Include non-automotive in TS16949 Registration Scope

D

Dan M

Involved In Discussions
#1
#1
Our facility manufactures a variety of products for different industries, including automotive. We have a TS registration with a narrow scope covering only the products made for automotive, which accounts for about 10% of production. The other 90% of production is covered by a separate ISO 9001 registration. It is the same auditor, he writes one audit report, but identifies the findings that apply to the (ISO 9001) vs. TS 16949 (automotive). We then receive 2 separate certificates. Would it be possible to just roll the non-automotive products into the TS scope? Is there a reason to not?
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
R

Reg Morrison

#2
#2
The IATF does not allow non automotive products to be certified to 16949. On top of that, why would you want to subject yourself to the requirements of 16949 for the non automotive products?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Crimpshrine13 IATF 16949 Audits to include Processes and Products from Non Subscribing Customers IATF 16949 - Automotive Quality Systems Standard 20
S Correction and Removal - Include Device used in Non-Production Environment? US Food and Drug Administration (FDA) 5
A Non-disclosure & Representative Agreements - include? 7.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K What to include in SOP Definitions section Document Control Systems, Procedures, Forms and Templates 3
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
R Do Medical Device Complaints include Clinical Trials? Medical Device and FDA Regulations and Standards News 3
S 510k: What to include if your own device is the predicate US Food and Drug Administration (FDA) 5
B Include cost of quality (and other wastes) in an ISO 9001 system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
G Control Plan - Include the processes for each sub component? APQP and PPAP 2
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
F Determining what type of scrap to include in my internal PPM calculation Quality Manager and Management Related Issues 5
qualprod ISO 9001:2015 Clause 8.3 - Is it possible to exclude one product but include it in other? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Calibration laboratory scope - Include software such as Gagetrak or Mini tab used? General Measurement Device and Calibration Topics 3
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
Q MDSAP Regions and how to include in procedures Other Medical Device Related Standards 2
G How to include machine error in uncertainty calculations? Measurement Uncertainty (MU) 5
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
B Quality Policy does not include a commitment to comply with legal requirements Quality Management System (QMS) Manuals 5
K Does ISO 13485:2016 - 7.2.3 Customer Communication include Marketing? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Does nonconforming product include reagents/disposables? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Manufacturing Work Instruction examples that include process pictures Manufacturing and Related Processes 3
Q To include Context and Interested Parties in Process Map? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Does CE Marking include compliance to WEEE and packaging waste? CE Marking (Conformité Européene) / CB Scheme 4
T Does nonconforming product disposition include parts bought from the supplier? IATF 16949 - Automotive Quality Systems Standard 15
shimonv Does 510(k) submission need to include UDI Data Other US Medical Device Regulations 6
Q Where to include other types of Nonconformities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Paul Simpson Does Knowledge Management include aspects of Information Security? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J How to understand the word "include" in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Include homogeneity uncertainty into budget table for thermocouples Measurement Uncertainty (MU) 1
J What does "other relevant management roles" include? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I As a part of validation, should i include the acceptance criteria of CPk index >1.33? Qualification and Validation (including 21 CFR Part 11) 4
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WEAVER Gage R&R Sample Selection - Can we include NG Samples? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
V ICH Q3 - To "Include OR Not to Include" impurities below reporting threshold General Measurement Device and Calibration Topics 2
P What to include in a Clinical Evaluation Plan EU Medical Device Regulations 2
G Does AS9100 Certificate include ISO 9001 Certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
B COA (Certificate of Analysis) - What information should they include? ISO 13485:2016 - Medical Device Quality Management Systems 2
H What does the PEM-gate review include? Manufacturing and Related Processes 3
P What should a Quality Plan Include and Examples Misc. Quality Assurance and Business Systems Related Topics 3
C Document Control - Details to include on Documents Document Control Systems, Procedures, Forms and Templates 2
D Need to include Premise of Outsourced Call Center in ISMS Surveillance Audit? IEC 27001 - Information Security Management Systems (ISMS) 4
C Include *ALL* business processes in QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Wireless Dongle - Include in Medical Device Testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7

Similar threads

Top Bottom