Template for Vendor (Supplier) Qualification

D

dolly_milly

#1
Hello All,

We have a poor vendor qualification program in place currently. I was wondering if anyone is willing to share their vendor qualification procedure & related questionnaires/ forms that clearly identifies following:

1) Defines type of vendors: Critical/ non-critical, contract manufacturer, contract labs, consultants
2) Have separate qualification procedure for each of them
3) A vendor response assessment form

Any help shall be greatly appreciated.

Thanks,
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2

Attachments

U

Umang Vidyarthi

#3
Re: Template for Vendor (Supplier) Qualification needed

Hello All,

We have a poor vendor qualification program in place currently. I was wondering if anyone is willing to share their vendor qualification procedure & related questionnaires/ forms that clearly identifies following:

1) Defines type of vendors: Critical/ non-critical, contract manufacturer, contract labs, consultants
2) Have separate qualification procedure for each of them
3) A vendor response assessment form

Any help shall be greatly appreciated.

Thanks,
Hello dolly_milly, :bigwave:Welcome to the cove:bigwave:

There is plenty of material on the subject as Marc has indicated. Since you are new, you may go to the 'post attachment list' at the top or use 'search' button, type your querry and off you go.

You may find two for ready reference here at post #2: Methods for determining Supplier Capacity in various industries

Umang :D
 
D

dolly_milly

#4
Re: Template for Vendor (Supplier) Qualification needed

Hello Marc & Umang,

Thank you for the help. However it has many good documents, none of them is very relavant to what I am looking for. I need a questionnaire that pertains to Medical device industry & is in accordance to ISO 13485:2003. Do you have anything specific to share?
 
R

RI_Tammy

#5
Re: Template for Vendor (Supplier) Qualification needed

Hello Marc & Umang,

Thank you for the help. However it has many good documents, none of them is very relavant to what I am looking for. I need a questionnaire that pertains to Medical device industry & is in accordance to ISO 13485:2003. Do you have anything specific to share?
Dolly, did you ever find anything relative to the ISO 13485 New Supplier Qualification form. I to am looking for that right now. I also need the form to clarify a supplier class, a checkpoint for quality contract and purchase specification criteria.

Thanks,
Tammy
 
D

dolly_milly

#6
Re: Template for Vendor (Supplier) Qualification needed

Dear Tammy,

No I am still hunting for it !! :( Let me know if you come across anything.

Thanks,
 
D

DrM2u

#7
Re: Template for Vendor (Supplier) Qualification needed

If I may, I would like to challenge your line of thought regarding the need for procedure(s). In accordance with ISO 13485:2003 clause 7.4.1 'the organization shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements". Nowhere in the standard is there a requirement for a documented procedure for suppllier selection, so I am challenging the need for one within your organization.

The standard goes on to say "the organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established." The standard does not require that the criteria is documented, only established. It also further implies that it is up to the organization to establish the criteria in accordance with its particular requirements. Therefore, using a supplier selection or evaluation template from another organization does not necesarily mean that it will meet your organization's needs; it does provide a reference to consider and build on, however.

My suggestion is to establish a cross-functional team and establish your own criteria and methods on how you select and monitor your suppliers, as well as what evidence you (will) retain that you are following your practice. An auditor WILL ask to see such evidence (it is required by the standard) but should not expect to see a documented procedure or instruction.
 
T

Thu Nguyen

#8
Re: Template for Vendor (Supplier) Qualification needed

If the company fails to develop a supplier re-evaluation program then what is a true root cause that you can think of.
 
C

chimie

#9
Re: Template for Vendor (Supplier) Qualification needed

Hello,

I am new to this site and have found it very helpful so far. Thank you.

I too need to figure out and write a procedure on how to qualify our vendors. Does anyone have a procedure they can share related to the pharma/biotech/med device industry?

Thanks!
 

harry

Trusted Information Resource
#10
Thread starter Similar threads Forum Replies Date
N Vendor (Supplier) Notification template Document Control Systems, Procedures, Forms and Templates 7
F Vendor (Supplier) Survey template needed Supplier Quality Assurance and other Supplier Issues 5
H Any template available to use for SQP? Oil and Gas Industry Standards and Regulations 0
C Mock recall template/procedure ISO 13485:2016 - Medical Device Quality Management Systems 1
M Reference to an archived template in multiple SOPs ISO 13485:2016 - Medical Device Quality Management Systems 2
K Benchmarking and tracking Nonconformities - Template? Benchmarking 1
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
OpExPro AIAG VDA DFMEA Template Required FMEA and Control Plans 6
bryan willemot Looking for an Approved vendors list template Document Control Systems, Procedures, Forms and Templates 11
S ISO9001:2015 Implementation / update plan template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6
M Data Protection and Privacy Policy - looking for a template/example EU Medical Device Regulations 1
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4
G Where to buy Template / sample SCSMS Manual, checklist Supply Chain Security Management Systems 1
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
CharlieUK Informational ADCO MED EU DECLARATION OF CONFORMITY TEMPLATE CE Marking (Conformité Européene) / CB Scheme 0
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
F MDR GSPR Checklist template EU Medical Device Regulations 9
M Email Template that go to a customer and then get returned to us for RMA/Warranty Document Control Systems, Procedures, Forms and Templates 1
C Ford's MMOG/le Template wanted Manufacturing and Related Processes 0
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
Q Example of the Risk Template Document Control Systems, Procedures, Forms and Templates 1
C Template for Excel Validation Reliability Analysis - Predictions, Testing and Standards 6
dgrainger Informational MDCG 2020:13 - Clinical evaluation assessment report template EU Medical Device Regulations 0
Q Internal audit plan template Internal Auditing 12
D New Equipment form / template Document Control Systems, Procedures, Forms and Templates 5
M Supplier Audit Report - Template for second party audit wanted Lean in Manufacturing and Service Industries 1
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
Anerol C Gage R&R Template AIAG 4th Edition IATF 16949 - Automotive Quality Systems Standard 3
J Looking for a EU MDR Gap Analysis template EU Medical Device Regulations 6
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 1
M Is there any pre-defined Control plan format/template acc. VDA? VDA Standards - Germany's Automotive Standards 1
J Level 3 KPI Excel Template Manufacturing and Related Processes 1
bobdoering Informational New AIAG PFMEA Process - Excel Template Attached FMEA and Control Plans 23
W ISO 9001:2015 Management Review Input Template wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
M PMS template for FDA submission (De novo submission for a Class II IVD) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Template for Attribute Gage R & R wanted Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
I Medical device Validation/Verification template ISO 13485:2016 - Medical Device Quality Management Systems 1
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
M Post Market Surveillance Plan Template EU Medical Device Regulations 12
M PMCF (Post Market Clinical Followup)/ PSUR template EU Medical Device Regulations 9
T QMS Template Help - Small machine shop/job shop Manufacturing and Related Processes 1
Ashok sunder Need ISO 45001:2018 HIRA template Occupational Health & Safety Management Standards 9

Similar threads

Top Bottom