Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form?

SANE

Starting to get Involved
#1
Dear all,

May I ask you for your input related to supplier re-evaluation. I feel unsure.
Our company has a supplier evaluation form used internally filled in by our company's employees annually.
For our critical suppliers a QSA exists keeping the possibility of a supplier audit as option.
Then we have a form for supplier self assesment.
I wonder to which class of suppliers this self- assessment form has to be sent on the defined regular basis (usually once per year) ?
  • all suppliers (with or without certifcate like ISO 13485, 21 CFR 820)
  • all critical suppliers (with or without certifcate like ISO 13485, 21 CFR 820)
  • critical suppliers only if no supplier audit is performed (with or without certifcate like ISO 13485, 21 CFR 820)
  • critical suppliers without certifcate like ISO 13485, 21 CFR 820
  • all non critial suppliers (with or without certifcate like ISO 13485, 21 CFR 820)
  • all non critical suupliers without any certificate as ISO 13485, 21 CFR 820
Can you tell me the reference in the ISO 13485 which gives me the hint which category of suppliers I have to send the self assessment.

Thinking about a risk based approach, I would only send this form to critical suppliers without certficate, but possibly this is a misinterpretation by myself.

Thanks for your support
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
13485:2016 7.4.1 says:
"The organization shall establish criteria for the evaluation and selection of suppliers...."
"The organization shall plan the monitoring and re-evaluation of suppliers..."

So, its really up to how your company wants to define these requirements. The criteria would have to be justifiable to an auditor.
(Note: I don't know if there are separate regulatory requirements for supplier monitoring that apply to your company.)
 

SANE

Starting to get Involved
#3
Dear Tagin,

thanks for this fast and helpful reply. I can work with this and understand that I have a certain flexibility as long as it is logic for the external auditor.
I took up the monitoring as short chapter in the SOP supplier management since it is performed but I did not list it as a separte step.
 

Ninja

Looking for Reality
Trusted Information Resource
#4
I wonder to which class of suppliers this self- assessment form has to be sent on the defined regular basis (usually once per year) ?
None. Kill the supplier self assessment (and definitely kill the form to send out).
Your company should assess the supplier, not the supplier assessing themselves.
{written as a supplier that gets those forms ... many ... all year long ... }
 

Ninja

Looking for Reality
Trusted Information Resource
#6
Many threads here on the forum regarding how to get suppliers to send the forms back... end result of most discussions is "you can't".
 

SANE

Starting to get Involved
#7
Dear all,
I inherited this kind of documentation and I am happy if I can skip the self assessment forms if it is just an unneeded compulsary exercise. We have the monitoring, evalution of the monitored performance by us using internal evaluation forms and for the critical ones Quality agreements combined with special income controls. The self assessment forms seemed so common but I did not find them requested by the ISO itself.
Based on your feedback, I dared to take them out from the QM system of a small company yesterday working with all the above listed controls.
Thanks a lot to all of you
 
