Section 8.3 relevant for design organisations

DuncanGibbons

Involved In Discussions
#1
Hi all,

I have a query about SAE AS9100D section 8.3, design and development of products and services.

Is this section relevant for design organisations mainly. Or is it applicable to both design and productions organisations?

Would the requirements not be addressed by the design organisation and flown down as part of their internal specifications to lower-tiered production organisations and manufacturers.
 
Elsmar Forum Sponsor

Randall Beck

Starting to get Involved
#2
Hi all,

I have a query about SAE AS9100D section 8.3, design and development of products and services.

Is this section relevant for design organisations mainly. Or is it applicable to both design and productions organisations?

Would the requirements not be addressed by the design organisation and flown down as part of their internal specifications to lower-tiered production organisations and manufacturers.
Design and development is for organizations that are responsible for defining the product function, life cycle, key characteristics and other requirements for manufacturing or servicing the product. They will usually flow all requirements down to the production organizations in order for them to manufacture the items to those requirements. These requirements will be the verification activities required to be performed in order verify compliance to the intended design.

A airline seat manufacturer may design a passenger seat with all the features necessary to ensure compliance with FAA flight safety laws and regulations and fit, form and function requirements for a particular airplane configuration but then will flow down all the manufacturing and testing requirements to a manufacturing facility to manufacture it. It is very common for manufacturing facilities like us to be design exempt. We can't change anything - we only have to show compliance to what they designed in our final product.
 

Big Jim

Super Moderator
#3
Could be both. If you both design and manufacture something you certainly are design responsible. If you design something that is manufactured by others you are design responsible. If you manufacture to someone else's specifications then you are not design responsible.
 
Thread starter Similar threads Forum Replies Date
I ISO 9001:2015 Section 9.3.2 C1 "customer satisfaction and feedback from relevant interested parties" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Relevant internal and external communication - ISO 9001:2015 section 7.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T 211, subpart B, section 211.22 as it applies to pharma printing Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
J Drawing Example Request: Inspection Section Plane of Aluminum Casting Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Annex X section I.I d of Directive 93/42/EEC EU Medical Device Regulations 3
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
B Employee Handbook in ISO 9001:2015 Section 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
lanley liao How to understand correctly the section of 5.11 MOC in API Spec Q1? Oil and Gas Industry Standards and Regulations 3
M SOPs - Reference Documents Section Document Control Systems, Procedures, Forms and Templates 4
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
N Nadcap AC7101/2 Rev. E Section 3.2 - Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K Section 13.6 Annex 1 MDD 93/42/EEC for Glove EU Medical Device Regulations 0
R IEC 60601-1 - Power Supply Cords (Section 8.11.3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
R [ASK] API Q1 Ninth Edition, Section 5.4.5 Oil and Gas Industry Standards and Regulations 4
K What to include in SOP Definitions section Document Control Systems, Procedures, Forms and Templates 3
K Why 'FD&C act section number' and 'section number' in the title of the act are different? US Food and Drug Administration (FDA) 7
M API Spec. Q1, 8th Ed. Section 7.5.2 vs. Q1, 9th Ed. Section 5.7.1.5 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
K IPC-610 Section 10.4.2.2 clarification - Distance to be measured Various Other Specifications, Standards, and related Requirements 0
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 section 5.3 Quality Policy - No framework for establishing and reviewing quality objectives ISO 13485:2016 - Medical Device Quality Management Systems 2
D Monitoring and measuring resources - Example of how section ISO 9001 7.1.5 would apply to a manufacture of software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
dgrainger MHRA - Creation of new UK Responsible Person section with added content. Medical Device and FDA Regulations and Standards News 0
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
B ISO 50001 Interpretation of section 3.3.9 (Outsourcing) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C IATF 16949:2016 Section 8.5.1.2 item d) accessible for use at the designated work area(s) IATF 16949 - Automotive Quality Systems Standard 5
W Tying the need for Demand Planning to a section of AS9100/9110 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
M AS9100d (section 7.1.3) example of compliance in machine shop environment. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L AS9102 Form 1 Section 13 Detail or Assembly Question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
eternal_atlas Section 7.8.4 Specific requirements for calibration certificates ISO 17025 related Discussions 2
T MDR on Good Laboratory Practice (GLP) - Pg 110, section 6.1 (b) EU Medical Device Regulations 1
M ASTM A6 Material Standard - Section Nominal Sizes Manufacturing and Related Processes 1
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
Y IEC 62304 Section 4.3(a) - 100% probability of failure IEC 62304 - Medical Device Software Life Cycle Processes 3
C AIAG's IATF 16949 section 7.1.5.1.1 - Torque MSA Requirement Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
C Applicability of ISO 9001:2015 Section 8.5 - Engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Documented processes required by IATF 16949 section 4.4.1 IATF 16949 - Automotive Quality Systems Standard 1
L AS9100D Requirements vis-a-vis Section 8.5.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Q ISO 9001, section 4.3 Determining the scope of our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Ajit Basrur Looking for examples of "User Training" - ISO 13485 section 7.2.1 d) ISO 13485:2016 - Medical Device Quality Management Systems 6
Q NADCAP NDT (specifically RT) - Checklist AC7114 Rev. K, section 8.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Medical Device Accessories - Health Canada - CMDR Section 21 Canada Medical Device Regulations 1
R Background of Annex X section 1.1d of MDD 93/42/EEC EU Medical Device Regulations 74
WCHorn Rendering Scrap Unusable before Disposal (AS9100D, Section 8.7) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6

Similar threads

Top Bottom