Impartiality of Internal Auditor ISO 9001/13485

D

Deli88

Involved In Discussions
#1
#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?
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
blackholequasar

blackholequasar

The Cheerful Diabetic
#2
#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!)
 
B

Big Jim

Admin
#3
#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.
 
B

Big Jim

Admin
#4
#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

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
#5
Big Jim said:
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.
Click to expand...
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​
 
G

Golfman25

Trusted Information Resource
#6
#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.
 
B

Big Jim

Admin
#9
#9
Sidney Vianna said:
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

Click to expand...
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.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R How to election the chairman of impartiality committee? CE Marking (Conformité Européene) / CB Scheme 7
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
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
T Ford CSR for Internal Auditors 2021 Internal Auditing 4
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
D INTERNAL LABORATORY IATF 16949 - Automotive Quality Systems Standard 4
S Transition training for Internal Auditor from ISO 9001: 2008 to the ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J IATF CB Auditor questions Internal Auditor Competence IATF 16949 - Automotive Quality Systems Standard 19
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
D Number of people to be interviewed during an internal audit? Internal Auditing 6
cgaro62 Using internal audits as part of document reviews Document Control Systems, Procedures, Forms and Templates 20
S Is it required to complete Internal Audits within one year? ISO 13485:2016 - Medical Device Quality Management Systems 29
C First Round of QMS Internal Audits - Ethical Dilemma Internal Auditing 7
T How to conduct combined internal audits (9001 and 13485) Internal Auditing 1
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
C API Q1 internal audit report Internal Auditing 3
AllTheThings ISO-17025 accredited TEST lab performing internal calibrations (Yes: Here is how) ISO 17025 related Discussions 6
M Must a company be 17025 accredited to perform internal calibrations? ISO 17025 related Discussions 7
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 2
A ISO 9001 Internal Audits - No production right now due to furloughs Internal Auditing 5
J Internal audit random sampling methodology Internal Auditing 2
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
W How do you phrase your internal audit questions? Internal Auditing 3
M IATF - Internal Audit 3 year span Internal Auditing 4
Thee Bouyyy Internal NCR - API Q1 5.4.2b - API 16C Clause 4.1.3 Internal Auditing 9
Q ISO 9001-2015 Internal audit finding Internal Auditing 14
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 18
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 15
J ISMS - Internal Audits Internal Auditing 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 8
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

Similar threads

Top Bottom