Standard (EN?, prEN?,ISO?) that deals with Certificate of Analysis?

M

Monica Lewis

#1
Marc,

Have you or anybody else heard about a Standard (EN?, prEN?,ISO?) that deals with
certificate of analysis for raw material or final product (content, who should sign it etc.)
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
I haven't heard of a documented standard, however the 'normal' minimums are:

Test performed
Units of measure
Upper and lower limits
The actual reading obtained
Signature of responsible company official
 
T

Texasrussian

#3
Ugh, my boss is going to freak, the customer is wanting a new COA to list individual part measurements, five per part on the COA, which would have 100 parts or about a ten page COA. I read the customer's specification and their requirement "implies" lot averages which will keep the COA to one page and no mention of indiviual values on their COA section. Textile rolled good is the part.

We already input the inspection into a spreadsheet, but I fear formatting the COA the customer wants will be another two hours of work. I've mention to the customer quality engineer, but he still pushing back that he wants the long version of the COA. How to handle?
 

Jim Wynne

Staff member
Admin
#4
Ugh, my boss is going to freak, the customer is wanting a new COA to list individual part measurements, five per part on the COA, which would have 100 parts or about a ten page COA. I read the customer's specification and their requirement "implies" lot averages which will keep the COA to one page and no mention of indiviual values on their COA section. Textile rolled good is the part.

We already input the inspection into a spreadsheet, but I fear formatting the COA the customer wants will be another two hours of work. I've mention to the customer quality engineer, but he still pushing back that he wants the long version of the COA. How to handle?
Tell your customer you'll be happy to revise your pricing just as soon as you receive documented requirements.
 

Wes Bucey

Prophet of Profit
#6
Tell your customer you'll be happy to revise your pricing just as soon as you receive documented requirements.
Yes! Add-on requirements after the contract is agreed can easily push a profitable contract into red ink unless the supplier has the intestinal fortitude [guts] to face the customer and say "Whoa! Let's revisit our pricing."

Note, though, that if it was already in the contract and the supplier just missed it by lack of diligence - there's a different worry.
 
Thread starter Similar threads Forum Replies Date
F USB-IF standard EU Medical Device Regulations 0
F Is USB-IF standard compliant with ISO13485? Medical Device and FDA Regulations and Standards News 3
A Is there a standard on tolerances of substances ? Medical Device and FDA Regulations and Standards News 1
P Pooled Standard Error - Minitab Statistical Analysis Tools, Techniques and SPC 0
SABRINA DJILALI SAIAH Implementation of the ISAS-MEDIA 9001 standard in a TV channel ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B European Harmonized vs IEC standard IEC 62366 - Medical Device Usability Engineering 2
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Standard -Machinist Handbook Customer Complaints 4
N EN 813, EN 12277, EN 1497 - Testing some harness prototypes to an EN standard Various Other Specifications, Standards, and related Requirements 0
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
S Shore A hardness Tester Acceptance Criteria Standard Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J SAE J1739 standard IATF 16949 - Automotive Quality Systems Standard 2
Marcel DS LV 123 - BMW, AUDI, Mercedes Standard VDA Standards - Germany's Automotive Standards 1
F Standard Calibration Procedures: Recommended Practice ISO 17025 related Discussions 0
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
Y UL 1998 Standard: software classes Software Quality Assurance 0
G What to do with correction factors overlooked by an accredited standard (6.4.11)? ISO 17025 related Discussions 5
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
Skooma Deburring and Tolerances - Is there a Standard for deburring or removing material? Manufacturing and Related Processes 3
B Purchasing AS9100D Standard in Japanese AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
M Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012 Medical Device and FDA Regulations and Standards News 11
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
P Cenelec updated standard information CE Marking (Conformité Européene) / CB Scheme 1
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
M Viable count Measurement ISO Standard Other Medical Device Related Standards 1
I When exactly was "competence" added to the ISO-9001 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
S Average and standard deviation of Cumulative Data Statistical Analysis Tools, Techniques and SPC 5
R Standard Filter for Calibration Colorimeter ISO 17025 related Discussions 1
B Standard for Dielectric Strength Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 3

Similar threads

Top Bottom