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. The standard is also based on the EU regulations on medical devices (2017/745) and in vitro diagnostic medical devices (2017/746). 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
What are the advantages of certification under ISO 13485?
- Legally compliant
- Competitive advantage
- Builds trust among customers
- Improved collaboration with suppliers and service providers
How long is the certification valid?
The TÜV PROFiCERT certificate for DIN EN 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 DIN EN ISO 9001, enabling the two standards to be audited together.