Thread starter Similar threads Forum Replies Date
S Supplier Control - Supplier quality management certificates (ISO, etc) ISO 13485:2016 - Medical Device Quality Management Systems 2
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
Sidney Vianna SI 5 06 - ISO/TS 169494:2002 7.4.1.2 Supplier quality management system development IATF 16949 - Automotive Quality Systems Standard 42
G Supplier management when the supplier is your headquarter IATF 16949 - Automotive Quality Systems Standard 3
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Supplier Quality Standard vs Senior Management Direction Supplier Quality Assurance and other Supplier Issues 2
M Supplier Management outsourcing - Business idea Supplier Quality Assurance and other Supplier Issues 8
A How to view supplier APQP timeline and do risk management APQP and PPAP 4
J Support and guidance with supplier quality management system Supplier Quality Assurance and other Supplier Issues 1
S IATF 16949 Supplier Management - Supplier Tooling Requirements Supplier Quality Assurance and other Supplier Issues 1
J IATF 16949 Cl. 8.4.2.3 - Supplier Quality Management System Development IATF 16949 - Automotive Quality Systems Standard 59
W IATF 16949 Clause 8.4.2.4.1 Second Party Audits (Supplier Management) IATF 16949 - Automotive Quality Systems Standard 45
S SQM (Supplier Quality Management) - Centralized or divided per Business Group Benchmarking 0
Q Critical Supplier's Senior Management Changes Supplier Quality Assurance and other Supplier Issues 4
xfngrs CQI-19 Sub-Tier Supplier Management IATF 16949 - Automotive Quality Systems Standard 1
R Broken Supplier Management System Supplier Quality Assurance and other Supplier Issues 6
T Process Validation, NPD (New Product Development), and Supplier Management Qualification and Validation (including 21 CFR Part 11) 7
S Supplier Management Suggestions and Form/Template wanted Document Control Systems, Procedures, Forms and Templates 3
B Risk Management while selecting the Supplier Document Control Systems, Procedures, Forms and Templates 3
C Supplier Management and Receiving Inspection Improvement Statistical Analysis Tools, Techniques and SPC 20
C Supplier Management Requirements - AS9100 vs. ISO13485 Supplier Quality Assurance and other Supplier Issues 5
Q SCAR Process SCAR that works for Class III Medical Device Supplier Management Supplier Quality Assurance and other Supplier Issues 4
A Starting Supplier Management System in a Company Supplier Quality Assurance and other Supplier Issues 4
J Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not exist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S Customer Audit needs to see External Supplier Management Procedure Supplier Quality Assurance and other Supplier Issues 7
Q Supplier Quality Management Development IATF 16949 - Automotive Quality Systems Standard 10
B Supplier Management Meeting Agenda Supplier Quality Assurance and other Supplier Issues 1
T Supplier - Outsourced process IT management Supplier Quality Assurance and other Supplier Issues 3
L Courses in Supplier quality management - Sydney or NSW Supplier Quality Assurance and other Supplier Issues 6
A Supplier Development and Management Procedure Supplier Quality Assurance and other Supplier Issues 4
J Supplier Management - Unable to visit the suppliers Supplier Quality Assurance and other Supplier Issues 9
K Auditing the Internal Vendor (Supplier) Management Process Supplier Quality Assurance and other Supplier Issues 2
P Supplier Management System in MS Access Supplier Quality Assurance and other Supplier Issues 12
C Small Company Supplier Management Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Vendor (Supplier) Management in TS16949 General Auditing Discussions 4
F What are the Performance Indicators for Supplier Quality Management Department Supplier Quality Assurance and other Supplier Issues 11
P Supplier Modification Management procedure example wanted Supplier Quality Assurance and other Supplier Issues 7
A Supplier Quality Management Strategies - Semiconductor Assembly and Test Services Supplier Quality Assurance and other Supplier Issues 6
P TS16949 vs. AS90001 - 7.4.1.2 Supplier Quality Management System Development IATF 16949 - Automotive Quality Systems Standard 7
J Automotive makers strategy and benchmarking on supplier quality management Supplier Quality Assurance and other Supplier Issues 2
M Registrar requiring sub-supplier management Supplier Quality Assurance and other Supplier Issues 12
D Supplier Quality Management including Supplier performance evaluation methods Supplier Quality Assurance and other Supplier Issues 2
T 7.4.1.2 Supplier quality management system development Supplier Quality Assurance and other Supplier Issues 3
S How are you undertaking Supplier assessment and Educating Upper Management in ISO9000 Supplier Quality Assurance and other Supplier Issues 13
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 8
G Supplier doesn't accept the complaints Supplier Quality Assurance and other Supplier Issues 19
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
D Approved supplier list for R&D ISO 13485:2016 - Medical Device Quality Management Systems 5
M SemaTech SSQA Standardized Supplier Quality Assessment - my favorite tool ever Manufacturing and Related Processes 1

Similar threads

Top Bottom