This is a topic that can be of great benefit to a lot of people.

I've had extensive experience communicating this topic to managers and execs 
throughout my career, and there is a logical approach that I've adopted which 
seems to work well.

First, there are three major components of any compliance system regardless 
of where you are in the world. They are:

1.  Minimum Requirements (Standards) - what are the minimum technical 
requirements necessary to gain responsible market access in a given regiion?

2.  Conformity Assessment - how do you prove that you meet the minimum 
requirements and whom do you need to prove it to?

3.  Enforcement - what happens if you don't comply with (1) or (2) above?

Naturally, each country or region has a different system for each component.  
For example, the standards may be voluntary or mandatory, industry driven or 
agency controlled, etc.  For conformity assessment, third party involvement 
may be necessary or manufacturer self-declaration may suffice, or there is no 
requirement.  The necessity for conformity assessment may be legal mandated 
or market driven.  Production control may be involved and may be comprised of 
a host of different methodologies  - post market surveillance, production 
inspections (ala UL FUS), quality system registration, or some hybrid of any 
of the above.  Enforcement may be proactive or complaint driven.  There may 
be legal ramifications for non-compliance, or simply liability concerns in 
the event of injury or damages.

There is much more to this, and at the risk of indulging in too much self 
promotion, please e-mail privately if you're interested in hearing more about 
it.




Greg Galluccio
www.productapprovals.com



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