Maintaining Dual Standards ISO 9001 and ISO 13485 - Contract Manufacturer

A

Atish

#1
Hi Guys, I am a new member and this is my first post. I work for a contract manufacturer. Our customers design products and supply us with the design. We design the process and manufacture the product. We are ISO 9001:2008 certified. We cater to the automotive, industrial and the medical device sector and we have now decided to pursue ISO 13485 certification. We hope to keep both standards (9001, 13485). 2 questions that immediately come to my mind are,
1. In order to keep both standards, would we have to classify each part as either medical or non-medical (in which case it would fall under 13485) OR would we have to create 2 organizations with 2 different standards?
2. Since we do not do any design work, which of the 13485 requirements not apply to us?
 
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R

rclanzillotto

#2
Re: Maintain Dual Standards ISO 9001 and ISO 13485

The scope of your ISO 13485 conformity could be your medical product lines only. This needs to be spelled out in your Quality Manual.

For design activities, review section 7 and decide what is not applicable to you. Then state the non-applicablily in the quality manual. Presumaby you do not determine the design input, but do you prepare the specification? conduct verification and validation tests? How is Risk Analysis handled? this needs to be clearly sorted out between you and your customer, then stated in the Quality manual. Good Luck
 
Q

Qualqueen

#3
1. In order to keep both standards, would we have to classify each part as either medical or non-medical (in which case it would fall under 13485) OR would we have to create 2 organizations with 2 different standards? 2. Since we do not do any design work, which of the 13485 requirements not apply to us?
You do not have to create 2 organizations with 2 different standards. My company is also 9001 / 13485 and the standards are quite similar.

For design activities, review section 7 and decide what is not applicable to you. Then state the non-applicablily in the quality manual. Presumaby you do not determine the design input, but do you prepare the specification? conduct verification and validation tests? How is Risk Analysis handled? this needs to be clearly sorted out between you and your customer, then stated in the Quality manual. Good Luck
As rclanzillotto stated, review section 7 and decide which requirement is not applicable to you. You then need to have a rational for why you're making these exclusions. Risk management (7.1) is a very important part of `13485. Hope this helps.
 
I

ISO 9001 Guy

#4
Why not run both kinds of parts according to the same system? Perhaps using two different types of Travelers, but using the same basic system.
Make one checklist using both standards, because there are slight differences. Three columns: ISO 9001, ISO 13485, and comments. Take the requirements from ISO 9001 and paste them (each requirement to its own row) in the first column. The same for ISO 13485. When the requirements are identical, keep the 9001 and 13485 requirements on the same row. When there are differences, be sure to allow each requirement its own row. Once your documents have been developed (using the process approach, of course, to ensure the documents are useful and make sense), use the checklist to ensure the documents sensibly address the requirements.
This will also help you identify which requirements (of 13485) do not apply to you. More information is needed here. Since you do not design, the requirements of 9001/13485, 7.3 are excludable. If your devices are not implantable, you can exclude still others (e.g., 7.5.3.2.2). Even 8.2.4.2 is presumably excludable (even though it resides in section 8, not section 7) if implantables are not encountered. If you do not engage in installation activities, 7.5.1.2.2 is excluded; if you do not service your product, 7.5.1.2.3 is excluded. If you are under no obligation to provide sterile product, you can exclude 7.5.1.3 and 7.5.2.2.
I hope this helps!
 
A

Atish

#5
Thanks for the information, it is very helpful. You mentioned that your company has both standards so then do you classify your products as medical/non-medical? If you do then lets say if you were to compare the documentation needed for a medical product (under 13485) and that needed for a non-medical product (9001), what would be the additional documents for the medical product? Can you give me an example? Thanks in advance.
 
I

ISO 9001 Guy

#6
It's hard to answer your question. Without knowing what you do, what markets your product is sold in, etc. FDA/MDD will require device history records, meaning that you must retain production records for medical product. So, you need to keep the Travelers, if that's what you use. Consider modifying your . . . Travelers . . . to capture all information required of 13485--traceability, etc. Develop the Travelers to accommodate all possible information. If requirements do not apply (e.g., for non-medical product), make it easy to remove them or nullify them. You might consider printing medical product documentation on blue paper (or something) to distinguish it from non-medical product. (This same color-coding could identify what information the Traveler must contain, given its status as medical or non-medical).
 
A

Atish

#8
Another question is if we were to have both standards (13485 and 9001), given that we are a contract manufacturer, what would be the best way to classify product as falling under 13485 or 9001? Obviously medical device products would be under 13485, but do we reserve the right to 'classify' a product as medical or non-medical? Can we simply say that unless our customer demands that their product be manufactured in a 13485 system, we will produce it under 9001:2008. The reason is the extra work and documentation that goes with 13485 (Risk management plan, Quality plan, etc).
 
R

rclanzillotto

#9
Although perhaps not required, I would strongly recommend ISO 13485 for your medical device, in particular for patient equipment. Most any customer would expect it and I would be wary of those who don't. You take on some risk when you send medical devices into distribution...even as a contract manufacturer. You need to be proactive with respect to risk analysis; etc. IMHO. I could understand ISO 9000 for certain types of components but not Medical Devices
 
M

MIREGMGR

#10
I'd think you'd want your contract review team to be unwilling to sign off on an incoming P.O. unless Sales has gotten the customer to objectively clarify what it is that they are expecting.

Presumably those of your customers who want you to make a non-medical device will have an expectation that your QS will include those elements of 9001 that are not part of 13485. Those making medical devices will expect those parts of 13485 that are not part of 9001.
 
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