Seeking ISO 9001:2000 Internal Audit Matrix Examples

T

tomjess

#1
Internal Audit Matrix

I am looking for an example of a matrix for Internal audits (9001:200). I am doing one but keeping stuck, I know it should be simple, but I suppose I'm the simple one.

Thanks
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Leader
#3
Remember.... For internal audits there are going to be company specific aspects which will differ company to company. That is part of audit planning.

Take a good look at your internal audit system and determine what type of audit you're going to do. Is it going to be primarily process focused or a strict ISO 10011-1-1994 “Guidelines for Auditing Quality Systems - Auditing” type of audit.

Russ Kochis said:

Tomjess,
This is what our registrar uses, hope it helps.
Russ, Thanks for the form! We all appreciate it!
 
C

compliance - 2006

#5
19011

I have a question on which maybe you all can provide input.....Our company is about 300 people on site and about 500 total. Our internal auditor resides in our QA department. During our last registrar audit, we received a minor nonconformance because of a conflict of interest in our internal auditing program. Since the internal auditor audits all of the quality systems, hence her boss, our registrar indicated that we have a conflict of interest. 19011 is different from the old regulation because it includes "conflict of interest" in the section for internal audits. Of course there are mixed feelings about this throughout our organization, but our internal auditor agrees with the finding and her boss does not. What are your thoughts? If the audit program weren't in the QA department, where would it be?
 
#6
compliance said:
Our internal auditor resides in our QA department. During our last registrar audit, we received a minor nonconformance because of a conflict of interest in our internal auditing program.
That sounds reasonable. Being the sole auditor she would be forced to audit her own work (the audit program), which is no good when you look at ISO 9001:2000, clause 8.2.2. The NC seems solid imo. Clause 4d in ISO19011:2002 deals with the same thing
d) [font=Arial,Bold]Independence: [/font][font=Arial,Italic]the basis for the impartiality of the audit and objectivity of the audit conclusions[/font]

[font=Arial,Italic][/font]Auditors are independent of the activity being audited and are free from bias and conflict of interest. Auditors maintain an objective state of mind throughout the audit process to ensure that the audit findings and conclusions will be based only on the audit evidence.
... but you are not audited acc. to ISO19011.
compliance said:
our internal auditor agrees with the finding and her boss does not. What are your thoughts? If the audit program weren't in the QA department, where would it be?
Imo your auditor is correct, but the answer is not to move the audit program elswhere. What you need is someone who is not responsible for running it to audit it. Here we solve the problem by letting an auditor not working in the quality department audit it.

Besides, your auditor could probably need a bit of help anyway. One single auditor in a company with 500 people sounds very thin....

/Claes
 
C

compliance - 2006

#7
Thanks for your input. We actually do have someone other than the auditor audit the internal audit program, but that's it. The finding was directly related to the auditor auditing the quality system and hence auditing her boss (for example, her boss could make her exclude some findings related to him or his system and ultimately, she would have to comply since he is her boss.) Their concern was that the auditor might not be able to audit without some enforced bias. The finding was not that the auditor herself was not independant from the areas she audits. Do you still feel the same? I still think it's a valid finding, but as I mentioned, others do not.
 
#8
compliance said:
Do you still feel the same? I still think it's a valid finding, but as I mentioned, others do not.
Oopsie.... That's a bit different, actually:
ISO9001:2000 said:
...Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
Ok... Your auditor is not auditing her own work, so that's ok, and unless your registrar can point out reasonable cause for their concern for bias I'd say they are out on a very thin limb. "Might not be able to audit without enforced bias" is not enough imo. They have to prove their point. I agree that auditing your boss is obviously less than ideal, but there is nothing in the standard saying that you cannot do it.

