Does anyone use iQMS for their ISO based document control?

Renea Koski QSM

Starting to get Involved
#1
I am new to a company that uses the iQMS ERP system for their manufacturing processes. I was told there are several modules for ISO like document control, CAPA, customer feedback, etc. What I have found so far is very limiting and not really conducive to ISO standards (13485.) I am not finding my information in the help section and they want to charge me $192 for training each time.
Can anyone shed some light on this system??
 
Elsmar Forum Sponsor

StepPCHen

Involved In Discussions
#2
I've never used it, we have been on a paper based system since 2002 up until Feb 2022. Currently coming to the end of the final transition phase to an eQMS with Greenlight Guru. I would definitely recommend them
 
#3
I've never used it, we have been on a paper based system since 2002 up until Feb 2022. Currently coming to the end of the final transition phase to an eQMS with Greenlight Guru. I would definitely recommend them
I am starting the process with GG and was wondering what you have used as attributes? do you have any recommendations?
 

GStough

Leader
Super Moderator
#4
I am new to a company that uses the iQMS ERP system for their manufacturing processes. I was told there are several modules for ISO like document control, CAPA, customer feedback, etc. What I have found so far is very limiting and not really conducive to ISO standards (13485.) I am not finding my information in the help section and they want to charge me $192 for training each time.
Can anyone shed some light on this system??
I've not used it before but have audited suppliers who do. From what I've seen, it looks like a good system. You've been told correctly. There are several modules and if it's anything like Master Control, your company will want to purchase all of them on the most recent revision. Trying to piece them together after the fact is not recommended (that is, if they work in the same manner as Master Control). Do you have all the modules or just the manufacturing piece?
 

Renea Koski QSM

Starting to get Involved
#5
I am not using the iQMS Quality modules...I find them limiting. .. but again, we haven't updated in quite awhile and we are getting ready to upgrade it in Jan. I currently use QT9. . .it is extremely useful for ISO 13485:2016 and extremely reasonable in price too! They have constant help and also have online training academy if you get stuck. There is also an employee training portal that offers unlimited users. It is great to set-up trainings and record trainings.
 
#6
In an "out of the box state"...the iQMS Quality Module for was limited for us as it did not communicate with our ERP system as they were designed on two different system platforms but were sold by the same company.

We did see great potential but it was $$$ to have the system customized. We are a small company and outsource our IT and programming for the most part but if you have in house IT people or others that can take that role, that could be a cost that you can absorb.

I recommend asking allllll the questions and be very careful to not let the seller over promise and under deliver what any system can do for you.

Its all wonderful until you send the check and plug it in and then they tell you "oh that's extra" and you are stuck. Also, it's very important to have the actual users of any system in the sales pitch!

If Quality Team is not fully involved in the sales and decision making process you could be stuck with something that costs you an annual fee to use and whose benefit is not fully recognized. Good Luck!
 
Thread starter Similar threads Forum Replies Date
V Quality Module - Does anyone here use the IQMS Quality Module in your ERP system? Quality Assurance and Compliance Software Tools and Solutions 10
R Does anyone know how ASQ exam requirements are verified? Professional Certifications and Degrees 3
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 2
Q Does anyone know what this call out means? Manufacturing and Related Processes 3
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 3
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
M Honda Audits - Does anyone have any experience with the QAV audit? General Auditing Discussions 13
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
J Does anyone here use ISOXpress/IMSXpress QMS software? Software Quality Assurance 12
K Does anyone have a copy of a GM 5 Phase Problem solving form Problem Solving, Root Cause Fault and Failure Analysis 1
M Does anyone have a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 8
B Does anyone charge for annual layouts? APQP and PPAP 8
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
W Does anyone have any experience with the Easy Metric System? General Measurement Device and Calibration Topics 2
J Does anyone have a good APQP template that meets IATF requirements? APQP and PPAP 3
D IATF 16949 - 8.5.2.1 Traceability Plan - Does anyone have an example? IATF 16949 - Automotive Quality Systems Standard 4
C Does anyone have an AS9100:2015 audit schedule template? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Does anyone have example test report of defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
G Definition Parallel Loop - Does anyone know what the term Parallel loop means? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
B Does Anyone utilize MS Outlook Read Receipts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Does anyone know what is going on in DQS? Registrars and Notified Bodies 1
P Scope Document - Does anyone happen to have an Example Scope Document (4.3)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Does anyone have a list of the IATF "Shalls" they would be willing to share? IATF 16949 - Automotive Quality Systems Standard 4
S Plant within a Plant - Does anyone currently manage their facility this way? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Does anyone have an example Authority Listing SOP example? Misc. Quality Assurance and Business Systems Related Topics 3
S Does anyone know what a healthcare GDSN data pool actually looks like? Hospitals, Clinics & other Health Care Providers 2
R Does anyone have any experience on change control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ScottK Does anyone have experience with how MDD unanounced audits of suppliers are going? EU Medical Device Regulations 21
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
S Does anyone use the Boeing STP0565 and STP0637 specs? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Does anyone have a breakup of Establishments based on Device Classes ? Other US Medical Device Regulations 1
R Legal Register - Does anyone have an example of a legal register? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A MDS software - Does anyone have experience with iPoint? RoHS, REACH, ELV, IMDS and Restricted Substances 8
P Does anyone have a DFMEA process Interface Matrix .xls template FMEA and Control Plans 7
S Does anyone know about FIAT Normation N.9.91320/02 ? Customer and Company Specific Requirements 2

Similar threads

Top Bottom