There is a new handbook ISO 13485:2016 – Medical devices – A practical guide just published. It was written by a group of technical experts from ISO’s technical committee ISO/TC 210. The handbook provides users with practical guidance and accurate interpretation of the requirements specified in the ISO 13485:2016, Medical devices –Quality management systems – Requirements for regulatory purposes.
Mapped to the structure of ISO 13485:2016, the new handbook offers a step-by-step guidance for all organisations in the medical devices sector wishing to implement and maintain a quality management system. It covers guidance applicable to various stages of a medical device’s life cycle, including the gathering of customer requirements, design, development, production, supply chain, installation, servicing and post-market surveillance of medical devices.
The handbook can serve as a practical guide for auditors, regulatory agencies and certification bodies, providing in-depth perspective on how requirements can be fulfilled to meet national regulations. It thus allows for a better understanding of the standard when preparing or conducting external and internal audits, as well as establishing local regulations and guidelines.
Alongside its thorough description of ISO 13485, the new handbook also incorporates information from other sources of best practice most commonly used in the medical devices industry to meet the requirements of ISO 13485:2016.