SBS - The best value in QMS software

Is hiring a CB for certification and periodic audits an outsourced activity?

S

samsung

#1
There are some processes which an organization can not carry out on it's own (or not allowed to do) and therefore these processes have to be outsourced. One such activity/ process is Certification Audit which fits into the definition of 'Outsourcing' as stated in 9001.

Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
Are there organizations which treat 'hiring the CB for certification and periodic audits' as an outsourced process?

Your opinion please.

Thanks.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
This is taking it a little too far ~~~
Even though I have the strength to internal audit as effectively or better than a CB, I have no recognition to certify myself.
Outsourcing CB amounts to exercising such controls over the CB to provide product / service to your requirements and not to the requirements of the international standards ... :mg:
You evaluate and select CB, there by it is a good purchasing process of contracting with a CB (I would not use the word hire)
 
Last edited:
#3
There are some processes which an organization can not carry out on it's own (or not allowed to do) and therefore these processes have to be outsourced. One such activity/ process is Certification Audit which fits into the definition of 'Outsourcing' as stated in 9001.



Are there organizations which treat 'hiring the CB for certification and periodic audits' as an outsourced process?

Your opinion please.

Thanks.
No! It has nothing to do with your processing of product to meet customer requirements, like machining, painting, plating, welding or something similar.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#4
If we look at the document
ISO 9000 Introduction and Support Package: Guidance on 'Outsourced Processes'


We can see
2.1) What is an “outsourced process”?

The Oxford English Dictionary defines the verb “outsource” as “to obtain….. by contract from a source outside the organization or area; to contract (work) out”

As now defined in ISO 9001:2008 Sub clause 4.1 NOTE 2, an “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
The operative word here is chooses as Somashekar said before you cannot choose to use a CB, there is no alternative.
 

Randy

Super Moderator
#5
:bigwave:
No! It has nothing to do with your processing of product to meet customer requirements, like machining, painting, plating, welding or something similar.
Uh, Andyyyyyyy! What if a condition of contact (7.2.1) is that an accredited 3rd party registration be obtained as part of the deliverable?
 

Jim Wynne

Staff member
Admin
#6
:bigwave:

Uh, Andyyyyyyy! What if a condition of contact (7.2.1) is that an accredited 3rd party registration be obtained as part of the deliverable?
I would say that if you've obtained accredited third-party registration, you've fulfilled that requirement of the "contact."
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
No! It has nothing to do with your processing of product to meet customer requirements, like machining, painting, plating, welding or something similar.
Correct. Just like getting your medical device product approved by the FDA is not an outsourced process.
 

Randy

Super Moderator
#9
I worked (previous employer) on a Cost + Award Fee contract that had a stipulation along with all the others that 3rd party certification to ISO 9001 was an absolute within the 1st year of the contract delivery (a $200million + contract). The certificate in hand was just as important to the customer as the M1 tanks we repaired and a portion of the award fee was attached to having it. The cert was a measurable and a deliverable. The cert was no different that any other contract or product specification that had to be planned, realized and delivered.

I ain't on nuttin and I'm 60 lbs lighter. Ya'll need to get out of the manufacturing only mind-set.
 
#10
I worked (previous employer) on a Cost + Award Fee contract that had a stipulation along with all the others that 3rd party certification to ISO 9001 was an absolute within the 1st year of the contract delivery (a $200million + contract). The certificate in hand was just as important to the customer as the M1 tanks we repaired and a portion of the award fee was attached to having it. The cert was a measurable and a deliverable. The cert was no different that any other contract or product specification that had to be planned, realized and delivered.

I ain't on nuttin and I'm 60 lbs lighter. Ya'll need to get out of the manufacturing only mind-set.
Ok, but how is that anything to do with outsourced process, as applicable to the implementation of an ISO 9001 based system?
 
Thread starter Similar threads Forum Replies Date
O Is hiring more difficult right now? Career and Occupation Discussions 13
M Hiring Decisions - How much effort do you put into the hiring process these days? (7/2020) Misc. Quality Assurance and Business Systems Related Topics 6
T Internal Audit Schedule when Hiring Out Internal Auditing 7
F Cost of hiring ISO 17025 Consultant to Build Laboratory From Scratch ISO 17025 related Discussions 6
W Hiring an External Auditor to perform our AS9100 Compliance Audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Audit Man Day Requirements - Small AS9100 Company hiring New Employees AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
Wes Bucey A justification to take HR out of hiring Career and Occupation Discussions 3
F Anyone have experience of a hiring a Social Anthropologist? Human Factors and Ergonomics in Engineering 9
Jim Wynne You've Come a Long Way, Baby - Gender in Hiring Coffee Break and Water Cooler Discussions 2
Stijloor China is hiring, and young Americans are going Career and Occupation Discussions 16
DanteCaspian Procedure outline for hiring process Misc. Quality Assurance and Business Systems Related Topics 1
E Service Company Hiring Procedure Reconciliation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Need guide to write email/letter to hiring manager Career and Occupation Discussions 3
L Medical Devices Jobs - Abbott is currently hiring ISO 13485:2016 - Medical Device Quality Management Systems 1
C Need opinion to keep alive candidacy - Position hiring placed on Hold Career and Occupation Discussions 12
Ajit Basrur FDA Embarks on Major Hiring Initiative for its Public Health Mission US Food and Drug Administration (FDA) 0
W What are the requirements for having documented hiring standards? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Marc Company Makes Hiring Mistake, Sues Employee To Get Money Back Career and Occupation Discussions 11
A IBM hiring more than 14,000 new workers in India this year Coffee Break and Water Cooler Discussions 7
Marc Brain Scans in Hiring - Brain imaging spreads to nonmedical uses Career and Occupation Discussions 3
Claes Gefvenberg How do you (try to) make certain you're hiring the right person? Career and Occupation Discussions 17
R Outsourcing Internal Audits - Hiring a contractor to plan and perform internal audits Internal Auditing 21
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
G IATF Rules for COVID 5th revision - Re-certification audit timing IATF 16949 - Automotive Quality Systems Standard 3
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
K USB VID/PID certification Various Other Specifications, Standards, and related Requirements 2
L IATF 16949 certification costs IATF 16949 - Automotive Quality Systems Standard 3
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
R China Quality Certification Various Other Specifications, Standards, and related Requirements 1
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
N Any experience with Registrars that deny Certification to a Registrant? Registrars and Notified Bodies 4
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
J Hitrust Certification (HIPPA etc.) Other Medical Device Regulations World-Wide 0
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
M What happens to certifications if the issuing certification body loses accreditation? Supplier Quality Assurance and other Supplier Issues 2
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 1
K Regulatory Affairs Certification (RAC) Exam - November 2020 preparation Professional Certifications and Degrees 0
B Advantages of a corporate certification scheme IATF 16949 - Automotive Quality Systems Standard 8
N Harmonized Standards for MDR Certification EU Medical Device Regulations 7
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 3

Similar threads

Top Bottom