When you’ve done as much as I have in the quality management business, you feel the need to share your knowledge and experience with others. And this is exactly what I deliver in this book. My book is filled with all the things that will make your implementation project a success. The main strategy of this book is: I put words into actions. Just read and do. For example:
- What is risk management? Do you know how to integrate the risk management processes in the QMS and achieve an effective risk management system? Did you ever analyzed risks? Are you sure it is what the ISO 13485 expects? I explain in details what risk management is and how to systematically harmonize risks management system and the quality management system. I give you tools and tricks to answer this new ISO 13485 Standard requirement. Just read and do.
- What do you really know about Validation of Software applications for the quality management system? Can you identify the types of software that must validated? Do you know how to validate them? The book explains what is expected from you regarding Validation of Software applications. I suggest ways to understand which software must be validated in the QMS and I propose a system for managing the validation. In fact I dedicate a whole chapter for the matter. Just read and do.
- What is contamination control in the eyes of the ISO 13485 Standard? Can you tell me the relation between the infrastructures and the contamination control? How would you manage contamination control, integrate it in the QMS and answer the ISO 13485 Standard requirements? I explain this issues in details describe you which steps are required in order to integrate it in the QMS.
The book is 860 pages long. What are you to do with a book with 860 pages? Read it all? It will take you a year. You do not have to. The table of contents in my book is identical to the table of contents of the standard so you can orient yourself quite easily and find the specific advice you are looking for. You have a question regarding an ISO 13485 standard requirement? Just find the relevant chapter and save time.
Buy the book if you desire to master the ISO 13485 Standard. It is the most detailed, specific and accurate document you will find about the ISO 13485 Standard requirements giving you a direct presentation of techniques of how to develop and implement processes. It will motivate and inspire you. You will learn how to leverage your QMS in an effective and very easy to understand way. And it will make your life easier when implementing the ISO 13485 Standard in your quality management system.
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