I have some curiosity about the differences between the way medical equipment maintenance is regulated/
controlled in the US and in Europe and would appreciate a brief “education”
on this topic from colleagues either in Europe or here in the US. I
understand that the ISO 9000 quality standards are widely recognized in Europe
and compliance with ISO 9002 is a virtual prerequisite for doing any
kind of maintenance business with virtually all European governmental agencies.
My specific questions are:
1. What standards are currently used for medical equipment maintenance in Europe,
and who generally enforces compliance with those standards?
2. Are in-house programs periodically surveyed by staff from the enforcing jurisdiction
in a manner similar to that used by The Joint Commission and/or the various
State healthcare facility licensing agencies here in the US?
3. Is diagnostic imaging equipment scrutinized more critically than the
(generally simpler) biomedical devices?
4. Are there independent service organizations in any European countries? And, if so, in which
countries are they most commonly found?
5. Are the equipment manufacturers’ service divisions subjected to different
requirements from either in-house servicers or the ISOs (if any)?
Malcolm Ridgway
Senior Vice President
Masterplan Inc.
Chatsworth, California
(818) 734-8376
www.masterplan-inc.com
