Distributors cannot convert to TS?

Casana

Casana

Blueberry Nut
#1
#1
I recently was forwarded a copy of an AIAG newsletter (Quick-Bytes) that says that TS16949 does not allow distributors to be certified to ISO/TS. To quote:

”The definition of ‘site’ is ‘where value-added manufacturing processes occurr.’ In other words, there must be manufacturing processes, not other processes involving just paperwork.”

This is going to leave in limbo all distributors who are QS certified, as well as any purchasing managers who now require QS certified distributors.

Just wondering if others are aware of this nuance and if there’s rumors for any fixes.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
M Responsibilities of Importers / Distributors - MDR EU Medical Device Regulations 7
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
T Different Authorized Representative and distributors in Saudi Arabia Other Medical Device Regulations World-Wide 0
T PPAP for distributors? APQP and PPAP 1
C ASL - Buying from unqualified manufacturers through qualified distributors Supplier Quality Assurance and other Supplier Issues 2
S Degree of control of distributors - PMS EU Medical Device Regulations 2
R Qualification of Distributors such as McMaster-Carr and Digikey to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 3
JoCam Distributors Responsibilities - Medical Device Recalls EU Medical Device Regulations 1
H Supplier Development - Distributors only? The new GM Standards IATF 16949 - Automotive Quality Systems Standard 4
T Oversight of Distributors - Supply chain requirements under the MDR EU Medical Device Regulations 9
Sidney Vianna Informational UTC ASQR Rev.11 has a mistake; certification of distributors to IATF 16949 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
I ISO 9001 and VWAD (Verified-Accredited Wholesale Distributors certification) Coffee Break and Water Cooler Discussions 1
C Do Distributors need to register with competent authorities in the EU? EU Medical Device Regulations 2
JoCam Medical Device Certificates of Free Sale - Distributors EU Medical Device Regulations 9
J Recall Effectiveness - Accessory to Medical Devices shipped through Distributors Customer Complaints 3
D Customer Specific Requirements / Distributors (IATF 16949) Customer and Company Specific Requirements 1
H Local Representative / Distributors - United Arab Emirates Other Medical Device Regulations World-Wide 2
Sidney Vianna IAF Endorsed Accredited 13485 Certification helping Control of Medical Distributors ISO 13485:2016 - Medical Device Quality Management Systems 0
M What level of control should be exercised on distributors? Supplier Quality Assurance and other Supplier Issues 10
C Multiple distributors in Spain EU Medical Device Regulations 2
F Distributors Audit guide Supplier Quality Assurance and other Supplier Issues 4
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
Y Is CFDA registration required if the full system is registered by our distributors? China Medical Device Regulations 2
JoCam Choose Medical Device Distributors prior to Device Registration? Other Medical Device Regulations World-Wide 6
O Distributors and ISO 13485 - DHF and DMR Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 7
E Obligations of Foreign Distributors of US Medical Devices US Food and Drug Administration (FDA) 1
K Multiple Distributors in Argentina Other Medical Device Regulations World-Wide 3
Y Thai FDA Medical Device Registration with 2 distributors Other Medical Device Regulations World-Wide 2
Buckyb Boeing QMS Requirements for Tier 2 Distributors AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
J Inspection Requirement For Medical Device Distributors Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
E Regulatory Requirements for Distributors of Medical Devices Other Medical Device Regulations World-Wide 6
J Tracking the End Customer by Distributors 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Internal Audits required before Registration Audit - Distributors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Are IVD Distributors subject to "Qualification" under our Quality System? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Supplier Evaluation Procedure in case of Agency (Distributors) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Q Should distributors be also certified to IS0 9001? IATF 16949 - Automotive Quality Systems Standard 16
Q How can Six Sigma be implemented in Retail Distributors (Logistics and Supply Chain) Six Sigma 4
B Sticker with Distributors Logo according CE requirements (Medical Devices) CE Marking (Conformité Européene) / CB Scheme 6
S ISO 9001 Standards for Stocking Distributors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Supplier Approval for Distributors of Equipment Misc. Quality Assurance and Business Systems Related Topics 5
1 Third Party Certifications - Certificate of Compliance for Distributors Document Control Systems, Procedures, Forms and Templates 2
A Selection and Control over Distributors of Components for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I Do company sales agents/distributors need to go through supplier evaluation process? Other Medical Device and Orthopedic Related Topics 5
M Canadian Registration & the Responsibilities of Distributors Canada Medical Device Regulations 12
G PPAP to distributors or catalog parts??? APQP and PPAP 9
T Measuring Quality Performance of Distributors - Product defects Supplier Quality Assurance and other Supplier Issues 2
Sidney Vianna AS/EN 9120:2009 for Distributors - News from the IAQG website AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0

Similar threads

Top Bottom