Hi,
Does anybody wants’ to share quality policy that covers ISO 9001; ISO 13485 and MDD 93/42/EEC?
Thank you all in advance
Ana
The MDD does not call for a quality policy to be established explicitly. The nearest is as in ANNEX II, 3.2 where written policies and procedures such as quality programmes, quality plans, quality manuals and quality records are necessary.
Now, about the 9001 and 13485 policies, the main difference is about continual improvement of QMS effectiveness in 9001 and maintaining the effectiveness of the QMS in 13485.
So here is our combined policy that stands accepted.
We, at xyz company are committed to comply with the requirements and achieve customer satisfaction through innovation & continual improvement in our process approach, in the design and manufacture of aabbccddeeff devices.
This will be done by maintaining the effectiveness of the Quality management system and by periodic review of feedbacks and our objectives.
We shall operate within the framework of all applicable regulatory requirements.