/Claes
 
Thread starter Similar threads Forum Replies Date
S Responsibilities between government owner and private subcontractor of a power plant seeking ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
QMMike New Trend of not seeking Official ISO 9001 Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
T ISO 9001:2015 Training for Management Team in NM - Seeking Suggestions and Providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Seeking AS9001 standard (Australia's ISO 9001) - Does anyone of you have? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
B Seeking training and reference material for ISO 9001 aimed at IT Service Organization Training - Internal, External, Online and Distance Learning 3
C Seeking ISO 9001 and ANSI Z10 crosswalk (cross reference matrix) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Seeking: ISO 9001:2000 Internal Audit Checklist for Newbie Internal Auditing 20
B Writing ISO 9001:2000 Procedures - Seeking trained opinion on my procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M ISO 9001:2000 Implementation Project Plan - Seeking MS Project Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
M Seeking ISO 9001:2000 Auditing Tools - Check List, etc. General Auditing Discussions 6
L Seeking: cGMP FDA-based Quality Manual with ISO 9001 and EN Requirements Quality Management System (QMS) Manuals 4
I ISO 9001:2000 Preventive Action Procedure: Seeking examples ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N Seeking: The ISO 9001 Clauses ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Seeking: ISO 9001:2000 Audit Check List General Auditing Discussions 21
S Seeking: ISO 9001:2000 & TS 16949 Gap Analysis IATF 16949 - Automotive Quality Systems Standard 3
I Seeking: Sample ISO 9001:2000 Quality Manual Quality Management System (QMS) Manuals 4
A ISO 9001 Clause 7.4.1 Supplier Rating System - Seeking simple system example Supplier Quality Assurance and other Supplier Issues 28
R Seeking ISO 9001:2000 Overview Presentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Tracking ISO 9001 documentation - Seeking software recommendations Quality Assurance and Compliance Software Tools and Solutions 3
K Seeking: Ideas for Measuring the Processes as Required by ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Marc Integration of ISO 14001 with ISO 9001 - Seeking Example Manual Miscellaneous Environmental Standards and EMS Related Discussions 36
K Seeking ISO 13485 Registrar Recommendations Registrars and Notified Bodies 15
P Seeking Information on ISO 15504 - Information Technology Process Assessment Other ISO and International Standards and European Regulations 3
Q Seeking Examples of current ISO/TS 16949 Training Procedures IATF 16949 - Automotive Quality Systems Standard 2
T I'm seeking ISO 13485:2003 Supplier Audit Checklist Supplier Quality Assurance and other Supplier Issues 1
T ISO 9000 / Lean Six Sigma Survey - University Study - Seeking Respondents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q ISO 13485, FDA's QSR, CMDR, MDD: Seeking Internal Audit Correlation Matrix Various Other Specifications, Standards, and related Requirements 3
V Seeking ISO 17025 accreditation - How necessary are Quality Control activities? ISO 17025 related Discussions 7
I Statement of Applicability per ISO 27001:2005 Information Security - Seeking Example Other ISO and International Standards and European Regulations 5
Q Various Excellence Models, Awards and ISO 9000 - Seeking Cultural Comparisons Misc. Quality Assurance and Business Systems Related Topics 9
E Contract manufacturer seeking help understanding ISO 13485 Validation requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
B ISO 13485 Training Organizations in the US - Seeking Reviews and Recommendations Training - Internal, External, Online and Distance Learning 2
E ISO/TS16949 - Seeking refresher material as well as a motivation tool Training - Internal, External, Online and Distance Learning 1
C Measurement Uncertainty (ISO 17025) - Seeking Lay Person Understanding ISO 17025 related Discussions 8
B EMS Manual based on ISO 14001-2004 - Seeking Examples ISO 14001:2015 Specific Discussions 19
H Seeking Power Point Presentation Concerning Iso 17025 ISO 17025 related Discussions 4
T Internal Auditor Training Presentation - ISO/TS 16949 - Seeking Information Training - Internal, External, Online and Distance Learning 10
L ISO 13485: 2003 - Clause 8.4 Analysis of Data - Seeking an example procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
A Registrar For ISO / TS 16949: Seeking Recommendations Registrars and Notified Bodies 36
Q Seeking Recommendations: Public ISO 14001 Lead Auditor training course Training - Internal, External, Online and Distance Learning 11
apestate Job shop seeking QMS intends to manufacture devices, is ISO-13485 appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
R Seeking ISO 17025 tools to help keep my employees in the mind frame of ISO 17025 ISO 17025 related Discussions 1
I Seeking: References for online literature about ISO/TS Implementation Book, Video, Blog and Web Site Reviews and Recommendations 1
J ISO 14971 - Risk Analysis - Seeking guide and / or summary ISO 14971 - Medical Device Risk Management 4
M Seeking Boilerplate Templates for ISO Type Documents Document Control Systems, Procedures, Forms and Templates 2
howste Seeking: ISO registered training/corrections companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Business Plan - Seeking Example based on ISO/TS 16949 requirements Document Control Systems, Procedures, Forms and Templates 4
I Is ISO 10015 still in effect? Seeking Materials - Guide for Training ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D 50ml Syringe testing to ISO 7886-1:1997 - Seeking Test Laboratory Other ISO and International Standards and European Regulations 1
S ISO 14001 Supplier Questionnaire - Seeking Example Supplier Quality Assurance and other Supplier Issues 22

Similar threads

Top Bottom