ISO 13485

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Logo of the German Institute for Standardization DIN EN ISO 13485
Area Quality management
title Medical devices - Quality management systems - Requirements for regulatory purposes
Latest edition 2016-03
ISO 13485

The ISO 13485 is an ISO - standard , the requirements for a comprehensive quality management system for the design and manufacture of medical devices represents.

The current edition was published in 2016 and directly replaces the last version from 2012. In ISO 13485: 2012, earlier standards such as EN 46001 and EN 46002 (both from 1997), ISO 13485 and ISO 13488 were taken from the Year 1996 summarized and supplemented. In Germany the standard is available as DIN EN ISO 13485.

content

Although it is a stand-alone document, ISO 13485: 2003 is largely identical to ISO 9001 . While ISO 9001 stipulates that the organization as a whole must strive for continuous improvement (quality management), the core requirement of ISO 13485 relates to product safety and effectiveness. Here the fulfillment of the requirements for the product should be ensured through the effectiveness of the introduced processes.

ISO 13485 contains detailed requirements on topics that affect the design, manufacture and placing on the market of medical devices. The 2016 version goes into more detail for the first time on product safety of medical IT and prescribes safety precautions for the storage of patient-related data. ISO 13485 is specifically aimed at medical devices, falls within the legally regulated area and serves to demonstrate conformity with the current Medical Device Directive 93/42 / EEC (MDD) , IVD Directive 98/79 / EC (IVDD) and the directive for active implantable devices medical devices 90/385 / EEC (AIMDD) , as well as the European Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

The application of ISO 9001, on the other hand, takes place on a purely voluntary basis and without the basis of a legal requirement. The conformity assessment procedures according to the above directives must be completed before medical devices can be legally placed on the EU market. In order to prove this, among other things, the certification of the quality management system according to EN ISO 13485 (at the time of certification in the most recently valid harmonized version) by a notified body for medical devices is required.

Specific differences to ISO 9001 are:

  • the promotion of specific guidelines as a management responsibility. An example of such specific guidelines is Quality System Regulation 21 CFR 820 (QSR) for medical devices sold in the United States.
  • Work environment controls to ensure product safety.
  • Focus on risk management activities during product development.
  • Inspection and traceability requirements for implantable devices.
  • Requirements for documentation and validation of the processes for sterile medical devices.
  • Requirements for the effectiveness of corrective and preventive actions .

The standard, which was adopted by CEN as EN ISO 13485: 2016, has been harmonized with the EU directives on medical products 93/42 / EEC, 90/385 / EEC and 98/79 / EC .

Certification

The certification is carried out by notified bodies , or by accredited certification bodies for. B. in Germany by DQS or TÜV , in Switzerland by SQS and in Austria by TÜV AUSTRIA (certification body).

In Switzerland there has been seldom asked about conformity or proof of certification, especially when it comes to care beds and mattresses. Hospitals are generally from the Swissmedic monitors, nursing homes are cantonal monitored.

See also

literature

  • DIN eV (editor), Randolph Stender (author): Quality management for manufacturers of medical devices: Commentary and practical guide to the third edition of DIN EN ISO 13485 . Beuth 2017. ISBN 3410256962 .

Individual evidence

  1. ↑ ISO Catalog: ISO 13485: 2016 Medical devices - Quality management systems - Requirements for regulatory purposes
  2. ↑ Medical Devices - New EU Regulations . On the website of the Federal Ministry of Health of October 12, 2018. Accessed on March 14, 2019.
  3. ↑ Summary list of titles and references of harmonized standards related to medical devices - DG Enterprise & Industry. European Commission .

Web links