Definition Audit - Definition of what an audit is - Is there more to auditing?

Elsmar Forum Sponsor
M

M Greenaway

#3
None in particular Claes, just though it might interest others.

I stumbled on it today thinking 'who are these guys trying to steal the IRCA's limelight' and was very interested in the 'wider' world of auditing shown in this website. I was particularly interested in the comments made in the discussion forum that showed a certain disdain for ISO9000 internal auditors that felt they knew it all about auditing.

I was also interested to read there definition of what an audit is, particularly the openness of it being a 'consultancy' exercise as well - in the ISO world we would smart at such suggestions.

I think those interested in auditing could do well to see what these guys are about - I even saw that someone was doing an MSc in Auditing !!

I think the site also shows how the ISO9000 world is in 'catch up' regarding auditing effectiveness, comments made in the discussion forum suggest that these guys see ISO auditors as 'box ticking policemen' - perhaps true, very interesting !
 
J

Jimmy Olson

#4
The problem with considering the comments on that site is that it is not geared towards quality auditors, but financial auditors instead.

Financial and business auditors have always looked down their noses at quality auditors and consider quality audits a waste of time. However, with things changing, they may be looking to the quality auditors when they have to start looking at business processes.
 
J

Jimmy Olson

#5
Hi Jim :bigwave:

Sorry to dissapoint you, but I won't be drawn into a debate on semantics by a trick question. :D
 
J

Jimmy Olson

#6
Ok Jim, I will give you the benefit of the doubt :D

When I mentioned Quality Auditors I was using a generic term to refer to a traditional ISO Quality Systems Auditor. This is in contrast to a Financial Auditor who will primarily focus on the finance side of a business. As it stands now, there is a difference between the two, even though they are similar. But, both sides are going to have to adapt in the futre as they begin to merge.
 
J

Jimmy Olson

#7
Jim,

I do think the role of a quality auditor does need to change. I know of too many internal auditors that could quote the standard word for word, but don't understand anything about how their company operates. In order to be an effective auditor I think you need to understand the various processes of the company and how they all relate to each other.

I'm not sure about managers being part of the audit team, but they definitely need to support the audit program (so I guess in a way they would be part of the team). The auditor role should still fall to one or two people (or however many depending on company size). But the auditor should have a wider range of skills and knowledge than what is provided in a traditional ISO 9001 auditor course. This is why I see a merging of auditors being a good idea. If you have a person who understands the company processes and also has an understanding of business practices, I think this would be an ideal person to conduct audits. This would also be very beneficial to the company as well.

Sure, you're required to check compliance to the standard, but why stop there? Check to see if all the processes are effective and efficient and look for areas to improve.
 
M

M Greenaway

#8
Jim

My thoughts are that you cannot check for compliance to ISO9001 from a desk, you have to see what is actually being done complies.

I do agree that efficiency and effectiveness checks, and the degree to which we meet objectives are better done by other formal measurement methods, and in fact ISO9001 tells us to do this 'outside' of the audit process in clause 8.2.3 on measurement of processes.
 
M

M Greenaway

#9
Jim

I appreciate the argument, but how does that fit with the ISO9001 clause 8.2.2 on INTERNAL audit, where it says that this process shall determine whether the QMS conforms to the requirements of ISO9001.

Also would anyone consider that a six monthly review of the system by an external body is adequate to determine the conformance of the system ?

(assuming that those that chose the ISO9001 model did so because they wanted their system to match it for positive benefits)
 
C

Craig H.

#10
For what its worth, I agree that the monitoring of the quality system must be an ongoing process. However, the bi-yearly look at that system by someone who is not working within it can be valuable precisely because they are not involved in the system.
 
