Quality Management System (QMS) ISO 13485 Certification

Maintain regulatory compliance by being ISO 13485 certified

QMS ISO 13485 medical devices BSI

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

With over 280 BSI QMS assessors globally supported by BSI product experts, our ISO 13485 certificates are known and trusted in the medical device industry by authorities, suppliers and manufacturers around the world.



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.







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.