ISO 19011:2018 Released July 2018

Sidney Vianna

Post Responsibly
Staff member
Admin
#1
Elsmar Forum Sponsor

xfngrs

Quite Involved in Discussions
#2
Denise Robitaille also has a webinar on Omnex's main webpage. You can create an ID and password and listen to it.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
From the press release: “...Other key changes in the 2018 version include the addition of a risk-based approach to the principles of auditing to reflect the enhanced focus on risk in both management standards and in the marketplace,” she said.

“There are tips on auditing risks and opportunities as well as information on applying risk-based thinking to the audit process...."

I know of, at least, one global CB which released a RISK BASED CERTIFICATION protocol, back in 2004.;)

But, at the end of the day, for many people, a certificate is a certificate is a certificate...
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
The risk-based approach principle in 19011:2018 states:

The risk-based approach should substantially influence the planning, conducting and reporting of audits in order to ensure that audits are focused on matters that are significant for the audit client and for achieving the audit programme objectives
In the 3rd party auditing certification scenario, most registrants are interested in the certificate (to satisfy customer/contractual requirements). Since, in that scenario, the audit client is also the registrant, there is an OBVIOUS conflict, as the organization does not want to disclose to the CB auditors the QMS "skeletons in the closet" and expose the biggest challenges in terms of product conformity and customer satisfaction.

I wish the people involved with the revision of ISO 19011 would explain why they did not follow the "expanded scope" of the ISO HLS and made the risk-based approach to include other interested parties. Something such as

The risk-based approach should substantially influence the planning, conducting and reporting of audits in order to ensure that audits are focused on matters that are significant for the audit client and other interested parties as well as for achieving the audit programme objectives
 
Last edited:
#5
The risk-based approach principle in 19011:2018 states:



In the 3[sup]rd[/sup] party auditing certification scenario, most registrants are interested in the certificate (to satisfy customer/contractual requirements). Since, in that scenario, the audit client is also the registrant, there is an OBVIOUS conflict, as the organization does not want to disclose to the CB auditors the QMS "skeletons in the closet" and expose the biggest challenges in terms of product conformity and customer satisfaction.
Added to which, the qualification (Lead Auditor) of a CB auditor isn't going to be on the radar screen of any C suite professional - which will disbar all but the best auditors from talking "risk"...
 
Last edited:

xfngrs

Quite Involved in Discussions
#6
This may be off topic but it is about 19011:2018. I am a little confused by the Virtual Audit information. Originally our certification company told us Virtual or Remote audits would no longer be allowed at all for the new IATF. I haven't actually seen that anywhere. Now 19011 comes out referencing them and how to handle them. Are they talking about auditing Virtual organizations? Or are they talking about the ability to remote audit some parts of an audit...i.e. the documents for the process. And is this just for ISO 9001 or does it apply to IATF and other specialized industries as well?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
It would be extremely unlikely that the IATF would approve anything outside the traditional audit protocol of on site, face to face audits.

Remember, the IATF process for CB approval is outside the traditional IAF, ISO 17021 based accreditation mechanism.
 
#8
This may be off topic but it is about 19011:2018. I am a little confused by the Virtual Audit information. Originally our certification company told us Virtual or Remote audits would no longer be allowed at all for the new IATF. I haven't actually seen that anywhere. Now 19011 comes out referencing them and how to handle them. Are they talking about auditing Virtual organizations? Or are they talking about the ability to remote audit some parts of an audit...i.e. the documents for the process. And is this just for ISO 9001 or does it apply to IATF and other specialized industries as well?
In a technical sense, ISO 19011 doesn't apply to CBs (any longer). They have the ISO/IEC 17021 series which guides their audits etc.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
Indeed, the 2018 Edition of ISO 19011 even states the following:
This document concentrates on internal audits (first party) and audits conducted by organizations on their external providers and other external interested parties (second party)
In other words, as Andy mentioned, ISO 19011:2018 is no longer intended to address the needs of 3rd party auditors.
 
Thread starter Similar threads Forum Replies Date
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 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
sridharafep 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 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
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
A Refusal to discuss ISO 9001 obligations... what to do? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
B Can we be ISO 9001 certified without a physical office? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
J Informational ISO 24971:2020 Released ISO 14971 - Medical Device Risk Management 0
S ISO 45001 and outsourcing the transporation of products Occupational Health & Safety Management Standards 2
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
Sidney Vianna Informational New edition of ISO 29001 released (June 2020) Oil and Gas Industry Standards and Regulations 0
R Who is the customer in the ISO/IEC 17025:2017? ISO 17025 related Discussions 1
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
L Combining 3 ISO 9001 registrations into 1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 7
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
N EN ISO 13640:2002 vs EN ISO 23640:2011 Other Medical Device Related Standards 1
O ISO 13485 vs. GMP - Comparison matrix wanted EU Medical Device Regulations 0
Similar threads


















































Top Bottom