Received and answer to my Email enquiry.
Hi Craig,
A bit more on ISO 13485:2003. First, it is a standard that was developed for regulatory use. It is based on ISO 9001:2000 with the following primary differences. Requirements for customer satisfaction have been replaced with requirements that the quality management system ensures you are meeting customer requirements. This is because of the nature of some medical devices, they may work perfectly but leave the patient with little satisfaction (i.e. a needle). The second difference is that instead of having requirements for continuous improvement of the QMS, these requirements have been replaced with requirements for maintaining the effectiveness of the quality management system. This is to ensure that for regulatory purposes, the quality system that is in place is maintained. These are the main differences with ISO 9001:2000.
ISO 13485:2003 is part of the requirements under CMDCAS (Canadian Medical Devices Conformity Assessment System), it is also recognized as being harmonized with the Medical Device Directives 93/42/EEC for European Union, Australia also used the European system. This means that under the EU Directive they will accept an ISO 13485 certificate as evidence of compliance with the quality system requirements of the Directive. Japan will be adopting ISO 13485 as part of their new system under their Pharmaceutical Affairs Law in 2005. I am not sure about other countries.
Hope this is helpful. If you have any questions, let me know.