Design and Construction wiki

Design and Construction wiki 2019-08-27

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M Procedure for Design and Development in Construction Document Control Systems, Procedures, Forms and Templates 4
G Process Map for Highway Design & Construction needed Process Maps, Process Mapping and Turtle Diagrams 1
M Exclusion of Design and Development - Construction and Renovation of Premises Design and Development of Products and Processes 11
M What is ?Design and Development? in Construction - Clause 7.3 ISO 9001 Design and Development of Products and Processes 16
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
M Design Development MDR Design and Development of Products and Processes 0
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
C Essential Design Output(s) and Design transfer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
O How can I justify excluding the R&D group and the design and development clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2

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