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Outsource Production Line need ISO13485 Certificate

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bennylee

#1
Our company is 13485 medical device design firm, we perform the full design process by our own.
Now, we want to set up our own branded products, then we are looking for outsource production line.
Hence, I have some question about ISO13485 certificate issue for main production site.
  1. If full production process in outsource production line (including SMT, Assembling & Final Packing). When receiving the products, some random checking by AQL is performed in our site, ISO13485 must require for this production site, right ?
  2. If not full production process in outsource production line (including SMT, Assembling only), but the device is already fully assembled in production line, only the final packing & final testing is performed in our site, may I know if ISO13485 still required for this production site?

Thanks in advance !
 
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somashekar

Staff member
Super Moderator
#2
Our company is 13485 medical device design firm, we perform the full design process by our own.
Now, we want to set up our own branded products, then we are looking for outsource production line.
Hence, I have some question about ISO13485 certificate issue for main production site.
  1. If full production process in outsource production line (including SMT, Assembling & Final Packing). When receiving the products, some random checking by AQL is performed in our site, ISO13485 must require for this production site, right ?
  2. If not full production process in outsource production line (including SMT, Assembling only), but the device is already fully assembled in production line, only the final packing & final testing is performed in our site, may I know if ISO13485 still required for this production site?

Thanks in advance !
In both the cases., YES.
The key is in outsource process control, full production or partial production and the ISO13485 at your outsource production site will form one vital control method.
You may also have to decide on how your contractual quality agreement is established that will clarify responsibility and DHR requirements. You may also include audits of manufacturing line by you or on your behalf or by your regulators based on requirements, as you are responsible for regulatory.
 
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