Is a confirmation trial obligatory in development of a product?

M

magedology

#1
Hello all

I work for a company manufacturing Master-batch for plastic we don`t have design just development and make new color of exist product.

Chemist start try many formula to get best color that match with customer need.

Situation now as the Chemist found best one he make a small production and send it to customer.

Is confirmation trial is obligatory according to ISO 9001:2008 ?

I include the formulation sheet I made please check .
 

Attachments

Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#3
Chemist start try many formula to get best color that match with customer need. Situation now as the Chemist found best one he make a small production and send it to customer.
Is this not confirmation trial ... ?
When your customer does not give formula, then are you not designing and developing as you say ....
Chemist start try many formula to get best color that match with customer need.
... Making a new color from an existing product is a simple design development, with much learning from the existing product being used.
 
M

magedology

#4
Is this not confirmation trial ... ?
When your customer does not give formula, then are you not designing and developing as you say ....

... Making a new color from an existing product is a simple design development, with much learning from the existing product being used.
I understand from your words that the small production is a confirmation, so no need for confirmation trial.

Thanks for your time :thanx:
 
Thread starter Similar threads Forum Replies Date
M Is a confirmation trial is obligatory in development of a product? Design and Development of Products and Processes 3
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Pmarszal Delivery Confirmation? Do we need to save? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L Supplier Revision Confirmation of Received Engineering Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
I Confirmation of Computer Software to satisfy Intended Application Misc. Quality Assurance and Business Systems Related Topics 2
Uriel Alejandro P.O. As evidence of customer confirmation of requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A ISO 10012:2003 question (Confirmation ID) Other ISO and International Standards and European Regulations 1
lianayada ISO 10012:2003 question (Confirmation ID) General Measurement Device and Calibration Topics 2
B Validation vs. Confirmation in the context of an Analytical Laboratory General Measurement Device and Calibration Topics 10
T Material Standard Confirmation - Mill cert standards for raw material? ie Bar, round ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Confirmation of software - Exactly what the last paragraph of 7.6 is asking for? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F ISO 10012 and ISO 17025 - Doing research about metrology systems confirmation ISO 17025 related Discussions 7
T Monitoring & Measuring Software confirmation (validation) - TS 16949 Section 7.6 Statistical Analysis Tools, Techniques and SPC 1
W 7.6 Software confirmation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C ISO 10012-1 4.10 Confirmation Labeling General Measurement Device and Calibration Topics 2
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
U Medical device trial budget - 2 hospitals for Class IIa medical device in Sweden Other Medical Device and Orthopedic Related Topics 2
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 7
T Medical device Clinical trial exemption list China Medical Device Regulations 2
F China Device Assisted Technology Clinical Trial China Medical Device Regulations 4
R Clinical Trial to sell in the EU - Necessary or Not? ISO 13485:2016 - Medical Device Quality Management Systems 5
J Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
Q EU ROHS and GUI Usability Trial Requirements EU Medical Device Regulations 10
H IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
JoCam Trial of New Medical Device EU Medical Device Regulations 8
M Does Medical Device Usability Study = Clinical Trial? Other Medical Device and Orthopedic Related Topics 26
Q South Africa Clinical Trial Inspections by MCC Quality Manager and Management Related Issues 1
S Clinical Trial Informed Consent Forms ("retro-signing") US Food and Drug Administration (FDA) 2
A Singapore - Requirements for Import of Medical Devices for Clinical Trial Other Medical Device Regulations World-Wide 2
B Health Canada Acceptance Policy of Foreign Clinical Trial Data for Devices Canada Medical Device Regulations 2
Q What documentation is required for Design Feasibility trial? ISO 13485:2016 - Medical Device Quality Management Systems 5
C Retention of Clinical Trial Data after a Clinical Trial has ended Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
N Can a Clinical Trial Lead Investigator Surgeon be a Expert Clinical Evaluator? ISO 13485:2016 - Medical Device Quality Management Systems 3
W Production Trial Run in AIAG APQP and Run at Rate (GP-9) GM 1927 APQP and PPAP 2
N Medical Device PIT (Physician Initiated Trial) Study without CE Mark EU Medical Device Regulations 3
R CE Mark requirements on US Clinical Trial Product CE Marking (Conformité Européene) / CB Scheme 2
I IVD product for use in a Drug Clinical Trial (FDA matters) US Food and Drug Administration (FDA) 3
J Labeling Contraindication vs. Clinical Trial Exclusion Criterion Other US Medical Device Regulations 7
bio_subbu CDSCO issues Draft Guidelines for Approval of Clinical Trial & New Drugs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M Production Trial Run Checklist or PV Build Checklist wanted APQP and PPAP 3
D Subtleties of Adverse Events - How should it be captured and handled in the trial? Other US Medical Device Regulations 4
B Ford Project Trial Acronyms Customer and Company Specific Requirements 9
D EU Clinical Trial Startup vs. US IDE (Investigational Device Exemption) ISO 13485:2016 - Medical Device Quality Management Systems 1
I Medical Device Clinical Trial Audit Checklist wanted ISO 13485:2016 - Medical Device Quality Management Systems 2
S Clinical Trial Study Reports - SOP Other US Medical Device Regulations 3
C Manufacturing Trial Report Templates - Help wanted Document Control Systems, Procedures, Forms and Templates 8

Similar threads

Top Bottom