ISO 13485:2016

Medical devices. Quality management systems. Requirements for regulatory purposes

The ISO 13485 standard sets requirements for quality management in the development of medical devices and for the implementation of related services, in order to comply with customer requirements and applicable legislation.
ISO 13485 is a sector-specific standard, and compared to ISO 9001 its main accents are:

• • infrastructure elements are maintained;
  • the requirements for defining and managing the work environment are presented in more detail;
  • records related to product risk management actions are required;
  • documented design and development procedures are required;
  • the approval of a new product (whether it is suitable for its intended or actual use) must take place before its delivery or application. This includes clinical trials;
  • documented procedures for purchasing and records of input control of purchased materials are required;
  • traceability based on records for identified batches is required;
  • has special requirements for control, installation and maintenance;
  • there are specific requirements for implantable medical devices;
  • documented procedures for product storage are required;
  • considerable attention is paid to the requirements for improvement.

Document ISO / TR 14969: 2004 provides guidance on the application of the quality management system requirements contained in ISO 13485. To this end, it contains explanations that help to better understand the requirements and presents methods and approaches suitable for fulfillment of requirements.