Does 13485 auditor have a right to inspect non-CE products?

N

nantmel

#1
Hi all,

This is a debate that I've been having with my boss at the moment... We are an ISO13485 registered company making medical devices for the EU market predominantly. However, we also have a 510K exempt product being sold in America.

We have a 13485 surveillance audit coming up, and there are some discrepancies with the paperwork for the non-CE product headed for the States. My boss argues that it doesn't matter right now as the auditor is only there to audit to CE mark, and can't challenge us on the non-CE product. I am arguing that she has a right to challenge us on all devices we produce, as 13485 is a way of assuring everything under our roof happens according to a set of procedures and controls. Who is right about this?

Secondarily, if I'm right and 13485 does apply to these products, how would a company that manufactures both medical devices and non-medical devices navigate this? Would they have to manufacture them all to 13485 requirements?

Many thanks for your help!


(NB. This is ignoring the fact that we need the paperwork in line to prove GMP for the states too! But with too much work and not enough staff the imminent audit is taking priority)
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
If the scope of the ISO 13485 certificate does not have any explicit exclusions, the auditor could use any medical device product as part of the sampling for the audit, including products that are not destined to the European market.

As for excluding non medical devices from the audit, this should be self-evident, and also adequately phrased in the scope of certification, but, you can always remind the auditor of that during the opening meeting s/he is supposed to conduct.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
ISO 13485 and CE marking are different things.

An ISO 13485 audit will cover anything you make under that Quality Management System scope whether CE marked or not.

I'll tell you the FDA may not be happy that you excluded listed medical devices from the US from your QMS registration unless you're running a secondary QMS to meet FDA requirements.

Look at the scope on your registration certificate... does it specify CE Marked Devices? Or does it say "medical devices".
Take my meaning?
 
N

nantmel

#4
Thank you for your help. The scope specifies certain types of medical device but doesn't specify CE Marked Devices specifically.


I've been able to point my boss to this to clear up the confusion.



Thanks again!
 

Statistical Steven

Statistician
Staff member
Super Moderator
#5
Thank you for your help. The scope specifies certain types of medical device but doesn't specify CE Marked Devices specifically.


I've been able to point my boss to this to clear up the confusion.



Thanks again!
As Scott mentioned, the key driver to what is included or excluded is what QMS do the products follow. If your CAPA system is for both the CE and non-CE marked devices, then they are part of the audit. Typically, there is a single QMS for the company, but not always.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
Thank you for your help. The scope specifies certain types of medical device but doesn't specify CE Marked Devices specifically.


I've been able to point my boss to this to clear up the confusion.



Thanks again!
Good news. Glad to hear it.
 
Thread starter Similar threads Forum Replies Date
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
M Does ISO 13485 or MDR require you to state the origins of customer requirements or user needs? Design and Development of Products and Processes 2
L Does anybody have quiz's available? ISO 13485:2016 Training Material Training - Internal, External, Online and Distance Learning 2
K Does ISO 13485:2016 - 7.2.3 Customer Communication include Marketing? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Does MDSAP replace ISO 13485, or do both have to be maintained? ISO 13485:2016 - Medical Device Quality Management Systems 25
A Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
S BSI's ISO 13485 certificate does not mention AC 2009 corrigendum Registrars and Notified Bodies 5
G Does anyone have a ISO 13485 Gap Analysis form they'd be willing to share? Quality Manager and Management Related Issues 3
M Does ISO/IEC 17021 Accreditation work for 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
I Does my company need to be ISO 13485 registered? ISO 13485:2016 - Medical Device Quality Management Systems 7
I Does ISO 13485 have a Periodic Document Review Requirement? ISO 13485:2016 - Medical Device Quality Management Systems 7
T Does ISO 13485 require Gauge R&R's? ISO 13485:2016 - Medical Device Quality Management Systems 3
E Does European Manufacturer with ISO 13485 need QSR820 for FDA registration? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
W Can a site that does not manufacture or assemble a device be ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 18
D Does anyone know about ISO 13485:2004? ISO 13485:2016 - Medical Device Quality Management Systems 7
C Does ISO 13485 certification require a company to follow 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 13
T Does ISO 13485 have any Trainer Requirements ISO 13485:2016 - Medical Device Quality Management Systems 8
N Poor control of testing chemicals ? which ISO 13485/9001 clause does it contravene? ISO 13485:2016 - Medical Device Quality Management Systems 8
H cGMP calendar and ISO 13485 - Does ISO 13485 QMS require a cGMP calendar? ISO 13485:2016 - Medical Device Quality Management Systems 10
Le Chiffre ISO 13485 Process Model Diagram - Does anyone have one? ISO 13485:2016 - Medical Device Quality Management Systems 9
A What does the FDA think about 13485? Will the FDA upgrade 21 CFR 820? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 0
D What does a level 1 (PSW) PPAP actually promise? APQP and PPAP 12
R GS1 DataMatrix code does not meet GS1 Specification EU Medical Device Regulations 0
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3
M Does C=0 strictly mean 1 bad, all bad, all the time? ISO 13485:2016 - Medical Device Quality Management Systems 6
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 3
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
M What does "constantly" mean ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
H How does a gas turbine work on diesel fuel? Oil and Gas Industry Standards and Regulations 12
G What does performance specification include? US Food and Drug Administration (FDA) 1
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9

Similar threads

Top Bottom