ISO 13485 - Medical Devices | Forum profile

Quote: Originally Posted by maxwell Greetings: I am wondering what methods are being used to re-evaluate suppliers. My company requires that an initial supplier survey form be completed and is now trying to determine what method to use for re-evaluation of approved suppliers. Re-evaluation needs to be done annually; the initial supplier survey form is a bit long so we are looking to streamline the re-evaluation process. I am interested in how...

The following article has some info, including a part on changing: Identifying the Right Notified Body for Entering the European Market

I am re-reading the guidance note on my registrar's ISO 9001:2008 upgrade document - "Check that any outsourced processes are identified and that control over them is adequate." My company has identified them with the fact that we perform incoming inspection on outsourced processes. I find it odd that the outsourced process clause has been in ISO 9001 / ISO 13485 respectively since the 2000 / 2003 revisions in one form...

5.5.1 States: "Top management shal ensure that responsibilities and authorities are defined, documented...." Here is a clear example of where documentation is mandated. This is why I say there is no requirement to document the identification of outsourced process control. One could make the case that 4.2.1 d) could require the documentation of outsourced processes controls, but that is an argument for another thread.

Absolutely, and getting the take from different auditors and clients, is one of the best ways to learn and improve. Elsmar Cove is great for that.

This particular problem has been very stubborn, but perhaps it's getting closer to becoming diminished for some of us. Following is a quote from an email notice sent by our EC Authorized Representative. I've masked their identity to avoid commercial-identification concerns and also because I believe they think they're on iffy legal ground telling their customers this info: Quote: In regards to the Italian Registrations we...

Sidney - thanks - I am thinking thats what my customer was trying to communicate, but it didn't come out as clearly as you put it. Does anyone know if TUV in Germany has any such "lineage" policies?

Hi mates, Facing the problem to open up this file attached. HELP..... Tiff....

Quote: Originally Posted by DrM2u Therefore the customer's registrar should have no questions about a supplier's certificate of registration as long as it is issued by an accredited registrar. Things do change if the customer's procedures require the supplier's certificate to be linked to a certain accreditation body, but that limits the options for registrars. I think you are confusing certification with notification. The...

"Information regarding the worldwide medical devices regulations" are generally a service (which is called Regulatory Intelligenece) offered by some companies such as Clinivation. Associations do usually have information of this kind, but due to the nature of trade associations (which are generaly comprised of manufacturers form all sectors) it´s simply impractical to have all the information available. They also tend to...