ISO 13485 Book and Training Class Recommendations wanted

[texkb]

My boss has recently informed that he wants me to become more involved in managing our quality system. They are planning to send me to an ISO 13485 class but in preparing for that I have been looking for a good book to give some information on ISO 13485 that helps break down the standards, I have already viewed the actual ISO 13485 standard guide. Unfortunately I have been able to find any books that help break down the standards down so I was hoping that there would be suggestions from the cove. Also in terms of ISO 13485 training classes is there a particular training service that is preferred and what type of class is best? Is it best to start with an introductory class to the ISO 13485 quality management system or is best to do some research and reading on ISO 13485 on my own and then take an internal auditor class?

Thanks for your advice.

 

[DannyK]

I would recommend reviewing ISO TR 14969.
The best source for training for ISO 13485 are the certification bodies.
If you will be selling your own product you should learn about the regulatory requirements.

 

[Ajit Basrur]

Thanks for the concised and apt response, DannyK

 

[Marcelo]

Read the ISO 9001 Quality Systems Handbook by David Hoyle. It's the best book on quality systems standards in my opinion. Although written directly for ISO 9001, the ideas are the same for ISO 13485 (and remeber ISO 13485 is based on ISO 9001).

 

[texkb]

Thanks mmantunes! In looking at the description and reviews of this book this seems like just the book for us to further our quality management system.