ISO 13485 Standard

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 underEU Medical Device Directive (MDD), theEU 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

Related Links:

• Scilife for Medical Devices
• Medical Devices: Risk Based Classification for Patient Safety
• What is ISO 13485 for Medical Devices, and how is it different from ISO 9001?
• Medical Device Conferences and Events
• EU MDR: Key Changes and Important Steps