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Meeting requirements of clause 8.5.1 f) - validation

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Guest user Created:   Apr 21, 2017 Last commented:   Oct 14, 2021

Meeting requirements of clause 8.5.1 f) - validation

I have enjoyed many of your explanations and webinars on ISO 9001:2015. In fact, I am currently involved with your ISO 9001:2015 Auditor Training on line.
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Strahinja Stojanovic Apr 21, 2017

I am trying to understand ISO 9001:2015, clause 8.5.1 f. We are a small company that purchases various "powders", mixes different product together, sometimes bakes them and sells the result (still a powder) to the electronic business to manufacturer electronic components.

Of course we are in the process of reviewing, understanding , and implementing the new standard.

Right now I am trying to understand how our company complies to 8.5.1 f) or can we say this is not applicable to our business?

Answer:

Validation is applied when the final product cannot be verified by other means. This activity is often excluded and you can say it is not applicable to your business if you can check your final product against product requirements and verify its compliance.

F or more information, see: How to establish process validation in the QMS https://advisera.com/9001academy/blog/2017/01/31/how-to-establish-process-validation-in-the-qms/
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BIKRAM SARAF Oct 14, 2021

Dear Sir,

 

Good morning from India.

I understand the point cited by you.But I having some queries.

1..Our product is calcinated pet coke & power , for which we have substantial approach for monitoring & measurement, hence we have excluded 8.5.1.f.

But we have some smaller outsourced activities ( not directly associated with our products/services),For example motor winding & weilding.

Does it require to add 8.5.1.f to our QMS.

 

Regards,

B K Saraf.

 

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Carlos Pereira da Cruz Oct 14, 2021

If “motor winding & wielding” are not incorporated in your product clause 8.5.1 f) is not applicable.

If “motor winding & wielding” services are considered relevant perhaps your organization should include requirements for your suppliers of those products.

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Oct 14, 2021