Outsourcing Internal Audits - Hiring a contractor to plan and perform internal audits

R

Richard K

#1
There has been discussion on the mailing lists about outsourcing internal audits, including whether it is permitted by the standard. As far as I can tell, there is nothing in ISO 9001:1994 that prevents outsourcing. However, I have just now managed to look at ISO/CD2 9001:2000, and in 8.2.1.2 it states 'The organization shall carry out objective audits...' My question is, is this wording the same in the DIS, and if so, what exactly does 'carry out' mean? Is hiring a contractor to plan and perform an internal audit 'carrying out' an audit?

Richard
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Hello and welcome to the Cove!

You can outsource Internal Audits under the 'proposed' ISO9001:2000.

See Internal Auditors Have Real Jobs for a good thread on this topic. I 'glean' from several listservs, so some stuff may be redundant if you're on any of the lists I'm on. Also see Internal Auditor Training

As far as 'The organization shall carry out objective audits...' there is nothing telling a company how to do this. This just says the audits shall be done and that the audits shall be objective (the old 'you can't audit yourself'). One arguement is that a company can outsource any function and process. If a company hires me to do their internal audits, I am technically a 'temporary' employee.

Carry out means to follow or 'do' your internal audit procedure. As in to 'Carry Out' a plan. It implies acting on.
 
R

Richard K

#3
Thanks for the reply, Marc. Your interpretation sounds good to me. It seems though that the new wording might strengthen the case for those who argue otherwise. Are there any registrars that cause difficulties over this point?

Richard
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
So far I have yet to hear of a registrar which rejected contracted internal audits. To me this is a ghost issue - people talk about it as an issue - but it's not an issue.

What possible reason could a registrar have for telling a company that they cannot outsource internal audits? I don't see the verbiage in any way addressing the issue of contracted internal audits one way or the other.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#5
Marc,

I was wondering myself if the "objective audits" opened the door for performing self audits, objectivity and independence being separate. I was hoping that the new wording actually was as a result of having found objectivity being more important than independence (single person entities having ISO accreditation for example). If this is true, then I will be happier auditor. What do you think?

Regards,

Kevin
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
OK - I guess the definitions of objective vs independent is now the issue of discussion.

At that at this point I will agree that it's possible that objectivity being more important than independence could be the reason, but I doubt there are many 'one person shows' that want to register. I'd love to hear from someone on the committee who could elaborate.
 

barb butrym

Quite Involved in Discussions
#8
once again the discussion turns to this old topic. Speaking for a few registrars, and from experience as well.....Registrars have no problem with outsourcing the internal audit function, most welcome it. The 'temporary employee' thing of which marc speaks is a good justification when needed..... the key is in the definition of a 1st party audit.....the client and auditee/auditor have the interest of the company in hand (continuous improvement...if you will)...not that of a second party or independant body. Who pays the bill, who gets the value....etc. Who assigns/gets CA? Who controls the audit? The standard is looking for an independant and objective self-assessment, not clouded with hidden agendas.
The audit trail will tell all....if an objective audit is not performed the trail will ...in most cases...reveal that loud and clear...other times it will be hidden but the experience auditor will see it anyway.

As to independance.....I think if the audit is clearly objective (as evidenced by the audit trail?????) and not totally independant (as we all know it may not always be)there will be room to allow it as the DIS is currently written. Must be a case by case decision, by the registrar's auditor as I personally see it (not reflecting any input from registering bodies to date)

[This message has been edited by barb butrym (edited 14 December 1999).]
 

barb butrym

Quite Involved in Discussions
#10
kevin...our conversations about the new wording always end up with the intent is the same, the presentation of the requirements has changed.....the shift has gone from the 20 seperate elements to tieing them together where they really belong... and nothing has gone away (and little added that wasn't already implied)..the shift is to require a system to span the entire company, as well it should....not just stand alone. Anyone already doing the standard as it was really intended (abet not written) is already pretty well in compliance. the registrars are still mute but off the record have the same opinions.

As to the comments on this particular subject...my LA colleagues agree with me.

[This message has been edited by barb butrym (edited 15 December 1999).]
 
