EMS for Medical Device Facility with Ethylene Oxide (ETO) Sterilization process.

V

Vassilis

I would like to ask for your help regarding implementation of a EMS in a medical devices industry which uses ETO sterilization equipment facilities.
My question is that i should take the following steps for the planning of the EMS?
1) Introduction to organisation activities
2) Environmental aspects analysis
3) Environmental Policy ,target and goals .

If anyone has an example of EMS from Medical Devices Industry which has ETO sterilization facilities would be a great help for me!!

Thanks a lot in advance!!

Vassilis!
 

Randy

Super Moderator
If the steps will work for you, sure do it that way.

What you need to do is no different than what an oil refinery would do:

1. Identify the requirments

2. Meet the requirements

Just read through the ISO 14001 Forum which started around 1998 and you'll probably find the answer to every question you have.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
What Randy said. :agree:

Asking this forum for an EMS is like getting a bunch of "canned" documents for ISO 900X. The EMS needs to be what you do to manage your hazardous materials in such a way as to meet the various requirements. Please use the Search tool in the tool bar (yellow font) and explore the ISO 14001 forum for the insight you can use to make an EMS that really works.
 

Stijloor

Leader
Super Moderator
If anyone has an example of EMS from Medical Devices Industry which has ETO sterilization facilities would be a great help for me!!

Hello Vassilis,

This (or this) may not exactly what you're looking for, but it may be a start.
Also, as Jennifer stated, you may want to further search threads and posts here.

Stijloor.
 
V

Vassilis

Thank you all guys!!I think that i see what an ems is all about...:notme:
 
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