Medical vs. Non Medical - Differences in Quality Systems

Ajit Basrur

Staff member
Admin
#1
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 ?

:bonk:
AB
 
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Wes Bucey

Quite Involved in Discussions
#2
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 ?

:bonk:
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.
 

amjadrana

Involved - Posts
#3
If you buy electronic version of ISO 13485:2003, the differences between ISO 13485:2003 and ISO 9001:2000 are highlighted in colour. In Annex B of the ISO 13485:2003 standard there is an explanation of differences between ISO 13485:2003 and ISO 9001:2000 in table format.

On the internet under the link below there is a matrix regarding FDA, ISO 9001and ISO 13485 corespondence. I hope that it helps.

http://www.quality-works.com/download/ISO-9001-2000-ISO-13485-2003-FDA-QSR-correspondence-matrix.pdf

Amjad Rana
 

Ajit Basrur

Staff member
Admin
#4
Hi,

This is my first post to the column.

Reading this prompts me to another question - apart from the differences in Quality Systems between ISO 13485 and ISO 9001 and FDA 21 CFR part 820, what changes are expected in the mindsets of people working on medical products and non medical products. The most important thing I perceive is GMP concepts, good documentation practices etc.

Any more points ?

Thanks,
Qualityalways
:thanx:
 
G

Gert Sorensen

#5
Qualityalways said:
Hi,

This is my first post to the column.

Reading this prompts me to another question - apart from the differences in Quality Systems between ISO 13485 and ISO 9001 and FDA 21 CFR part 820, what changes are expected in the mindsets of people working on medical products and non medical products. The most important thing I perceive is GMP concepts, good documentation practices etc.

Any more points ?

Thanks,
Qualityalways
:thanx:
The first thing you should perceive is that when you are in the medical device sector the items you produce has a significant influence on the quality of peoples lives, and dependant on what devices you manufacture if you produce defects people can eventually die. If we - at our plant - make a serious bummer someone is sure to buy the farm :bigwave:
 

Al Rosen

Staff member
Super Moderator
#6
Gert Sorensen said:
The first thing you should perceive is that when you are in the medical device sector the items you produce has a significant influence on the quality of peoples lives, and dependant on what devices you manufacture if you produce defects people can eventually die. If we - at our plant - make a serious bummer someone is sure to buy the farm :bigwave:
"Buy the Farm" is an american slang expression that I'm not sure everyone around the world knows, so here is an explanation.
 

Ajit Basrur

Staff member
Admin
#10
Thanks Al and Gert,

I for one surely did not know this phrase but I guessed that it could mean some disaster, after reading the entire response from Gert.

:thanx:
 
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