluate results, and sign calibration certificates.” 9:|z^r  
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There is a distinct difference in the training and areas of competence between testing personnel and calibration personnel. Testing lab personnel have to be trained in their area of specialty— such as electrical testing, electromagnetic compatibility testing, chemical testing, soil testing, etc. Calibration lab personnel have to be trained in measurement uncertainty, traceability, and calibration lab equipment. It would seem that calibration labs skills would be transferable from one calibration lab to another while a chemical testing lab person would have difficulty transferring to an electrical testing lab. s}MD;V& 0  
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Clause 5.3 on Accommodation and Environmental Conditions would require very few changes. For example, the first sentence in 5.3.1 would read as follows for testing labs, “Laboratory facilities for testing, including but not limited to energy sources, lighting and environmental conditions, shall be such as to facilitate correct performance of the tests.” In many technical disciplines, the environmental conditions for calibration laboratories are more stringent than the environmental conditions for testing laboratories. 'j^A87\M_  
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The title of Clause 5.4 should be altered to read “Test Methods and Method Validation” for testing labs. For calibration labs the title would read “Calibration Methods and Method Validation.” There would be a separation of testing and calibration throughout the clause to differentiate between the two functions. It would be appropriate to move Clause 5.4.5.1 into Clause 3 (Terms and Definitions) since it is the definition of validation—viz., “Validation is the confirmation by examination and the provision of specific evidence that the particular requirements for a specific intended use are fulfilled.” =oZHN,  
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Clause 5.4.6 on Estimation of Uncertainty of Measurement would have to be rewritten to clarify the intent. For example, Clause 5.4.6.1 would read as follows for calibration laboratories, “A calibration laboratory shall have and shall apply a procedure to estimate the uncertainty of measurement for all calibrations and types of calibrations.” Clause 5.4.6.2 would be eliminated for calibration laboratories. Clause 5.4.6.3 would remain the same—viz., “When estimating the uncertainty of measurement, all uncertainty components which are of importance in the given situation shall be taken into account, using appropriate methods of analysis.” ^Eu]i