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Records required for ISO 9001 clause 7.1.5.1 - Fitness for purpose of the monitoring and measurement resources

tony s

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Since the standard is applicable to all types of organization, the term "fitness for their purpose" of the various "monitoring and measuring resources" can be demonstrated on the following examples:
  • for measuring equipment (e.g. calipers, micrometers, etc.) - the appropriate discrimination, bias, number of distinct categories, etc. should be ensured;
  • for medical devices - the safety of the material, design, ease of use, ergonomic requirements, FDA approval, etc. should be ensured;
  • for examination or evaluation tools (e.g. on schools/universities) - the relevance, clarity of the set of questions, currentness, approval of education body, etc. should be ensured....
 
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