Component Molding Controls and Certification to ISO 13485 - Contract Manufacturer

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Viki N.

Hi All,

We are a contract manufacturer that molds plastic components for use in a finished device that we also assemble to customer's specifications and send to the OEM. We do not do design.

Currently, our Assembly areas are certified to ISO 13485, but our molding areas are certified to ISO 9001. We want to go ISO 13485 across the board, but are unsure what kind of controls for the molding areas we really need vs. what we already do for device assembly. Surely, molding the components can't be held as stringently. Off the top on my head, I would think more controls in the following would be required: Work Environment, Supplier Control, Risk Mgmt., Product Contamination Control, Batch Records, Identification & Traceability & Status, Non-conforming Product Control, and Complaint/Corrective Action.

Has anyone had experience with external auditing of component molding and what areas of the ISO 13485 Standard was concentrated on?

Thanks for any feedback,
Viki
 
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Phil Fields

Hi Viki,
Why is your assembly area ISO 13485 registered, is this a customer requirement?

Phil
 
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Viki N.

Phil,

Our assembly areas make finished devices for one thing and yes, most of our customers have required this. Now...they want our molding areas also ISO 13485 and 21 CFR 820 as well, and usually try and audit us to those standards (the molding areas). We usually end up with quite a few findings even though we try to remind them that the molding areas are not ISO 13485.

Viki
 
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Phil Fields

Viki,
Check you ISO 13485 Standard (2nd ed, 2003-07-15), Annex B. Annex B describes the differences between 13485 and 9001.

I hope this is a help,
Phil
 
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Viki N.

Thanks, Phil!

I will just really need to review our molding areas to make sure we meet the requirements as needed.

Viki
 

somashekar

Leader
Admin
Phil,

Our assembly areas make finished devices for one thing and yes, most of our customers have required this. Now...they want our molding areas also ISO 13485 and 21 CFR 820 as well, and usually try and audit us to those standards (the molding areas). We usually end up with quite a few findings even though we try to remind them that the molding areas are not ISO 13485.

Viki
Care to tell us the findings per 13485 in your molding area ... ?
My Option: If you also mold plastic parts that are general engineering plastic parts for other customers, then during your audit cycle of 13485, the molding area can be under the 9001 scope and your CB can very well handle this and issue both 13485 and 9001 seperately with scope clearly stated.

If you are molding some plastic parts here for your medical assembly which you would have otherwise outsourced, you would exercise all controls in the molding area as you would when outsourced. Your medical devise risk management will address the molding process also. These are very well the backbone of the 9001. If your 9001 implementation is to good depth, I see no reason why you seek 13485 for the molding area. Your 13485 scope would never say anything about your molding activity.
 
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Viki N.

Hi,

I guess the bottom line is that our customers are the real culprits as supplier auditing has hit an all-time high. We have no problems with our CB. We have separate quality manuals and most procedures are different and clearly identified.

I would say that for molded components, some of our customers and/or protential expect to see DHR-type records. We have all the required records, define retention periods, have lot identification and traceability as required but they seem to want it like we keep our device lot records. They also write findings for not having a specific procedure when the 9001 Standard does not require it. Another one is environmental type controls that are only required in ISO 13485. Our molding facilities are very clean and if required by a customer, we will use a clean tent to further control the environment. Another good one was we didn't "trend" our mice traps or bait stations and another customer actually wrote we didn't have enough of them inside or out. We pay an outside service for pest control. Or...no "cleaning validations" for our molds. All of our medical component tooling gets a "medical grade" cleaning with approved medical grade lubricants/cleaning agents only.

IMHO, the pettiness of some of the write-ups is ridiculous, but the customer is always "right" and a company jumps through hoops to get or keep the business. The C/A responses, changing/adding procedures/forms, etc. bury us at times in paperwork especially those employees assigned to them. :frust: Anyway...we will have to look more into this. Thanks for your feedback.
 
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Roland Cooke

Care to tell us the findings per 13485 in your molding area ... ?
My Option: If you also mold plastic parts that are general engineering plastic parts for other customers, then during your audit cycle of 13485, the molding area can be under the 9001 scope and your CB can very well handle this and issue both 13485 and 9001 seperately with scope clearly stated.

If you are molding some plastic parts here for your medical assembly which you would have otherwise outsourced, you would exercise all controls in the molding area as you would when outsourced. Your medical devise risk management will address the molding process also. These are very well the backbone of the 9001. If your 9001 implementation is to good depth, I see no reason why you seek 13485 for the molding area. Your 13485 scope would never say anything about your molding activity.

There's a whole bunch of reasons why you might want to include your molding operations under ISO13485.

The most obvious one is, if you already have ISO13485 for some aspects of your business for medical device customers, why would you not have all of your (relevant) operations similarly covered?
Do your customers KNOW that your molding operations are not under ISO13485? That's a hell of a risk to run. :mg:


In practical terms, there are the more stringent requirements that might be applicable, batch records, etc.

Plastic molding for medical devices is often done in cleanrooms, even if not, usually under stronger environmental controls - no use of mold release agents etc.


Finally it is incorrect to indicate that their scope would not reference plastic molding activities. As long as it is legitimate and comprehensive, in concert with their Registrar of course, their scope can say whatever they want it to say. [Edited] For example (only): Plastic molding and contract assembly for the medical device industry; control of outsourced molding and assembly operations for the medical device industry.


The ISO9001 scope can be more general, if they are in non-medical markets as well.
 
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Viki N.

Roland,

You have some good points, thanks. Note: We do let our customer know that our molding is under 9001; however, they choose to audit to 13485 anyway. I think with a little focused effort, we could meet the requirements of 13485 in our molding areas and be done with it.

Viki
 
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