Thread starter Similar threads Forum Replies Date
R IATF 16949 - Outsourcing of internal audits Internal Auditing 10
D Contracted Internal Auditors - Outsourcing Internal Audits Internal Auditing 14
Crusader Your Internal Audit Team: Internal or Hired External? Outsourcing Internal Audits Internal Auditing 97
K Outsourcing ISO 9000 Internal Audits Internal Auditing 12
apestate Outsourcing Internal Audits - Is this a bad idea? Internal Auditing 14
Marc Outsourcing Internal Audits - 60 Retail Stores - Effectiveness vs. Compliance Internal Auditing 6
M Outsourcing and internal controls Internal Auditing 1
V Outsourcing Internal Quality Auditing functions Internal Auditing 26
S ISO 45001 and outsourcing the transporation of products Occupational Health & Safety Management Standards 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
G QMS requirements for legal manufacturer when outsourcing manufacturing process Other Medical Device Regulations World-Wide 23
B ISO 50001 Interpretation of section 3.3.9 (Outsourcing) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Supplier Management outsourcing - Business idea Supplier Quality Assurance and other Supplier Issues 8
S Outsourcing manufacturing - Who controls the suppliers of parts to the CMO? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Outsourcing process design (8.3.3) IATF 16949 - Automotive Quality Systems Standard 1
T ISO 13485 for software outsourcing company ISO 13485:2016 - Medical Device Quality Management Systems 7
G Outsourcing Processes within the Same Company (ISO 13485) Quality Manager and Management Related Issues 4
smryan Compliance Officer Outsourcing? RoHS, REACH, ELV, GADSL, IECSC Other ISO and International Standards and European Regulations 5
B Must a Design Outsourcing Company have ISO13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
R Microbiology Testing Outsourcing - Transport Qualification and Risk Assesssment Qualification and Validation (including 21 CFR Part 11) 2
J Definition Outsourcing - How Far Does it Go? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
J API Q1 9th Edition - Question on Outsourcing 5.6.1.6 Oil and Gas Industry Standards and Regulations 1
S Outsourcing a Core Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Medical Device Outsourcing Batch Traceability Requirements Other Medical Device and Orthopedic Related Topics 2
G Definition Work Transfer vs. Outsourcing Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
Crusader 7.6 Calibration (referencing outsourcing) in the Quality Manual Quality Management System (QMS) Manuals 5
S Outsourcing PPAP Function APQP and PPAP 8
C How to handle Outsourcing with Same Site - Separate Cert ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Y ISO9001 Implementation for Business Process Outsourcing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Outsourcing Calibration - NIST, OEM, and Calibration Laboratory General Measurement Device and Calibration Topics 2
L Risk Management in Outsourcing Company ISO 14971 - Medical Device Risk Management 16
A Outsourcing Records Storage - Compliance Aspects to be considered during Audits Document Control Systems, Procedures, Forms and Templates 7
R Outsourcing of a Semi-Finished Product - Which major things to address in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Outsourcing Shipping Product directly from our Warehouse to the End Customer ISO 13485:2016 - Medical Device Quality Management Systems 2
T Brief Survey for OEM's about Outsourcing Supplier Quality Assurance and other Supplier Issues 5
E Business Process Outsourcing - Training Plans for Employees where you deliver labour ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B ISO 13485 and Medical Device Manufacturing Outsourcing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K What's the difference between Outsourcing and Work Transfer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J General Procedure for Outsourcing of Human Resources and Service Processes wanted Document Control Systems, Procedures, Forms and Templates 1
J Extending QMS Scope to External Company Site (Outsourcing) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna From Human Resources to Outsourcing ? ISO expands work in five areas Other ISO and International Standards and European Regulations 4
O Outsourcing part of Design & Dev Process- Still requiring D&D ver & val-7.3.5, 7.3.6? IATF 16949 - Automotive Quality Systems Standard 6
B Distributor Outsourcing Value Added Services - Is it work transfer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
T To share and (hopefully) to hear feedback - Outsourcing to China Quality Manager and Management Related Issues 20
R ISO/TS 16949:2009 Clause 4.1 General Requirements (Outsourcing) Clarification IATF 16949 - Automotive Quality Systems Standard 6
L Outsourcing Special Processes such as Plating, Painting, NDT as related to AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
L Outsourcing of Quality Tests (same company but different division) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Outsourcing manufacturing of final product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Terms & Conditions done by Outsourcing Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Outsourcing - Type of Control - Request for Interpretation on Clause 4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom