SBS - The Best Value in QMS software

Obligations as a contract manufacturer during an MDSAP audit

H

Heilea

Registered
#1
#1
A customer has a MDSAP audit that is approaching and I am wondering what the obligations are as a contract manufacturer during the audit. I want to make sure the customer is taking responsibility where appropriate and not pushing it all on my company because we are considered a critical supplier. Thank you in advance
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#2
#2
Responsibilities should be well-defined in your contract / quality agreement. If you're not already certified to 13485 by an accredited certification body then it's likely their auditor will need to visit you. Further, if they're selling into the EU, you can probably expect an unannounced audit within your client's 3-year cert window.
 
D

DannyK

Trusted Information Resource
#3
#3
I agree with yodon.
If you do not have a quality agreement with your customer, then your customer will have an issue at their MDSAP audit.
You can be proactive by asking your customer to define the responsibilities in a quality agreement.
 
H

Heilea

Registered
#4
#4
Thank you both for the reply. We are 13485 certified. There is a quality agreement in place which outlines Site Audits by the customer. Maybe I did not ask the question in the right away. While the customer is going through their MDSAP audit they have indicated that we will be audited by their auditor conducting the MDSAP. Being one of their critical suppliers we understand that we will need to provide information their auditor needs, however, I am curious on if its a requirement my company must be audited to complete our customers MDSAP audit.

I am not sure if that is more confusing or not
 
A

Anne48

Registered
#6
#6
I am not sure how to attach a seperate thread here ...... its all a bit new to me :) but I started a new discussion based on a similar question:

My company was recently audited by NB and was given a finding because the audit criteria used to audit a Supplier - Contract Manufacturer - was not audited first to ISO13485:2016 and then to MDSAP or MDR. The audit was conducted to ISO9001 as the supplier was 9001 certified. I accept they should have been audited to ISO13485 but I am confused as to the MDSAP and MDR requirement.
The CM in question is based in US so understand that 21 CFR is applicable but I presume that is all? Can anyone clarify? We do sell the product in Austrialia, Canada and Brazil but as my company is the Legal Manufacturer I presume we must meet TGA, HC and ANVISA requirements and not the CM?
We also sell the product in EU so does MDR apply to CM? I would have thought it applies to the Legal Manufacturer only.
I tried to get some further info from the auditor but didnt get very far!

If anyone can help that would be great!
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
U Distributor obligations under MDR EU Medical Device Regulations 5
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
K Importer in EU, but not distribute in the EU - MDR obligations EU Medical Device Regulations 0
M FULFILMENT of compliance obligation versus COMPLY with compliance obligations ISO 14001:2015 Specific Discussions 2
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
A Refusal to discuss ISO 9001 obligations... what to do? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Informational TGA – Medical device annual reporting – Sponsor obligations Medical Device and FDA Regulations and Standards News 0
W Compliance Obligations - legislative, regulative and others Miscellaneous Environmental Standards and EMS Related Discussions 4
A Pharmaceutical Manufacturer's obligations - Laboratory Test instruments General Measurement Device and Calibration Topics 0
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
S Manufacturers Obligations for Medical Device Servicing and/or Repair EU Medical Device Regulations 10
C Obligations of a company going out of business. CE mark product EU Medical Device Regulations 2
W Obligations of a company going out of business 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Medical Device Relabeler Obligations Other US Medical Device Regulations 14
E Obligations of Foreign Distributors of US Medical Devices US Food and Drug Administration (FDA) 1
D FDA MDDS - Listing Obligations for a Generic Data Interface US Food and Drug Administration (FDA) 3
N Consultant Obligations, CFR 803 and Sterility Quality Manager and Management Related Issues 4
M CE Marking Process - Obligations of an Authorized Representative CE Marking (Conformité Européene) / CB Scheme 1
K Contract Manufacturer Do they need a complaint procedure? Medical Device and FDA Regulations and Standards News 8
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
J Need a contract monitoring Tool General Information Resources 0
Y Procedures on Contract Review Document Control Systems, Procedures, Forms and Templates 3
C SharePoint Contract Management Software General Information Resources 0
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
T Selection Of Contract Manufacturers Supplier Quality Assurance and other Supplier Issues 2
chris1price Contract Sterilization Service Providers ISO 13485:2016 - Medical Device Quality Management Systems 5
A Requirements for Contract Manufacturers Other Medical Device and Orthopedic Related Topics 3
Nikki9154 MDSAP inquiry for China Contract Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 4
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
bryan willemot Contract Review and risk managment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 1
M Contract manufacturer MDR Quality Management System (QMS) Manuals 1
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
Nicole Desouza Contract / Customer Order Review Checklist Needed Manufacturing and Related Processes 12

Similar threads

Top Bottom