SBS - The Best Value in QMS software

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?
 
Free Trial of DISCUS Desktop
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 with a Mask on...
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
S Instructions for use multiple manufacturing locations ISO 13485:2016 - Medical Device Quality Management Systems 0
F [Line Balancing] Line Efficiency in Fan Manufacturing Lean in Manufacturing and Service Industries 0
S CE and Manufacturing license Manufacturing and Related Processes 1
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
P How to measure DPPM in Chemical batch manufacturing Quality Tools, Improvement and Analysis 1
M MSA Study Type 1 not capable. We are at the limit. And manufacturing wants to continue producing. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
lanley liao How to keep the manufacturing capability under the API monogram Oil and Gas Industry Standards and Regulations 6
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ed Panek What are the limits on manufacturing changes and substantial changes? EU Medical Device Regulations 6
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
K One CE Mark holder - multiple manufacturing sites EU Medical Device Regulations 3
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required? Other Medical Device Regulations World-Wide 12
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
S Manufacturing Execution Systems Software Costs Manufacturing and Related Processes 0
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
DuncanGibbons Additive Manufacturing Processes Thread Manufacturing and Related Processes 5
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
H Line Balancing in Backpack Manufacturing Manufacturing and Related Processes 2
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L SAE AS9145 vs. SAE AS6500 (Manufacturing Management Program) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
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 5
qualprod 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

Similar threads

Top Bottom