Introducing the project ISO 13485:2016 – A Complete Guide to Quality Management in the Medical Device Industry

The quality management world of the medical device industry has gone through a significant change represented by the publication of the new revision of the ISO 13485 Standard, the 2016 revision. This revision brings new challenges to organizations as well as changes to old challenges. This book is a complete guide to implementing all of thBuye requirements of the standard. In order to present the reader with a practical and useful guide, I have provided a definition of my quality policy and objectives.

My quality policy

Presenting and reviewing the ISO 13485:2016 standard requirements through analysis, interpretation, and demonstration, with explanations, insightful examples, and events from various industries and sectors.

My quality objectives

• Commitment to the highest level of consulting regarding the ISO 13485:2016 standard.
• Reviewing all the topics and issues related to the realization of a product or service with reference to various types of processes and products.
• Providing support in the implementation of an effective quality management system.
• Facilitating the documentation of processes.
• Providing a reference to the new challenges presented in the ISO 13485:2016 standard.

However, a policy and related objectives are ineffective without also having in place designed and structured tactics and methods to achieve them:

• This guide is designed and structured to mirror the standard’s table of contents in order to simplify navigation and use.
• Each clause and subclause of the standard is discussed and analyzed through quality and regulatory perspectives, such as the implications for an organization—its processes, risk management, resources, infrastructures, work environment, control and effectiveness, and documents and records.
• The ISO 13485:2016 standard acts like a complicated web of prerequisites with relations between them. A full and comprehensive reference to the interrelations between the different clauses and subclauses has been included.
• Putting words into actions—the book will assist in translating the requirements and objectives into feasible activities and tasks. It visualizes situations with everyday events from the different sectors, branches, and products or services.

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