SBS - the best value in QMS software

Definition Sole source VS. Single Source - Definitions

  • Thread starter TempusVernumProcella
  • Start date
T

TempusVernumProcella

#1
#1
A question was raised regarding a Sole-source letter that we as a company have generated to provide to customers stating that our product is Sole-source, meaning to say that we are the registered holder (R) of the InVitro device and that we manufacture this device solely at our facility; it is not manufactured anywhere else.

There seems to be confusion on this definition and use of the term 'Sole'; as it has been assumed that we actually provide a 'Single-source'.

To my knowledge, that is incorrect. :frust:

Can we shed some light on this?

Thanks!:magic:
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
T

TempusVernumProcella

#3
#3
To add to the question - We are the sole manufacturer of this specific product device in the world, however, we DO sell percentages of this product to customers through contract agreements with select distributors. There is a similar product on the market made by a competitor but it is not favored by customers.

Can we as the HQ/sole mfg company still claim that the product is Sole-source?


I appreciate any and all inputs on this as I am trying to educate my teammates.



Much obliged.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Contacting a "Must Use" (aka Sole Source) Supplier's Registrar Supplier Quality Assurance and other Supplier Issues 6
F How to submit a PPAP when a subcontractor is the sole manufacturer IATF 16949 - Automotive Quality Systems Standard 2
S Evaluation of Supplier / Sole supplier Supplier Quality Assurance and other Supplier Issues 5
K Audit a sole supplier? Supplier Quality Assurance and other Supplier Issues 9
V Can the Management Representative represent top management as the sole auditee? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A Management Representative cum sole auditor - is it an NC? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
A Supplier Corrective actions (8D format) - Sole supplier needs help Supplier Quality Assurance and other Supplier Issues 7
H Feeling Really Frustrated - Sole quality person - Wood Products Career and Occupation Discussions 35
S Sole distributor and sell plastics resins - Are we a Service Provider? Service Industry Specific Topics 2
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B IEC 60601 Cl. 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L IEC 62368-1 / Electrical Energy Source vs. Power Source? CE Marking (Conformité Européene) / CB Scheme 2
F Electrical Metrology (Source/Generation and Measurement) General Measurement Device and Calibration Topics 1
R Supplier related drawings and verification of process requirements - Source Inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Supplier Controls we can place on Single-Source Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 2
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
C Looking for source of silicone contamination in ISO Class 8 Cleanroom Other Medical Device Related Standards 2
Ron Rompen Source needed for Spline Form gauge (GO and NOGO members) General Measurement Device and Calibration Topics 3
PastorBee13 Source for the blades for Reef Snap Gages General Measurement Device and Calibration Topics 2
S Source of QMS templates including templates for design verification/design validation Document Control Systems, Procedures, Forms and Templates 2
Ed Panek Sensitive Supplier Issue - Single source supplier ISO 13485:2016 - Medical Device Quality Management Systems 6
H Gamma Irradiation - dose audit and source replenishment Other Medical Device Related Standards 7
I Uncalibrated source to calibrated meter, then compare to UUT General Measurement Device and Calibration Topics 4
P Datron/Wavetek 4808 Option 70 Wideband Source - User and Service Manuals needed General Measurement Device and Calibration Topics 2
Q Source of practice to Evaluate Risks? (ISO 9001:2015) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
E Source for The Enforcement Regulations in English - Article 228-20 Japan Medical Device Regulations 8
R FAI (First Article Inspection) on source-controlled parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
E PMDA Act, Nov 2014 revisions - source in English? Japan Medical Device Regulations 3
A Reference Source for Polarity Symbol Other ISO and International Standards and European Regulations 1
J Legal source to purchase a copy of the 9001:2015 Draft ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Crusader Calibration Source not ISO 17025 accredited ISO 17025 related Discussions 6
D Product Testing Source - Specific testing on an electronic parking brake IATF 16949 - Automotive Quality Systems Standard 1
K Ideas for an Open Source Calibration Database Software Calibration and Metrology Software and Hardware 3
R What can I expect in a Government Source Inspection? Quality Manager and Management Related Issues 13
A How to understand the source of variability and "stream-to-stream variation" Six Sigma 8
B Convenient source for finding a listing of changes to BS EN ISO standards Various Other Specifications, Standards, and related Requirements 5
M KANO Model - Changing the source Quality Tools, Improvement and Analysis 2
G Six Sigma Case Studies - Does anyone have a good source for LSS case studies? Six Sigma 8
S Source of Online or Home Based HACCP - FSSC22K Training Food Safety - ISO 22000, HACCP (21 CFR 120) 2
H Source for Compiling and Maintaining an EHS Legal Register Miscellaneous Environmental Standards and EMS Related Discussions 4
C Nuclear Industry--Unqualified Source Material CMTR Requirements Various Other Specifications, Standards, and related Requirements 1
N Boeing Portal - ASAP for Source Inspection Customer and Company Specific Requirements 4
W Seeking a Freelance Mechanical Inspector - Source Inspection in Bangalore, India AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be included? CE Marking (Conformité Européene) / CB Scheme 5
G Source of a Clear Fixture Block on a x-y Video Microscope - Rafaelco? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M TS 16949 7.4.1.3 - Difference between Approved Source and Customer Designated Source IATF 16949 - Automotive Quality Systems Standard 2
P Source Inspection vs. Right of Access clause in a Purchase Order - Differences AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
N Outside source to provide Basic Measurement Training - Louisville, KY Training - Internal, External, Online and Distance Learning 1
M Incoming Source of Variation & Source of Variation in Process Flow Chart IATF 16949 - Automotive Quality Systems Standard 3
E Faro Laser Tracker Calibration Source Needed General Measurement Device and Calibration Topics 5

Similar threads

Top Bottom