ISO 13485

The ISO 13485 is an ISO standard that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. The current edition was published in 2003 and replaces earlier documents such as EN 46001 and EN 46002 (both from 1997 ), the ISO 13485, which was published in 1996 and the ISO 13488 ( also from 1996 ). In Germany, the standard is available as DIN EN ISO 13485.

Although it is a stand-alone document, ISO 13485 is largely identical with the ISO 9001. While ISO 9001 is the requirement that the organization as a whole must strive for continuous improvement, the core claim of the ISO 13485 relates to product safety. Here is the fulfillment of the requirements for the product by the effectiveness of its processes should be ensured.

The ISO 13485 contains detailed requirements about topics that relate to the production and marketing of medical products. It falls within the statutory range and is used to represent the compliance with the European Medical Device Directive 93/42/EEC, 90/385/EEC on active implants and in-vitro diagnostic medical devices 98/79/EEC. Depending on the classification of the medical device is the application in the context of conformity assessment procedures for manufacturers of medical devices mandatory (under the Medical Device Directive 93/42/EEC, for example, for products in Classes In, Is, IIa, IIb and III). The application of ISO 9001 is done, however, on a purely voluntary basis and without the basis of a legal requirement. The conformity assessment procedures referred to above guidelines must be fully exhausted before medical devices in the EU may be legally placed on the market. To prove this, such as the certification of the quality management system according to EN ISO 13485 is required ( at the time of certification in letzgültig harmonized version) by a Notified Body for medical devices.

Specific differences to ISO 9001 are:

  • The promotion of specific policies as a management responsibility. An example of such specific guidelines, the Quality System Regulation 21 CFR 820 ( QSR) for medical devices that are sold in the United States.
  • Controls the work environment to ensure product safety.
  • Focus on risk management activities during product development.
  • Requirements for inspection and traceability for implantable devices
  • Requirements for documentation and validation of processes for sterile medical devices.
  • Demands on the effectiveness of the Corrective And Preventive Actions.

The standard adopted by CEN as EN ISO 13485:2003 / AC: 2007 has been adopted, has been harmonized with the EU Medical Device Directives 93/42/EEC, 90/385/EEC and 98/79/EEC.

Certification

Certification is carried out by the notified bodies, eg in Germany by TÜV.

See also

  • List of ISO standards
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