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Verification and validation - BSI Group

1 Verification and validation November 9th 2016 Copyright 2016 BSI. All rights reserved. Trev and Spike present the definitive guide to Verification and validation 3 Objectives Descriptions and definitions Examples ISO 13485:2016 requirements Use of Statistics Verification (BS EN ISO 9001:2015) confirmation, through the provision of objective evidence that specified requirements have been fulfilled. Any set of criteria can be subjected to Verification . Verification : Did we make what we said we would make? validation (BS EN ISO 9001:2015) Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. Does it do what it says on the tin? The intended purpose is achieved, validation . Quality (BS EN ISO 9001:2015) degree to which a set of inherent characteristics of an object fulfils requirements.

7.3.7 Design and development validation Design and development validation shall be performed in accordance with planned and documented arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. The organization shall document validation plans that include methods,

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