ISO 13485

ISO 13485 Quality Management System for Medical Devices

Efficient medical device quality management system and testing

Efficient medical device quality management system and testing


Perhaps more than any other type of manufactured product, the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients, users and, where appropriate, other persons. For these reason, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system that has been independently audited and verified. Medical devices manufactured or supplied by organisations without a verified quality management system are routinely denied legal entry into major markets, usually resulting in extended delays in gaining access and lost revenue opportunities.

As of 19 December 2016, TÜV SÜD Product Service GmbH has been accredited by the German national accreditation body (DAkkS) to issue quality management system certificates to the latest edition of ISO 13485:2016 standard. Companies with existing certificates will need to upgrade their certification to the new standard by 31 Mar 2019.

The certificates issued henceforth will carry a three-years validity until the cessation date of the superseded standard is being published by European Commission. After which, the validity date will be the day of cessation. Manufacturers holding certificates covering a longer period will need to prepare ahead and ensure an upgrade to the new certification before the cessation date.

Fulfil requirements with expert regulatory guidance by downloading our guide for Process Validation in Medical Devices

Download guide Process Validation in Medical Devices

WHAT IS ISO 13485:2016?

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers.

Originally developed in the 1990s, the standard details requirements for a quality management system that meets both customer requirements and regulations in the European Union (EU), Canada and other major jurisdictions around the world. This standard is similar in scope and intent to ISO 9001, but it includes additional requirements specific to medical devices while excluding certain ISO 9001 provisions. Therefore, in most jurisdictions, ISO 9001 certification is not an acceptable substitute for certification to the requirements of this standard.


In the EU, the requirements of ISO 13485 Quality management for medical device have been harmonised with the essential requirements of the EU’s Medical Device Directive (93/42/EEC), the Directive for In Vitro Diagnostic Medical Devices (98/79/EC) and the Directive for Active Implantable Medical Devices (90/385/EEC).

Certification by an accredited certification body provides a presumption of conformity with the essential requirements of these important directives. In the U.S., the Food and Drug Administration (FDA) permits device manufacturers to submit the audit reports as a substitute of the evidence of compliance with its quality systems regulations (QSR). Health Canada also requires medical device manufacturers marketing their products in Canada to have their quality management system certified to ISO 13485:2016 


TÜV SÜD Product Service is the largest EU Notified Body in the world, and our technical professionals have first-hand knowledge and in-depth expertise with all types of medical devices. In addition, we are a leading global management certification body for quality management systems, including management systems applicable in the manufacture of medical devices.

Each audit team consists of experts with the skills and expertise needed to accurately assess the compliance of your management system and is headed by a lead auditor who will oversee the audit and any required management change notices.

Finally, our on-site or off-site Technical Documentation Assessment will provide you with the information you need to understand your exposure to non-compliance issues. This unique combination of experience makes TÜV SÜD ideally suited to address the needs of medical device manufacturers seeking to achieve or maintain ISO 13485 certification


TÜV SÜD Indonesia offers a complete range of testing, certification and auditing services to manufacturers of medical devices, helping them to manage risks and to protect and promote the health and safety of patients, users and, where appropriate, other persons.

Our global network of more than 700 dedicated medical health and services professionals include noted scientists and physicians recognized as authorities in their respective fields. These capabilities make TÜV SÜD Indonesia the preferred single source for worldwide compliance with medical device regulations.

Latest updates on ISO 13485

Talk to our experts at [email protected]



in vitro diagnostic infographic

The In Vitro Diagnostic Medical Device Regulation

Following the publication of regulation (EU) 2022/112, the IVDR will be rolled out gradually.

Learn More

New Medical Device Regulation

The Medical Device Regulation

Understand the requirements of the MDR

Learn More


Next Steps

Site Selector