ISO 19011 revision - Your thoughts

Paul Simpson

Trusted Information Resource
#1
Hi all. Freshly arrived in Cairo for the TC 207 meeting. There is a joint working group on ISO 19011 revision - as ever any thoughts gratefully received.
 
Elsmar Forum Sponsor
#2
Re: ISO 19011 revision

Hi all. Freshly arrived in Cairo for the TC 207 meeting. There is a joint working group on ISO 19011 revision - as ever any thoughts gratefully received.
Tough gig, Paul!

There should be a much bigger differentiation of audit process between the 'formality' of external audits and that of internal audits. Everything is painted with the same brush, yet it's clear to me that because we have a 'one size fits all' and most training tends to emulate the external process (on which the earliest lead auditor courses were based) there needs to be a fundamental shift towards internal auditors behaving more like 6 Sigma Green Belts, than CB auditors!

Indeed, if I had my way, the whole internal audit process would be based more on the SS model, but I know that's pushing the envelope too much!

There should also be a definition of a clear role of an 'audit manager' and what should be considered in scheduling internal audits. Clearly, people have little idea what 'status and importance' mean in any practical sense and, as a result 'get away with' scheduling one or two a year to emulate the CB's audits - crazy......

Furthermore, (if I may) internal auditors need to be versed not just in 'ISO' - as they often are, but modern CI techniques like Lean and SS. Too many are oblivious of issues that if they had the 'eyes' to see, they'd have recorded 'ineffectiveness' NC's rather than 'following procedures' reports!.

One last thing - align the whole 'independence' thing. 19011 says one thing, ISO 9001 says something else! Let's have some consistency guys!

Any more?

Thanks and good luck with the committee!
 
Last edited:

Big Jim

Super Moderator
#3
Re: ISO 19011 revision - Cairo TC 207 meeting - Your thoughts - June 2009

I also agree that there should be better differentiation between internal and external audits, but would like to see it even more along the line of 1st, 2nd, and 3rd party lines. There should be better guidance for not just internal audits, but for supplier audits as well.

I'm not sure there should be stress toward other quality concepts. I just don't think they always fit. That should be part of understanding the organization being audited and that should be according to managements emphasis.

I also agree that the "auditor does not audit their own work" should be better explained and coordinated with ISO 9001.
 

Stijloor

Staff member
Super Moderator
#4
Re: ISO 19011 revision - Cairo TC 207 meeting - Your thoughts - June 2009

Hi all. Freshly arrived in Cairo for the TC 207 meeting. There is a joint working group on ISO 19011 revision - as ever any thoughts gratefully received.
The standard should address:

1. Certification audits. (for obtaining system certification to some Standard)
2. Process audits. (for assessing the effectiveness of processes within a quality system)
3. Continual improvement audits. (audits to verify that the process is indeed improving based on performance data)

There should be a clear distinction (as AndyN already alluded to) between registration (3rd party) audits and internal (1st party) audits.

I agree with AndyN that most internal audits copy/emulate the external audit approach including opening and closing meetings and ongoing arguments about major and minor nonconformities!!! :frust::frust::frust:

Stijloor.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Re: ISO 19011 revision - Cairo TC 207 meeting - Your thoughts - June 2009

There should be a clear distinction (as AndyN already alluded to) between registration (3rd party) audits and internal (1st party) audits.

I agree with AndyN that most internal audits copy/emulate the external audit approach including opening and closing meetings and ongoing arguments about major and minor nonconformities!!
I agree as well. Clearly, the goals and constraints of 1st, 2nd and 3rd party audits are different.

Maybe the ISO TC should acknowledge the wisdom of the US delegation, by developing a 19011 version that addresses the 3 forms of auditing, separately. What do you think about QE19011S-2004? (ISO 19011)

I also think that the competence requirements for auditors should be beefed up. Auditors should be required to understand how a management system subset is critical as a business support function. The body of knowledge for auditors should require an understanding of business results and how quality/environmental/health & safety/information security/etc... affects it's achievement.
 
Last edited:

Stijloor

Staff member
Super Moderator
#6
Re: ISO 19011 revision - Cairo TC 207 meeting - Your thoughts - June 2009

Friends,

I always believed that ANSI/ISO/ASQ QE19011S-2004 (the US version of ISO 19011) is a superior document. It addresses the needs of the various audit stakeholders. Audit training and auditing practices must be drastically improved to (re)gain the trust in the audit process. I hope that TC 207 will address these needs.

