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

D

D_Wood

#1
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
 
Last edited by a moderator:
Elsmar Forum Sponsor
A

Aaron Lupo

#2
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

D_Wood

#3
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-
 
A

Aaron Lupo

#4
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

D_Wood

#5
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
 
A

Aaron Lupo

#6
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.
 
A

Aaron Lupo

#7
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

D_Wood

#8
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

D_Wood

#9
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-
 
A

Aaron Lupo

#10
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?
 
Thread starter Similar threads Forum Replies Date
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 5
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 1
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 31
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
O ISO 13485 vs. GMP - Comparison matrix wanted EU Medical Device Regulations 4
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
F ISO 13485 - EU countries that could request another audit ISO 13485:2016 - Medical Device Quality Management Systems 2
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 10
JoCam Increase to bi-annual ISO 13485 audits ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485 for general purpose disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 9
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485 extended Site (Two companies) ISO 13485:2016 - Medical Device Quality Management Systems 2
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
C ISO 13485 Requirement in Australia/NZ for class 1? ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom