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qmsWrapper Blog - Take Back Compliance - The Art of Managing Through Quality

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Validating or Not Validating for Intended Use?

Validating or Not Validating for Intended Use?

When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA. Although Validation for intended use documentation is useful for several reasons.
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ISO 9001 – 2015 Checklist

ISO 9001 – 2015 Checklist

If you do QMS right, it’s not a burden, not an added layer of management that gets in the way. The following checklist will guide you.
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ISO 13485 – 2016 Checklist

ISO 13485 – 2016 Checklist

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager, the following checklist will guide you.
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Approval Workflows in QMS

Approval Workflows in QMS

Maintaining compliance is not an easy job. QMS approval processes are supporting the accurate recording of acceptance or agreement in business documents.
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