ISO 13485 - Medical device manufacturers
ISO 13485 specifies requirements for a quality management system that can be applied by an organisation for the design and development, production and installation as well as the maintenance of medical devices.
ISO 13485 - Medical device manufacturers
ISO 13485 specifies requirements for a quality management system that can be applied by an organisation for the design and development, production and installation as well as the maintenance of medical devices.
Summary
The standard is aimed at organisations that must comply with one of the European directives for medical devices (90/385/EEC, 93/42/EEC, new (EU) 2017/745 and 98/79/EC, new (EU) 2017/746) in order to affix the CE mark to their products, and other parties involved in the development, manufacture and marketing of medical devices.
For medical device manufacturers, ISO 13485 is therefore the necessary addition to their management system in accordance with ISO 9001.
It should be noted that the requirements for the quality management system specified in this international standard apply in addition to the technical requirements for products.
Development
ISO 13485:2003
This standard was developed on the basis of ISO 9001:2000, but the requirements for "customer satisfaction" and "continual improvement" in particular have been modified. For this reason, conformity with ISO 13485:2003 does not always mean conformity with ISO 9001:2008, although ISO 13485:2003 has the same structure as ISO 9001:2008 and the requirements in both standards are largely identical.
ISO 13485:2003/AC:2007
The corrigendum ISO 13485:2003/AC:2007 concerns the removal of references (in the foreword) to EN 46003, which is no longer valid and has been withdrawn. No changes have been made to the basic requirements of ISO 13485:2003.
EN ISO 13485:2012
This European version of the standard does not contain any changes to the requirements, only the preface and Annexes ZA, ZB and ZC have been modified.
ISO 13485:2016
This new version of the standard was published on 25 February 2016.
The transition period is 3 years and ends on 24 February 2019, by which time all users must have converted in order to have a valid certificate.
Utilisation & Benefits
ISO 13485 is aimed at manufacturers, distributors and reprocessors of medical devices and can be used to assess an organisation's ability to meet regulatory requirements relating to the product. The standard applies in addition to technical requirements for a medical device.
Validity of Swiss certifications under accreditation in Switzerland and abroad
You are currently discussing the legal uncertainty regarding the export of medical devices to the EU under the previous law under the MRA CH-EU. This affects, among other things, the EU's recognition of certificates for legacy medical devices that benefit from the transitional periods in the EU. For further information on the export of legacy medical devices to the EU, please contact SECO and Swissmedic.
The validity of Swiss certifications under SAS accreditation is not affected by this. Such certification documents, e.g. for the international standards ISO 9001, ISO 14001, ISO 45001, ISO 13485, ISO 22000, retain their current validity in Switzerland and abroad.