ISO 13485 Handbook Released

ISO has just published an ISO 13485 handbook and it’s available now from Document Center Inc.  This new guidance document is titled ISO 13485:2016 – Medical devices – A practical guide.  It was developed by members of the committee to assist you in implementing this important quality standard.  It contains their best advise for success!

ISO 13485 Medical Devices – A Practical Guide addresses the challenges faced by those of you in the medical device industry using the ISO 13485.  This is the requirements document for regulatory Quality Management Systems (QMS).  The handbook is therefore divided into mirror sections for the structure of the ISO 13485.  And, like many other guidance documents, each comments area is prefaced by the actual text of the 13485 standard.

As you move through the handbook, you’ll find an ISO 13485 clause, a paragraph on the intent of the clause, and then the guidance.  Whenever possible, actual examples are used.  So for the 13485 clause on human resources, there is discussion on the processes you’ll need to identify training needs.  And for this, an example of a professional extrusion specialist’s need for additional training is given.  After all, the improper operation of an extrusion machine might negatively affect your medical devices’ safety and performance.

This ISO 13485 Handbook is 220 pages of detailed information on using the ISO 13485:2016 Edition.  This will prove to be an invaluable tool for industry, as implementation of the ISO medical device standards has been impacted by recent changes in the documents themselves.

You’ll want to get your copies from an authorized ISO distributor like Document Center Inc.  Just order at our webstore,  Here is a direct link to the order page for ISO 13485 Medical Devices – A Practical Guide for your convenience.  And you can find the order page for the ISO 13485 here.

When picking a format for using the ISO standards, you have a number of choices with Document Center Inc.  Of course, we have the usual paper copy and pdf download options.  But your organization may prefer cloud access.  You can talk with our staff about our Standards Online subscription services.  Many of our medical device customers find this an excellent solution to the stringent document control requirements for regulatory certification.

Learn more by reaching out to us by phone (650-591-7600) or email (  We have been working with standards since 1982 and recognize the needs that standards users have beyond just purchasing documents.  Our services range from reporting to notifying to delivery and maintenance of your compliance documents.  Make us your Standards Experts!

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Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

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