Does Outsource of Processes refer to things like heat treat of the product?

G

GARY MOORE - 2009

#1
outsource of processes

Does outsource of processes mean product? Such as sending product out for heat treat, plating, etc. or functions such as
purchasing, HR, accounting.
 
Elsmar Forum Sponsor
M

M Greenaway

#2
Gary

It could be applied to any process, but I would think a company would be most interested in the processes relating directly to the product.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#3
Jim said "the 'standard' requires us only to worry about outsourced process that affect product conformity with requirements but are NOT product realisation processes."

I'm having a brain timeout. Which processes affect product conformity but are not product realization processes?
 
#4
controlling outsourced processes

So it would appear that - even though what Martin says makes IMO sound common sense - that the 'standard' requires us only to worry about outsourced process that affect product conformity with requirements but are NOT product realisation processes.
Go back even further. clause 1: Scope says:
"...requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product..."

4.1 deals with the processes need for the QMS. The QMS needs to demonstrate its ability to consistently provide product. The processes mentioned in 4.1 include the processes included in clause 7, as well as processed that are not included in clause 7. Any process governed by the QMS that is outsourced (whether it is related to product realization or not) must be controlled.
 
#5
clause 7.1 says that clause 4.1 deals with processes OTHER than product realisation processes
Here is what the standard says in 7.1 Planning of product realization:

"...shall be consistent with the requirements of the other processes of the quality management system (see 4.1)."

It does not say that all processes in 4.1 are “other” processes. What is says is to find more information, refer to 4.1. 4.1, then, refers to the processes of the QMS, which takes us back to my previous post. I cannot see where anyone can conclude that 4.1 is only the “other” processes. In fact 4.1 a) specifically points to 1.2. 1.2 specifically mentions Clause 7. Therefore processes in Clause 7 are part of the processes in 4.1. All 7.1 is saying is that if you wish to get a better understanding of the processes that are not part of this Clause, then refer to 4.1.
 
S

shreeniwas

#6
As per definition of Subcontractor in Glossary QS9000, provider of finishing services , production materials, production / service parts is a subcontractor . As such if the services outsorced by you are not finishing services , you need not treat the service provider as a subcontractor from QS point of view (and the subcontractor development , ISO compience etc does not remain mandatory for such service providers). Do you agree with me?
 
Thread starter Similar threads Forum Replies Date
D Does waste water equipment need calibration if we also outsource testing? Miscellaneous Environmental Standards and EMS Related Discussions 12
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Watchcat Does "Similar Device" = "Predicate"? EU Medical Device Regulations 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Definition Open Audit - What does an Open Audit mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P What does UPH/m² mean? Quality Tools, Improvement and Analysis 3
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
Sidney Vianna IAQG SCMH explains "positive risk"..........but does it? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Does pitch/increment/resolution of a ruled scale apply to measurement uncertainty as line item? Measurement Uncertainty (MU) 10
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
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
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
DitchDigger Boston Fire Code: Who Does What? (CAL TB 117-2013; CAL TB 133) Occupational Health & Safety Management Standards 2
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
K EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules? EU Medical Device Regulations 2
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
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
C Does ITAR apply to Exporters only? Other ISO and International Standards and European Regulations 6
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom