13485cert

Where can I learn about this Quality Management System (QMS) stuff?

In ISO, ISO 13485, Quality Management Systems on November 10, 2012 at 7:03 pm

A blog follower from Jon Speer’s website, Creo Quality, recently sent me a message asking for sources of good guidance on this Quality Management System (QMS) Stuff. There are a bunch of links below for you to follow and some practical advice. Enjoy learning!

J’aime Pink Martini et le chant de China Forbes.

The single best guidance document on the implementation of a QMS system in accordance with ISO 13485 is “13485 Plus” (type in the words in quotes to the CSA search engine).

There are also a bunch of pocket guides you can purchase for either ISO 9001 or ISO 13485 to help you quickly look-up information you are having trouble remembering. One of my Lead Auditor students recommended one pocket guide in particular and she was kind enough to give me her copy.

There are some webinars out there that provide an overview of QMS Standards. Some are free and some have a modest fee. I’m not sure the value is there for these basic overview webinars, but if you need to train a group it’s a great solution. I know BSI has several webinars that are recorded for this purpose.

AAMI has an excellent course on the Quality System Regulations (QSR) which combines 21 CFR 820 and ISO 13485.

There are a number of blogs I recommend on my website.

You can try to identify a local mentor–either in your won company or at your local ASQ Section.

You can join the following LinkedIn subgroup: Medical Device: QA/RA. You will need to become a member of the parent group (Medical Device Group)–if you are not already one of the 140,000+ members connected with Joe Hage. George Marcel and I manage this subgroup for Joe. George is out in the Bay Area and I’m in the Green Mountains.

You can visit the Elsmar Cove website and participate in the discussions you find there. I wrote a blog about Elsmar Cove a while back (wow almost 2 years ago now).

The best way to learn this stuff is to do all of the above.

And for the encore performance…

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  1. Thanks for the love, Rob. I’m eager to see you share your vast subject knowledge with the group.

  2. This was a HUGE help… if our med device is a stand alone software, do you know if a software validation needs to be done in advance of the QMS stuff?

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