Paul, we're counting on you! ;) See the pyramids later.

Stijloor.
 

Randy

Super Moderator
#7
Re: ISO 19011 revision - Cairo TC 207 meeting - Your thoughts - June 2009

See if you can get them to agree to doing real work instead of going on a global tour and producing zilch like TC176 did:lol:
 

Stijloor

Staff member
Super Moderator
#8
Re: ISO 19011 revision - Cairo TC 207 meeting - Your thoughts - June 2009

See if you can get them to agree to doing real work instead of going on a global tour and producing zilch like TC176 did:lol:
Randy, you would make an excellent contributing member! :whip: :lol:

Stijloor.
 
P

Polly Pure Bread

#9
Re: ISO 19011 revision - Cairo TC 207 meeting - Your thoughts - June 2009

Hope for the best, expect the worst
 

howste

Thaumaturge
Super Moderator
#10
Re: ISO 19011 revision - Cairo TC 207 meeting - Your thoughts - June 2009

I'd like to see more emphasis on management direction in internal audits. In most systems I see top management reviewing the results of audits, but I don't see too many systems where top management plays an active role in providing direction for the audit program or individual audits. I see way too many internal audits where the audit manager or individual auditors are the only ones deciding what should be emphasized and followed-up on in audits.
 
Thread starter Similar threads Forum Replies Date
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 8
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
Pmarszal ISO 19011:2018 - Risk Based Approach for planning, conducting and reporting of internal audits Internal Auditing 8
Sidney Vianna ISO 19011:2018 Released - July 2018 Other ISO and International Standards and European Regulations 1
Sidney Vianna ISO 19011:2018 Released July 2018 General Auditing Discussions 8
Sidney Vianna ISO 19011:2018 is released July 2018 Other ISO and International Standards and European Regulations 0
Q ISO 19011 - Looking for a Presentation Material Other ISO and International Standards and European Regulations 6
S How to transition from ISO 19011:2002 to ISO 19011:2011 General Auditing Discussions 2
S ISO 19011 - Remote Auditing Imported Legacy Blogs 5
F Is this situation against ISO 19011? Internal Auditing 2
A ISO 19011 Can't see the wood from the trees! Customer and Company Specific Requirements 2
A ISO 19011:2012 - Emphasis on Risk Analysis, Competence of Auditors and Vocabulary Internal Auditing 2
C Practical Examples of completed ISO 19011:2011 Audit Reports General Auditing Discussions 5
U Need speaker for ISO 19011:2011 at Quality Conference Texas General Auditing Discussions 3
AnaMariaVR2 GMP News: New Version of ISO 19011 on Auditing published Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
S Certification Bodies - ISO 19011 and ISO 17011 Requirements Registrars and Notified Bodies 2
D Does anyone know about an ISO 19011 Amendment? General Auditing Discussions 2
S Quality Auditing System - Audit Plan per guidance from ISO 19011 Internal Auditing 8
M Internal Auditor Competency based upon Skill Sets based on ISO 19011 Internal Auditing 20
Paul Simpson New ISO 19011 - What do Covers think should be in the next edition? General Auditing Discussions 12
L Where to buy the ISO 19011 guidance document General Auditing Discussions 18
Stijloor What do you think about QE19011S-2004? (ISO 19011) General Auditing Discussions 9
P Has anyone compared ISO 19011:2002 to ISO 20000-2 (Service Management)? Internal Auditing 4
M ISO 9001:2000 Audit Nonconformance - "Failure to have the document ISO 19011" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
R What are the Shortcomings of ISO 19011? General Auditing Discussions 33
Geoff Cotton What is ISO 19011? Has it superceded ISO 14010, 14011, 14012 & 10011? General Auditing Discussions 6
S I have a copy of ISO 19011. Do you have one? General Auditing Discussions 15
S What will ISO 19011 replace? General Auditing Discussions 22
S ISO 19011 (Quality and/or environmental management systems) has been published by ISO General Auditing Discussions 5
S ISO 19011 - Where can I find a copy? General Auditing Discussions 17
R ISO/FDIS 19011 (Espa?ol) General Auditing Discussions 0
Marc ISO 19011 - Report on US TAG Standards Group Meetings General Auditing Discussions 17
T ISO 10011 Dead - 19011 Is Released - A summary of differences General Auditing Discussions 18
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 2
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom