Definitive definition of design?

zenquality

Starting to get Involved
#1
Please let me have your definitive definition of "Design".

This topic is the No. 1 source of confusion for audit clients.

Best regards,

Zenquality
 
Elsmar Forum Sponsor

John C. Abnet

Teacher, sensei, kennari
#2
Good day @zenquality ;
Specific to your topic, the supporting vocabulary (ISO 9000) provides the following definition....

ISO9000
3.4.8 design and development
Set of processes that transform requirements for an object into more detailed requirements for that project.

The actual standard itself actually (in my professional opinion) provides better information within the clauses for "design...inputs"; "design...controls"; "design...outputs".


Do you have a specific example of what you are trying to accomplish (i..e what specifically prompted your question)?

Hope this helps.

Be well.
 
Thread starter Similar threads Forum Replies Date
M Definitive answer on Type 1 vs Type 2 vs Type 3 Gage Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
W Definitive screening design in Minitab 17 Manufacturing and Related Processes 1
M CQIA (Certified Quality Improvement Associate) Exam: The Top 3 Definitive Books? Book, Video, Blog and Web Site Reviews and Recommendations 4
Douglas E. Purdy Definitive Understanding of 8.2.2.3 Manufacturing Process Audit IATF 16949 - Automotive Quality Systems Standard 36
Wayne Searching for Zero - The Definitive Dimensional Metrology Reference Book, Video, Blog and Web Site Reviews and Recommendations 7
Manix Revision & Versions! Definitive difference between a Version and a Revision? Document Control Systems, Procedures, Forms and Templates 13
J Corrective Action vs. Preventive (Predictive) Action (CAPA) - A Definitive Discussion Preventive Action and Continuous Improvement 177
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 3
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
S Importer definition EU Medical Device Regulations 0
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
M Definition of Done - New Product Phase to the sustaining phase Manufacturing and Related Processes 3
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
D Tolerance definition based on expected Cp/cpk Reliability Analysis - Predictions, Testing and Standards 14
D BS EN 62304 - Medical-Relevant Data C.5 - Definition of IEC 62304 - Medical Device Software Life Cycle Processes 5
P Definition of production tooling in IATF16949 clause 8.5.1.6 IATF 16949 - Automotive Quality Systems Standard 4
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
J Here is my definition of Defect Mapping Quality Tools, Improvement and Analysis 2
D Definition of "Critical Laboratory Equipment"? General Measurement Device and Calibration Topics 1
R Definition Key Supplier - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
A Definition of customer in ITP (Inspection & Test Plan) Contract Review Process 3
F MEDDEV 2.7/1 rev 4 and MDR - Definition of Description of Principles of operation EU Medical Device Regulations 4
S Definition of "servicing activities" - Spinal Implants ISO 13485:2016 - Medical Device Quality Management Systems 4
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12
C Function definition for DFMEA FMEA and Control Plans 1
W Key functional characteristic definition - Tolerances and Deviations Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Definition Waiver - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
M Informational MHRA guidance – Assistive technology: definition and safe use Medical Device and FDA Regulations and Standards News 0
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 15
Pancho Definition Quality Assurance Program - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
M Inputs on definition of very similar processes for multi site audit sample - IAF MD1 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
U Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Medical Device Accessory - Health Canada guidance / definition on what an accessory is Canada Medical Device Regulations 3
C MDR Importer/Distributor Definition Questions EU Medical Device Regulations 5
G Medical Device "Immediate Container" Interpretation of Definition US Food and Drug Administration (FDA) 2
S Definition of Convenience Kit for a Combination Product US Food and Drug Administration (FDA) 0
M Are Risks and Opportunities Required as Part of the Process Definition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Definition of "Sensitive Products" Clause 8.5.4 (c) in AS9100 Rev. D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Marc Definition Jidoka - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
Marc Definition DFMEA (Design FMEA) - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
J Definition of repackager v. manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S MDR Annex II Design & Manufacturing info - 'Adjuvants' definition EU Medical Device Regulations 3
C Informational CFR 21 Definition for Data or Raw Data Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
I Lot or Batch definition for IVDs Imported Legacy Blogs 0
S Mains outlet MSO definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Mikishots Definition Defined - Definition and meaning of "defined" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 10

Similar threads

Top Bottom