Definition Design Responsible - Good Definition in the context of AS 9100

Q

quality1

#1
Hi Cove friends,

We had a meeting today to discuss if we want to exclude 7.3 from our scope for AS9100 certification. The first thing I asked is if we understand what "Design Responsible" is? After long discussion and opinions, we're all confused now as to what we really do. Can anyone give a good definition of what "Design Responsible" really is please?:eek:

Thanks
 
Elsmar Forum Sponsor

harry

Super Moderator
#2
Hi Cove friends,

We had a meeting today to discuss if we want to exclude 7.3 from our scope for AS9100 certification. The first thing I asked is if we understand what "Design Responsible" is? After long discussion and opinions, we're all confused now as to what we really do. Can anyone give a good definition of what "Design Responsible" really is please?:eek:

Thanks
With regards to definitions, there are some good discussions in the similar discussion box below the page. The alternative is to discuss with your CB - they know your system better than any others.
 
Thread starter Similar threads Forum Replies Date
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
C Advice on becoming a AS9100 Auditor - Need to audit organizations that are Design Responsible AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
J Not Design Responsible - Can we exclude all or parts of AS9100 clause 8.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M Design & Development - Only 1 Engineer - Who is responsible for Approval? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Design History File Maintenance - Who is responsible for the Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Configuration Management requirements if this facility is not design responsible AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
A Is a Distributor responsible for Design History Files 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
J Scope of Registration ? Design Responsible ? Outsource Design??? IATF 16949 - Automotive Quality Systems Standard 2
M IMDS Submissions for multiple parts requested, but not Design Responsible IATF 16949 - Automotive Quality Systems Standard 13
C Design Responsible - Determining if Organization is Design Responsible Design and Development of Products and Processes 15
M Design Improvement, but not OEM or Design Responsible Design and Development of Products and Processes 6
D Quality Plan - Necessary for any Order? Mature Processes & Not Design Responsible Design and Development of Products and Processes 6
Z Suppliers: "Design Responsible", "Manufacturing" and "Service Suppliers" Design and Development of Products and Processes 5
T Design responsible? Tier 2 / 3 manufacturer of steel products - TS 16949 Design and Development of Products and Processes 6
S Seeking Internal Audit Plan - Design Responsible Manufacturing company Design and Development of Products and Processes 3
J More Design Questions - Parent Company Design Responsible Design and Development of Products and Processes 6
B TS 16949 for R&D Design Centre - What part are we responsible for? Design and Development of Products and Processes 3
T Not responsible for product design - Exactly which parts of 7.3 do not apply? Design and Development of Products and Processes 3
B My company makes product to order - Are we design responsible? Exclude 7.3? Design and Development of Products and Processes 17
R Design Responsible Design and Development of Products and Processes 2
B DESIGN RESPONSIBLE? Design and Development of Products and Processes 3
M Design Responsible? Design and Development of Products and Processes 5
DuncanGibbons Section 8.3 relevant for design organisations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J Significant change related to design and intended use EU Medical Device Regulations 3
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
U NOC - What is considered a "design change" EU Medical Device Regulations 5
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9
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 6
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 Qualification and Validation (including 21 CFR Part 11) 5
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3

Similar threads

Top Bottom