Can outsourced processes be excluded from QMS scope?

Silex7

Involved In Discussions
#1
Hi,

Can manufacturing process (outsourced) be excluded from QMS scope ? if a company is making its manufacturing process (after its design) from outsourced manufacturer, should that be excluded in the scope? ( speaking here in term of QMS scope, not the audit scope)
And if so, what clauses should be excluded ? ( if we thought of c. 8.5 for example, it can not be excluded since the company does a control for the outsourced manufacturer )
Any thoughts?
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Can manufacturing process (outsourced) be excluded from QMS scope ?
No, you can't exclude them. 8.4 stipulates that you HAVE TO ENSURE that outsourced processes conform to requirements. If you outsource processes, services or products, YOUR ORGANIZATION is still responsible for them.
 

Silex7

Involved In Discussions
#3
No, you can't exclude them. 8.4 stipulates that you HAVE TO ENSURE that outsourced processes conform to requirements. If you outsource processes, services or products, YOUR ORGANIZATION is still responsible for them.
Thank you, in this case the scope statement should be : "Provision" of manufacturing not explicitly manufacturing , right ?
 

John Broomfield

Staff member
Super Moderator
#4
"Manufacturing services" would cover both in-house and outsourced manufacturing.

...and state the scope of your accredited certification completely enough to make sense to your customers.
 
#6
This topic comes up frequently and the short answer is no. You cannot exclude something because it is outsourced. You are still responsible for it. You can't sidestep it.

TC 176 (the committee that wrote ISO 9001) has provided guidance on this topic if you need it.
 

Randy

Super Moderator
#7
This topic comes up frequently and the short answer is no. You cannot exclude something because it is outsourced. You are still responsible for it. You can't sidestep it.

TC 176 (the committee that wrote ISO 9001) has provided guidance on this topic if you need it.
The long answer is, it depends. A GOCO activity may have absolutely no control over some aspects of the service or product they deliver other than filing a quality report to a government entity...Been there, done that
 

Randy

Super Moderator
#9
GOCO = Government Owned Contractor Operated. One previous job I had was with a logistics contract valued at $240Million for performing maintenance and logistics support at a major military installation. As a contractor we had absolutely no say or control over material used, subcontract work, replacement parts acquisition, tooling or anything else that would or could be considered "outsourced". We sold manhours and that's it. Even much of the training & certification of contractor personnel is arranged by the various government agencies involved.

There are numerous GOCO's that are certified to 9001, 14001, & 45001 and a couple probably to 9110 or 9120, I know 1st hand because I audit some of them.

Contracts can be Fixed Price, Cost + Award Fee and other financial methods.

There's a lot more going on that just manufacturing.
 
#10
GOCO = Government Owned Contractor Operated. One previous job I had was with a logistics contract valued at $240Million for performing maintenance and logistics support at a major military installation. As a contractor we had absolutely no say or control over material used, subcontract work, replacement parts acquisition, tooling or anything else that would or could be considered "outsourced". We sold manhours and that's it. Even much of the training & certification of contractor personnel is arranged by the various government agencies involved.

There are numerous GOCO's that are certified to 9001, 14001, & 45001 and a couple probably to 9110 or 9120, I know 1st hand because I audit some of them.

Contracts can be Fixed Price, Cost + Award Fee and other financial methods.

There's a lot more going on that just manufacturing.

This prompted me to turn to The Auditing Practices Group publications on the TC-176 website, as I remembered under ISO 9001:2008 there were definite guidelines about excluding outsourced processes. Much to my surprise, the current set of publications do not mention anything about outsourcing and non-applicability.
 
Thread starter Similar threads Forum Replies Date
Q Process description for outsourced processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Outsourced processes how to interact with projects - We are an governmental department with 2 persons ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K ISO 14001:2015 clause 8.1 on outsourced processes ISO 14001:2015 Specific Discussions 1
Q Control of outsourced processes - drop shipped products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Outsourced Major Processes - Working for Two Sister Companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D Clear definition of Outsourced Processes (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 6
J ITAR flow down to Processors (Outsourced Processes) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J ISO 13485:2016 QMS: Outsourced Processes ISO 13485:2016 - Medical Device Quality Management Systems 11
P Records for outsourced special processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
A Outsourced Processes Control (Finished Medical Device Delivery, Storage) ISO 13485:2016 - Medical Device Quality Management Systems 10
C 7.2 Customer Related Processes - Everything we do is Outsourced ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
GStough "Outsourced Processes" in a Government Contract Service Provider Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C How to Define and Document Controls of Outsourced Processes Food Safety - ISO 22000, HACCP (21 CFR 120) 5
A Methods for Approval of Internal and Outsourced Manufacturing Processes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Determining what are, and are not, Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
D Approved Supplier Control Requirements for Outsourced Special Processes Supplier Quality Assurance and other Supplier Issues 4
A 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 36
A The auditor documented that we did not have control of Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Outsourced Process - Why certain "processes" are not included - ISO9001-2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
A Additional Control Measures for Outsourced Processes under ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
6 Description of Outsourced Processes in ISO 22000 Manual Food Safety - ISO 22000, HACCP (21 CFR 120) 4
O Methods used to Control Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E Does the ISO/TS 16949 scope have to include all processes, even if outsourced? IATF 16949 - Automotive Quality Systems Standard 7
R Determining which Processes are Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Control of Outsourced Processes defined within the Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Support Processes, Exclusion and Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
C API Q1 8th ed/ISO TS 29001 Maintaining Responsibility for Outsourced Processes Oil and Gas Industry Standards and Regulations 6
R Outsourced Processes - Firm examples required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 34
kedarg6500 Third Party Logistics & Outsourced-Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Control of Outsourced Processes (not properly described in the quality manual) ISO 13485:2016 - Medical Device Quality Management Systems 44
V Outsourced Maintenance Processes IATF 16949 - Automotive Quality Systems Standard 3
P Outsourced Processes - Delivery of our Products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q Type and Control of Outsourced Processes - ISO 9001 Clause 4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
B Dealing with Outsourced Processes in a DMR ISO 13485:2016 - Medical Device Quality Management Systems 7
P Definition and control of outsourced processes - Service Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R How Can We Show Control Over Outsourced Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
S Validation Of Outsourced Special Processes under AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
somashekar Control Over Outsourced Processes - Share some experiences and methods ISO 13485:2016 - Medical Device Quality Management Systems 6
Sidney Vianna Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
M Outsourced Processes & Process Design - Interpretation of the "Outsourced Processes" Design and Development of Products and Processes 8
F Outsourced special processes - How to control outsourced special processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Validation of outsourced processes - Calibration - How do we validate that? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
F Outsourced Processes - Not all identified in the Quality Manual ISO 13485:2016 - Medical Device Quality Management Systems 6
T ISO 9001:2000 - Clause 4.1 - How to control outsourced processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
H Definition Outsourced Processes - Definition and Identification of Outsourced Processes Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
Y ISO 13485:2003 Documentation Requirements for Outsourced Processes and Services ISO 13485:2016 - Medical Device Quality Management Systems 24
T ISO9001:2000-sec 4.1-relating to outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Identifying Outsourced Processes - Training, Calibration, Consulting - TS-16949 IATF 16949 - Automotive Quality Systems Standard 2
R Outsourced processes - Same Company, Different Location ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Outsourced Processes vs. Contract Personnel ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom