Verification and validation

"IV&V" redirects here. For NASA's IV&V Facility, see Independent Verification and Validation Facility.
For the software activities, see software verification and validation.
For validation of tests, see Test validity.

Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose.[1] These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".

In reality, as quality management terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably.[2][3][4]

However, the PMBOK guide, a standard adopted by the Institute of Electrical and Electronics Engineers (IEEE), defines them as follows in its 4th edition:[5]

  • "Validation. The assurance that a product, service, or system meets the needs of the customer and other identified stakeholders. It often involves acceptance and suitability with external customers. Contrast with verification."
  • "Verification. The evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition. It is often an internal process. Contrast with validation."

Similarly, for a Medical device, the FDA (21 CFR) defines Validation and Verification as procedures that ensures that the device fulfil their intended purpose.

  • Validation: Ensuring that the device meets the needs and requirements of its intended users and the intended use environment.
  • Verification: Ensuring that the device meets its specified design requirements

ISO 9001:2015 considers

  • Validation: To ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Design validation is similar to verification, except this time you should check the designed product under conditions of actual use.
  • Verification: Design verification is confirmation by examination and provision of objective evidence that the specified input requirements have been fulfilled. Verification activities such as modelling, simulations, alternative calculations, comparison with other proven designs, experiments, tests, and specialist technical reviews.
  1. ^ Global Harmonization Task Force - Quality Management Systems - Process Validation Guidance (GHTF/SG3/N99-10:2004 (Edition 2) page 3
  2. ^ Ad Sparrius (2016). "Everything You Thought You Knew about Validation and Verification is Probably Dodgy" (PDF). 12th INCOSE SA Systems Engineering Conference. Archived from the original (PDF) on 6 August 2018. Retrieved 30 April 2018. There are some authors who apparently regard these two terms as synonymous, others who seem to be only vaguely aware of the differences. Some even appear to believe that V&V is one word! ... There is such a fundamental difference between these models that the term validation has many years ago been selected to be different from the term verification. Nevertheless, it is debatable whether the distinction between validation and verification should be continued.
  3. ^ James D. McCaffrey (28 April 2006). "Validation vs. Verification". Retrieved 30 April 2018. Two terms that sometimes confuse software test engineers are "validation" and "verification". ... Obviously the two IEEE definitions are so close to each other it's hard to determine the difference.
  4. ^ "Difference between Verification and Validation". Software Testing Class. 27 August 2013. Retrieved 30 April 2018. In interviews most of the interviewers are asking questions on "What is Difference between Verification and Validation?" Lots of people use verification and validation interchangeably but both have different meanings.
  5. ^ "P1490/D1, May 2011 - IEEE Draft Guide: Adoption of the Project Management Institute (PMI) Standard: A Guide to the Project Management Body of Knowledge (PMBOK Guide)-2008 (4th edition)" (4th ed.). IEEE. June 2011: 452. doi:10.1109/IEEESTD.2011.5937011 (inactive 1 November 2024). Retrieved 28 March 2017. {{cite journal}}: Cite journal requires |journal= (help)CS1 maint: DOI inactive as of November 2024 (link)