Medical devices can be simple or complex, but all of these can benefit from being designed and manufactured under ISO 13485 which is the most widely used medical device quality management standard.
ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the quality management system. This differs from ISO 9001 which focuses on customer satisfaction and continual improvement. Whereas both customer satisfaction and continual improvement are as important to medical device manufacturers as to any other business today, these things are hard to measure and tend to be somewhat subjective.
So when it came time to adapt ISO 9001 to the medical device industry, these potentially subjective requirements were changed to meeting customer requirements and maintaining the effectiveness of the quality management system, which are more easily measurable.
The other major difference from ISO 9001, which is also consistent with the fact that this is a regulatory standard, is that there are more requirements for documented procedures.
It used to be the case that holders of ISO 13485 automatically were issued with a certificate of compliance to ISO 9001 but no longer. If an organisation requires both ISO 13485 and ISO 9001 then both would need to be assessed separately.
Accreditation of Certification Bodies (CB’s) in the UK is carried out by UKAS (United Kingdom Accreditation Service) UKAS is the sole accreditor in the UK.
We can help you set up a medical devices quality management system and get you ready for assessment.