Classifying a Supplier

#1
Hi everyone,

I work for a company that is in a mixed use building like a communal property so this building controls for temp/ventilation/pest for all the companies renting the space.
We are trying to classify them as a supplier.

But we don't know what rank to classify them as and how to do it.

Anyone have any experience with such suppliers?
 
Elsmar Forum Sponsor
#3
The risk to your medical device and the extent of the controls you have. Since you have decided to operate from such a location, your risk management of purchasing would have covered these.
I am not aware here about the criteria for your supplier ranking. Your risk management output must help you decide the rank...
 

ChrisM

Quite Involved in Discussions
#4
I'm not convinced that you need to classify them as a supplier; I would suggest that they are addressed through "provision of resources".
In the 3 or 4 medical device companies that I have worked for, the Landlord was never classified as one of our suppliers for QMS purposes.
 
Thread starter Similar threads Forum Replies Date
E Can we still use MEDDEV 2.4/1 rev. 9 when classifying a medical device product under MDR? EU Medical Device Regulations 4
J MDR reporting and CAPA thoughts? Classifying Complaints on Risk 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
D Down Classifying a Medical Device from Class II to Class I Other US Medical Device Regulations 21
M Classifying Software - Insulin Calculator EU Medical Device Regulations 13
M Classifying a Multiple Risk Medical Device System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Classifying Defect Reports from Business Partners US Food and Drug Administration (FDA) 4
S Directives for Classifying Standalone Software as Medical Devices CE Marking (Conformité Européene) / CB Scheme 3
J FDA classifying all PACS software devices as Moderate Level of Concern? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
B Classifying findings as Major vs. Minor findings in the AS9100 world AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
C Classifying documentation changes for priority Document Control Systems, Procedures, Forms and Templates 1
S Classifying SMD chip resistor and SMD array resistor - Electronic Components Various Other Specifications, Standards, and related Requirements 9
D Classifying Nonconformance so that they can be Actioned in Relation to Time Frames Nonconformance and Corrective Action 7
A Classifying Documents for Different Document Levels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Suppliers - Classifying Critical and Major suppliers & how to define them? Supplier Quality Assurance and other Supplier Issues 2
O Classifying Characteristics QS-9000 - American Automotive Manufacturers Standard 4
G Ergonomic issue caused by supplier material ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J API Q1 - 5.6.1.2 (b) - Initial Supplier Evaluation—Critical Purchases Oil and Gas Industry Standards and Regulations 1
M ISO 13485 Supplier Question ISO 13485:2016 - Medical Device Quality Management Systems 13
S Supplier AS9100 certificate suspended - still ship goods ? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
S Supplier change management Supplier Quality Assurance and other Supplier Issues 3
Robin H Wanted: Supplier Quality Engineer Job Openings, Consulting and Employment Opportunities 0
G Root cause for outsourced pest control service not in approved supplier list ISO 13485:2016 - Medical Device Quality Management Systems 4
A Supplier capacity analysis template IATF 16949 - Automotive Quality Systems Standard 1
L PACCAR Parts Supplier Portal? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Supplier problem solving IATF 16949 - Automotive Quality Systems Standard 8
J Critical Supplier Initial evaluation for single purchases Oil and Gas Industry Standards and Regulations 16
T Supplier Evaluation - *ALL* Suppliers to business? ISO 13485:2016 - Medical Device Quality Management Systems 5
F Supplier : Product Qualification Supplier Quality Assurance and other Supplier Issues 0
M Supplier Scrap Cost Supplier Quality Assurance and other Supplier Issues 2
I Supplier Evaluation Process ISO 13485:2016 - Medical Device Quality Management Systems 4
Pmarszal Technical File - Critical Supplier List Questions CE Marking (Conformité Européene) / CB Scheme 2
W Rights of Supplier in Design & Build WP Manufacturing and Related Processes 0
D Critical Supplier will not allow us to audit Plant floor US Food and Drug Administration (FDA) 12
ScottK Opening for Manager, Supplier Quality Engineering on my team- Orangeburg, NY - On-site Job Openings, Consulting and Employment Opportunities 0
E Control of Sterile Barriers made by the supplier Design and Development of Products and Processes 4
B AS9100:D - Purchase Order required if ordering paint on supplier portal? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Supplier Evaluation report - Validation required or not ISO 13485:2016 - Medical Device Quality Management Systems 3
E Where can i get latest toyota and honda Supplier Quality Assurance Manual (SQAM) Customer and Company Specific Requirements 3
O AS9100 8.4.3 Supplier Terms and Conditions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S AS9100 Supplier Audit Checklist example AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Supplier Evaluation for Cold Chain Distribution of Human Tissues Supplier Quality Assurance and other Supplier Issues 3
Dazzur Sharing Suppliers Performance Data with Supplier. Supplier Quality Assurance and other Supplier Issues 6
H Pre-production units & Purchasing/Supplier/Material controls ISO 13485:2016 - Medical Device Quality Management Systems 6
Quality Specialist AS9100D Approved Supplier List requirements and how to apply Supplier Quality Assurance and other Supplier Issues 11
R Customer Listed on Approved Supplier List (ASL) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
GStough Audit Nonconformances (?) for Suppliers Not Registered to ISO and No Supplier Quality Agreement Exists General Auditing Discussions 24
C Supplier Audit - Looking for a quality audit checklist General Auditing Discussions 3
L Supplier Performance when your supplier is also the customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
L Supplier performance evaluation Supplier Quality Assurance and other Supplier Issues 8

Similar threads

Top Bottom