ISO 13485 Quality Management System for Medical Devices
Certify your quality management system for medical devices with ISO 13485
ISO 13485 is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.
EN ISO 13485:2012 has been harmonised against the three EU Medical Devices Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices), so certification to this standard by an accredited certification body such as TÜV SÜD Product Service automatically presumes compliance with specific clauses in these directives.
The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market. In the European Union, the fulfilment of EU Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.
The current European medical device quality system standard is EN ISO 13485:2012. When manufacturers are active in the world market, the focus on global or international standards (e.g. ISO) is not only advantageous - it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485:2012.
In June 2007, CEN (European Committee for Standardization) published a corrigendum to the European standard, EN ISO 13485:2012. This corrigendum only revises the Preface to the European standard as it applies to regulatory uses. The purpose of the change was to replace the old EN 46003. For example, it added references to Module E in several places. This links EN ISO 13485:2012 with Annex VI (final inspection) of the MDD. Therefore manufacturers can now be audited to the 13485 standard under Annex IV. However, there are no changes that directly affect manufacturers.
The latest "EN" standard must be used by Notified Bodies for approving medical devices. TÜV SÜD now indicates the following nomenclature on TÜV SÜD Product Service GmbH quality system certificates: 'EN ISO 13485:2012'. You may see some references to DIN EN ISO 13485:2012-11. This is the identical document. It is only the German adoption of the EN standard as its national standard.
- Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union.
- Consultancies or agencies, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, as well as medical component manufacturers.
- Manufacturers of in vitro diagnostic medical devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.
The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market. In the European Union, the fulfilment of EU Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.
The current European medical device quality system standard is EN ISO 13485:2012. When manufacturers are active in the world market, the focus on global or international standards (e.g. ISO) is not only advantageous - it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485:2012.
In June 2007, CEN (European Committee for Standardization) published a corrigendum to the European standard, EN ISO 13485:2012. This corrigendum only revises the Preface to the European standard as it applies to regulatory uses. The purpose of the change was to replace the old EN 46003. For example, it added references to Module E in several places. This links EN ISO 13485:2012 with Annex VI (final inspection) of the MDD. Therefore manufacturers can now be audited to the 13485 standard under Annex IV. However, there are no changes that directly affect manufacturers.
The latest "EN" standard must be used by Notified Bodies for approving medical devices. TÜV SÜD now indicates the following nomenclature on TÜV SÜD Product Service GmbH quality system certificates: 'EN ISO 13485:2012'. You may see some references to DIN EN ISO 13485:2012-11. This is the identical document. It is only the German adoption of the EN standard as its national standard.
- Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union.
- Consultancies or agencies, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, as well as medical component manufacturers.
- Manufacturers of in vitro diagnostic medical devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.
Your benefits at a glance
- Enhanced efficiency and marketability - Formal certification of your quality management system will help you to market your products and services and to improve the efficiency of your organisation.
- Expert partnership - Our experienced audit team has the goal of adding value to your business by identifying improvement opportunities in addition to risks from any non-conforming areas.
- Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Affairs Department, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.