Re: validation requirement: 9001 vs 13485?
My employer is 13485 certified. However, lots of our suppliers (providers of parts and/or raws) are only 9001 certified. There are validation requirements in both 13485 and 9001. The wording in 9001 is "weak" but the basics seems the same. What would be the reasonable requirement to these 9001 suppliers in process/equipment validation? Thanks! (We make cable assemblies for medical devices).
The requirement to validate a process is usually:
*That you cannot verify the quality afterwards.
*That the process is considered critical
*That you want to use the validated state for marketing purposes.
IMO you only validate processes where there is a very good reason to do it. Validation is an expensive and tiresome process, and you can practically break a company if you want to validate everything.
If your suppliers provide you with 1 or 2 of the above you should require validation, if not you should have a good description of the quality that you expect.
