Contracted Manufacturing - We use all contracted manufacturing sites

C

Cari

#1
#1
We are audited to QS9000, but have an ISO 9001 certificate, because we do not own any manufacturing. We use all contracted manufacturing sites. Some of the products we design are required by the customer to be QS compliant. So, we use a QS certified manufacturing facility. However, some of the products we design or not required to be QS compliant. So, can we still use a QS certified manufacturing facility? Or, does this affect their certificate, beacuse they would be manufacturing a design that is only ISO, not QS?
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
A

Al Dyer

#2
#2
Cari,

If I read you correctly, the "contracted manufacturer" is your supplier and you define the level of control imposed.

Also, I can't see why a company that is QS-9000 registered would have any problem working with an ISO designed product since they would already have the system in place to define supplier and customer requirements.

Hope this helps.

Any other insights from the forum?

ASD...

[This message has been edited by Al Dyer (edited 21 January 2001).]
 
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
#3
Right, Al. There is no reason a QS facility cannot manufacture (assemble, whatever) an ISO (or a non-iso) product. Registration does not imply or require exclusion.
 
F

freeda

#4
#4
We are a QS registered manufacturing company that produces both automotive parts and non-automotive parts. Our procedures/systems do not distinguish a QS part from an ISO part. The systems we have in place are the same for both. So your contracted QS company can produce both QS and ISO parts, as long as they are compliant with their procedures.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J Process FMEA w/ Contracted Manufacturing ISO 14971 - Medical Device Risk Management 2
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
T Misbranding (by someone we've contracted with) in a Publication 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
W ISO 13485 - The use of virtual offices (everything is sub-contracted) ISO 13485:2016 - Medical Device Quality Management Systems 4
S Contracted and Lost - Manufacture of a Patented Medical Device Other US Medical Device Regulations 10
D Contracted Internal Auditors - Outsourcing Internal Audits Internal Auditing 14
J Can externally contracted equipment and operators be part of an internal lab scope? IATF 16949 - Automotive Quality Systems Standard 2
Y Contracted to get the organisation ISO 13485 certified ISO 13485:2016 - Medical Device Quality Management Systems 45
C On-Site Contracted Services - Development and availability of key MRO items Service Industry Specific Topics 2
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
L SAE AS9145 vs. SAE AS6500 (Manufacturing Management Program) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 4
Q Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Z US Manufacturing Site Closing, device manufactured elsewhere Medical Device and FDA Regulations and Standards News 1
L Manufacturing site expansion - When to notify your NB EU Medical Device Regulations 3
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N China - Start manufacturing before change approval? China Medical Device Regulations 1
J Manufacturing procedure / work instruction depth ISO 13485:2016 - Medical Device Quality Management Systems 12
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
C Looking for China Good manufacturing practice China Medical Device Regulations 1
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
C Design Control - Ways of capturing inputs from manufacturing Other Medical Device Related Standards 5
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V Manufacturing without a Formal Drawing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Is there a standard / rules pertaining to eating in medical device manufacturing area? Manufacturing and Related Processes 5
Q What is the Normal Flow in an ERP for Manufacturing? Manufacturing and Related Processes 0
J Extent of Validation - New machine installed in manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 8
G QMS requirements for legal manufacturer when outsourcing manufacturing process Other Medical Device Regulations World-Wide 22
V Removing final inspector for medical device manufacturing Lean in Manufacturing and Service Industries 4
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
optomist1 Mobility Field Manufacturing Best - Worst Practices Manufacturing and Related Processes 5
M GSPR 23.3 (h) Manufacturing date on sterile barrier EU Medical Device Regulations 0
J Manufacturing Process Auditor Requirements - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 9
Similar threads
Top Bottom