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
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 12
J ISO 13485 for Metal Finishing Medical Device and FDA Regulations and Standards News 5
S How to calculate Effective Number of People for ISO 13485 Certification? General Auditing Discussions 2
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
H ISO 13485-paragraphs for a SaaS SAMD needed or not? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D Lead time to schedule an ISO 13485 audit General Auditing Discussions 2
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 6
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
E ISO 13485 in Clinical Trial conduct: Applicable or No ISO 13485:2016 - Medical Device Quality Management Systems 2
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 8
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
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 9
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 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom