Design Review, Verification and Validation
ISO 9000:2015 Definitions:
determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Quality Management Course
FREE! Subscribe to get 52 weekly lessons. Every week you get an email that explains a quality concept, provides you with the study resources, test quizzes, tips and special discounts on our other e-learning courses.
- EXAMPLES: Management review, design and development review, review of customer requirements, review of corrective action and peer review.
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.
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)