Questions about upgrading from ISO 9001 to ISO 13485 or do I have both?

W

wrustywrench

#1
Hello, I have posted before and am trying to use th ecorrect area this time.

We are a medium sized machine shop that makes automotive machines and tooling for the machines, currently ISO 9001-2000 certified.

We have th eopportunity to make some medical part and one customer requests we get ISO 13485 to do this,.

I have templates of all the required procedures, but have some major confusion...

Is we go 13485, does everyting we do fall under the 13485, like our machines ans such? Can we run two systems, one for our automotive and one for medical.

I see that we need device history files and device master records. Can these be lumped in to one file?? We presently keep machine folders and tooling forlders, and I was hoping we could just add medical parts folders.

we will only be making parts for devices, not complete devices. No sterilization and so forth. Do we have to fulfill all the requirements and have procedures if we are not doing that, or just use exclusions?

please advise, thanks,,,,you guys and gals ROCK..
 
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GStough

Leader
Super Moderator
#2
Re: questions about getting over to 13485

Hello, I have posted before and am trying to use th ecorrect area this time.

We are a medium sized machine shop that makes automotive machines and tooling for the machines, currently ISO 9001-2000 certified.

We have th eopportunity to make some medical part and one customer requests we get ISO 13485 to do this,.

I have templates of all the required procedures, but have some major confusion...

Is we go 13485, does everyting we do fall under the 13485, like our machines ans such? Can we run two systems, one for our automotive and one for medical.

I see that we need device history files and device master records. Can these be lumped in to one file?? We presently keep machine folders and tooling forlders, and I was hoping we could just add medical parts folders.

we will only be making parts for devices, not complete devices. No sterilization and so forth. Do we have to fulfill all the requirements and have procedures if we are not doing that, or just use exclusions?

please advise, thanks,,,,you guys and gals ROCK..
Hi wrustywrench,

You can indeed obtain and maintain dual registrations to ISO 9001 and 13485. The 13485 registration will apply only to the medical device(s) you make, and the device history files (DHF) and device master records (DMR) will apply only to the devices. These are separate requirements, and so you will probably want to keep them separate and not lumped together. In fact, the DMR can be simply a document that identifies and lists the elements (procedures, processes, formulas, forms, specifications, etc.) your company uses to make the device(s).

If you have a copy of the 21 CFR 820 QSR for medical devices (you can find this on the FDA's web site - www(dot)fda(dot)gov - ), you may want to read the requirements for establishing and maintaining the DHF and DMR. You may also need to establish design history files, as well, if you design the device. This is also covered in the 21 CFR 820.

I hope this helps. If you are already registered to 9001, it won't be a far stretch to get the registration for 13485. Hang in there! You won't have to do this alone, as there are plenty of Covers who are willing to help wherever we can. :)
 

harry

Trusted Information Resource
#3
Hi Wrustywrench,

I edited the title to include 'both' because I think the best solution is for you to have dual certification. ISO 9001 for the existing non medical business and ISO 13485 for the medical part. Let's see what the 'Medical' people say.

p/s Gidget beat me to it and I concur with her.
 
W

wrustywrench

#4
great info,,,,you guys and gals are great.

Now,,,do i have to have procedures for things we dont do?? like sterilization processes and so forth. We will not be designing any parts either, but we do design some machines that may be used for these parts (groovers).

Will these machines fall under medical, since they do not actually touch the human body?
 
Last edited by a moderator:

GStough

Leader
Super Moderator
#5
great info,,,,you guys and gals are great.

Now,,,do i have to have procedures for things we dont do?? like sterilization processes and so forth. We will not be designing any parts either, but we do design some machines that may be used for these parts ( groovers).

Will these machines fall under medical, since they do not actually touch the human body?
If you don't do sterilization, then no, you don't have to have procedures for it. If you don't design the devices, you can claim exclusion to the Design and Development requirement (7.3), but this should be stated in your quality manual and the justification for exclusion.

Something you will want to pay attention to, as well, is process verification and validation.
 
W

wrustywrench

#6
ok,, one more.

I read the CFR 820, where it says we need devise master records and history records. We dont have to actually call them that , do we?

Just as long as we have them.

and the QRS, we call ours a quality records list, that should be fine, correct.

and last but not least...I cannot find where we actually need a procedure for the Device master records ....

thanks agian
 

GStough

Leader
Super Moderator
#7
ok,, one more.

I read the CFR 820, where it says we need devise master records and history records. We dont have to actually call them that , do we?

Just as long as we have them.

and the QRS, we call ours a quality records list, that should be fine, correct.

and last but not least...I cannot find where we actually need a procedure for the Device master records ....

thanks agian

Well, I don't supposed you have to call them device master records and device history records, but many companies do. I've heard device history records/files referred to as quality and/or production records, batch records, lot records, etc. However, device master records are usually referred to DMR, to my knowledge, but perhaps others here have heard another term for them...?

A procedure for developing your DMR isn't necessarily required, but may be helpful for your people to know how to establish one, especially in case of personnel turnover in the future. In our case, we did write a procedure for developing a DMR, but it was primarily to assist our other manufacturing facility with developing one of their own. :)

I hope this helps. Good luck, wrustywrench! :agree1:
 
W

wrustywrench

#8
Thanks,, I think I have a LOT better idea.

We have machine files for our machines we build, we have tooling files for our tooling and I want to have "medical" files for our medical parts we woudl make. These would be in sense, device files with ALL information in them.

hopefully I can make it work out. A little training, a lot of training,,whatever. its friday and I feel like i got something acomplished.
 

GStough

Leader
Super Moderator
#9
Thanks,, I think I have a LOT better idea.

We have machine files for our machines we build, we have tooling files for our tooling and I want to have "medical" files for our medical parts we woudl make. These would be in sense, device files with ALL information in them.

hopefully I can make it work out. A little training, a lot of training,,whatever. its friday and I feel like i got something acomplished.
You're welcome. Yes, it's a great feeling, especially on a Friday! ;) :tg:

One thing I would mention in regards to what you decide to call the DHR/DMR/DHF records/files: an FDA investigator or 13485 auditor will usually refer to these as they are identified in the 21 CFR 820 and 13485 standard, so you will need to do some training of the folks who may be interviewed by an FDA investigator or ISO auditor, so that they will be able to make the connection between what the auditor/investigator is asking for/about and what they commonly call these same records/files. I've seen in our 3rd party audits where the auditor uses terminology as it's used in the standard and regs and sometimes the floor folks are clueless as to what they're talking about. Just another little something to consider. :cool:
 
W

wrustywrench

#10
exactly why i said, training and more training. I like not calling it exactly what the standard or CRF820 calls it,,,make me feel we "thunk" about it and used our own terms to do it.

might not work, but it sounds good to me at this point.
 
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