What will ISO 19011 replace?



what will ISO 19011 will replace?

ISO 19011 is published by ISO on 2002 October 2. This International Standard replaces many standards.
ISO 19011 replaces ISO 10011-1, ISO 10011-2 and ISO 10011-3 in the ISO 9000 family and ISO 14010, ISO 14011 and ISO 14012 in the ISO 14000 family. :eek:
Elsmar Forum Sponsor
Hi, Jim. What is your pessimism about? I wonder, was there any discussion of this danger ("kiss of death" for effectiveness of IA) on the Cove?


Please give us the reasons, Jim.

Why kiss the death? Jim, please give us the reasons. Your ideas sound very interesting.



Dera readers,
Please read more on No Internal Audit Necessary by Jim Wade at ISO 9001:2000 in this Cove.:vfunny: :eek:

M Greenaway


How does ISO9001 now specify audits against what it used to specify for audits ?

M Greenaway


Thanks, I have actually read the old and new standards.

The main difference I saw was it is now explicitly stated that internal audits are conducted against the requirements of ISO9001, where in the 1994 standard this was only implied.

However 'best practice' always said to audit against the standard, so although we now have clarity in the standard not much has really changed.

As for auditing processes, as opposed to activities - this sounds again like another battle of semantics brewing :vfunny:

Aaron Lupo

Jim Wade said:

Another example: formerly we had to audit activities, now we are encouraged to audit processes.

rgds Jim
Jim maybe the way you were trained was to audit activities, I was trained to audit the processes.

M Greenaway


What are you on about ?

The 1994 standard talked of conducting internal audits to 'verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.'

i.e. not just compliance, but equally effectivenes - now where does your argument stand against this ??


Super Moderator
I agree with my ol' Brit bud Jim here on much of what he's saying. I teach both QMS & EMS Internal Auditor courses for a couple of the major providers here in the states. A good majority of the material deals with what I believe to be 3rd party/registration specific stuff. Internal auditors and audits, to me anyway, should have a different focus than the 3rd party/registration types.

When teaching, I shun from the phrase "non-conformance" as much as possible. I focus on trying to develop the understanding that the IA process not only should be, but must be a value added, positive event for the organization. I use "opportunity for improvement" as another way of saying something isn't right or may not be happening the way it should be.

There are different dynamics to the internal audit process than the external one and a paradigm shift must take place to gain the realization of it.

Jim, I can't come to Jolly Old Engalnd right now, but I am definitely interested in what you have.

M Greenaway

I beleive the only difference is that internal audits are far better mainly because they can go deeper due to having more time available, and probably an existing understanding of systems that means they can short cut a lot of the traditional pre-amble you get at a surveillance visit.

The audit criteria for both is however, in my opinion, exactly the same.
Thread starter Similar threads Forum Replies Date
D "certified" in ISO 19011, as well as IATF required? IATF 16949 - Automotive Quality Systems Standard 6
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 ISO 19011 revision - Your thoughts General Auditing Discussions 53
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 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
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 1
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 3
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
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
H R&D Lab ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
C Biologic Evaluation based on ISO 10993-1 EU Medical Device Regulations 2
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 12
Ajit Basrur Any ISO standard or guidance documents on barcode and scanning? Other Medical Device Related Standards 1
J ISO 13485 for Metal Finishing Medical Device and FDA Regulations and Standards News 5
S How to calculate Effective Number of People for ISO 13485 Certification? General Auditing Discussions 2
C ISO Question - Do you say "I-S-O" or "I-Soh"? Misc. Quality Assurance and Business Systems Related Topics 14
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom