SBS - The best value in QMS software

What is the real purpose of a Certificate of Conformance "C of C"?

  • Thread starter Quality-Misfit - 2008
  • Start date

Jim Wynne

Staff member
Admin
#61
Jim and John,
Per the Uniform Commercial Code, shipping goods in response to a purchase order is certification that the goods so shipped meet the requirements of the PO unless accompanying documents state otherwise. Knowingly doing so meets the requirements for fraud, even without the cofc.
I agree. I believe generic certificates of conformance are useless for that reason. My response was to your statement: "Even if notarized, all the notary does is verify the person signing is in fact that person." Notarization often carries an oath along with it.
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#62
Jim and John,
Per the Uniform Commercial Code, shipping goods in response to a purchase order is certification that the goods so shipped meet the requirements of the PO unless accompanying documents state otherwise. Knowingly doing so meets the requirements for fraud, even without the cofc.
Geoff,

I would appreciate the exact reference in the UCC.

Many thanks,

John
 
V

vnadershahi

#63
More than likely your regulatory department might find C of C helpful when registering products abroad. Latin American countries are notorious for requesting C of C for medical device registration.
 
B

brianthermophilus

#64
would I be incorrect in saying on our COC that our product is manufactured in conformance to ISO? If so, what other verbiage would be correct on a COC?

Thank you.

Brian
 

Jim Wynne

Staff member
Admin
#65
would I be incorrect in saying on our COC that our product is manufactured in conformance to ISO? If so, what other verbiage would be correct on a COC?

Thank you.

Brian
See ISO 9001: What Does it Mean in the Supply Chain (PDF) especially page 10.

You need to be careful to not suggest that you have ISO-certified products. You have an ISO-certified QMS. It's OK to say that in a C of C, but your products don't conform because of ISO 9001. They conform because you've satisfied the product requirements.
 
G

GoKats78

#68
We do things a bit different...For us a COC is an additional document (to a PSW) that we use to inform our SUPPLIER that we are accepting their PPAP. I know..I know..that is the purpose of the PSW.

The problem is there is only one signatory on the PSW...our COC is signed by the managers of Spec Control, Quality, Cost Planning, & R&D (both US and Japanese must sign).

Everyone wants a chance to review and sign-off on the PPAP....
 
L

Leetcc

#70
I believe the C of C represents the beginnings of traceability. We purchase all our medical device components from China so having that designated spot for lot number control is key when product investigation has to happen. It ties in the lot number/quantity/Po number and part number.
 
Thread starter Similar threads Forum Replies Date
B Calibration in real life ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
qualprod Best approach to get a real value as average? Statistical Analysis Tools, Techniques and SPC 6
S Stability accelerated vs. real-time Other Medical Device Related Standards 3
S Standards for real time stability for medical devices Other Medical Device Related Standards 2
optomist1 DFMEA - Real Life Drama FMEA and Control Plans 25
R Real Example of a currently marketed Procedure Pack CE Marking (Conformité Européene) / CB Scheme 1
M FDA News FDA Safety communication – Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings Medical Device and FDA Regulations and Standards News 0
A Accelerated aging and real time study EU Medical Device Regulations 2
M Interesting Discussion Surface Cleanliness Real Time Test Tools General Measurement Device and Calibration Topics 2
Q Real Time Electronic SPC/Control Charting Statistical Analysis Tools, Techniques and SPC 4
M Real-time-aging Validation - ISO / ASTM Standard - Class 111 Orthopedic Implant Other Medical Device and Orthopedic Related Topics 1
shimonv Storage Conditions of 5-40 Celsius - Accelerated and real time aging - Dilemma EU Medical Device Regulations 3
P Is ISO 13485 of November 2016 Real? ISO 13485:2016 - Medical Device Quality Management Systems 4
Ninja What is the most useless {real} documented procedure you've seen? Coffee Break and Water Cooler Discussions 4
I How to sample in a real time release process? AQL - Acceptable Quality Level 4
M Is a Real Time Stability Study required to determine Expiration Date? EU Medical Device Regulations 9
O Medical Devices - Legal Manufacturer and Real Manufacturer EU Medical Device Regulations 5
R Self-Certification Is Not a Real Thing - an IAF article Registrars and Notified Bodies 13
L How to represent the ?real? or ?actual? players in organizational chart? Misc. Quality Assurance and Business Systems Related Topics 3
Marc CBS Taps the Real Stephen Colbert as Letterman's Replacement After Work and Weekend Discussion Topics 1
S Stated Accuracy of Portable CMM Arm and Real World Use Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
T Classification of Real-Time Thermocycler for CE Marking CE Marking (Conformité Européene) / CB Scheme 3
B Permissible Exclusion for Clause 7.5.2 in a Real Estate Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Real World Example of Document Control Failure Needed Document Control Systems, Procedures, Forms and Templates 5
Crusader Real World Continuous Improvement Examples for Accounting Personnel? Quality Tools, Improvement and Analysis 3
B Any swimming tips before I dive into the pond? Real estate development business Document Control Systems, Procedures, Forms and Templates 20
S What is real Innovation? (as described by ISO 9004, 2009 edition) Philosophy, Gurus, Innovation and Evolution 5
Y Advice on this real case on AQL (Acceptable Quality Level)? AQL - Acceptable Quality Level 3
S Pulling Data In Real Time From Excel using Minitab 15 Using Minitab Software 2
Sidney Vianna Mutually Beneficial Supplier Relationships in the real world - GM learned a lesson? Quality Manager and Management Related Issues 1
C Do you implement real SPC not just a paper work? Statistical Analysis Tools, Techniques and SPC 18
D Real Life Testing related to Relevance or Quantification of Test Duration Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
T Capability Analysis in the Real World Capability, Accuracy and Stability - Processes, Machines, etc. 7
optomist1 Real World SPC Dealing with Outliers Statistical Analysis Tools, Techniques and SPC 22
J Rotating operators through experiencing Inspection - A real eye opener... Training - Internal, External, Online and Distance Learning 6
P DFX & DFLSS (DFSS) Techniques & Processes - Real world example of the usage Six Sigma 1
A SPC Software Packages - Real Time and can link to Databases including Oracle Statistical Analysis Tools, Techniques and SPC 7
M Tracking Materials and Tooling - Evolving to Real Life Misc. Quality Assurance and Business Systems Related Topics 8
R Customer Rquest for Real Ppk? Get Real... APQP and PPAP 2
Marc Green Building: A Real Estate Revolution? University Of Michigan Banks On LEED Sustainability, Green Initiatives and Ecology 1
S Real-Time Production Location Technology Lean in Manufacturing and Service Industries 6
Kales Veggie Shop Floor Real Time SPC Inquiry Statistical Analysis Tools, Techniques and SPC 15
A How do you obtain real Management Commitment Quality Manager and Management Related Issues 18
O Project Documentation Submission Guidelines for Real Estate Construction Document Control Systems, Procedures, Forms and Templates 4
A Auditing sufficiency of documented quality objectives vs the real process Internal Auditing 14
Marc Flying will be a real pain now - New rules keep passengers in seats Travel - Hotels, Motels, Planes and Trains 7
J Online Monitoring of SPC Data and Charts in Real Time Statistical Analysis Tools, Techniques and SPC 12
K Belief To Faith - Great Motivator , A Real Story World News 5
G Try reading this - A real brain teaser Brain Teasers and Puzzles 16
C Shocking But Real Acronyms Coffee Break and Water Cooler Discussions 8

Similar threads

Top Bottom