ISO 13485:2003 Section 7.5.1.2.1 Cleanliness of Product

[jjthompson841]

Hello Everyone,

I am working for a company that is trying to convert from ISO 9001:2008 to ISO 13485:2003 and I am trying to address a few of the standard changes from one to the other. Currently we make medical components that are provided to the customer non-sterile and are molded without processing agents such as mold release.
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So do I need to add this to a current procedure that states that this is what is done or can this be taken as an exclusion for ISO 13485:2003? At this time there are no products that we sterilize and I do not see that changing at all in the near future we send as is to customer and they are responsible for the actually sterilization.

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Any help or clarification would be greatly appreciated.

 

[somashekar]

Hello Everyone,

I am working for a company that is trying to convert from ISO 9001:2008 to ISO 13485:2003 and I am trying to address a few of the standard changes from one to the other. Currently we make medical components that are provided to the customer non-sterile and are molded without processing agents such as mold release.
​

So do I need to add this to a current procedure that states that this is what is done or can this be taken as an exclusion for ISO 13485:2003? At this time there are no products that we sterilize and I do not see that changing at all in the near future we send as is to customer and they are responsible for the actually sterilization.

​

Any help or clarification would be greatly appreciated.

Hi thompson ...
Greetings and welcome to the COVE.
First up, you have got a good question.
What you make are terminally sterilized components, and perhaps your customer may have some cleaning process before the sterilization that he does.
However you are in the path and your way of handling / processing can pose a challenge to the customer's cleaning / sterilization process.
You need to continue and maintain your process as well as ensure that your processing / handling does not pose any new and unknown challenges to your customer's process. Your people may unknowingly contaminate the components by their own handling, personnel hygiene and stuff and by a lack of this understanding that processing and handling can induce unknown and unseen contamination.
You need to discuss this more with your customer and apply risk assessment methodologies to bring in controls (including personnel health and hygiene) and work environment as necessary to maintain required cleanliness in your complete workflow until packaging.