medical mfg standards

[toolingguy]

My company is going ISO 9001/2000. We are in need of a reconised manufacturing standards book that we can keep on site for auditing purposes and to use and implement. Our contracted "trainer" in the ISO process gave us a monumental handbook used in aerospace. We are a medical device mfg. with a cleanroom not an aircraft plant nor a DOD contractor. We need something specific to our needs that is preferrably either free or very, very, cheap.

We will be adhering to SPE guidlines for our tools, but the production enviorment is pretty much a free for all with no appearent logical methods employed so far. As far as ISO is concerned this won't do.

Any ideas would be welcome.

thanks!

 

[HEC]

Try the ISPE, International Society Pharma Engineers they have some good guides to GMP. Have another look at the aerospace hand book and look for the principals. Strip out some of the detail and you will probably get the system that will be suitable for you. The key is to strip out suficient detail that you do not create a hungry monster to be fed, and conversly strip out too much and not have sufficient control/monitoring of the process.
Good Luck!

Mark Hutton

 

[PSE]

toolingguy

In my experience, ISO does not really care what you do to make products as long as you do it consistently according to the practices you document (so be careful on how much you constrain yourselves in the procedures as you develop them). As a medical device manufacturer, as HEC indicates you should look at Good Manufacturing Practices (GMP) requirements (assuming you are in the US). Here is a couple of fda links that might help a bit.

http://www.fda.gov/cdrh/devadvice/32.html

http://www.fda.gov/cdrh/comp/gmp.html

Regards,

 

[mk2000]

toolingguy

In my experience ISO 9000/2000 and FDA are two deferent things in detail and similar things in principle. Since you deal with Medial device and you are going for ISO 9000 I assume you manufacture class II and below devices.

There are lots of links on the web on this topic (just google). As mentioned in the previous posts by PSE consistency is the key. There are a few tricks which can make certification useful and useless. Usually people form Defence background document everything to a magnitude greater than required which makes life difficult for a company not involved in a defence industry (although it is essential in defence industry).

I would suggest get an experienced ISO 9000 person on board who can give advice on how to get certified in the most effective way if you don’t have one already.

I might be able to help if you provide more details.

 

[ornerynorsk]

ISO 13485 is more applicable to you. Your ISO contractor / consultant should provide the framework for your quality and standards system. If not, find a different contractor.

 

[MMDeacon]

We manufacture medical electronics equipment, for our Final assembly lines we build to released assembly drawings. These are assembly operations where we assemble devices using torque drivers presses and manual assembly operations. Working to released documentation is sufficient. For our PWA assembly we work to IPC-A-610.