New to QMS and regulatory... advice on training/certification?

#1
Hi all. I work for a small newer company and I have been placed in charge of regulatory and carving out our own QMS apart of our manufacturers (we design and label will be under our name). I've been reading a lot of posts and I understand I'm in for a steep learning curve.

Do you recommend any specific training that could get me certified? Or any other resources. Thank you!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
somashekar Electronic data Back-up procedure, for Medical device QMS and regulatory purpose. ISO 13485:2016 - Medical Device Quality Management Systems 4
Marc What QMS and Regulatory Compliance Software are you using? Quality Assurance and Compliance Software Tools and Solutions 7
bio_subbu GHTF - Guidance on QMS Audits at Multiple Sites / Regulatory Auditing Strategy Other Medical Device Related Standards 1
R ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist ISO 13485:2016 - Medical Device Quality Management Systems 26
T Errors & Omissions in Creating QMS Procedures AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
T QMS Compliance Department KPIs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
A E-signatures for QMS? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Document control system for QMS in Google Drive? Document Control Systems, Procedures, Forms and Templates 6
W Looking for IATF 16949 (and ISO 17025) QMS software Suggestions Quality Tools, Improvement and Analysis 8
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 4
Q UK QMS Requirements UK Medical Device Regulations 2
B QMS On-Boarding ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Questions concerning QMS and/or company specific nonconformance Customer Complaints 2
B ISO cl. 5.3 - Ensuring that the integrity of the QMS is maintained ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Scalable QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Using an online software to maintain your QMS Quality Assurance and Compliance Software Tools and Solutions 7
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
E Visual Management Boards & QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
S Disparity between Job Descriptions in QMS & Contract ISO 13485:2016 - Medical Device Quality Management Systems 7
qualprod Minimize tomention other positions to ease the QMS management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S QMS certificate and Samlping EU Medical Device Regulations 0
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 3
Y Must Initial importers have any QMS? US Food and Drug Administration (FDA) 1
qualprod QMS global effectiveness? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q 13485 QMS turnkey ISO 13485:2016 - Medical Device Quality Management Systems 10
K New to Medical Device QMS and would like advice ISO 13485:2016 - Medical Device Quality Management Systems 20
N QMS standard for a research based Organisation Quality Manager and Management Related Issues 1
Moncia Integrated QMS and audit Other ISO and International Standards and European Regulations 5
J New QMS Auditor - seeking opportunities to gain audit experience Career and Occupation Discussions 3
Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
qualprod External consultant into a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
S Changing PCB Assembler and impact on QMS and MDD CE Certificate EU Medical Device Regulations 2
ChrisM Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
A CDRH Learn and DICE for Building a QMS 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A QMS inside a Non medical device firm ISO 13485:2016 - Medical Device Quality Management Systems 4
S HELP in setting-up QMS Quality Tools, Improvement and Analysis 4
S How long the QMS must be maintained after device EOL? ISO 13485:2016 - Medical Device Quality Management Systems 6
K Processes interaction of QMS Process Maps, Process Mapping and Turtle Diagrams 4
P Can I exempt products/services from my AS9100 QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J0anne QMS Implementation Iran ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
adir88 Substantial Change to QMS (Annex IX, Chapter I) EU Medical Device Regulations 0
Watchcat When to begin putting together postmarket production QMS for a mobile app? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
B QMS Functional Safety Checklist ISO 26262 - Road vehicles – Functional safety 0
D Proof QMS compliance for class I ISO 13485:2016 - Medical Device Quality Management Systems 1
A Need career advice on QMS & HSE (No hands on experience) Career and Occupation Discussions 6
M Sharing QMS Documents with Customers Document Control Systems, Procedures, Forms and Templates 13
M Options when MSA acc. to VDA 5 is NOK (Qms > 30%) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0

Similar threads

Top Bottom