Guest user Created: Jul 19, 2018 Last commented: Jul 19, 2018

QMS Scope and Quality Manual

"In the template Quality Manual included in our toolkit, under section 4.3 (also 4.1 & 4.2), it states that the [CEO] determines the Scope of the QMS, but does not indicate that as part of the Quality Manual. Since it is a key part of the requirement, should the determined scope be included here under sec. 4.3? or should it reference an external document with possible support information? Would a reference to the Process Map (fig. 2) suffice? or do we need a more specific documentation?”

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Carlos Pereira da Cruz Jul 19, 2018

Answer:

The Scope of the QMS normally does not change. So, include it in section 4.3 of the Quality Manual is a good option. The other option is also possible, keep it as an external document referred in Section 4.3. Scope and Process Map are two different things. For example, you can have a very similar Process Map for two companies in the same economic sector, but since they have different strategic orientations they have different scopes.

The following material will provide you information about QMS scope:

- ISO 9001 – How to define the scope of the QMS according to ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
- free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/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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Jul 18, 2018

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