ISO 13485 – quality management systems for medical devices
NSAI can offer registration to ISO 13485:2003, 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 13485:1996 and ISO 13488:1996.
The Standard is supported by a guidance document - ISO 14969:2004 - Quality management systems - Guidance on the application of ISO 13485:2003. This document was developed to help medical device designers and manufacturers apply the Standard.
Scope of ISO 13485
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:
- Section 4: Systemic Requirements – e.g. establishing a QMS; keeping records, manuals and other essential documentation
- Section 5: Management Requirements – e.g. defining policies; meeting customer requirements; planning; reviewing
- Section 6: Resource Requirements – e.g. maintaining equipment; allocating personnel; managing the infrastructure and the work environment
- Section 7: Realization Requirements – e.g. planning product requirements; communicating with customers; overseeing design, purchasing and production
- Section 8: 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.
How do I register?
To achieve NSAI registration to ISO 13485, first make sure you have in place the framework of a QMS based on the guidance and requirements set out in the Standard.
You can then get a quote from NSAI by completing our online quotation form
We will then arrange an on-site audit to review your QMS and Quality Manual, pinpointing weaknesses that need to be resolved before the main assessment.
When we are satisfied that you meet the requirements of ISO 13485, we will issue you with a certificate of registration.
Thereafter, we will support your registration with regular surveillance audits to check your QMS for continued compliance with ISO 13485.
Medical Device Directives
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.
On this website, you can find out more about how NSAI can help you with CE Marking for medical devices
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