Re: Medical vs Non Medical
AjitB said:
Hi all,
Some points to ponder - if I ask, can you list down the differences in quality systems for medical products vs non medical products, what would it look like ?
AB
Let's just look at the major difference between ISO 9000:2000 (9k2k) and ISO 13485 (medical devices) (MD):
9k2k emphasizes "continual improvement" whereas MD, because of its primary function of "harmonizing" requirements of regulators around the world, specifically deletes continual improvement as a factor.
The reason is simply based on the function of MD acting as a "one-stop" accreditation versus submitting applications to every country's regulators where your product may end up being sold or used. The regulators don't want "changes," even improvements, without having those changes vetted by their approved agent.
Otherwise, the basic premise of 9k2k and MD are similar, with some additional documentation required in MD, documentation which makes good business sense without being burdensome.