Certificate of Conformity Content and Regulations

AlanC

Involved In Discussions
#1
If I need to raise a C of C for a general product that is merely confirming that the product meets the drawing and customer order ( which is my basic understanding of all a C of C does) then what happens if a regulation/law specification is then applied. For example if the product is coated or treated in some way which is then covered in a controlled substance it's logical that the application then has to meet that required regulation for use. If I am a sub contractor and plating do I need to know the use of my customer before issuing my C of C to ensure they handle it correctly or is it if they ask me for it and if I can provide it ( controlled plating process etc) then what they do with it is upto them. Is my C of C quite meaningless from a regulation point of view and its upto whoever is requesting it to ensure the application meets the regulation and not me who is making it. But then if I ship it I need to be able to show to customs the product meets the regulation, which I guess I can only get from the end user
help alan
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Staff member
Super Moderator
#2
Hi Alan,

Your question is in a complex area where you might want to search more into legal and regulatory assistance rather than personal opinions and experiences here at the Cove.

As you do your legwork, you might want to read up on End User Statements and End Use certificates. From your post, that seems like what you are looking toward.
"I certify that I am buying your product for use X" kind of stuff. From one point of view, it's sorta like a CoC from your customer regarding the end use.
 

Jim Wynne

Staff member
Admin
#3
If I need to raise a C of C for a general product that is merely confirming that the product meets the drawing and customer order ( which is my basic understanding of all a C of C does) then what happens if a regulation/law specification is then applied. For example if the product is coated or treated in some way which is then covered in a controlled substance it's logical that the application then has to meet that required regulation for use. If I am a sub contractor and plating do I need to know the use of my customer before issuing my C of C to ensure they handle it correctly or is it if they ask me for it and if I can provide it ( controlled plating process etc) then what they do with it is upto them. Is my C of C quite meaningless from a regulation point of view and its upto whoever is requesting it to ensure the application meets the regulation and not me who is making it. But then if I ship it I need to be able to show to customs the product meets the regulation, which I guess I can only get from the end user
help alan
I don't know about the laws in the UK, but a generic "certificate of conformance" in the US is generally useless and impotent because under the Uniform Commercial Code, a tacit assurance of conformance is given by the act of accepting a contract and delivering goods against it.

If you as a supplier issue a cofc, all you are certifying is that you've met the requirements you've contracted to satisfy, not anything that might be added in the future, or anything you have no way of knowing about.
 
Last edited:
Thread starter Similar threads Forum Replies Date
J COC (Certificate of Conformity) when NOT purchasing medical devices direct from the Manufacturer Other Medical Device Related Standards 2
Q Signatures on C of Cs (Certificate of Conformity) Supplier Quality Assurance and other Supplier Issues 2
A Certificate of release/certificate of conformity/certificate of compliance Other Medical Device and Orthopedic Related Topics 3
G Definition Certificate of Conformance vs. Certificate of Conformity definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
R Supplier Certificate of Conformity/Conformance Standard Other ISO and International Standards and European Regulations 3
C PED Documentation (certificate and declaration) for Conformity Validation CE Marking (Conformité Européene) / CB Scheme 3
P Paying For CoC - Should we charge Customers for a Certificate of Conformity? Quality Manager and Management Related Issues 10
C Certificate of Conformity Competence - Training Staff the Responsibilities of Signing Quality Manager and Management Related Issues 5
S French Customer asking for an NFL 00-015C Certificate - Statement of Conformity Other ISO and International Standards and European Regulations 3
C Certificate of Conformity (for a shipment) Document Control Systems, Procedures, Forms and Templates 3
R Certificate of Conformity vs Certificate of Analysis Supplier Quality Assurance and other Supplier Issues 2
A Non-EU countries who use your EC Certificate & Declaration of Conformity Other Medical Device Related Standards 3
A What is a quality conformity certificate APQP and PPAP 2
L Certificate of Conformity? Supplier incoming material inspection CE Marking (Conformité Européene) / CB Scheme 3
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
S Certification Body Changeover - Transfer of Certificate Registrars and Notified Bodies 9
J How to keep MDD certificate valid when legal manufacturer has liquidity problem EU Medical Device Regulations 0
D ISO 17021 Certificate Registrars and Notified Bodies 1
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
Louddogsbark When your 13485:2016 certificate has been pulled ISO 13485:2016 - Medical Device Quality Management Systems 2
lanley liao The validity of API Spec Q1 certificate Oil and Gas Industry Standards and Regulations 2
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
U Certificate of Free Sale Other US Medical Device Regulations 7
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
S Philippines CMDL (Certificate of Medical Device Listing) Elsmar Cove Forum ToS and Forum Policies 0
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
A How to make sure whether the predicated device is marked with EC certificate? EU Medical Device Regulations 8
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Certificate Suspension? Shut down due to Covid-19 IATF 16949 - Automotive Quality Systems Standard 14
L Appears to be a certificate mill certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D ISO 9001 & AS9100 Certificate issued by a consultant for a Distributor Registrars and Notified Bodies 11
J CE Certificate and additional processing EU Medical Device Regulations 4
bryan willemot Chemical / physical certificate of conformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B IATF certificate suspended - Who do we notify? IATF 16949 - Automotive Quality Systems Standard 6
F Calibration certificate content - Average Value and True Value ISO 17025 related Discussions 6
H What is different between PED certificate and CPR certificate? Manufacturing and Related Processes 2
C Migrate ISO 9001:2015 Certificate Registrars and Notified Bodies 4
M How to read a calibration certificate for thermo hygrometer General Measurement Device and Calibration Topics 2
V Calibration certificate verification Qualification and Validation (including 21 CFR Part 11) 3
A Calibration Certificate Results General Measurement Device and Calibration Topics 3
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
E Calibration Certificate Content Requirements General Measurement Device and Calibration Topics 3
M IATF 16949:2016 clause 8.4.2.3 - We don't have ISO 9001:2015 certificate IATF 16949 - Automotive Quality Systems Standard 26
S Boeing D6-51991 Product Acceptance Software certificate and Artefact? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0

Similar threads

Top Bottom