Validation, Qualification, and Verification procedure
I am trying to write a procedure about Validation, Qualification, and Verification. I just started with the definition section. I need to simplify these words clarifying the difference between them. Would you please advise?
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My first instinct was to recommend you check ISO 9000:2015 definitions, but then I realized that ISO 9000:2015 uses qualification and verification interchangeably. Verification is commonly used in design activities to name a set of activities done to confirm that specifications were met. Meeting specifications is not a guarantee that requirements for intended use are met, that is the topic of validation: confirmation that requirements for intended use are met. Now, about qualification I have doubts about what you want to mean with it. Perhaps, qualification is the state after a verification well succeeded.
You can find more information below:
- The ISO 9001 Design Process Explained - https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/
- About conducting design and development reviews consider - ISO9001 Design Verification vs Design Validation - https://advisera.com/9001academy/knowledgebase/iso9001-design-verification-vs-design-validation/
- ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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Aug 11, 2020