SBS - The best value in QMS software

Is it possible to have two QMSs? One for each or our two products

mobylad

Starting to get Involved
#1
Is it possible to have two QMSs? one for each or our two products. We will have a period of time when the two product will be manufactured in parallel. We didn't originally have such a scenario as we thought that one (our new) product would take over from the other. Because the QMS structure is very different for both products, it made better sense to design a new QMS, including Quality Manual, Processes, Procedures, etc for the new prouduct. Now that we will have two products running in parallel for a period we are wondering if you can have two QMSs. Will a notified body and FDA accept this.

:lmao:
 
Elsmar Forum Sponsor
T

treesei

#2
Re: Two QMSs within one company

Yes it is possible. The company I worked for is exactly this situation. 90% of the products are consumer electronics under ISO 9001 QMS. 10% are medical devices under ISO 13485. The scope of the medical device products are specified on the ISO cert. There are designated areas for medical device products in the facility. It has been years and such system has not been challenged by anyone.
 

somashekar

Staff member
Super Moderator
#3
Re: Two QMSs within one company

Is it possible to have two QMSs? one for each or our two products. We will have a period of time when the two product will be manufactured in parallel. We didn't originally have such a scenario as we thought that one (our new) product would take over from the other. Because the QMS structure is very different for both products, it made better sense to design a new QMS, including Quality Manual, Processes, Procedures, etc for the new prouduct. Now that we will have two products running in parallel for a period we are wondering if you can have two QMSs. Will a notified body and FDA accept this.

:lmao:
A QMS is a system to manage processes well and improve upon it. We are used to calling it as Quality management system (QMS)
I can have one QMS and manage multiple products each very differently and as required by that product.
QMS is global for you, the product is just one around which you apply QMS requirements.
Keeping the products aside, there are many things in your company that are common.
It is possible, but to what effect ?
For me it sound cumbersome, complicated and not worth the doing.
 
#4
Re: Two QMSs within one company

... It is possible, but to what effect ?
For me it sound cumbersome, complicated and not worth the doing.
Agreed, and especially within the comparative scope of the 9001 & 13485 standards. They are similar enough to where you'd probably just be better off disclosing any heightened 13485-based documentation or validation requirements for your medical product within 1 set of procedures, which is 1 QMS.

Beyond that, make sure you consider the largely parallel requirements of Customer satisfaction/feedback (9001/13485) and discuss both improvement/maintenance (9001/13485) of your QMS, and you should be good to go... :2cents:
 
S

Shoes

#5
Re: Two QMSs within one company

I had to run 2 systems once. The Capability Maturity Model for software development and ISO for hardware development. It isn't easy but can be done when necessary.
 

mobylad

Starting to get Involved
#6
PS thanks for all the responses. I need to clarify that they are two medical device products. Our current product is manufactured in house, but the new medical device will be almost fully outsourced, however the QMS will remain within house. There would be significantly more work involved in adapting our current QMS to include the new product rather than having an additional QMS for the new product. Bear in mind that the current product will be only running in parallel with the new product for a short period before the new product will run on its own. So back to my original question (although adding some clarification), can a medical device manufacturer, manufacture two different medical devices with a separate QMS for each?
 

Ronen E

Problem Solver
Staff member
Moderator
#7
PS thanks for all the responses. I need to clarify that they are two medical device products. Our current product is manufactured in house, but the new medical device will be almost fully outsourced, however the QMS will remain within house. There would be significantly more work involved in adapting our current QMS to include the new product rather than having an additional QMS for the new product. Bear in mind that the current product will be only running in parallel with the new product for a short period before the new product will run on its own. So back to my original question (although adding some clarification), can a medical device manufacturer, manufacture two different medical devices with a separate QMS for each?
Sounds strange to me but if the period in which they run in parallel is short enough, you might be able to convince your NB. If you had the 2 QMS running in 2 different (geographical) locations it might have been a bit easier.

Cheers,
Ronen.
 
M

MIREGMGR

#8
can a medical device manufacturer, manufacture two different medical devices with a separate QMS for each?
My view is, yes because no rule says you can't.

You however may have to explain yourself to various people with raised eyebrows who think you're out of your mind and/or there must be a rule against it.
 
E

Elynn

#9
Agree with MIREGMGR - There is no rule that says "No".

If your organisation can afford the resources (manpower & $$) to maintain the separate QMSs, will not cause confusion to the users (the employees / workers) and make it easier for the new product, there should be no reasons to say "no"...

However, in the long run, you may wish to merge both into one by comparing the commons and differences... and just work on the clauses with differences.
 
