ISO 13485 is the standard which sets out the requirements for a quality management system (QMS) applicable to designers and manufacturers of medical devices.
The Standard is based on the approach of the general Quality Management System Standard, ISO 9001. It replaces two earlier standards governing medical devices: ISO 13485 and ISO 13488.
Key requirements ISO 13485 – quality management system for medical devices
The key sections of ISO 13485 set out a range of requirements for developing, implementing and maintaining a QMS tailored to the design and production of medical devices.
They are arranged as follows:
- Systemic Requirements – e.g. establishing a QMS; keeping records, manuals and other essential documentation
- Management Requirements – e.g. defining policies; meeting customer requirements; planning; reviewing
- Resource Requirements – e.g. maintaining equipment; allocating personnel; managing the infrastructure and the work environment
- Realisation Requirements – e.g. planning product requirements; communicating with customers; overseeing design, purchasing and production
- Remedial Requirements – e.g. monitoring and measuring quality; analysing quality-related data; taking remedial action.
The medical devices sector is highly regulated, with its products requiring a CE Marking before they can be sold on the European market. Registration to ISO 13485 demonstrates to your customers – and to the regulators – that you have a professional approach and are committed to quality and excellence.
By undergoing the regular assessments associated with ISO 13485, your QMS will be continually evaluated, thus helping you improve overall performance and giving you a competitive edge in domestic and international markets.
ISO 13485 supports compliance with European regulatory requirements
Compliance with ISO 13485 can be the first step towards achieving compliance with European regulatory requirements. NSAI is the Notified Body in Ireland for conducting the conformity assessment procedures to ensure compliance with a number of Medical Directives.