Should ISO 13485 Products be Separated from other Products in Manufacturing

N

NWrubberQA

#1
We are considering if we should become ISO13485 certified in order to sell more products to the medical market. We have ISO9001, AS9100 & TS16949 products. Due to the risk management, cleanliness & contamination, etc. requirements of ISO13485 I'm wondering if the product lines would need to be separate?
 
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DannyK

Trusted Information Resource
#2
Re: Should ISO13485 Products be Seperated from other Products in Manufacturing

It really depends on the product. If your medical device customers have more stringent requirements then it may be worthwhile. Otherwise if you are just selling a commodity, then there is no special reason to separate it.
 
G

George Weiss

#3
Re: Should ISO13485 Products be Separated from other Products in Manufacturing

13485 dictates that risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971: 2001
13485 emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective processes. FDA 13485 comment @
http://www.bulltek.com/English_Site/ISO9000_Introduction_English/FDA_GMP%20QSR_English/fda_gmp_qsr_english.html
21 CFR part 820 PDF @
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 http://www.delphiconsulting.com/part820.pdf
In the end. If you are making donuts and medical devices, then maybe the equipment doesn’t need the same oversight. FDA expresses that with medical devices, the manufacturer shall be in control of the process. Use the same equipment for several products. Keep the quality eye on the equipment as if it is always producing medical devices.
 
Last edited by a moderator:

somashekar

Staff member
Super Moderator
#4
Re: Should ISO13485 Products be Separated from other Products in Manufacturing

We are considering if we should become ISO13485 certified in order to sell more products to the medical market. We have ISO9001, AS9100 & TS16949 products. Due to the risk management, cleanliness & contamination, etc. requirements of ISO13485 I'm wondering if the product lines would need to be separate?
When you think the ISO 13485 way for some of your products, would you decide if some of the other products and the processes thereoff are a potential contamination source for your medical line products ?
Your good risk management per the ISO 13485 will clearly address if the best control will be a seperate line.
 

Ajit Basrur

Staff member
Admin
#5
Re: Should ISO13485 Products be Separated from other Products in Manufacturing

Great responses so far.

george1weiss - I would prefer to have an authentic reference for 21 CFR Part 820 in the FDA website
 
M

MIREGMGR

#6
Our experience has been that the easiest way to manage a product development and manufacturing enterprise is to synthesize a single quality management system that meets all of the requirements of all of the products, then always apply it.
 
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