Impartiality of Internal Auditor ISO 9001/13485

Deli88

Involved In Discussions
#1
I'm 99.999% certain this isn't allowed but I want to sound this off against some more experienced people than myself.

As part of out QMS we have 4 process, Purchasing, Customer Order, Production, and Management

As it stands I conduct 3 of the 4 audits, the 4th audit is against the management which I cannot conduct due the fact that I am responsible for this area as the QM.

Is it acceptable for another member of the quality team to conduct this audit or does the person need to be further removed?
 
Elsmar Forum Sponsor

blackholequasar

Involved In Discussions
#2
Newer employees may be able to get away with it, as they are brand new to the process in general, but as a rule of thumb... it's probably not far enough removed to allow internal auditing to be performed. I would bring someone else in to do this part of the audit.

Do you audit the same areas every year? Do you have any other team members for internal audits? (Some smaller companies struggle with this, I completely empathize - in the same boat myself!)
 

Big Jim

Super Moderator
#3
There is good guidance for this in ISO 9002:2016. ISO 9001:2015 DOES NOT prohibit you from auditing your own work. That clause from the 2008 version was removed. The guidance in 9002 helps you to keep it impartial and objective.

Some knucklehead auditors just won't let this obsolete requirement die.
 

Big Jim

Super Moderator
#4
I answered based on 9001. 13485 does indeed still require that you not audit your own work. The knuckleheads at 13485 are living in the past. They didn't move up to the High Level Outline and their standard is still based on ISO 9001:2008.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
There is good guidance for this in ISO 9002:2016. ISO 9001:2015 DOES NOT prohibit you from auditing your own work. That clause from the 2008 version was removed. The guidance in 9002 helps you to keep it impartial and objective.

Some knucklehead auditors just won't let this obsolete requirement die.
Just to remind people of the contentious thread on this subject: Informational - Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work)

Internal audits have to be "independent", impartial and objective. If anyone thinks that you can accomplish that, while auditing your own work, I disagree. The wording in ISO 9001:2015 was revised due to the High Level Structure text, but, in my opinion, the intent remains unchanged.

As for the guidance of ISO/TS 9002, see below. It is VERY SPECIFIC

Annotation 2019-12-13 113617.jpg
 

Golfman25

Trusted Information Resource
#6
What we do is we have 4 auditors who are department managers. Then we audit each other. So the purchasing manager/auditor audits the manufacturing guy. The Manufacturing guy audits management. Etc.
 

Big Jim

Super Moderator
#9
Just to remind people of the contentious thread on this subject: Informational - Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work)

Internal audits have to be "independent", impartial and objective. If anyone thinks that you can accomplish that, while auditing your own work, I disagree. The wording in ISO 9001:2015 was revised due to the High Level Structure text, but, in my opinion, the intent remains unchanged.

As for the guidance of ISO/TS 9002, see below. It is VERY SPECIFIC

The highlight is good but look at the rest of the sentence. ". . . or areas of the organization where specific job knowledge is required . . . "
and ". . . it may be necessary for a person to audit their own work ."

And then in the next sentence it gows on to tell you how to remain objective and impartial. "In this situation, the organization might have the internal auditor work with a peer, or have the results reviewed by a peer or a manager, to ensure results are impartial."

It would really be wonderful if TC-176 would explain exactly why they removed "auditors shall not audit their own work" from the latest version of the standard. In the meantime the only guidance we have from them is ISO 9002:2016, and what is there IS NOT ENOUGH TO JUSTIFY C,LAIMING THAT THERE WAS NO CHANGE.
 
Thread starter Similar threads Forum Replies Date
V IS/ISO/IEC 17025:2017 Clause 4.1 Impartiality ISO 17025 related Discussions 3
J ISO 17020 concerns of independence & impartiality of services Other ISO and International Standards and European Regulations 1
Sidney Vianna ISO 17021-1 Management of impartiality - Why is this collusion allowed? Registrars and Notified Bodies 0
P Procedure for maintaining Confidentiality And Impartiality in a Laboratory Quality Management System (QMS) Manuals 2
S ISO/TS 16949 IATF Rules: 2.9 Management of Impartiality IATF 16949 - Automotive Quality Systems Standard 8
M IATF - Internal Audit 3 year span Internal Auditing 3
T Internal NCR - API Q1 5.4.2b - API 16C Clause 4.1.3 Internal Auditing 5
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
M ISO13485:2016, MDSAP and Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 11
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Would this be a second site for the purposes of internal and third party audits? General Auditing Discussions 4
V Internal Auditor Competency KPI IATF 16949 - Automotive Quality Systems Standard 14
J ISMS - Internal Audits Internal Auditing 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
S ISO 9001:2015 Internal Auditing Internal Auditing 8
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
salaheddine96 Internal audit planning Internal Auditing 2
D CB and customer audits considered as internal audits? General Auditing Discussions 9
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
E MDR internal audit Internal Auditing 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
F Internal transfer of work from one line to another? Qualification and Validation (including 21 CFR Part 11) 3
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
R Monitor production quality - Internal KPIs Manufacturing and Related Processes 5
R IATF 16949 - Outsourcing of internal audits Internal Auditing 11
M Major vs. Minor for Internal Audits? Internal Auditing 10
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Tips on preparing for IATF 16949 Internal Lead Auditor exam Manufacturing and Related Processes 1
C Internal Audits in a tiny Dx Company Internal Auditing 33
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 12
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 24
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 40
S Risk based internal auditing Internal Auditing 6
O Informational Scaling back internal audits due to corona virus while avoiding a NC Internal Auditing 7
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16

Similar threads

Top Bottom