ISO 13485 for Engineers

This book is written to provide Quality engineers, medical engineers, device engineers with a practical and insightful companion to understand ISO 13485, Quality Management system for medical devices. It provides a straight-to-the-point perspective which should assist in the interpretation of the standard and provide a benchmark for what is expected in the application of the standard and compliance for industry. ISO 13485:2016 is an international standard for the quality management of medical devices. It is of value and applicable to a number of business areas that are involved in the various stages of a medical device and its product lifecycle. It may be applied by a design company, manufacturer, raw material supplier, calibration service, sterilization services or distributer. The scope of the standard covers:

• design and development
• production, storage and distribution
• installation
• servicing (if required)
• decommissioning and disposal

In particular, manufacturers of medical devices and typically mandated by regulatory bodies to comply with ISO 13484, and must demonstrate compliance and application of the standard subject to certification and an audit process. FDA, 21 CFR Part 820 is another example of a Quality Management system. While its official designation is a Quality System (QS) it serves a similar purpose to ISO 13485- Quality management system for medical devices. However, there is an important distinction. 21 CFR Part 820 has a regulatory standing in the United states. While many competent authorities require the application of ISO 13485, the framework of ISO 13485 is a standard opposed to a regulation.
Revised in 2016, ISO 13485:2016 "specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements." The scope of the standard can apply to any organisation or company involved throughout the life-cycle of a product, including design and/or development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of technical or professional services. The 2016 revision is designed to address recent developments in quality management and other updated regulations that relate to the industry. Improvements in the new version of the standard include broadening its applicability to include all organisations involved in the life cycle of the product, from the concept stage to end of life along with greater alignment with regulatory requirements and post-market surveillance including complaint handling.
Overview of Content: Introduction to ISO 13485, Directives and Standards, Competent Authorities, Notified Bodies, How ISO 13485 differs to ISO 900I ISO/TR 14969, Terms /Definitions, Process Approach, Plan-Do-Check-Act (PDCA)
Quality Management System, Introduction, Regulatory Requirements, Risk Based Approach, Changes within the QMS, Documentation, Quality Manual, Control of Records
Management Responsibility, Management Commitment, Customer Focus, Quality Policy, Planning, Management Review, Resource Management, Provision of resources, Human resources, Infrastructure, Work environment & contamination control, Product realization, Planning of Product Realization, Design and Development, Production and service provision, Ctrl of monitoring & measuring equipment Measurement Analysis PART 2 Good Documentation Practices, Introduction, Quality Management Systems PART 3 Validation Introduction, Equipment and Software Validation, Software Validation, Process Validation, Packaging Validation