Design vs. Repair / Refurbishment Modifications - ISO 9001 Design Exclusions

G

Greg P

#1
I would like to pose a question to anyone who may know the answer. Under clause 1.2 of ISO 9001 "Exclusions" The intent is to allow exclusion of design control requirements. My business is with repair/refurbishment. My question is: Where is the line drawn between what is design and what is rework/modifications to allow a device to function. I am in the process of writing our quality manual, and eventually when we get to a point that we want to apply for ISO certification I wouldn't want to get dinged by this clause. Any thoughts?

Greg P.
 
Elsmar Forum Sponsor
R

ralphsulser

#2
Re: Exclusions of ISO 9001 requirements

I would think that you are repairing something that has already been designed. Even if you rebuild it, it would be to the original design by someone else. Do you work to prints and drawings? Whoever provides the drawings are responsible for design.:2cents:
 
G

Greg P

#3
Re: Exclusions of ISO 9001 requirements

We refurbish game consoles. Sometimes we may replace original parts with sourced parts, and may add some rework or modifications which would not change any of the functionality of the device, but I am wondering if ISO would consider these activities design.
 
R

ralphsulser

#4
Re: Exclusions of ISO 9001 requirements

We refurbish game consoles. Sometimes we may replace original parts with sourced parts, and may add some rework or modifications which would not change any of the functionality of the device, but I am wondering if ISO would consider these activities design.
IMHO I think you can exclude design without any hassle from an ISO9001 auditor. It is still someone else's design.
 
G

Greg P

#5
Re: Exclusions of ISO 9001 requirements

Great! I appreciate your input. One last thought. We have a department within the refurbishment center that we call "R&D", what this group of guy's do is research and develop tests and fixes to product that even the original manufacturer does not do. In some cases they come up with fixes where the OM would just replace a part. Do you think the "R&D" label will get us into any trouble?
 
Thread starter Similar threads Forum Replies Date
T ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Company) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q ISO 9001:2008 requirement for Design Organization Approval prior to "Repair" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
E How to become a Repair Design Organisation, part 21 subpart M EASA and JAA Aviation Standards and Requirements 4
R Design and Development exclusion? We repair and refurbish electric motors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
DuncanGibbons Section 8.3 relevant for design organisations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J Significant change related to design and intended use EU Medical Device Regulations 3
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
U NOC - What is considered a "design change" EU Medical Device Regulations 5
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 2
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
W Need for current design or process control FMEA and Control Plans 2
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
L Design & Development of a SERVICE Service Industry Specific Topics 13
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A AS9102B - 3.6 Design Characteristics and form 3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
T Design Input detail & specificity ISO 13485:2016 - Medical Device Quality Management Systems 4
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
R Design and Manufacture Guidelines for Surface Mount Technology Misc. Quality Assurance and Business Systems Related Topics 9
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom