Advantages of certification to ISO 13485

  • Legally compliant
  • Competitive advantage
  • Builds trust among customers
  • Improved collaboration with suppliers and service providers

How long is the certification valid?

The certificate for ISO 13485 is awarded upon successful completion of the certification process. It is valid for three years and must be confirmed every year by a monitoring audit. The interval is thus the same as in the process for certification under the quality management system standard ISO 9001, enabling the two standards to be audited together.

ISO 13485 Quality Management for Medical Devices

Healthcare equipment is subject to high standards – after all, its quality can have a direct impact on both its effectiveness and the safety of patients and users. Quality management systems are certified in accordance with the international standard EN ISO 13485, with the inspection focusing on quality management in design and development, production, customer service and the assembly of medical devices.

What is ISO 13485?

ISO 13485 is very similar to ISO 9001, but was developed specifically for manufacturers and suppliers of medical devices. As part of the certification procedure – which consists of a document inspection in advance and a subsequent on-site company audit. 

The following issues are taken into account alongside the familiar requirements of ISO 9001

  • Monitoring of the working environment to ensure product safety
  • Focus on risk management activities during product development, production and the provision of services
  • Requirements relating to procurement, inspection and the provision of services
  • Requirements relating to the documentation and validation of specialized processes
  • Requirements relating to identification and traceability
  • Requirements relating to a market observation and reporting system
  • QMS 9001 Internal Auditor
  • QMS 9001 Lead Auditor
  • EMS 14001 Internal Auditor
  • EMS 14001 Lead Auditor
  • OHSMS 45001 Internal Auditor
  • OHSMS 45001 Lead Auditor
  • MD QMS 9001 Internal Auditor
  • BCMS ISO 22301 Internal Auditor
  • EnMS ISO 50001 Lead Auditor
  • FSMS ISO 22000 Lead Auditor
  • IATF 16949 Automotive QMS Lead Auditor
  • ISMS ISO 27001 Internal Auditor

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