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

SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
M

M Greenaway

#3
#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
#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
#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
#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
#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
#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
#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
#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.
 
You must log in or register to reply here.
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 19
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 3
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
M How to answer ISO9001:2015 audit finding of old revisions of documents being used? Document Control Systems, Procedures, Forms and Templates 7
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
I Audit is tomorrow but I refused to participate Misc. Quality Assurance and Business Systems Related Topics 16
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
D Verify Audit Trail of SaaS system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
D Re-labeler - audit the supplier EU Medical Device Regulations 2
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
A PPAP question for audit APQP and PPAP 16
D Number of people to be interviewed during an internal audit? Internal Auditing 6
B Gamma Quarterly Audit Medical Device and FDA Regulations and Standards News 1
A Anxiety - ISO Re-registration Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 69
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
S Quarterly Dose Audit Medical Device and FDA Regulations and Standards News 5
H When is a SOC 2 audit necessary? IEC 27001 - Information Security Management Systems (ISMS) 3
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D Special IATF audit of sub-supplier IATF 16949 - Automotive Quality Systems Standard 18
A Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
C API Q1 internal audit report Internal Auditing 3
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 2
A IRIS audit - Discussion about Special Processes General Auditing Discussions 11
J Internal audit random sampling methodology Internal Auditing 2
D Major NC from last audit not fixed not sure how to fix General Auditing Discussions 10
X Sample SOC2 audit report (or a redacted one) IEC 27001 - Information Security Management Systems (ISMS) 0
D Lead time to schedule an ISO 13485 audit General Auditing Discussions 2
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
W How do you phrase your internal audit questions? Internal Auditing 3
Z Steps to take before an MDSAP audit for Canada Canada Medical Device Regulations 2
V Csv, excel format - audit trail file of HPLC system ( Empower, openlab, EZchrom or any other ) Qualification and Validation (including 21 CFR Part 11) 0
G Not accepting a non conformity during an audit General Auditing Discussions 11
K IATF audit day requirements table 5.2 IATF 16949 - Automotive Quality Systems Standard 6

Similar threads

Top Bottom