Supplier Lab Requirements/Calibration Services

C

Carp

In QS-9000 Section II, under the Ford specific requirements (page 70), Ford says that 4.10.6 and 4.11.2b1 DO NOT apply to Ford suppliers.

In Section II of TE, under the Ford requirements (page 16), there is a list of sections that are found in QS 9000 Ford specific requirments, but do not apply to Ford specific TE requirements. Since the section of QS 9000 in question (supplier laboratory requirements and calibration services) is one of the sections that does not apply to Fords' TE Suppliers, it appears to contradict the statement in QS 9000. So, my question is: If interpreted as stated, does this means that 4.10.6 and 4.11.2b1 DO apply to Ford TE Suppliers? (We know that can't be what they intended to state because it's illogical to exempt the parts guys from this and still require the tool guys to do it, right? )
 

Marc

Fully vaccinated are you?
Leader
My opinion is that the QS (Third Edition) on page 70 is sufficiently clear to 'assume' the TE supplement (Second Edition) page 16 omitted the QS9000 4.10.6 and 4.11.2.b.1 exemption either by calculation (intent, maybe because they were already addressed in QS9000) or by mistake. Technically I see no contradiction. I would claim the QS9000 4.10.6 and 4.11.2.b.1 exemptions per Ford requirements on page 70 if I had a reason to do so.

However, I will say what I tell everyone - call your registrar (project manager or your assigned auditor) and ask what they want. As we all know, different registrars quite often see things differently. Some may not agree with me, but they would be hard pressed to do anything other than 'dance on the head of a pin' about the significance in the situation. It's a quick and easy call to ease the mind. Document the 'advice' they give you (who, time and day of call, etc.).
 
B

Bryon C Simmons

I agree with Marc on this one........call your registrar...the advice is free..just make sure that any questions that you raise with them, be sure your systems are in compliance when theay visit.....it has been my experience that they may target your questioned areas during the audit.....keep us posted.

Bryon
 
D

Dan Indish

As a Ford Tooling & Equipment Supplier, we have had discussions with Ford executive management on this subject. Executive management responsible for purchasing TE Supplier EQUIPMENT(TE-9000 management)say this is NOT a requirement.

Middle management responsible for buying SERVICES (QS-9000 management) for this equipment say it is.

Ford executive management has explained that this is part of their internal bureaucracy that needs to be straightened out, so they are currently enforcing this requirement which is written in Ford procedures.
 
Thread starter Similar threads Forum Replies Date
G Supplier audit of ETO Sterilization Lab - Need a checklist or advice Supplier Quality Assurance and other Supplier Issues 3
P Production location change by supplier without info to customer Benchmarking 16
adztesla Adding new supplier/ Medical device design change ISO 13485:2016 - Medical Device Quality Management Systems 2
D Supplier Qualification Qualification and Validation (including 21 CFR Part 11) 2
A ISO 9001 & API Q1 Approved Supplier/Sole Agent ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Raw Material Supplier Site Change US Food and Drug Administration (FDA) 0
P Supplier Development Process description Process Maps, Process Mapping and Turtle Diagrams 1
Javier Guan FSVP (Foreign Supplier Verification Program) for Finish Tobacco Importers? US Food and Drug Administration (FDA) 0
G MDR critical supplier audit checklist EU Medical Device Regulations 0
G MDR/UKCA Supplier Audits EU Medical Device Regulations 3
sonflowerinwales American supplier of faulty goods into the EU After Work and Weekend Discussion Topics 6
P Product label supplier, critical or non-critical vendor ISO 13485:2016 - Medical Device Quality Management Systems 6
R 5.6.1.2 Initial Supplier Evaluation—Critical Purchases Supplier Quality Assurance and other Supplier Issues 4
A Guidance on Supplier Qualification - Phase 1 pharma manufacturing Supplier Quality Assurance and other Supplier Issues 4
S Subcontractor's subcontractor - Outsourcing of Sterilization to a sub tier Supplier ISO 13485:2016 - Medical Device Quality Management Systems 11
K "Supplier's multi-disciplinary approach to decision making" IATF 16949 - Automotive Quality Systems Standard 4
Jen Kirley Lead Supplier Quality Engineer - MR in Florence, South Carolina USA Job Openings, Consulting and Employment Opportunities 0
G Ergonomic issue caused by supplier material ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
I Classifying a Supplier Medical Device and FDA Regulations and Standards News 3
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

Similar threads

Top Bottom