What to "un-exception" for DFM (Design for Manufacturability)

Project Man

Involved In Discussions
#1
We are a machine shop and currently certified to ISO13485 with the following exclusions: 7.3, 7.5.1.2.2, 7.5.1.2.3, 7.5.1.3, 7.5.2.2, 7.5.3.2.2, 8.2.4.2

We would like to include DFM in the scope of our cetification so my question is, What part(s) of 7.3 do I need to 'un-exception'?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Re: What to "un-exception" for DFM

Hi,

In my opinion, the whole of s. 7.3. Design For Manufacturing (DFM) is a result of a specific design input, but other than that it is a design endeavor just the same.

Cheers,
Ronen.
 

Project Man

Involved In Discussions
#3
Re: What to "un-exception" for DFM

Thanks Ronen. I should include that we would be submitting our suggestions to our customer and they would ultimately be responsible for the verification and validation.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: What to "un-exception" for DFM

Thanks Ronen. I should include that we would be submitting our suggestions to our customer and they would ultimately be responsible for the verification and validation.
Hi,

Whoever actually performs and reports the verification and validation, your procedure should highlight the arrangement. As much as possible, you should have copies of the reports on file.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
C Taking exception to customer requirements or specifications & AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
N Taking exception to REACH Requirement - Appropriate Language REACH and RoHS Conversations 4
R How to understand the exception of IEC 60601 sub-clause 8.11.5 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Taking an Exception to Clause 7.3 in ISO 9001 and ISO 13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Y Final Guidance - Exception From Informed Consent for Emergency Research US Food and Drug Administration (FDA) 4
K Can I take exception to Clause 7.5.1.4 Post Delivery Support? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 19
Steve McQuality RoHS for Medical Devices - "Medical Device Exception" RoHS, REACH, ELV, IMDS and Restricted Substances 2
R Exception to 6.4 a) thru d) - Excluded from the Scope of my Quality System ISO 13485:2016 - Medical Device Quality Management Systems 12
M Exception History Document Document Control Systems, Procedures, Forms and Templates 3
R Exception in design - Tooling - In steel manufacturing, which can be tools or tooling Design and Development of Products and Processes 1
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 2
N Acronym DFM (Design for Manufacturing) and DFT (Design for Testing) definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
N DFM, DFA and POKA YOKE - Are these three related? Manufacturing and Related Processes 4
C DFM (Design For Manufacturability) Checklist wanted Quality Tools, Improvement and Analysis 3
M Method to assess / calculate a design wrt DFM/DFA - Seeking template Design and Development of Products and Processes 4
C DFM Training exercise or game - Seeking Training - Internal, External, Online and Distance Learning 3
J DFA (Design for Assembly) & DFM (Design for Manufacturing) - Seeking Templates Document Control Systems, Procedures, Forms and Templates 4
M Design for Manufacturability (DFM) Software - Seeking advice Design and Development of Products and Processes 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 4
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 1
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 Reliability Analysis - Predictions, Testing and Standards 0
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
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Supplier of design and manufacture process ISO 13485:2016 - Medical Device Quality Management Systems 10

Similar threads

Top Bottom