ISO 13485 Quality management system for medical devices


ISO 13485

ISO 13485ISO 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.

ISO 13485: 2003 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 demonstrates compliance with specific clauses in these directives.

The standard is particularly suitable to the following organisations:

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.

TÜV SÜD Product Service is accredited by ZLG in Bonn, Germany, as a Certification Body for quality management systems to ISO 13485 and is the largest Notified body covering the medical device sector (identification number 0123), having certifiedover 2,000 management systems for medical device companies worldwide.

For more information on our services for the medical device industry, please click here.

Benefits of certification to ISO 13485 by TÜV SÜD Product Service

  • Formal certification of your quality management system will help you to market your products and services and to improve the efficiency of your organisation. 
  • 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.
  • Certification from TÜV SÜD Product Service is one of the most recognised and respected in the global medical device market.

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 13485:2003.  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 13485:2003.

ISO 13485 -- Who is certified to these standards?

  • 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. 
  • Companies, such as consulting shops, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, and 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.

Accreditations

TÜV SÜD Product Service is accredited as a Certification Body for quality management systems to ISO 13485.  In addition, TÜV SÜD is a Notified Body for certification to all relevant EU Directives.  With this complete service package, TÜV SÜD can assist medical companies in accessing markets nationally, in Europe, and globally.

About ISO 13485:

The title of the ISO 13485 standards is as follows:

  • ISO 13485:2003 Medial Devices - Quality management systems - Requirements for regulatory purposes.

What is ISO 13485:2003 / AC 2007?

There was no change to ISO 13485:2003, the international standard for Medical devices — Quality management systems — Requirements for regulatory purposes. The 2003 standard is the current revision.

In June 2007, CEN (European Committee for Standardization) published a corrigendum to the European standard, EN ISO 13485:2003 / AC 2007. 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 ISO 13485:2003 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 13485:2003 / AC 2007.' You may see some references to DIN EN ISO 13485:2007. This is the identical document. It is only the German adoption of the EN standard as its national standard.