ISO 9001 Clause 8.5.1 f
May i know if there are more practical examples for this clause? I have other views stating that this clause is referring to special processes which i don't really understand.
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ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
As far as I remember the wording of “special processes” come from the intial ISO 9001:1987 version. Imagine a manufacturing process where welding takes place, or where a sterilization process takes place. Is it possible to test welding quality? Is it possible to test sterilization effectiveness? Yes. Is it economically sound to do it every time? Normally, no. But organizations want to be sure that welding, sterilization, heat treatment, painting, and other activities are correctly performed. So, they have to validate process conditions and train people to be competent in performing the activities.
You can find more information about special processes below:
- How to establish process validation in the QMS - https://advisera.com/9001academy/blog/2017/01/31/how-to-establish-process-validation-in-the-qms/
- Enroll for free course - 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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Mar 10, 2020