Design Review, Verification and Validation

ISO 9000:2015 Definitions:

1. Review:

determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.

  • EXAMPLES: Management review, design and development review, review of customer requirements, review of corrective action and peer review.

2. Verification:

confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

  • The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.
  • The word “verified” is used to designate the corresponding status.

3. Validation:

confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

  • The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents.
  • The word “validated” is used to designate the corresponding status.
  •  The use conditions for validation can be real or simulated.

Review, Verification and Validation:

Reviews are conducted to evaluate the ability of the results of design and development to meet requirements;

Review: Will this design achieve the required objective?

Verification activities are conducted to ensure that the design and development outputs meet the input requirements;

Verification: Whether output meets input requirements (e.g. codes, specifications)

Validation activities to ensure that the resulting products and services meet the requirements for the specified application or intended use;

Validation: Does the product serve the required purpose? (live test)

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