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Quality Manual for ISO 13485 and ISO 9001

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Guest user Created:   Jul 27, 2020 Last commented:   Jul 27, 2020

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 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Carlos Pereira da Cruz Jul 27, 2020

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:

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Jul 27, 2020

Jul 27, 2020

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