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Clause 8.4

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Guest user Created:   Aug 03, 2018 Last commented:   Aug 03, 2018

Clause 8.4

I am working on my ISO project and ran into these questions:
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ISO 9001 PROCEDURE FOR ADDRESSING RISKS AND OPPORTUNITIES

Address the risks and opportunities related to your QMS.

ISO 9001 PROCEDURE FOR ADDRESSING RISKS AND OPPORTUNITIES

Address the risks and opportunities related to your QMS.

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Iciar Gallo Aug 03, 2018

8.4 Control of externally provided processes, products and services
1) Would this include control of purchased raw materials? In the case of us as a commercial printer: paper, ink, etc.? I can not find another section that specifies raw materials, but thought it might fall under the category of “products”.
2) Also, the the text of sections 8.7 and 10.2 which cover non-conformities seem to focus on final product and not on purchased product or services (including raw materials). Is it correct that the same procedures can be followed for non-conformities on purchased items as well as final outputs?

Answer:

1) Yes, it includes purchased products such as raw materials, components, supplies, machinery and equipment, maintenance, etc.
2) You are correct. Nonconformities can be found not only in final outputs but also in both purchased products and supplier performance, so your controls must be based on the prevention of these possible non-conformities.

To learn more about co ntrol of external providers you can see:
- How to evaluate supplier performance according to ISO 9001:2015: https://advisera.com/9001academy/blog/2015/10/27/how-to-evaluate-supplier-performance-according-to-iso-90012015/
- How to control outsourced processes using ISO 9001: https://advisera.com/9001academy/blog/2015/05/05/how-to-control-outsourced-processes-using-iso-9001/

Also these material can help you with clause 8.4 Control of externally provided processes, products and services:
- Book – Discover ISO 9001:2015 Through Practical Examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
– Free online training ISO 9001:2015 Foundations Course: https://advisera.com/training/iso-9001-foundations-course/

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