ISO 13485 Quality Management System

What is an ISO 13485 Quality Management System?

QMS ISO 13485 medical devices BSI

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.



EN ISO 13485:2016 - The harmonized standard is here

ISO 13485:2016, the Medical Device Quality Management System standard, has been harmonized to the European Medical Devices Directives: MDD, AIMDD and IVDD. EN ISO 13485:2016 now replaces the previous version of the standard, EN ISO 13485:2012, in the EU Official Journal, with the date of 'cessation of presumption of conformity' of EN ISO 13485:2012 stated as 31 March 2019.

Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.

The harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in 2020 and 2022, respectively. Find out more about MDR transition and IVDR transition.

BSI can now offer UKAS-accredited ISO 13485 certification to ISO 13485:2016 and to EN ISO 13485:2016. Talk to us to find out more.


BSI Medical Devices | The corona chat with Teresa Perry and Elemed





Medical Device Single Audit Program (MDSAP)

The MDSAP is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements. RAs include Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW.

Find our more about MDSAP and how it impacts your ISO 13485 certification.