ISO certificates… your QMS is certified, not your company Your QMS is certified! Before you celebrate and tell everyone about it, there are some questions that you should answer first: What’s exactly certified – your company, your QMS, or your device? What’s the best way to let the world know about this? Many companies get…
Easier QMS compliance in Canada and the US It’s now official! The FDA ruling on its 21 CFR 820 earlier this year has made for easier QMS compliance in Canada and the US. For a few years now the FDA has been taking steps to align its Quality System Regulations. More specifically, it has been…
When to put a Quality Management System in place In my previous article entitled “Why the Quality Management System is a Strategy Tool”, I asked you to consider the Quality Management System as a very critical part of the development plan for any product or medical device, and to to adopt a QMS to support…