Quality Manual for ISO 13485 and ISO 9001
I'm new in creating of Quality manual in both ISO 13485:2016 and ISO 9001:2015. May I know on how to indicate the Internal and external issue requirements in the Quality manual of ISO 9001:2015?
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ISO 9001:2015 does not require a Quality Manual. So, you can design your Quality Manual as best fits your organization’s purpose. For example, you can include the internal and external issues as a topic to be reviewed during management review or while updating quality objectives. Internal and external issues will affect the ability of an organization to perform.
You can find more information below:
- How to identify the context of the organization in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
- 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/
- 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 27, 2020