Thread starter Similar threads Forum Replies Date
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 22
M Inputs on definition of very similar processes for multi site audit sample - IAF MD1 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Definition Would a wrong definition constitute an Audit Finding? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
K Definition of Repeat Audit Findings Internal Auditing 11
W Definition Product Audit - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
K Definition Audit - Time for a new definition of the word Audit? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 15
B Definition of Calibration Frequency - Dispute during Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Audit "Finding" Definition and Significance General Auditing Discussions 7
S Audit Trails - Definition, Description and Software Internal Auditing 9
D Definition Major Audit Nonconformance - Definition of Major Nonconformance Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
J Definition of Special Characteristics Delta C and Delta S - Need for Customer Audit Capability, Accuracy and Stability - Processes, Machines, etc. 2
L Audit Definition in ISO 9000:2000 includes "documented process"? General Auditing Discussions 2
E Definition Audit Finding - In 'Registrar Language' what is the Definition of a 'Finding'? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 11
A Definition Major vs. Minor Nonconformance (Finding) - Internal Audit - Definition & Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 38
Marc Definition Process Audit - Internal and External - ISO9000 - A Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
N Definition Discovery Audit - Can someone give me a text book definition? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
G During internal audit - finding poor action plans ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Need help in determining applicable clause for an audit finding (based on AS9120B) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Opening meeting - internal audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Ed Panek Audit Protocol? Simultaneous surveillance and recertification audits. ISO 13485:2016 - Medical Device Quality Management Systems 11
D Is a lost calibrated tool an non-conformance for an audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 58
D IATF16949 external audit plan IATF 16949 - Automotive Quality Systems Standard 3
B 8.5.1.1 Control Plan - question audit NC IATF 16949 - Automotive Quality Systems Standard 5
D ISO 9001:2015 Recertification Audit Timing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Mr Roo Discovered dishonesty after performing an internal audit General Auditing Discussions 4
Q 10.3 Continual improvement - How to audit it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
H Audit Checklist for European Authorized Representative EU Medical Device Regulations 0
Q Product audit assessment IATF 16949 - Automotive Quality Systems Standard 3
S Customer audit report review and approval ISO 13485:2016 - Medical Device Quality Management Systems 3
Moncia Integrated QMS and audit Other ISO and International Standards and European Regulations 5
G Audit & Agreements for "Test Laboratory" Supplier? US Medical Device Regulations 4
J New QMS Auditor - seeking opportunities to gain audit experience Career and Occupation Discussions 3
M IATF external audit NC closure IATF 16949 - Automotive Quality Systems Standard 4
W IATF 9.2.2.1 Internal Audit how to determine risk IATF 16949 - Automotive Quality Systems Standard 12
M Multiple time zones in the Audit Trail Qualification and Validation (including 21 CFR Part 11) 7
X Looking for 17025 auditor to perform internal audit on IT software testing laboratory ISO 17025 related Discussions 3
A API Q1 9th Edition Surveillance Audit - Quality Policy Oil and Gas Industry Standards and Regulations 2
S Audit Finding - Design History File (DHF) Index: few (3 to 4) reports not identified ISO 13485:2016 - Medical Device Quality Management Systems 3
xfngrs 3 year audit cycle IATF 16949 IATF 16949 - Automotive Quality Systems Standard 10
Q NACE Code 25.6 no reduction in CB audit days? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
J 9001 Internal Audit of Client Onboarding process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
H Streamlining audit response and corrective action processes ISO 13485:2016 - Medical Device Quality Management Systems 9
Q Corrective Action Notification - Registration Audit ISO 13485:2016 - Medical Device Quality Management Systems 12
chris1price Irradiation site for dose audit Other Medical Device Related Standards 2
PQ Systems 5 Ways to Reduce Stress on Your Next Audit Using GAGEpack Software 0
PQ Systems Audit Prep – Time for a System Health Check Using GAGEpack Software 0
N API Q1 Audit Surveillance - Questions Oil and Gas Industry Standards and Regulations 2
A Alternative to on site audit in China EU Medical Device Regulations 2
J Help to understand and response to API AAR during the re-certification audit Oil and Gas Industry Standards and Regulations 17
B Internal audit checklist Internal Auditing 5

Similar threads

Top Bottom