Contracting Sub-assemblies From Suppliers

W

WoodDuck

:bigwave:

Hello fellow Covers,

I?m probably over thinking this but it?s best to ask an expert when one lacks experience. We are considering outsourcing some low risk subassemblies of our device to one of our suppliers. They presently make a wheel for us out of nylon round stock. We would like them to add a bearing and axle to the wheel and send them to us already assembled. Our factory presently completes this assembly, which uses standard, off the shelf parts. Once we have the assemblies from the supplier, we would use them as we continue to build the final product. So far it seems quite simple to me, but here is where I need some help. These assemblies could be sold to our customers as replacement parts, as they do wear out over time. Do we need to add the supplier as one of our sites for manufacturing if we sell them as is, with no additional work at our factory? I?ll also add that the parts would be sent to someone who we certified to install them.
 
Ronen E

Ronen E

Problem Solver
Moderator
WoodDuck said:
:bigwave:

Hello fellow Covers,

I?m probably over thinking this but it?s best to ask an expert when one lacks experience. We are considering outsourcing some low risk subassemblies of our device to one of our suppliers. They presently make a wheel for us out of nylon round stock. We would like them to add a bearing and axle to the wheel and send them to us already assembled. Our factory presently completes this assembly, which uses standard, off the shelf parts. Once we have the assemblies from the supplier, we would use them as we continue to build the final product. So far it seems quite simple to me, but here is where I need some help. These assemblies could be sold to our customers as replacement parts, as they do wear out over time. Do we need to add the supplier as one of our sites for manufacturing if we sell them as is, with no additional work at our factory? I?ll also add that the parts would be sent to someone who we certified to install them.
Click to expand...

Those wheels are not Medical Devices. Treat them with that notion in mind.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
F AS9100 - Validation, FAIR's, ITAR and Sub-Contracting AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J SFAR 36 Done By Another Repair Station? Sub-Contracting Repairs Federal Aviation Administration (FAA) Standards and Requirements 5
P Sub-Contracting a major update to the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Sub-contracting software documents - How to document? Document Control Systems, Procedures, Forms and Templates 4
T Inspection Records for a Building Contracting Firm Service Industry Specific Topics 1
Wes Bucey Contracting/Temping - Viable Alternates in Tough Times Career and Occupation Discussions 47
S Should Quality Policy be marketing oriented? Contracting firm for aerospace software AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Help on Quality Objectives - Engineering contracting firm ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Confusion about Pre-Sub meeting, agreement meeting and determination meeting before IDE US Medical Device Regulations 0
Ed Panek Looking for help... FDA Pre Sub, IVD, Investigational level experience US Medical Device Regulations 0
S Subcontractor's subcontractor - Outsourcing of Sterilization to a sub tier Supplier ISO 13485:2016 - Medical Device Quality Management Systems 11
W Sub-Balloon Rules? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
H IEC 61010-1 Clause No. 10.5 Resistance to Heat - Sub Clause 10.5.3 Insulating Material CE Marking (Conformité Européene) / CB Scheme 6
S Do we have to create a new PPAP to our customer if our Sub Contractor had to change? APQP and PPAP 10
H Required explanation of sub clause 7.2.101.2 (Exception) of IEC 61010-2-020:2006 CE Marking (Conformité Européene) / CB Scheme 5
D Definition of Sub-supplier in chemicals IATF 16949 - Automotive Quality Systems Standard 3
B Sub-contractor cleanroom monitoring ISO 13485:2016 - Medical Device Quality Management Systems 0
JoCam Sub-distributor controls EU Medical Device Regulations 2
S Device with different options for a sub-component - CE marking implications EU Medical Device Regulations 2
B GMDN for sub assemblies? EU Medical Device Regulations 0
D Special IATF audit of sub-supplier IATF 16949 - Automotive Quality Systems Standard 18
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M Pre-Sub preparation (for de Novo request) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
S Process Inspection -Sub assembly process inspection sheet Lean in Manufacturing and Service Industries 3
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V IS/ISO/IEC 17025:2017 Clause 7, sub clause 7.11 Control of data and information management ISO 17025 related Discussions 1
R AS9100 DELTA FAI - Sub-supplier for plating changed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
G Control Plan - Include the processes for each sub component? APQP and PPAP 2
R FDA - How to discontinue/obsolete medical devices that share sub-components with others that will still be distributed Other US Medical Device Regulations 5
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
C Design for Assembly in DFMEA - Failure Effect of Sub-System(s) FMEA and Control Plans 5
L 510 (K) Pre-Sub meeting - Does it worth? US Food and Drug Administration (FDA) 4
A Examples of Pre-Sub, SRD, PMA Shells and Templates Other US Medical Device Regulations 3
M IATF 16949 Clause 8.3.5.2 sub-clause (l) - Process maintainability requirements IATF 16949 - Automotive Quality Systems Standard 15
A FDA Sub contractor Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J IATF Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers IATF 16949 - Automotive Quality Systems Standard 12
D Supplier Scorecard, Assessment of Pass Through Items From Sub Tier Suppliers Supplier Quality Assurance and other Supplier Issues 4
M NADCAP Chemical Processing: Question about testing sub-contractor requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
V Own foreign manufacturing facilities declared as sub-contractors ISO 13485:2016 - Medical Device Quality Management Systems 5
B IATF 16949 Cl. 7.1.5.3.2 - External Laboratory Sub-Supplier Requirements IATF 16949 - Automotive Quality Systems Standard 2
L Managing Finance Processes - Identification of Sub Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Help with SCAR - Not all sub-assemblies had properly received a First Article Nonconformance and Corrective Action 2
M Notified Body (NB) Audits of Sub-Contractors and Critical Suppliers EU Medical Device Regulations 35
B 60601-1-2 ME Equipment sub system definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
H AS9120 stockist now able to work with Airbus sub contractors? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
xfngrs CQI-19 Sub-Tier Supplier Management IATF 16949 - Automotive Quality Systems Standard 1

Similar threads

Top Bottom