ISO 13485 is a standard issued by the International Organization for Standardization (ISO). It sets out the requirements of QMS for the medical device industry.
ISO 13485 empowers an organization to align or integrate its own quality management system with medical device industry requirements. It prepares manufacturers to address the requirements under EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations.
ISO 13485 is based on ISO 9001:2015 standard. ISO 9001 is an internationally recognized standard widely adopted by organizations across multiple industries for building world-class Quality Management Systems. ISO 13485 standard has the same purpose; however, it includes additional specific requirements for companies that manufacture medical devices. We can say that ISO 13485:2016 is based on ISO 9001:2015 but it is more specific to medical device companies.
The additional requirements of ISO 13485 for ISO medical devices include:
Documentation requirements for medical device files
Work environment requirements
Contamination control requirements
Production requirements for cleanliness of products
Production requirements for sterile medical devices
Requirements for reporting to regulatory authorities