Question about Design Exclusions - Clause 7.3 of ISO 9001

B

Benjibb

#1
Hi,

My company doesn't actually design anything, we recieve the designs for the product we produce and then seek approval from the industry regulators (Mastercard and Visa) for the designs. Once the designs are approved by the customer and the industry regulators, we simply produce the product according to the designs. Does this mean I can exclude clause 7.3 ?

Thanks
 
Elsmar Forum Sponsor
H

Houcka

#3
As long as you include the exclusion in the Scope section of your Quality Manual, it shouldn't be a problem.
 
#5
Hi,

My company doesn't actually design anything, we recieve the designs for the product we produce and then seek approval from the industry regulators (Mastercard and Visa) for the designs. Once the designs are approved by the customer and the industry regulators, we simply produce the product according to the designs. Does this mean I can exclude clause 7.3 ?

Thanks
Who actually does the design? Who do you receive it from? Is design sublet?

You have not given us enough information to determine clearly that an exclusion is appropriate.
 
B

Benjibb

#6
Ok, so we get the artwork designs from the customer and the pass them on to the supplier who seek approval from the industry regulators. Once approved the designs are passed back to us, with samples which we then pass on to the customer for approval before the purchasing process can begin.
 

somashekar

Staff member
Super Moderator
#7
Ok, so we get the artwork designs from the customer and the pass them on to the supplier who seek approval from the industry regulators. Once approved the designs are passed back to us, with samples which we then pass on to the customer for approval before the purchasing process can begin.
Clearly a case for exclusion as you can justify the same. Any other stuff that you do on behalf of your customer is a part of the validation more under the 7.5.2
 

Paul Simpson

Trusted Information Resource
#8
Just becaue the word 'design' is used doesn't mean it is covered by clause 7.3 of ISO

It looks to me as if the OP is not actually designing. We can call it what we like but if someone supplies you with a specification (written spec, drawing, artwork, representative sample) and you manufacture to that specification you are not designing and therefore there is no need to justify an exclusion.

Design is involved when a customer comes to you with a set of requirements to be met and leaves it to you (as the expert) to propose a product or service that meets those requirements.
 

somashekar

Staff member
Super Moderator
#9
Re: Just becaue the word 'design' is used doesn't mean it is covered by clause 7.3 of

It looks to me as if the OP is not actually designing. We can call it what we like but if someone supplies you with a specification (written spec, drawing, artwork, representative sample) and you manufacture to that specification you are not designing and therefore there is no need to justify an exclusion.

Design is involved when a customer comes to you with a set of requirements to be met and leaves it to you (as the expert) to propose a product or service that meets those requirements.
:) you have said the justification for exclusion and this is simply put in the quality manual.
 
Thread starter Similar threads Forum Replies Date
W ISO 9001:2008 Clause 7.3 Design and Development Exclusions Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
W Question on Clause 7 Design Related Exclusions Design and Development of Products and Processes 19
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
H IATF 16949 Cl. 8.3 - Design and Development Exclusion Question IATF 16949 - Automotive Quality Systems Standard 4
M Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K ISO 9001 Section 7.3 Design and Development Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
somashekar A question on D&D Outputs in Design and Development Stages (7.3.3) ISO 13485:2016 - Medical Device Quality Management Systems 4
S TS 16949 7.3.3.2 Question - Manufacturing Process Design Output. IATF 16949 - Automotive Quality Systems Standard 8
A We Design and Develop - All of our Manufacturing is Outsourced - ISO 13485 Question ISO 13485:2016 - Medical Device Quality Management Systems 18
M DOE (Design of Experiments) - CQE Primer question Professional Certifications and Degrees 4
B Question about the word "Design" in AS9100 Clause 8.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J Design Review Participants - Medical Devices - Question Design and Development of Products and Processes 10
D Design Input - Question on Specific Performance Criteria for Medical Devices Design and Development of Products and Processes 3
J Shared Services and TS16949 question - Automotive Design Center IATF 16949 - Automotive Quality Systems Standard 4
K Yet another design question - Customer is asking for a print but we do not do design Design and Development of Products and Processes 19
J Design or not design that is my question Design and Development of Products and Processes 4
V Question about API Q1 - Can Design be Excluded? Oil and Gas Industry Standards and Regulations 4
Ron Rompen Question regarding CMM probe damage General Measurement Device and Calibration Topics 4
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
C Complaint Return Sample Size Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
8 Drawing Feature Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
D Question: How to analyze numerical and attribute data Reliability Analysis - Predictions, Testing and Standards 11
D Question on electronic signatures and initials on batch records ISO 13485:2016 - Medical Device Quality Management Systems 3
A Special Characteristic question from Automotive CSR Customer and Company Specific Requirements 9
Ron Rompen GDT Question - is this even correct? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A PPAP question for audit APQP and PPAP 16
C ISO Question - Do you say "I-S-O" or "I-Soh"? Misc. Quality Assurance and Business Systems Related Topics 14
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
D Question on Supplier Quality (SCAR) ISO 13485:2016 - Medical Device Quality Management Systems 6
A +0/-.001 Tolerance question - Feature size is 1.249 +0/-.001 - Actually measures 1.2493 (.0003 OHL Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
D Question on Documented Calibration versus ISO 17025 Accredited Calibration ISO 13485:2016 - Medical Device Quality Management Systems 2
S Configuration Item definition question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C Quality Management System Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 11
J IATF 16949 Calibration/Verification records question ISO 26262 - Road vehicles – Functional safety 6
I IMDS Error Message Question RoHS, REACH, ELV, IMDS and Restricted Substances 1
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 3
C Gauge R&R Question Using Minitab Software 1
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
K Question on MDR classification EU Medical Device Regulations 4
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
D Work Instruction Question ISO 13485:2016 - Medical Device Quality Management Systems 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
John C. Abnet VDA 6.3 - Question 7.3 - "blocking of parts" VDA Standards - Germany's Automotive Standards 6
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question regarding "storage and distribution" ISO 13485:2016 - Medical Device Quality Management Systems 1
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 3

Similar threads

Top Bottom