Adding ISO 13485 to an AS9100 QMS

outdoorsNW

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#1
Management at my AS9100D certified company has asked about adding ISO13485 certification.​

The guides I can find online, including Elsmar, are either for older revisions, are broken links, or are focused on going from ISO13485 to 9100 or ISO9001 to 13485 rather than AS9100 to ISO13485. (I know AS9100 is all of 9001, but the added 9100 requirements may cover 13485 requirements 9001 does not.)​

We are a contract manufacturer of electronics and do not do design. Most of our current customers are aerospace, so we are used to aerospace FOD controls, product preservation, etc.​

We will avoid sterile products except possibly if the customer will take all responsibility for getting the product from commercially clean to sterile.​

Labeling, if any, would be as required by the customer. Medical products would not be sold under our name.​

Having taken a quick look at the latest rev of 13485 including Appendix B, I don’t immediately see any big changes required.​

How practical are combined AS9100-ISO13485 audits?​

How many more days would typically be added for a 100 person company?​

Does anyone know of an up to date guide for adding 13485 to an established AS9100 quality system?​

I would like to hear from people what areas we would likely have to update and what pitfalls we may encounter.

 
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Sidney Vianna

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#2
How practical are combined AS9100-ISO13485 audits?
From a CB audit team perspective it is highly unlikely that your current CB auditors would be deemed competent for ISO 13485, so chances are you will have new auditors assessing your system against a new standard and the possibility for conflict of interpretational issues.

Becoming part of the medical device supply chain will also make your organization a potential "target" of the FDA oversight system, just like being part of the Aerospace supply chain makes you a potential recipient of a FAA audit, too.
 

shimonv

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#3
Combining in the full sense of the word is not a good idea.
I worked once with such a contract manufacturer. He had a designated area for medical device manufacturing and some specific SOPs for medical. Not all SOPs can be adapted in an effective way. I remember they had a CAPA SOP and Medical CAPA SOP, and so on. It's a big job.

And continuing with what Sidney wrote, you will also need an additional internal audit to cover the Medical part of your QMS.

Shimon
 

outdoorsNW

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#4
Thanks Sydney and Shimonov.​

Good to know that a single auditor for both standards is unlikely.​

I don’t see a clause that allows a contract manufacture to exclude parts of 4.2.3 that are handled by the customer or OEM.​

Looking at the 13485 requirements for the medical device file (4.2.3) the section says "shall include" the items in subsections a to f. However as a contract manufacturer of only part of the device, selling only to the product OEM or other subcontractors working for the OEM, parts of section 4.2.3 may be difficult to comply with. Will we be allowed to simply put in the file whatever the customer tells us and not have to fight them to give us information to comply with every clause?​
 

DannyK

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#5
I am qualified to audit both AS9100 as an AEA and as a lead auditor for ISO 13485:2016.
As a consultant, I have also been involved in helping several contract manufacturers get certified to both. I am able to do an integrated internal audit since I know both standards quite well.

Regarding the comment about 4.2.3 from outdoorsNW, if you are a manufacturer of part of the device, that means you are manufacturing the assembly and not the final device. Auditors cannot expect you to have the full contents of clause 4.2.3.
 

sandra2014

Involved In Discussions
#6
I am qualified to audit both AS9100 as an AEA and as a lead auditor for ISO 13485:2016.
As a consultant, I have also been involved in helping several contract manufacturers get certified to both. I am able to do an integrated internal audit since I know both standards quite well.

Regarding the comment about 4.2.3 from outdoorsNW, if you are a manufacturer of part of the device, that means you are manufacturing the assembly and not the final device. Auditors cannot expect you to have the full contents of clause 4.2.3.
Hello,
 

sandra2014

Involved In Discussions
#7
We are certified to both AS9100D and ISO 13485:2016, we are a contract manufacturer of components for medical device clients. We do not design or manufacturer the 'medical device'. Our CB auditors have never addressed this issue with us, we currently have ISO 13485:2016 4.2.3 as in compliance, and we would like to revise our QA Manual to deem ISO 13485:2016 clause 4.2.3 as 'non applicable', since we are not the medical device manufacturer (our client is). Would this be an acceptable action?
 

Sidney Vianna

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#8
Would this be an acceptable action?
Since the file requires production and testing procedures, you would be expected to support the design responsible/legal manufacturer with part of the files, so I don't think you could/should claim full exemption to it.
 

DannyK

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#10
Sandra, I agree with Sidney's answer. The legal manufacturer is responsible for the medical device files in 4.2.3. In your quality manual you can state that you will maintain the files as per the contractual requirements with the legal manufacturer. Some of my clients were building circuit card assemblies and were not informed about where the assembly was being used.
 
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