SBS - The best value in QMS software

Non-medical device is in the ISO 13485 audit scope?

L

luloo117117

#1
Hello,

One question: our company, a medical device company, makes medical and non-medical products. We are applying ISO 13485 now, but not sure our non-medical products should also comply with our quality system and are audited by BSI auditor too?

Thanks

Leon
 
Elsmar Forum Sponsor
G

Gert Sorensen

#2
In as far as the product is not part of the scope of your certification then it should not be audited. However, it may be listed on your certificate as well and then BSI can and should audit it.
:bigwave:
 

harry

Super Moderator
#3
Hello,

One question: our company, a medical device company, makes medical and non-medical products. We are applying ISO 13485 now, but not sure our non-medical products should also comply with our quality system and are audited by BSI auditor too?

Thanks

Leon
Discuss and seek advice from your CB.
 

yodon

Staff member
Super Moderator
#4
We're in a bit of a similar boat. We have a single quality system for all the work we do - including medical and commercial. In our quality system, we define projects that are either fully in scope (13485) or not. For those that are not in scope, we define what aspects of the quality system apply. For example, no matter what we do, we control our documents the same way. Thus, Document Control applies to all projects. We have a matrix in our quality system that lays out what the various project types must comply with in the system.

When we are audited, the auditor asks for evidence of compliance from the various project types. (We also keep a table listing each project and what type it is).

Very straight forward and clear to the auditor. Hope that helps. This is just OUR approach. The recommendation by harry to discuss with your CB is sound.
 
R

Roland Cooke

#5
ISO13485 can apply to related activities, not just devices. Sterilization companies, component manufacturers, translation companies, Authorised Reps etc can also hold ISO13485..

Possibly what you want to consider is additional registration to ISO9001, for any activities that fall outside of ISO13485.
(Some registrars would charge for this which might make it an unviable option. SGS doesn't charge, just fyi).
 

somashekar

Staff member
Super Moderator
#6
Hello,

One question: our company, a medical device company, makes medical and non-medical products. We are applying ISO 13485 now, but not sure our non-medical products should also comply with our quality system and are audited by BSI auditor too?

Thanks

Leon
Hii...
We have been successful in clearly defining in the scope, the products covered under the ISO 13485 QMS and the ISO 9001 QMS. During the audit process, the same has been considered and audited and certified. This is done after discussions had with our certifying body. So I am sure you can have a clear way of doing this when you define the scope well in your level I document itself....
Good Luck...
 
M

MIREGMGR

#7
Per the present revision of MDD, some products that are used in a medical context are PPDs instead of medical devices.

It seems obvious that a medical device company that markets surgical facemasks needs a quality system to control that activity. 13485 should work that way.

It's not directly relevant to 13485, of course, but my understanding is that the FDA regards surgical facemasks as personal protective devices rather than medical devices, but nonetheless considers them to be within its purview and governed by the QSR.
 
R

Roland Cooke

#8
Your product only needs to be regulated as a medical device in any of the countries you intend to market for your ISO13485 scope to include it.
 

rthompson

Starting to get Involved
#9
We're in a bit of a similar boat. We have a single quality system for all the work we do - including medical and commercial. In our quality system, we define projects that are either fully in scope (13485) or not. For those that are not in scope, we define what aspects of the quality system apply. For example, no matter what we do, we control our documents the same way. Thus, Document Control applies to all projects. We have a matrix in our quality system that lays out what the various project types must comply with in the system.

When we are audited, the auditor asks for evidence of compliance from the various project types. (We also keep a table listing each project and what type it is).

Very straight forward and clear to the auditor. Hope that helps. This is just OUR approach. The recommendation by harry to discuss with your CB is sound.
Yodon, Would you be willing to provide an example of your matrix? Much thanks.
 
