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ISO 13485 in the Swiss Context

Overview​

ISO 13485:2016 (Medical devices — Quality management systems — Requirements for regulatory purposes) is the internationally recognised QMS standard for medical device manufacturers. For Swiss market access, ISO 13485 certification from an accredited body is the standard evidence of QMS compliance required by EU-designated NBs conducting Annex IX Chapter I audits.

ISO 13485 Certification for Swiss Market Access​

ISO 13485 certification does not replace the NB QMS audit under MedDO Annex IX — but it is typically a prerequisite for and is assessed as part of the NB audit. The NB QMS audit under MedDO Annex IX goes beyond ISO 13485 to assess MedDO-specific requirements.

ISO 13485 certification provides:

  • Evidence of a documented, implemented QMS
  • Third-party verification of QMS compliance
  • A baseline for the NB's Annex IX audit
  • Acceptance for most other global markets (FDA QMSR, TGA, Health Canada, PMDA all accept or recognise ISO 13485)

The NB Annex IX audit additionally assesses:

  • Whether the QMS scope covers all device types being certified
  • MedDO-specific obligations (UDI processes, SSCP maintenance, GSPR compliance management)
  • PMS system integration with the QMS
  • PSUR preparation processes

Choosing an ISO 13485 Certification Body​

ISO 13485 certification should be obtained from an accredited certification body — one that is accredited by a member of the International Accreditation Forum (IAF) to certify against ISO 13485. In Switzerland, the national accreditation body is SAS (Schweizerische Akkreditierungsstelle). Internationally recognised accreditation bodies include UKAS (UK), DAkkS (Germany), COFRAC (France), and ANAB (USA).

Note: ISO 13485 certification body accreditation is distinct from EU MDR NB designation. Check that your chosen ISO 13485 certification body is accredited with the appropriate scope.

Scope Considerations for Switzerland​

For Swiss market access, the ISO 13485 QMS scope should cover:

  • All device types being placed on the Swiss market
  • Design and development (for Class IIa and above)
  • Manufacturing processes (if manufacturing in-house)
  • Distribution activities (if the certificate holder is also the importer or distributor)

If the manufacturer uses a contract manufacturer or outsources any quality-critical processes, the scope and supplier control processes must be documented in the QMS.

Official Sources​

Disclaimer

AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.