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
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
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
lyobovnik Work From Home Exception for Quality Managers? Quality Manager and Management Related Issues 19
Ed Panek COVID 19 Exception and MDSAP Canada Medical Device Regulations 5
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
M Medical Devices - DFM Medical Device and FDA Regulations and Standards News 5
Awais Where to get started on DFM / DFMA Manufacturing and Related Processes 2
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
X Design stage overview (Product specification) EU Medical Device Regulations 3
gohyl Fixture Setup Design Manufacturing and Related Processes 3
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 2
T Software item classification and Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 4
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Sidney Vianna ISO 9001 News ISO 9001 Design Specification to be developed - May 2022 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Design output vs acceptance criteria ISO 13485:2016 - Medical Device Quality Management Systems 8
M Design Control Procedure Medical Device and FDA Regulations and Standards News 4
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
S Link Between Essential Performance Requirements and Essential Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G Calculating Ppk for Design Verification - Variable Sampling Design and Development of Products and Processes 15
G How many Design FMEAs do you have? FMEA and Control Plans 4
G Updating FMEAs after Design Updates FMEA and Control Plans 4
Stoic Details of Operational Qualification (OQ) test design for plastic extrusion processes, effect of material property noise, and GHTF/SG3/N99-10 US Medical Device Regulations 2
H R&D and Design procedures - can one procedure cover both activities Design and Development of Products and Processes 6
J Design Verification Testing and Statistics Reliability Analysis - Predictions, Testing and Standards 3
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
S Audit Finding - Design History File (DHF) Index: few (3 to 4) reports not identified ISO 13485:2016 - Medical Device Quality Management Systems 3
S Is the Design Service Provider required to be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 13
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
C MDR - Annex II _3. DESIGN AND MANUFACTURING INFORMATION_a EU Medical Device Regulations 3
C Items used for Design Verification Design and Development of Products and Processes 7
S Software design document NMPA guidance and consultant China Medical Device Regulations 4
L Corrective and Preventive Actions aligned to design related defects. After Work and Weekend Discussion Topics 5
E DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request Medical Device and FDA Regulations and Standards News 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 4 – Design Controls Other US Medical Device Regulations 0
D Finding Optimum Design Parameters using Taguchi method? Using Minitab Software 2
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom