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Exemption for design clause 8.3

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Guest user Created:   Oct 16, 2019 Last commented:   Oct 16, 2019

Exemption for design clause 8.3

If we develop tools, jigs and fixtures for production operations, can we get exclusion for ISO 9001 clause 8.3 for design. Although we get drawings and product specifications from our customers, some time we have to make minor changes in the product because of our process capability constraints . Can we still get exemption for design clause 8.3? please advice

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Carlos Pereira da Cruz Oct 16, 2019

I believe it is a common situation among manufacturers that work for brands. The customer (the brand) designs and specifies the product, the manufacturer because of any of several motifs can suggest changes. Changes have to be validated by the customers. So, the final word on the product and the final responsibility is always on the customer side. In these cases, exemption for design clause 8.3 is applicable.

The following material will provide you more information about scope and clause applicability:

- Article - What clauses can be excluded in ISO 9001:2015? - https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/
- Free webinar on demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/
- Enroll for free in this course -  ISO 9001:2015 Foundations Course - https://training.advisera.com/course/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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Oct 16, 2019

Oct 16, 2019