MDSAP Audit Plan - Please share an Audit Plan/Schedule/Agenda

M

Maiar

#1
#1
Hello,
Has anyone had already an MDSAP audit?
Could you share the audit plan/ schedule/ Agenda?
Thanks
 
Download Free White Paper
Elsmar Forum Sponsor
Edward Reesor

Edward Reesor

Trusted Information Resource
#2
#2
I was instructed by a very informed person (who will be performing audits) to go to this FDA link (.pdf) for the information on the audit . They plan on using this document for their own audit plan, step by step.

This and other documents can be found here.

It doesn't appear that anyone has a template you can use, but the links I have provided have several documents where templates may exist. Personally, I have been taking the lines from the linked document and adding it to my own Internal Audit tool.
 
C

cnpacs

Registered
#3
#3
You can google "MDSAP Documents", the first link is the FDA website for MDSAP. All MDSAP documents listed there.
MDSAP audit will follow process approach, with four primary processes:
1. Management;
2. Measurement, Analysis and Improvement;
3. Design and Development;
4. Production and Service Controls;
And a supporting process
• Purchasing
The MDSAP audit process has two additional supporting processes:
• Device Marketing Authorization and Facility Registration
• Medical Device Adverse Events and Advisory Notices Reporting.

Similar to US FDA inspection method.
 
Last edited by a moderator:
xcanals_tecno-med.es

xcanals_tecno-med.es

Involved In Discussions
#5
#5
Dear all

The audit plan depends on the organization as some tasks are applicable or not depending their activities (e.g. nos sterile devices --> task )
The tasks are reviewed following strictly the order established in the companion document and the total number of hours is calculated according the xls from MDSAP)

I attach a model of the plan used by a AO

Regards

:2cents:

Xavier Canals
 

Attachments

R

rmurp

Starting to get Involved
#7
#7
Highground, we are in the middle of an MDSAP audit. They are looking at our report and schedule and are not happy with it. They are expecting to see every element of the MDSAP companion document addressed in every audit we conduct internally. They also want to see time frames for each limit addressed in our agenda... I am so confused as I don't think much has changed in the style of auditing from the past expectations. Did you find the auditors wanting to see anything new in the audit schedule, plans and agenda?

thanks help! going crazy
 
Highground

Highground

Involved In Discussions
#8
#8
rmurp said:
Highground, we are in the middle of an MDSAP audit. They are looking at our report and schedule and are not happy with it. They are expecting to see every element of the MDSAP companion document addressed in every audit we conduct internally. They also want to see time frames for each limit addressed in our agenda... I am so confused as I don't think much has changed in the style of auditing from the past expectations. Did you find the auditors wanting to see anything new in the audit schedule, plans and agenda?

thanks help! going crazy
Click to expand...
The MDSAP companion document is mainly for the auditors. You only need to audit your QMS and the regulations you have approvals for your devices. Who is auditing you?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
S Is MDSAP Audit Required? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
Z Steps to take before an MDSAP audit for Canada Canada Medical Device Regulations 3
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
A MDSAP Audit Questionnaire Medical Device and FDA Regulations and Standards News 7
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 11
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 4
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 22
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 13
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
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
M MDSAP Medical devices Supplyers Canada Medical Device Regulations 1
Q ISO 13485 certificate needed if I go for MDSAP certification? ISO 13485:2016 - Medical Device Quality Management Systems 3
J CMO in Canada do they need MDSAP/13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
I MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 5
chris1price MDSAP and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
M MDSAP required for Device Initial Importer/Distributor into Canada? Other Medical Device Regulations World-Wide 11
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 6
S Where to start for MDSAP for Canada? Canada Medical Device Regulations 5
S Submit to Health Canada with only MDSAP report? Canada Medical Device Regulations 5
B Site removal from MDSAP multi-site Certificate ISO 13485:2016 - Medical Device Quality Management Systems 4
B MDSAP Withdrawal? ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO13485:2016, MDSAP and Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 9
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 5
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 5
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

Similar threads

Top Bottom