QMS Certification for Medical Devices

As a result of the excellent work of the GHTF (Global Harmonisation Task Force), the key global regulatory authorities are co-ordinating their requirements with respect to Quality Management Systems to be employed by medical device manufacturers.

The key change is new version of ISO 13485. Once published it is expected that this will become an EU harmonised standard (replacing the EN 46000 series) and as such will have the legal presumption of conformity enabling demonstration of compliance with the relevant annexes of the three EU Medical Devices Directives. The current versions of ISO 13485 / 13488 are already the backbone of regulatory requirements in the USA, Canada and Australia.

By way of a single audit, AMTAC are able to provide CE Marking authorisation, ISO 13485, EN 46001 and ISO 9001 certification - providing appropriate certification for the EU, USA, Canada & Australia.

ISO 13485 THE 'STAND ALONE STANDARD'

ISO 13485:200X

The standard ISO 13485:1996 Quality Management Systems for Medical Devices is currently under revision, the changes are likely to be significant and a draft copy of the standard has been released for comment by the medical devices industry and the appropriate regulatory bodies. The changes are largely as follows:

1. ISO 9001:2000 has been used as the base standard
2. Additional revisions have been made in the form of exclusions from ISO 9001:2000, including customer satisfaction and continuous improvement.
3. Particular requirements for the medical devices industry are also included and certain text from ISO 9001:1994 and ISO 13485 have been retained.

Replacing EN 46000

It is intended by the standards agency that ISO 13485:200X will replace EN 46000 as the harmonized standard for the Medical Devices Directive (93/42/EEC). It is also intended that the new standard will be 'stand alone' i.e. it will replace the current practice of using ISO 9000 and EN 46000 as the route to conformity with the Directive.

This will not be decided until the standard has been published and reviewed by the European Commission and accepted by them for harmonization and published as such in the Official Journal. Until this process is completed EN 46000 will continue to be used.

What Standard to Implement

The decision on which standard to use when implementing a quality management system, is entirely in the hands of the manufacturer, either standard (ISO 9000/EN 46000 or ISO 13485:1996) will currently suffice. The law in the form of Medical Devices Directive (93/42/EEC) does not demand any specific quality assurance system , other than that defined in Annex II, V or VI of the Directive. However, it does state that if an appropriate harmonised standard is used then this should be considered as demonstrating conformity.

Impacts on the Medical Devices Industry

The potential impact on the medical devices industry is that ISO 13485:200X, when published and harmonised by the EU, will satisfy regulatory requirements, but ISO 9001 is commercially recognised as a symbol of quality. In creating a new standard for the Medical Devices Industry, it is likely to sever the connection with ISO 9000, which might have a significant impact for many manufacturers.

If this is the case, some might take the option of maintaining quality systems that meet the requirements of both standard (i.e. include in the system those requirements such as customer satisfaction that will be excluded from ISO 13485:200X).