ISO 13485
internationally agreed standard that sets out quality management system requirements specific to the medical device industry
How to understand the QMS requirements in accordance with EU rules and ISO 13485
As a general obligation under EU rules, manufacturers seeking to place medical devices on the EU market must "establish, document, implement, maintain, maintain and continuously improve a quality management system (QMS)".
Creating a QMS is not an easy task, it requires the commitment of top management and the allocation of a large amount of resources.
As a general obligation under EU rules, manufacturers seeking to place medical devices on the EU market must "establish, document, implement, maintain, maintain and continuously improve a quality management system (QMS)".
Creating a QMS is not an easy task, it requires the commitment of top management and the allocation of a large amount of resources.
When to start? MDR and IVDR requirements
Starting with the basics, the QMS is a structured system that documents the processes and responsibilities for planning and implementing quality objectives and policies. The QMS enables organizations to coordinate and direct their activities in accordance with regulatory and customer requirements, as well as to continuously improve their efficiency and effectiveness.
The implementation and maintenance of a QMS is necessary to place medical devices and in vitro diagnostic (IVD) medical devices on the EU market in accordance with the MDR (EU Medical Devices Regulation 2017/745) and IVDR (EU IVD Regulation 2017/746) respectively. . Articles 10 and Annexes IX of each regulation list the minimum aspects that the QMS must take into account. In addition, manufacturers can rely on the internationally recognized ISO 13485:2016 standard to customize their QMS. Its observance, although not mandatory, will ensure compliance with the QMS requirements set out in the MDR and IVDR.
Starting with the basics, the QMS is a structured system that documents the processes and responsibilities for planning and implementing quality objectives and policies. The QMS enables organizations to coordinate and direct their activities in accordance with regulatory and customer requirements, as well as to continuously improve their efficiency and effectiveness.
The implementation and maintenance of a QMS is necessary to place medical devices and in vitro diagnostic (IVD) medical devices on the EU market in accordance with the MDR (EU Medical Devices Regulation 2017/745) and IVDR (EU IVD Regulation 2017/746) respectively. . Articles 10 and Annexes IX of each regulation list the minimum aspects that the QMS must take into account. In addition, manufacturers can rely on the internationally recognized ISO 13485:2016 standard to customize their QMS. Its observance, although not mandatory, will ensure compliance with the QMS requirements set out in the MDR and IVDR.
Certifying your QMS: the role of accredited certification bodies and EU notified bodies
An implemented system according to ISO 13485 in an organization can only be certified by accredited certification bodies. A list of approved ISO certification bodies, including ISO 13485, can be found on the International Accreditation Forum (IAF) website.
Manufacturers wishing to obtain the CE marking for their products in the EU may require the involvement of a Notified Body depending on the risk classification of the device. In such cases, the notified body will be responsible for assessing and (re-)certifying the manufacturer for conformity with EU regulations. The conformity assessment procedure usually includes an audit of both the Technical Documentation and the QMS; for this reason, the designated notified bodies are also accredited ISO 13485 certification bodies.
For manufacturers who first want to place their device on the EU market, it may be a good strategy to choose a body accredited to both ISO 13485 (accredited certification body) and MDR/IVDR conformity assessment (notified body). A list of designated notified bodies is available in the NANDO database.
An implemented system according to ISO 13485 in an organization can only be certified by accredited certification bodies. A list of approved ISO certification bodies, including ISO 13485, can be found on the International Accreditation Forum (IAF) website.
Manufacturers wishing to obtain the CE marking for their products in the EU may require the involvement of a Notified Body depending on the risk classification of the device. In such cases, the notified body will be responsible for assessing and (re-)certifying the manufacturer for conformity with EU regulations. The conformity assessment procedure usually includes an audit of both the Technical Documentation and the QMS; for this reason, the designated notified bodies are also accredited ISO 13485 certification bodies.
For manufacturers who first want to place their device on the EU market, it may be a good strategy to choose a body accredited to both ISO 13485 (accredited certification body) and MDR/IVDR conformity assessment (notified body). A list of designated notified bodies is available in the NANDO database.
ISO 13485 is the main and most international QMS standard for the medical device industry, followed worldwide, including in Europe.
Its latest and current version is ISO 13485:2016, harmonized by the European Commission (EN ISO 13485:2016).
The standard is not mandatory, but compliance with it is highly recommended and creates a presumption of conformity with EU regulations.
Its latest and current version is ISO 13485:2016, harmonized by the European Commission (EN ISO 13485:2016).
The standard is not mandatory, but compliance with it is highly recommended and creates a presumption of conformity with EU regulations.
How can we help?
How can CN help? We offer consulting projects for medical device manufacturers and other organizations in the medical field on the development and implementation of QMS in accordance with ISO13485:2016 and in accordance with EU regulations. Our services include:
- Development of QMS documentation in accordance with ISO 13485:2016
- Full implementation of QMS according to ISO 13485:2016
- Internal audits according to ISO 13485:2016
- Gap assessment with previous versions of ISO 13485 and EU requirements
- Assistance in addressing identified gaps