The design of management systems is complex, as some standards build on each other, while others take a completely different approach and have different objectives.
When we speak of standards, we refer to individual sets of rules such as the 2016 edition of EN ISO 13485, i.e., EN ISO 13485:2016. If a quality management system is developed exclusively according to these requirements, in this case the EN ISO 13485:2016 version, it is a single management system. If several standards are implemented at the same time under the specifications of a leading standard, it is called an integrated management system. It is also common that several single management systems are operated simultaneously.
Internationally, EN ISO 13485:2016 is the industry standard for the medical device industry and its suppliers as well as service providers. EN ISO 13485:2016 still follows the historically used eight-chapter structure but can be combined with other standards almost without difficulty. Among the most important are:
- (EU) 2017/745 Medical Devices Regulation (MDR)
- (EU) 2017/746 In Vitro Diagnostic Medical Devices Regulation (IVDR)
- ISO 9001 (quality management in general)
- ISO 14001 (environmental management)
- ISO 14971 (risk management)
- ISO 45001 (occupational health and safety)
- ISO 50001 (energy management)
- MDSAP (Simplified Auditing and Initial Approval Programme for the markets of the participating countries)
- U.S. 21 CFR 820 (standard in the USA, comparable to EN ISO 13485:2016)