I

isoalchemist

#10
Also in agreement with MIREGMGR and ELYNN, but I'm a bit confused by your statement
There would be significantly more work involved in adapting our current QMS to include the new product rather than having an additional QMS for the new product.
If both products are medical devices and controlled under 21CFR820 and/or ISO13485 what you infer is that all of your business processes ( Man Rev., Purchasing, Audit, Doc Control etc.) are being forced to change because of the product. That seems strange....IMHO I'd take a step back and examine what is really different and needs to change before attempting to maintain 2 QMS systems.:2cents:
 
Thread starter Similar threads Forum Replies Date
K Is it possible to avoid the OQ? ISO 13485:2016 - Medical Device Quality Management Systems 8
G Special 510K possible? Only the packaging has changed Other US Medical Device Regulations 0
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
M Informational EU – Possible EUDAMED delay Medical Device and FDA Regulations and Standards News 3
M Is it possible to get iso 13485:2016 certified as a one man band ISO 13485:2016 - Medical Device Quality Management Systems 1
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
dhuot1990 USP 41 Hanging Scale - Is it possible to make a hang scale adhere to USP41 Standards? ISO 17025 related Discussions 3
F Apple Watch is not a medical device. How can this be possible? CE Marking (Conformité Européene) / CB Scheme 1
qualprod ISO 9001:2015 Clause 8.3 - Is it possible to exclude one product but include it in other? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Ashok sunder Is it possible to reduce FMEA Occurrence and Detection Ranking after corrective action taken for customer complaints? FMEA and Control Plans 6
B Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards? ISO 14001:2015 Specific Discussions 6
E Is it possible to start an ISO 9001 QMS from scratch (Really) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Some possible misunderstandings on the application of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
P Is it possible to make an educated decision using a very very small sample size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
a_bardi Is it possible to exclude internal audit from qms scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G ISO 9001:2015 - Is control possible with Excel adaptable measurement sheets? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
S Indications for Use - Is it possible to have a different indication for use EU Medical Device Regulations 1
C %GRR <10% not possible. How to get approval by auditor? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
M Is Automated Internal Auditing Possible? Internal Auditing 13
A Integrated Management Systems - ISO 50001 and ISO 9001 possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Is it possible to receive EASA STC within 48 hours after modification? EASA and JAA Aviation Standards and Requirements 1
3 Israel: 1 Medical Device, Multiple Registrations = Possible? Other Medical Device Regulations World-Wide 3
Marc Yahoo probes possible huge data breach - BBC News - 2016 World News 1
Marc Yahoo probes possible huge data breach World News 0
S Preparing a Root Cause Report - Possible Root Causes Document Control Systems, Procedures, Forms and Templates 11
M Future of ISO 14971 - Possible revision? ISO 14971 - Medical Device Risk Management 9
M Is IEC 60601 compliance possible when only generic power-supply is specified? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Is it possible to have more than one authorized representative in Saudi Arabia? Other Medical Device Regulations World-Wide 6
Y Is it possible to check the authenticity of a CFDA registration certificate? China Medical Device Regulations 7
T Reduced Audit days when UPGRADING from AS9100 to TS16949 - Is it possible? IATF 16949 - Automotive Quality Systems Standard 2
Ajit Basrur Is Biocompatibility study performed on medical devices for possible contaminants? Other Medical Device Related Standards 4
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Is it possible to randomly select samples from 1 column to many column Using Minitab Software 2
Marc Google Fiber chooses nine metro areas for possible expansion After Work and Weekend Discussion Topics 1
Hershal ILAC is preparing to start the possible revision to ISO/IEC 17025 ISO 17025 related Discussions 2
0 Is it possible to use a threaded ring gage to calibrate the M8 gage? Calibration and Metrology Software and Hardware 4
A Is it possible for STC application before issue of TC ? EASA and JAA Aviation Standards and Requirements 4
B Is it possible that a virus sends spam on Facebook? After Work and Weekend Discussion Topics 6
Ronen E Incretin Mimetic Drugs for Type 2 Diabetes: Possible Increased Risk Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
R Is it possible for medical power supply to declare CE based on MDD? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S Is it possible to have a General Change Control SOP and Form? Document Control Systems, Procedures, Forms and Templates 6
J Quality Management Process Model Possible Interactions and Effects ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T Is "World Class" Quality possible by Accident? Coffee Break and Water Cooler Discussions 18
J Two Quality Management Systems - ISO 13485 in one company possible? Quality Manager and Management Related Issues 4
Marc Great Lakes - 24 foot waves possible! October 2012 Coffee Break and Water Cooler Discussions 1
R Possible Actions for Nonconforming Product besides issuing NC Nonconformance and Corrective Action 6
M Is it possible to get Natural Tolerance (Tn) with Non Normal Distribution? Statistical Analysis Tools, Techniques and SPC 9

Similar threads

Top Bottom