Applicability of requirements of entire section 7.4 of TS16949:2002

K

krishkaar

Involved In Discussions
What is the status of the applicability of requirements of entire section of 7.4 as per TS16949:2002 in the following situation ?:
The Customer organisation is a TS16949:2002 registered and supplier organisation is ISO 9001:2000
1. Supplier Organisation receives materials from Customer for processing.
2. For some reason, Customer also provides essential tools like Grinding wheels / inserts / thread rolls required for production.
3. The Organistaion's procurments activities are limited to some consumables like Coolant / Hydraulic oil / Rust preventive oil / cotton waste / standard hand-tools / machinery spares for maintenance.
Thanks
 
D

Diana Cadwalader

Applicability of 7.4 (TS2)

Can you please explain more?

From what you have written it sounds like the supplier is ISO9001:2000. They have procurement activities of materials that are key to their operations. They have the obligation to conform to all of 7.4 under ISO9001. In addition, it sounds as if there is customer owned tooling in the instance you described. There would be some obligation of the supplier to clearly mark and identify that customer owned tooling and if there were any repair, breakage, etc of that equipment, it would need to be defined in contract review how the customer wanted the supplier to handle those maintenance issues. Contract review would also need to define life expectancy of that equipment since the tooling is going to wear over time and at some point need to be replaced. Who bears this replacement cost? Sometimes this is substantial cost and the supplier has not gotten this clarified in the contract so then has to bear the cost of that replacement in order to continue supplying product to the customer long term.

So I guess the long and short of it is, all of 7.4 under ISO9001 applies to the supplier. Supplier should also look at comprehensive contract review where customer is supplying tooling.

Hope this helps.
 
K

krishkaar

Involved In Discussions
Applicability of Sec 7.4 (TS2)

No. I am afraid the question has not been understood.

The supplier organisation's procurement activities are limited to purchase of some spares and consumables.

All other materials and tools required are provided by the Customer. These receipts are properly handled through a Process - Control of Customer Supplied Property" and also suported with Contract review at appropriate stage.

My Question is on the limited procurement activities Vs. Sec 7.4 (Purchase) ???
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Clarification of Applicability of TS 16949 Requirements to a Non-Automotive Business IATF 16949 - Automotive Quality Systems Standard 13
P 7.1, 7.3 and APQP Requirements Applicability in Transfer Case IATF 16949 - Automotive Quality Systems Standard 1
S Applicability of REACH Requirements RoHS, REACH, ELV, IMDS and Restricted Substances 7
C QS9000 TE vs. TS16949 - Registration Applicability and Requirements Conflicts IATF 16949 - Automotive Quality Systems Standard 3
P 4.10.6 Supplier laboratory requirements - applicability QS-9000 - American Automotive Manufacturers Standard 11
H California Prop 65 Applicability RoHS, REACH, ELV, IMDS and Restricted Substances 8
B AS9100 applicability to aircraft operation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
C Applicability of classification rule 9 under MDR EU Medical Device Regulations 6
R EU MDR Article 22 applicability of medical device with components. EU Medical Device Regulations 4
H Resin Identification Code Applicability REACH and RoHS Conversations 1
L Non Applicability of Clauses in ISO13485 for Medical Devices Medical Device and FDA Regulations and Standards News 4
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
S Defibrillator Protection applicability When using Multiple applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
F Applicability of CSR's IATF 16949 - Automotive Quality Systems Standard 1
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 2
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
S Applicability of 60601 vs. 60335 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
R MDD x PPE Directive - Statement of Non-Applicability EU Medical Device Regulations 3
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 14
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 13
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
V Applicability of IEC 62366-1 usability to resorbable bone substitutes IEC 62366 - Medical Device Usability Engineering 9
Enternationalist Commission Regulation (EU) No. 207/2012 E-IFU Applicability EU Medical Device Regulations 5
M ROHS : Applicability for AIMDs RoHS, REACH, ELV, IMDS and Restricted Substances 2
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Applicability of Means of Protection, working voltage in an Automated External Defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Applicability of IEC 60950-1 Table K2 - Minimum clearances between circuits Various Other Specifications, Standards, and related Requirements 0
R Applicability of ISO 14708-3 RF Transmitter and Implantable RF Receiver Other Medical Device Related Standards 1
R Applicability of ISO 14708-3 - RF transmitter and implantable RF receiver Other Medical Device and Orthopedic Related Topics 1
M Oxygen enriched environment applicability - Operating table used in general surgeries in hospital IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E CB scheme applicability for battery powered medical devices CE Marking (Conformité Européene) / CB Scheme 0
I IATF 16949 - 8.4.2.3 - Applicability to Shipping Suppliers IATF 16949 - Automotive Quality Systems Standard 11
S CQI-12 - Applicability to Raw Materials Customer and Company Specific Requirements 1
C Applicability of ISO 9001:2015 Section 8.5 - Engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Applicability of EN 13795 for Incise Drape EU Medical Device Regulations 0
S Applicability of the standard IEC 60601-2-18 to an arthroscopy pump IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Partial non applicability of ISO 9001 Cl. 7.1.5 (not having services)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M User Interface of Unknown Provenance (UOUP) applicability IEC 62366 - Medical Device Usability Engineering 8
E Applicability of Low Voltage Directive (LVD) for 12V equipment CE Marking (Conformité Européene) / CB Scheme 4
Y Counterfeit Parts - AS9100 D Cl. 8.1.4 - Can I claim no applicability? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M IEC 62304 Applicability - GUI Control Software IEC 62304 - Medical Device Software Life Cycle Processes 3
Richard Regalado Sharing a Statement of Applicability (SOA) for ISO/IEC 27001:2013 IEC 27001 - Information Security Management Systems (ISMS) 2
G Not quite old news: Statement of Applicability IEC 27001 - Information Security Management Systems (ISMS) 3

Similar threads

Top Bottom