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Joe Kovacs Joe Kovacs, Quality manager at qmsWrapper. I am constantly working on developing more and more effective quality management solutions that could contribute to the development and production of superior quality products and services.
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 (ensure accuracy, reliability, consistent intended performance, the ability to discern invalid or altered records, etc.) people mainly think of it as a regulatory requirement only. In FDA's...
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ISO 13485 – 2016 Checklist

ISO 13485 – 2016 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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Quality Manual or Workflow Processes? What should I establish first?

Quality Manual or Workflow Processes? What should I establish first?

  So, what documentation hierarchy should we adopt? It turns out that this question is a classic for a reason. People have been asking it for many years, and there is more than a little confusion on the answer. The Quality Manual requires many references to the applied company and the workflow processes. Synchronously, most quality management related...
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The Temptation of ISO 13485 Template Kits

The Temptation of ISO 13485 Template Kits

Be careful what you use when building up your QMS system! The expanding Internet means more: more data, more collaboration, and more complex systems of interactions. You can find hundreds of both expensive and free templates for ISO 13485, offered by various consultants, companies and experts. But even if the ISO compliance is guaranteed on some...
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