ABSTRACT
This chapter describes the origin, implementation, and use of the quality management system requirements in medical devices globally based on a commonly used standard International Organization for Standardization 13485. It highlights some of the key changes and additions for the 2016 version of the standard. A standard is, in essence, an agreed repeatable way of doing something. The standard International Organization for Standardization 13485:2003 Medical devices—Quality Management systems—requirements for regulatory purposes has grown to be the certification standard of choice for medical device manufacturers. A standard is, in essence, an agreed repeatable way of doing something. The Global Harmonization Task Force has published guidance on the Control of Products and Services Obtained from Suppliers. Clearer requirements are provided on the validation need for the processes for production and service provision-usually following a master validation plan approach, identification and traceability, customer property including drawings and IP, and the preservation of the product.
