ISO 13485:2016 Handbook

This article is an edited version of an ISO news release.

The medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose.

Medical devices range from simple bandages and tongue depressors to the most sophisticated radiotherapy equipment, implants, and software for disease screening. These medical devices play a key role in the welfare of the public, whose safety depends on the quality and consistency of those medical products.

However, implementing a quality management system (QMS) that maintains the effectiveness of its processes, and meets applicable regulatory requirements, can be challenging for the medical device sector. Organizations may be treading on the finest of lines between distributing safe and effective medical devices quickly to the market, and gaining the trust of customers and meeting regulatory requirements.

A new handbook published in 2017, ISO 13485:2016 – Medical devices – A practical guide“, seeks to address these expectations. The handbook provides users with practical guidance and an accurate interpretation of the requirements in ISO 13485:2016, Medical devices -Quality management systems – Requirements for regulatory purposes.

Mapped to the structure of ISO 13485:2016, the handbook offers step-by-step guidance for all organizations in the medical devices sector wishing to implement and maintain a quality management system. It covers guidance applicable to various stages of a medical product’s life cycle, including the gathering of customer requirements, design, development, production, supply chain, installation, servicing, and post-market surveillance of medical devices.

Aimed at all organizations, regardless of size and the nature of their business, it helps create a level playing field and facilitate the market access of their products globally. The handbook can be used as the go-to reference when questions arise about specific requirements, their interpretation, and implementation strategies.

The handbook also serves as a practical guide for auditors, regulatory agencies, and certification bodies, providing in-depth perspective on how requirements can be met to meet national regulations. It 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.

The handbook has more than 200 pages and can be purchased for about $90 at this ISO web page.