Is ISO 13485 compulsory - Fabrication of precision metal parts for medical industry?

E

Esthyl - 2010

#1
Dear all,

I would like to get some views here :)

My company plans to fabricate precision metal parts for medical industry. We have already obtained ISO9001:2000, is it compulsory to have ISO 13485:2003 as well?

Looking forward for your input! Thanks in advanced. ;)
 
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Ajit Basrur

Staff member
Admin
#2
Re: Is ISO 13485 compulsory - fabrication of precision metal parts for medical indust

Dear all,

I would like to get some views here :)

My company plans to fabricate precision metal parts for medical industry. We have already obtained ISO9001:2000, is it compulsory to have ISO 13485:2003 as well?

Looking forward for your input! Thanks in advanced. ;)
It is not required theoretically :)
 

somashekar

Staff member
Super Moderator
#3
Re: Is ISO 13485 compulsory - fabrication of precision metal parts for medical indust

Dear all,

I would like to get some views here :)

My company plans to fabricate precision metal parts for medical industry. We have already obtained ISO9001:2000, is it compulsory to have ISO 13485:2003 as well?

Looking forward for your input! Thanks in advanced. ;)
ISO 9001 is good enough if you have addressed all the processes in the right perspective. Is your customer demanding it ? If so then perhaps he is pushing from the CMDCAS point of view. ISO 13485 is not necessary if you are capable of meeting your customer's outsourced process control requirements.
 
E

Esthyl - 2010

#5
Re: Is ISO 13485 compulsory - fabrication of precision metal parts for medical indust

It is not required theoretically :)
All right, it means we still can do it without ISO 13485:2003, but it will be an added advantage with having it.

ISO 9001 is good enough if you have addressed all the processes in the right perspective. Is your customer demanding it ? If so then perhaps he is pushing from the CMDCAS point of view. ISO 13485 is not necessary if you are capable of meeting your customer's outsourced process control requirements.
We are now just at the stage of planning to develope business into medical industry, hence wish to gather more relevant information for preparation. :agree1: with you that customers will request for ISO when they are suggested by auditors to get all their vendors ISO certified, , as a step of continuous improvement to ensure incomings more reliable. So, I would have to strengthen the outsourcing process for products dealing with medical industry.

Thanks guys for your input... :thanx:
 

Ajit Basrur

Staff member
Admin
#6
Re: Is ISO 13485 compulsory - fabrication of precision metal parts for medical indust

All right, it means we still can do it without ISO 13485:2003, but it will be an added advantage with having it...............
Absolutely - you got it right :agree1:
 

harry

Super Moderator
#7
Re: Is ISO 13485 compulsory - fabrication of precision metal parts for medical indust

There's nothing to stop you from complying with the requirements first or gradually complying with the requirements and go for certification when the need arises.
 
E

Esthyl - 2010

#8
Re: Anyone has experience in expanding its product range to medical industry?

Your inputs has triggered me to another thought: anyone has experience in expanding company product range from other industry (eg. semicon, food) to medical industry? What are the changes that you have made to previous ISO 9001?

As I am very new to medical industry, my assumption is medical equipments need to be well handled as it is health concerned. Perhaps need stringent control at inspection, proof of sterilization on the equipments by vendors.

It will be appreciated if you could suggest guidance for relevant website or reading material. :)
 
E

Esthyl - 2010

#9
Re: Is ISO 13485 compulsory - fabrication of precision metal parts for medical indust

There's nothing to stop you from complying with the requirements first or gradually complying with the requirements and go for certification when the need arises.
Thanks for telling me the truth, it makes sense :agree1: Having ISO 13485 will be the competitive edge as days pass. Your info had made a point that I have to ever prepare for it, that the day will come finally, if our company wants to survive and grow in the industry.

:thanks:
 
Z

zhang126

#10
Re: Anyone has experience in expanding its product range to medical industry?

New/revised SOPs shall cover,
1. compliance with regulations, such as QSR 21 CFR820, MDD etc (particularly design control, change control, SW validation, process validation)
2. complaint handling
3. assissing adverse event investigation if you are a parts supplier
4. allowing regulatory inspection, such FDA, a notified body etc.
5. document, records retention time complying with regulation
6. DMF, DHR, DHF, TF shall be established
7. 21CFR part 11 compliance if you have SW in your production, process control, quality records handling
8. (any more formthe cove?)
 
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