Looking for Best ISO 13485/FDA QSR Quality System Development Software

Q

QUALITYTRAINER

#1
Looking for Best ISO 13485/FDA QSR QS Development Software

Hi,

Boy am I frustrated! I have a lot of experience in the Q&R field, but am currently in a small company and need to develop an ISO 9001, ISO 13485 & FDA QSR compliant quality system. Since I'm not a big fan of typing and I have some serious resource constraits, I'm looking for available tools that I can purchase to use as a framework for defining the quality system of this business. The reason that I am frustrated is that I just purchased software from a company that said they had a quality system that would be simple and small and meet our needs perfectly. When I looked at it, the quality manual alone was 122 pages (and this was just ISO 9001 & QSR, I was going to add the delta for 13485).

Does anyone have a suggestion as to where I can purchase software that I can use that is small, simple and ensures that the regulations requirements are coverred. At this point, I'm considering writing the whole thing, but hope that I won't need to.

Any help would be appreciated. Thanks. :bonk:
 
Elsmar Forum Sponsor

Al Rosen

Staff member
Super Moderator
#2
QUALITYTRAINER said:
Hi,

Boy am I frustrated! I have a lot of experience in the Q&R field, but am currently in a small company and need to develop an ISO 9001, ISO 13485 & FDA QSR compliant quality system. Since I'm not a big fan of typing and I have some serious resource constraits, I'm looking for available tools that I can purchase to use as a framework for defining the quality system of this business. The reason that I am frustrated is that I just purchased software from a company that said they had a quality system that would be simple and small and meet our needs perfectly. When I looked at it, the quality manual alone was 122 pages (and this was just ISO 9001 & QSR, I was going to add the delta for 13485).

Does anyone have a suggestion as to where I can purchase software that I can use that is small, simple and ensures that the regulations requirements are coverred. At this point, I'm considering writing the whole thing, but hope that I won't need to.

Any help would be appreciated. Thanks. :bonk:
Hi QT:
I don't know what experience you have with the FDA QSR but you might want to write your procedures around the FDA Requirements and your Quality Manual organized around 13485. They are pretty much "harmonized". I did this and provided a cross reference to the QSR in the Quality Manual.

You may find this thread helpful:
http://elsmar.com/Forums/showthread.php?t=6160&page=2&pp=15
as well as some others in the Cove. Try doing a search.

This web page may also help:
http://www.clinivation.com/pages/resources/downloads.htm

Post any other specific questions. I don't think you will be happy with anything that's "canned" and you will still need to work on it. BTW, did you get your money back?
 
Q

QUALITYTRAINER

#3
No, I didn't get my money back. This URL that you pointed me to has some templates that it says are available for use and then in the legal section it talks (as I would expect) that the information is copyright protected. Do you know if these are available for use, free of charge? It doesn't feel right. If it looks too good to be true, it probably is.
 

Al Rosen

Staff member
Super Moderator
#4
QUALITYTRAINER said:
No, I didn't get my money back. This URL that you pointed me to has some templates that it says are available for use and then in the legal section it talks (as I would expect) that the information is copyright protected. Do you know if these are available for use, free of charge? It doesn't feel right. If it looks too good to be true, it probably is.
I wouldn't think you could use anything without modification. I just thought the templates would give you some insight as to the requirements and as a starting point for your procedures. Why not call them to discuss the limits of the use of the templates. After all they are available for download and are in MSWORD. Of course be prepared for a sales pitch. I would think the templates could be used for the purpose of developing procedures. But since I'm not a lawyer, I don't know what is covered by their copyright.
 
D

DaveofOH

#5
Roadmap

Here's a cross-reference that I put together that maps FDA QSRs alongside ISO 13485:2003 and ISO 9001:1994. Hope this helps. It is not copyrighted. Looking at the dates, you're probably well past this now.
I'm now where you were.
Has anyone flowcharted the four main processes of 13485 showing their interconnections? Ditto not wanting to recreate the wheel... Oh, the 4 processes I'm referring to are: QMS, Managment Responsibility, Product Realization and Measurement, analysis and improvement.

Thanks. :)
 

Attachments

Thread starter Similar threads Forum Replies Date
C I am looking for the best practices on calibration labeling General Measurement Device and Calibration Topics 5
M Looking for Best Way to Communicate Process Changes to Production Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A I'm looking for VDA 6. Has anyone the best site where I can buy that? VDA Standards - Germany's Automotive Standards 2
J Looking for partners Paid Consulting, Training and Services 2
bryan willemot Looking for an Approved vendors list template Document Control Systems, Procedures, Forms and Templates 11
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
M Data Protection and Privacy Policy - looking for a template/example EU Medical Device Regulations 1
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
blackholequasar Looking into Nadcap for the first time AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
S We are looking for EU authorised Representative for both Class I and Class IIb devices EU Medical Device Regulations 7
K Looking for a job as Quality Engineer Career and Occupation Discussions 2
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
mihzago Looking for an Australian/ NZ Sponsor Other Medical Device Regulations World-Wide 4
S New Foreign Exporter Looking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Looking to Impress - New Job - Advice, Thoughts, Comments Welcome Career and Occupation Discussions 23
J Looking for a training organization that can provide in house DFMEA training FMEA and Control Plans 4
A Looking for a third party to calibrate our measure equipment - South Carolina General Measurement Device and Calibration Topics 6
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
N Looking for Gamma sterilization facility in China ISO 13485:2016 - Medical Device Quality Management Systems 4
A 5 x 5 Risk Matrix - Looking for a good example Manufacturing and Related Processes 2
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
J Looking for a EU MDR Gap Analysis template EU Medical Device Regulations 6
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 1
A New to QC, looking for resources Problem Solving, Root Cause Fault and Failure Analysis 3
bryan willemot Looking for a certified test report for aerospace parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
K I’m looking for a square probe for my linear height gauge Manufacturing and Related Processes 1
C Looking for China Good manufacturing practice China Medical Device Regulations 1
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
A We're currently looking for any studies performed on various PPE materials Qualification and Validation (including 21 CFR Part 11) 1
C Looking for APQP Training recommendations preferably in the aerospace industry APQP and PPAP 2
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
H Looking for Tips on finding an IATF consultant Consultants and Consulting 6
W My company is looking to start a materials testing lab that conforms to ISO17025:2017 ISO 17025 related Discussions 3
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
bryan willemot Looking for a good CoC to put with my certification sheets when we send parts Document Control Systems, Procedures, Forms and Templates 1
L I'm looking for Translation Procedure Guide MEDDEV 2.5/5 Rev.2 (NOT Rev.3) CE Marking (Conformité Européene) / CB Scheme 0
K Looking for a good Six Sigma book Six Sigma 7
G Looking to move to an electronic QMS software Software Quality Assurance 11
C Looking for source of silicone contamination in ISO Class 8 Cleanroom Other Medical Device Related Standards 2
F Looking for a Japan MAH recommendation that is not too expensive Japan Medical Device Regulations 6
P Looking for Risk Assessment Template - Not necessarily Asset based IEC 27001 - Information Security Management Systems (ISMS) 1
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Looking for FMEA plastic injection molding FMEA and Control Plans 8
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6

Similar threads

Top Bottom