What are "Design Records"

Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
#2
Depends upon your company, but stuff like minutes of critical reviews, validation data, verification data, and such. Maybe customer requirements (PO).
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Medical Device Service Records linked to DHR (Design History Record)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W Design History Verification Records Control and Approvals US Food and Drug Administration (FDA) 3
U Medical Device Design Review Records Requirements Design and Development of Products and Processes 16
D Design & Development Input Records Requirements - ISO 9001 Clause 7.3.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Procedure for Control and Maintain of Records in each Design Stage 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
K Post format for Design and Development Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P Quality formats - ISO 13485 Design and development related records and formats ISO 13485:2016 - Medical Device Quality Management Systems 7
H Are Tooling Design Records required by TS 16949 Design and Development of Products and Processes 2
S Engineering Design Review minutes as Verification & Validation Records Design and Development of Products and Processes 7
N Design and development inputs, how many records are maintained? Design and Development of Products and Processes 2
J Design and Development Documentation and Records Requirements Design and Development of Products and Processes 7
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 3
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 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 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 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
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A Design process goal for ISO 9001 Manufacturing and Related Processes 23
Z Definitive definition of design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Design FMEA for Industrial Machinery FMEA and Control Plans 3

Similar threads

Top Bottom