This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation.
Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author's many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication.
In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context.
- A pragmatic and down to earth approach towards the reader's understanding of ISO 13485:2016 standard requirements implementation.
- Uses examples and cases from real-life based on the author's many years of experience in quality management.
- A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader.
- Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement
- Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Itay Abuhav has been acting as a consultant for many organizations in various areas for the past 15 years, specializing in the quality management/control industry, consulting with a number of small- to medium-sized firms dealing with implementing quality management systems, with a major focus on the European medical device industry. He is highly qualified to certify organizations to various standards: ISO 9001 and ISO 13485. The author has two active websites related to these topics, namely, www.9001quality.com and www.13485quality.com.
Scope, Normative References. Terms and Definitions. Context of the Organization. Understanding the Organization and its Context. Understanding the Needs and Explanations of Interested Parties. Determining the Scope for the Quality Management System. Quality Management System and its Processing. Leadership. General Customer Focus. Policy. Establishing the Quality Policy. Communicating the Quality Policy. Organizational Roles, Responsibilities and Authorities. Planning. Actions to Address Risks and Opportunities. Qualty Objectives and Planning to Achieve Them. Planning of Changes. Support. Resources. General. People. Infrastructure. Environment for the Operation of Processes. Monitoring and Measuring Resources. Organizational Knowledge. Competence. Awareness. Communication. Documented information. General. Creating and Updating. Control of Documented Information. Operation. Operational Planning and Control. Requirements for Products and Services. Customer Communication. Determining the Requirements for Products and Services. Review of Their Requirements for Products and Services.Changes to Requirements for Products and Services. General. Design and Development Planning. Design and Development Inputs. Design and Development Controls. Design and Development Outputs. Design and Development Changes.