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Sabina Benedek As an engineer, I am always looking for challenges and my job is all about new challenges. I work as a QMS consultant at qmswrapper.com, so if there is any question about QMS, I will know the answer.
ISO 9001 – 2015 Checklist

ISO 9001 – 2015 Checklist

  A checklist on where to start, and what to do first Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project, you’re reading this because your strategy requires QMS oversight and your first question is likely “where to start” and “what...
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Same Tasks over and over Again? Let a Workflow Process Help You.

Same Tasks over and over Again? Let a Workflow Process Help You.

In the world of standards, regulations and protocols it is really easy to get confused. They are complex and always changing. Often, the issue is in the details and details are easily missed. Then when you try to make things compliant, you have to constantly be on top of every little detail if you don't...
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QMS Manager: Job or Role?

QMS Manager: Job or Role?

Diving deeper into ISO 13485:2016 meeting roles, defining them as the ISO standards and regulations expected from us, we can get a headache of how to define QMS management. 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 recommend...
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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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