Management Systems for legally regulated Devices


You've got ISO 9001 - so what?

No doubt, a Quality System according to ISO 9001 is useful and wise but is it really enough for a medical devices manufacturer? This all depends on the chosen conformity assessment procedure based on product classification.

There is no need to have a certified Quality System for all kind of medical devices! Only a few products require a "Full Quality Assurance System" as described in the annexes II (MDD) and IV (IvDD). A Quality System according to ISO 9001 is not sufficient for these devices. They need conformity to the standard ISO 13485 and the annexes of the Directives.

consulting & more will be pleased to show You the most effective way to conformity assessment in consideration of Your individual wishes and needs.

Process orientated Quality Management vs. Project Management

Latest since the year 2000 we are talking about the process approach to Quality Management. This idea is defined in the international standard ISO 9001:2000 and now in the ISO 13485:2003 too.

The concentration on the processes makes it easier to implement and maintain Quality Management Systems even in small companies. But this strategy makes also sense in bigger organizations, because it fits very much better to Project Management than the chapter approach.

You are right now in the middle of a project called "Implementation of Quality Management"? Are You just working on integration of the new standards into Your established Quality System? consulting & more will support You in putting the processes into the correct order. The services of consulting & more can start with external supervising of the project and can end with a complete document review or analysis and documentation of processes.

How to realize a multi-center Quality Manual?

Some time ago the most enterprises with more than one manufacturing site had several Quality Manuals. Today it is not profitable any more to realize such expenditure of administration. Even for independent companies of a group the individual certificate is no more profitable!

The result is the construction of a multi-center Quality Manual - or Umbrella Manual - for the whole group companies which sometimes seems to be a little complicated but is worth it!

In most of the cases a fully electronic Quality Management Manual is the best way to go for the group companies. consulting & more can realize this for You together with our partner companies.

Do You have questions? We organize the whole service for You!