Hello Trevor,
In simple answers, yes a type of validation or qualification of the methods, equipment, and fixtures should be done because this could be different based on each company and setup. It may not need a "validation" per se but at least a qualification supporting the exact equipment and fixtures used are accurate and reproducible.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 20-Jan-2023 09:04
From: Trevor Tuffy
Subject: Test Method Validation - ISO Standard
Looking for some guidance/advice in relation to Test Method Validation.
If you are following the test method outlined in an ISO Standard, is it necessary to conduct a Test Method Validation to demonstrate that your test set-up (equipment, fixtures, etc.) is capable of producing reliable results?
For example, ISO 20679 Annex D, provides a test method for determining the peak tensile force of connections. The test method specifies the tensile testing apparatus must be capable of exerting a force greater than 15 N, and that the testing speed of 500 mm/min. The test method also states "if necessary, use an appropriate fixture to avoid deforming the connectors". In this example, it is necessary to validate the method, equipment, and fixture used to show that it is repeatable and reproducible.
Thank you.
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Trevor
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