Thread starter Similar threads Forum Replies Date
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
J Medical System with non-medical device and FCC US Food and Drug Administration (FDA) 5
K Relying on mitigations implemented in non-medical device IEC 62304 - Medical Device Software Life Cycle Processes 5
C Medical Device Stability Studies - Non-validated pilot production Other Medical Device Related Standards 1
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
A Medical Device Class 2A, non sterile bodyworn packaging requirements CE Marking (Conformité Européene) / CB Scheme 7
N Medical device non sterile packaging requirement CE Marking (Conformité Européene) / CB Scheme 1
JoCam Non-medical device accessory for a medical device EU Medical Device Regulations 27
N Registering a Class 1 Sterile Medical Device - Currently selling a Non-Sterile 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
S Australian Registration of Non-CE Marked Medical Device CE Marking (Conformité Européene) / CB Scheme 2
C Biocompatibility Test for a Non Contact Medical Device US Food and Drug Administration (FDA) 11
I Label of a Medical Device sold in EU - Non translated information EU Medical Device Regulations 7
J 510k file requirements for non-sterile medical device accessories 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
N How to register a non notified Medical Device in India Other Medical Device Regulations World-Wide 5
J Non-Sterile Class 2 Medical Device Shelf Life Other Medical Device Related Standards 3
T Self Declaration for CE Class I, Non-Invasive Medical Device EU Medical Device Regulations 10
M Class II Medical Device Design Control Non Conformance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Shipping Stability for Class III IVD (Non Sterile) Medical Device Other Medical Device Related Standards 7
J Biocompatibility for Class I Non-Sterile Medical Device EU Medical Device Regulations 2
G Labeling Requirements - Medical Device is Rx in USA, non-Rx in EU 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Is a new 510(k) needed? Add Non Medical Device into a Medical Device App Other US Medical Device Regulations 13
A Launching a CE Mark Class I (non-measuring and non-sterilzed) Medical Device EU Medical Device Regulations 1
S Clinical or Non-Clinical Data in 510(k) Submission for a type II Medical Device US Food and Drug Administration (FDA) 1
B FDA Requirements for Retaining Non-Conformance Tags (Medical Device Manufacturers) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Expiry Dates on a Non-Sterile Class 1 Medical Device (5 Year Shelf Life). Other Medical Device and Orthopedic Related Topics 11
W Is a Non-Automatic Weighing Instrument a Medical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
sagai Is service related software a non medical device? IEC 62304 - Medical Device Software Life Cycle Processes 4
A Need to register with CA for Class I (Non-Sterile and Non-Measuring) Medical Device EU Medical Device Regulations 4
C Safe Handling of Non-Device Refurbished Medical Equipment US Food and Drug Administration (FDA) 3
A Medical Device Labeling - Non-Pyrogenic Symbol Other Medical Device Related Standards 6
C Non-Invasive Medical Device Machines - Singapore Registration Other Medical Device and Orthopedic Related Topics 4
E IEC/EN 60601 Testing and CE Marking for a Non Medical Device CE Marking (Conformité Européene) / CB Scheme 11
V CE Marking for Device under (Research and Education) Non Medical. CE Marking (Conformité Européene) / CB Scheme 3
M Non-Conformance Procedure FlowChart for a Medical Device company Document Control Systems, Procedures, Forms and Templates 3
A Single Multifunction device CE approval - Medical and non-medical EU Medical Device Regulations 4
J Can a non-medical device manufacturer (mold making) be certified to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 11
Q A Non-Quality Culture at a medical device manufacturing company Career and Occupation Discussions 13
A Medical device with NON medical PC - USB galvanic insulation ISO 13485:2016 - Medical Device Quality Management Systems 2
A Documentation required for launch of a non-sterile exempt class 1 medical device ISO 13485:2016 - Medical Device Quality Management Systems 7
L Classification as medical device or non-medical device? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Procedure packs with non-medical devices EU Medical Device Regulations 1
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
D Do purchasing controls apply to non-medical parts? ISO 13485:2016 - Medical Device Quality Management Systems 5
S Service record requirements for Non-Serviceable Medical Devices CE Marking (Conformité Européene) / CB Scheme 1
S Industry Labelling Standards - non medical Manufacturing and Related Processes 0
A Information on good laboratory practices (GLP) for the non-medical or food industry wanted Manufacturing and Related Processes 1

Similar threads

Top Bottom