Supplier Management Requirements - AS9100 vs. ISO13485

cutsdean

Involved In Discussions
#1
We are an aerospace company developing a medical product for military use. We are busy adapting and modifiying our management system to meet the requirements of ISO13485, but have an issue over supplier management.

We currently have supplier groups for General, Aerospace Production, Stockists, Engineering & Nuclear. It has been suggested that we have another category for medical, but some of the suppliers used for medical product are also Aerospace suppliers. Are there any great differences in the way suppliers should be handled in ISO13485 to that of any other management system?

Any help would be most greatful
 
Elsmar Forum Sponsor

MRWardell

Involved In Discussions
#3
We are an aerospace company developing a medical product for military use. We are busy adapting and modifiying our management system to meet the requirements of ISO13485, but have an issue over supplier management.

We currently have supplier groups for General, Aerospace Production, Stockists, Engineering & Nuclear. It has been suggested that we have another category for medical, but some of the suppliers used for medical product are also Aerospace suppliers. Are there any great differences in the way suppliers should be handled in ISO13485 to that of any other management system?

Any help would be most greatful
Some quick thoughts. Since you are AS9100 your supplier approval process is probably pretty robust. The FDA/13485 expectation is that you are qualifying your vendors and that the qualification process recognizes the level of criticality of the part or service. Our registrar has the expectation that we do on-site audits of the most critical vendors, at least when we qualify them. Supplier scorecards or some other method of assessing supplier performance is also important. One word of caution - I could not tell from the posting if this is a medical device you designed, or if you are contract manufacturing. Either way, I would suggest you investigate your responsibility to comply with FDA regulations - 21 CFR 820. Here is a link to a great FDA website and document which can provide some guidance. http://www.fda.gov/MedicalDevices/D...MedicalDeviceQualitySystemsManual/default.htm
 
M

MIREGMGR

#4
...your responsibility to comply with FDA regulations
Noting the OP's apparent UK location, this may not apply depending on the customer's location and preferences, of course.

Questions for the OP, which may reveal my lack of knowledge of AS9100 mechanisms: is the organization's certification-oversight with respect to AS9100 and ISO 13485 by the same third party ("notified body" or whatever terminology is appropriate for AS9100), or separate ones? Do some or all of the "medical"-group suppliers have their own ISO 13485 certification?
 
Last edited by a moderator:
J

JJC1979

#5
I have implemented an AS9100 and ISO 13485 system at the same time in my previous life:) What you are doing for AS9100 should be sufficient for ISO 13485, however if you have suppliers that are producing a custom part for the product that you are producing; you will want to at least have some type of management in regards to supplier audit or assessment. The first question would really be for me, what are you doing for supplier management in regards to complying with AS9100. Meaning what does your procedure dictate that you will do for supplier management of your suppliers at this point in time?
 
S

ssz102

#6
sorry i have no experice on aerospace and medical products
but i hoping other people can reslove this problem
 
Thread starter Similar threads Forum Replies Date
S IATF 16949 Supplier Management - Supplier Tooling Requirements Supplier Quality Assurance and other Supplier Issues 1
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
S Supplier Control - Supplier quality management certificates (ISO, etc) ISO 13485:2016 - Medical Device Quality Management Systems 2
J Support and guidance with supplier quality management system 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 40
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
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
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
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
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
J Minimum Supplier Certifications for Food Supplements Food Safety - ISO 22000, HACCP (21 CFR 120) 1
R Supplier/Vendor Surveys (360) Supplier Quality Assurance and other Supplier Issues 1
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
B AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Supplier Audit Report - Template for second party audit wanted Lean in Manufacturing and Service Industries 1
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Ed Panek Corona Virus impact on Supplier Audits and Received Parts ISO 13485:2016 - Medical Device Quality Management Systems 4
Similar threads


















































Top Bottom