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Internal records vs QMS

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Guest user Created:   Jan 12, 2016 Last commented:   Jan 12, 2016

Internal records vs QMS

 I have some questions about some internal documents that my company uses on a daily basis that doesn't seem to be required by ISO 9001:2008. There are multiple logs and check sheets that the owner likes to have to easily see different things, without having to do a lot of research there is just a log. I was once told that if it affects the product then it needs to be a quality form, but if these
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StrahinjaS Jan 12, 2016

check sheets don't affect the product, Where do they go? Are they included as reference or just separate from the quality documents?

Answer:

Besides the mandatory documents and records, the ISO 9001 standard also requires the documents and records that the organization identified as necessary.

I assume that that logs and check sheets are used for processes and activities monitoring so they should be incorporated in procedures describing those processes. They may not affect the product quality directly, but they can be important for monitoring and measuring process, also they can be referenced in procedure for management review as a input element.

If the logs and check sheets are used for monitoring processes and activities they should definitely be a part of quality documents.

Here are very informative articles regarding the subject:

Some Tips to make Control of Records more useful for your QMS https://advisera.com/9001academy/blog/2014/01/28/tips-make-control-records-useful-qms/
Monitoring and Measurement: The basis for evidence-based decisions https://advisera.com/9001academy/blog/2020/09/21/how-to-perform-monitoring-and-measurement-according-to-iso-9001/

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Jan 12, 2016

Jan 12, 2016