ISO 13485 and ISO 17025 Interface - Laboratory vs. Parent Company

[D_Wood]

I'm in the process of preparing a quality system for our test lab compliant with ISO/IEC 17025. Our company was ISO 9001, and just "upgraded" to ISO 13485. Has anyone had their lab accredited to IEC 17025? How easy/difficult was it to interface the lab's quality system (17025) with the parent company's quality system (13485)?

What areas would you consider were the most troublesome, or created the most work towards compliance with 17025?
Thanks,
Dan

 

[Aaron Lupo]

Re: ISO 13485 and ISO 17025 Interface

D_Wood said:

I'm in the process of preparing a quality system for our test lab compliant with ISO/IEC 17025. Our company was ISO 9001, and just "upgraded" to ISO 13485. Has anyone had their lab accredited to IEC 17025? How easy/difficult was it to interface the lab's quality system (17025) with the parent company's quality system (13485)?

What areas would you consider were the most troublesome, or created the most work towards compliance with 17025?
Thanks,
Dan

Dan-
Did you drop 9001 or just add 13485?

We have not added 17025 yet, however we have looked at it. As far as how difficult would it be to interface the labs quality system with 13485, IMHO it should be a seamless transition. The biggest problem I have seen is that, companies trying to get 17025 do not understand measurement uncertainty or do not participate in Interlaboratory comparisons (ILCs). Does this help any?

 

[D_Wood]

Thanks ISO_GUY,

Now that you mention it, I don't know if we dropped 9001, or just added to it. I saw the new certificate for ISO 13485 yesterday and remembered the talk about us going that way. Some of the reasoning behind that was that the FDA was not satisfied with the 2001 version of ISO 9001, and are happier with the 13485 requirements when it comes to medical device manufacturers.

I am reading everthing I can on the measurement uncertainty requirements, and methods for measuring, etc. Dave Scott has helped me too.

I haven't even addressed the interlaboratory comparisons yet. I don't know if that is required in all cases, or just unde rcertain types of testing. I'm afraid when it comes to EMC testing it probably will be required. There is a lot of uncertainty in EMC testing. It is amazing how different results are obtained from lab to lab. It's all in the test setup methods that create the variances.

Thanks again. A new directive from our corporate leaders have "inspired" us to obtain lab accreditation to 17025 for our test lab. Yours truly has been assigned the task. I welcome the challenge, it makes coming to work more interesting.

-Dan-

 

[Aaron Lupo]

D_Wood said:

Thanks ISO_GUY,

Now that you mention it, I don't know if we dropped 9001, or just added to it. I saw the new certificate for ISO 13485 yesterday and remembered the talk about us going that way. Some of the reasoning behind that was that the FDA was not satisfied with the 2001 version of ISO 9001, and are happier with the 13485 requirements when it comes to medical device manufacturers.
-Dan-

Actually, Dan the 1996 version of ISO 13485 is almost identical to 9001:94. Now if you are talking about 13485:2003, which has not yet been released, that would be more in line with the FDA requirements. ISO 9001:2000 and 13485:2003 do have some similarities, however they do place importance in different areas.

Have you addressed the CMDCAS issue yet? Also, just curios who is your Notified Body?

 

[D_Wood]

ISO GUY said:

Have you addressed the CMDCAS issue yet? Also, just curios who is your Notified Body?

TUV Rheinland. I guess no, What are CMDCAS ?
It has been maybe a week since I was told of my new task. I'm still very green yet.

Dan

 

[Aaron Lupo]

D_Wood said:

TUV Rheinland. I guess no, What are CMDCAS ?
It has been maybe a week since I was told of my new task. I'm still very green yet.

Dan

Canadian Medical Device Conformity Assessment System. The main purpose of CMDCAS is to provide documentation from a third party registrar, that medical device companies are actually complying with the quality systems requirements of sections 32(2) (f), 32(3) (j), or 32(4) (p) of the Medical Device Regulations. As of January 1st, 2003, medical device companies submitting an application for a Class II, III or IV medical device must also submit a copy of a valid CAN/CSA-ISO 13485-98 or CAN/CSA-ISO 13488-98 quality system certificate issued by a CMDCAS recognized Registrar. The certificate is evidence that there has been an impartial assessment of the manufacturer's quality system, and found it to be in compliance with the quality system requirements of the Medical Devices Regulations.

 

[Aaron Lupo]

D_Wood said:

Thanks ISO_GUY,



I haven't even addressed the interlaboratory comparisons yet. I don't know if that is required in all cases, or just unde rcertain types of testing.
-Dan-

Sorry I forgot to address this. Participation in an ILC is mandatory.

 

[D_Wood]

On the Canadian Medical part of our quality system, we have Ragulatory Affairs, and a friend of mine happens to handle this apsect.

Looks like I will have to get into that ILC stuff. I think I saw where I may be able to compare measurements from our production facility (across town) with those recorded in our lab. Again, I haven't really looked into this yet.

As in the words of Arnold, "I'll be back".
-Dan-

 

[D_Wood]

Iso Guy,

Been awhile since I've said anything. I spoke with our new head of quality yesterday and was informed we will be ISO 13485 only by June 1st. I am assuming this is the new 2003 version.

I was also told I have to tread very carefully in developing a QS for the lab under 17025. I was informed that all of my Document Control and other "Instructional Processes" must be entered into & controlled by our corporate QS. This was a real blow to my plan, since the new corporate system uses software control, which is very cumbersome and non-user friendly.

I did not get an absolute answer when I asked if all the test procedures and test records were to be entered into the corporate QS as well. I think I will be able to get away with defining a "template" used for test procedure development along with its instructions, as well as defining a "template" for recording test data, which eventually ends up in a formal test report, of which its template must also be defined and entered into corporate QS. Where will the formal test reports be kept or maintained? Probably wherever we keep our original test data - in our lab's document control center.

One way or another, control of documentation is going to be split between the lab and corporate. It's just a matter of determing where to draw the line.

-Dan-

 

[Aaron Lupo]

I am not sure if 13485:2003 will be out by then, but hey you never know. I do know people will be getting certified to EN/ISO 13485/8:2000 and will have 3 years to cut over to the 13485:2003. If there is anything I can help out with just yell!

Are you already 17025? If not are you a calibration house or a testing house or both?