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Showing posts tagged with: QMS

6 Things Your DM Software Should Have

6 Things Your DM Software Should Have

ISO 12651-2 defines a document as "recorded information or object which can be treated as a unit". Err… Yup!... Got it!... Been treating recorded objects as a unit for, well… forever…   Sometimes you just have to admire their creativity! Compliance requests essentials On the more serious side, we’re still talking compliance and for that, there are 6...
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QMS Manager: Job or Role?

QMS Manager: Job or Role?

When digging deeper into a part where ISO 13485:2016 defines roles,  we can get a headache of how to define QMS management. It might be tricky to come to define Is it a job or is it a role in an organization? A QMS manager is a one-person Job with a very critical role, so we...
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Understanding Roles & Processes in ISO 13485:2016

Understanding Roles & Processes in ISO 13485:2016

What is a role and how does it connect to processes?   The 2016 edition is much more complicated than the 2003 edition so here is a little help to make things a little more understandable. In ISO 13485:2016 there are many new terms, definitions, and requirements compared with the 2003 edition. "First, a stab of the ISO bureaucrats…...
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ISO 13485:2016 - New terms to take note of

ISO 13485:2016 - New terms to take note of

Differences and similarities between the ISO 13485:2003 and ISO 13485:2016 editions. ISO 13485:2003 only had a few defined terms with clear definitions. However, in the new edition of ISO 13485:2016, sixteen new terms are added with longer definitions. Let's see what are the differences and similarities between the editions. Terms that remained the same Advisory notice - giving...
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