Considering adding ISO 13485 certification - Your thoughts?

[rlsavard]

The company I work for is in the final stages of implementing ISO 9001. On a recent visit to a potential customer (a medical device company) they provided some insight to what would be involved in adding the 13485 certification. Their understanding was that we would really only be responsible for traceability due to the nature of our services. This traceability would encompass sending material certs, batch tracking, etc. We would simply be producing parts from a drawing another company provides. These parts are sent to another company for completion (welding, sterilization, etc.) so it seems like a large portion of 13485 would not apply to us, although I do not have a copy of the standard to verify this with. So...is all of this true? Thanks in advance for the help!

 

[AndyN]

The company I work for is in the final stages of implementing ISO 9001. On a recent visit to a potential customer (a medical device company) they provided some insight to what would be involved in adding the 13485 certification. Their understanding was that we would really only be responsible for traceability due to the nature of our services. This traceability would encompass sending material certs, batch tracking, etc. We would simply be producing parts from a drawing another company provides. These parts are sent to another company for completion (welding, sterilization, etc.) so it seems like a large portion of 13485 would not apply to us, although I do not have a copy of the standard to verify this with. So...is all of this true? Thanks in advance for the help!

Based on the information you've provided, you're basically correct. The further down the supply chain and for the actual medical device, the less demanding the standard and the various regulations become.

In some respects - continuous improvement - it's less demanding! A lot of the requirements might be flowed down from your customer as to what they require you to do, but the ISO 9001 look up/comparison table in the back of 13485 will give you a pretty good idea, won't it...

 

[somashekar]

The company I work for is in the final stages of implementing ISO 9001. On a recent visit to a potential customer (a medical device company) they provided some insight to what would be involved in adding the 13485 certification. Their understanding was that we would really only be responsible for traceability due to the nature of our services. This traceability would encompass sending material certs, batch tracking, etc. We would simply be producing parts from a drawing another company provides. These parts are sent to another company for completion (welding, sterilization, etc.) so it seems like a large portion of 13485 would not apply to us, although I do not have a copy of the standard to verify this with. So...is all of this true? Thanks in advance for the help!

If you are not manufacturing a medical device or a medical module that directly goes into a medical device and performs certain functions or operations, then this ISO 13485 is not relevant to you. However being associated with a Medical device company as a supplier, your correct and appropriate application of the ISO 9001 concepts will itself go a long way in meeting the requirements, both internal to your company and to your customer. Remember that ISO 13485 is built on the ISO 9001 platform. Good luck

 

[rlsavard]

Thank you to Andy and Somashekar for your quick replies.

Andy - The ISO 9001 look up/comparison table in the back of 13485 you were talking about is not available, as I do not have the 13485 standard, but thanks for the thoughts anyway.

Somashekar - Although it may not necessarily be relevant to us, the potential customer we met with said it would be easier to recommend us as a supplier of their parts if we had the certification.

Thanks again for your help, any other comments or suggestions are appreciated!

 

[somashekar]

Thank you to Andy and Somashekar for your quick replies.

Andy - The ISO 9001 look up/comparison table in the back of 13485 you were talking about is not available, as I do not have the 13485 standard, but thanks for the thoughts anyway.

Somashekar - Although it may not necessarily be relevant to us, the potential customer we met with said it would be easier to recommend us as a supplier of their parts if we had the certification.

Thanks again for your help, any other comments or suggestions are appreciated!

A good discussion with your potential customer about what aspects he is keen about your quality management system, and how the same can be met with the ISO 9001 QMS deployment in your organization should bring in the necessary confidence and understanding between both.