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Changes & exclusions in ISO 9001

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Guest user Created:   May 14, 2019 Last commented:   May 14, 2019

Changes & exclusions in ISO 9001

1) whats the difference between clause 6.3 and 8.5.6 of QMS ?. they both tells about change.
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Iciar Gallo May 14, 2019

2)is design and development of product and services applicable for production dept?

Response:
1) Clause 6.3 Planning of changes - ISO 9001 requires the organization to carry out changes in the QMS in a planned maner when it is determined the need of changes.

Having a plan include tasks, deadlines, responsibilities, resources, needed information, etc.)

Clause 8.5.6 - Control of changes - ISO 9001 requires the organization to review and control changes for products/service provision, to the extent necessary to ensure continuing conformity with requirements. Therefore it is necessary to stablish a process to manage changes, i.e. to review , approve and communicate that adequately changes have been implemented effectively. Also changes should be validated in order to not affect the QMS.

Basically clause 6.3 is referred to planning while clause 8.5.6 is referred to stablishing controls

Examples include : change in a process, change in exte rnal providers, changes in developing documented information, etc.

For more information about changes in ISO 9001:2015, see this article:

- QMS change management in 7 steps: https://advisera.com/9001academy/blog/2016/11/29/qms-change-management-in-7-steps/

2) If you conduct in the Production Department some kind of Design and Development then requirements of clause 8.3.1 &8.3.2 apply. For example if your organization only accepts customer’s designs for manufacture then you can exclude this requirement from the scope of your ISO 9001.

For more information about design and development in ISO 9001:2015, see this article:
https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/

Also these materials can help you to understand ISO 9001:2015 requirements:
- Book – Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free on-line training – ISO 9001:2015 Foundations: https://advisera.com/training/iso-9001-foundations-course/

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May 14, 2019

May 14, 2019

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