SBS - The best value in QMS software

MDSAP Audit Questionnaire

Elsmar Forum Sponsor
#3
Thank you - I have reviewed it from the FDA and also the one attached.
When one address all the requirements of MDSAP, would you cover all the regulatory requirements for each country e.g. Vigilance Contact Points, Incident Reporting, Record Keeping in your different SOP's?
 

Attachments

yodon

Staff member
Super Moderator
#4
You do need to address all the requirements ("what to do") in your QMS. The implementation details ("how to do") may be pushed down to lower-level docs or forms or something.
 
#5
You do need to address all the requirements ("what to do") in your QMS. The implementation details ("how to do") may be pushed down to lower-level docs or forms or something.
From this - do you not consider the "how"/lower-level docs not part of your QMS? does that mean they are not subject to the audit?
 

yodon

Staff member
Super Moderator
#6
From this - do you not consider the "how"/lower-level docs not part of your QMS? does that mean they are not subject to the audit?
Yes they are part of the QMS. They *shouldn't* be subject to the audit (but I've seen auditors demand to see "how" things are done - which sparks a lively debate).
 
#7
Yes they are part of the QMS. They *shouldn't* be subject to the audit (but I've seen auditors demand to see "how" things are done - which sparks a lively debate).
I am considering completely rewriting our procedures/instructions because there is too much "how" things are done which are not required to show compliance. It's also challenging because it's difficult for me to convince the departments to create more instructions to standardize the "how" as we grow as an organization because there is a belief that they are subject to audit.
For these 'lower-level' docs, how do you keep them separate from the audit? I was thinking that I should make sure there are no references in the procedures to them, but maybe only reference upwards from the "instruction". Any insight or suggestions?
 
Thread starter Similar threads Forum Replies Date
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
K MDSAP Audit Approach 2020 for Brazil Other Medical Device Regulations World-Wide 1
K MDSAP Audit Approach 2020 ISO 13485:2016 - Medical Device Quality Management Systems 3
R What happens during a Stage 1 MDSAP audit? ISO 13485:2016 - Medical Device Quality Management Systems 4
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 15
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
XRAY_3121 Informational MDSAP Audit Findings - Document change orders Other Medical Device Regulations World-Wide 12
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
A ISO-13485 7.1 - Preparing for our MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
C Substantial Change in MDSAP Audit Other Medical Device Regulations World-Wide 1
S Internal Audit Program under MDSAP and 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 10
J Revised MDSAP Audit Model - Health Canada - October 30, 2017 ISO 13485:2016 - Medical Device Quality Management Systems 7
Edward Reesor MDSAP (Medical Device Single Audit Program) Costs Canada Medical Device Regulations 7
M MDSAP Audit Plan - Please share an Audit Plan/Schedule/Agenda ISO 13485:2016 - Medical Device Quality Management Systems 7
A MDSAP Internal Audit Program example wanted Internal Auditing 3
Ronen E FDA encourages industry to participate in Medical Device Single Audit Program (MDSAP) Other US Medical Device Regulations 10
somashekar MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback ISO 13485:2016 - Medical Device Quality Management Systems 35
V MDSAP Requirements for Device Designer Canada Medical Device Regulations 1
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6
Ed Panek COVID 19 Exception and MDSAP Canada Medical Device Regulations 4
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
Nikki9154 MDSAP inquiry for China Contract Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 4
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
R Exporting to Canada and MDSAP Canada Medical Device Regulations 7
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
M MDSAP and 13485:2016 gap analysis Quality Management System (QMS) Manuals 1
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
M MDR Impact on MDSAP Countries Other Medical Device Regulations World-Wide 16
Watchcat What's up with MDSAP lately? Medical Device and FDA Regulations and Standards News 2
K Comparison essential requirements EU compared to those of MDSAP countries Other Medical Device Regulations World-Wide 3
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
J MDSAP Companion and HC requirements Canada Medical Device Regulations 4
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 5
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
B MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record Other Medical Device Regulations World-Wide 3
W Informational MDSAP Substantial change / Change of notice forms Document Control Systems, Procedures, Forms and Templates 2
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
M Medical Device News EU interesting developments – embracing MDSAP and UDI alignment Medical Device and FDA Regulations and Standards News 0
M Medical Device News MDSAP Stakeholder Day – December 5, 2018 presentations Medical Device and FDA Regulations and Standards News 0
Ajit Basrur MDSAP Presentations - Dec 5, 2018 - Stakeholders Other Medical Device Regulations World-Wide 0
JoshuaFroud FDA Form MDSAP AU F0029.1.004 - Help with Completion US Food and Drug Administration (FDA) 0
Sidney Vianna Interesting Discussion Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate? Canada Medical Device Regulations 0
T MDSAP AO Cost ISO 13485:2016 - Medical Device Quality Management Systems 2
Q MDSAP Regions and how to include in procedures Other Medical Device Related Standards 2
S Initial Importer and ISO 13485 (MDSAP) - Will the US company be included? ISO 13485:2016 - Medical Device Quality Management Systems 1
S MDSAP Scope ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom