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.
| Aspect | Review | Verification | Validation |
|---|---|---|---|
| ISO 9000:2015 Definition | Determination of the suitability, adequacy, or effectiveness of an object to achieve established objectives. | Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. | Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. |
| Purpose | To evaluate the design's ability to meet objectives and identify areas for improvement. | To ensure the product meets all specified design and requirement specifications through objective evidence. | To ensure the product performs satisfactorily in its intended use environment, through objective evidence. |
| Focus | On evaluating design documentation, processes, and plans for their capability to meet objectives. | On assessing the product against specific requirements and specifications. | On confirming that the product meets user needs and intended use in real or simulated environments. |
| Activities | Management reviews, design and development reviews, reviews of customer requirements, and peer reviews. | Inspections, testing, reviewing documents, and performing alternative calculations. | Testing, performing alternative calculations, reviewing documents, and scenario-based assessments. |
| When it Occurs | Throughout the design phase and at key milestones in the development process. | After the completion of development stages, prior to validation. | At the end of the development process, before product release. |
| Outcome | Identification of improvements, confirmation of design adequacy, and suitability for objectives. | Evidence that the product meets specified requirements. | Evidence that the product is capable of meeting its intended use in specified conditions. |
| Responsibility | Carried out by the design team and stakeholders involved in the development process. | Conducted by quality assurance teams, engineers, and testers. | Involves end-users, customers, and sometimes independent validators. |
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)