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Capstone Design Courses, Part IIDesign Verification and Validation

Capstone Design Courses, Part II: Design Verification and Validation [Design verification and validation are included among the design control requirements of ISO 9001:2000 Quality Systems Management—Requirements. According to ISO 9000:2005 verification (Section 3.8.4) is defined as “confirmation, through the provision of objective evidence, that specified requirements have been fulfilled” and validation (Section 3.8.5) is defined as “confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled” [1]. Validation has more to do with meeting customer needs (making the right product) and verification has more to do with processes used to produce the product (making the product right). In comparing the two definitions, the differences between “specified requirements” and “requirements for a specific intended use or application” are ambiguous. In most situations, verification occurs upstream of the final product, where validation involves the final product design. There are situations where verification and validation occur simultaneously on the final product. The ISO 9000 family of standards is flexible enough to allow this approach. What is most important is that an organization completes both phases.] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Capstone Design Courses, Part IIDesign Verification and Validation

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Publisher
Springer International Publishing
Copyright
© Springer Nature Switzerland AG 2012
ISBN
978-3-031-00524-4
Pages
33 –36
DOI
10.1007/978-3-031-01652-3_9
Publisher site
See Chapter on Publisher Site

Abstract

[Design verification and validation are included among the design control requirements of ISO 9001:2000 Quality Systems Management—Requirements. According to ISO 9000:2005 verification (Section 3.8.4) is defined as “confirmation, through the provision of objective evidence, that specified requirements have been fulfilled” and validation (Section 3.8.5) is defined as “confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled” [1]. Validation has more to do with meeting customer needs (making the right product) and verification has more to do with processes used to produce the product (making the product right). In comparing the two definitions, the differences between “specified requirements” and “requirements for a specific intended use or application” are ambiguous. In most situations, verification occurs upstream of the final product, where validation involves the final product design. There are situations where verification and validation occur simultaneously on the final product. The ISO 9000 family of standards is flexible enough to allow this approach. What is most important is that an organization completes both phases.]

Published: Jan 1, 2012

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