ISO 9001 Auditing Practices Group
Welcome to the website of the ISO
9001 Auditing Practices Group.
The ISO 9001 Auditing Practices Group is constituted as an
informal group of quality management system (QMS) experts, auditors and practitioners,
drawn from the ISO Technical Committee 176 Quality Management and Quality
Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).
The
Co-Conveners of the ISO 9001 Auditing Practices Group are Mr B.Venkataraman (Director, NABCB,
This website has been established as an on-line source of papers and
presentations on auditing QMSs. The ideas, examples and explanations
given reflect the process-based approach that is essential for auditing the
requirements of ISO 9001:2000 Quality management systems - Requirements.
The website is primarily aimed at QMS auditors, consultants and quality
practitioners.
The papers and presentations that make up the content of this website are not
definitive. They reflect a number of different views in QMS auditing. As
such, their content may not always be consistent. It is not intended that
the website's content will be used as specified requirements, an industry
benchmark, or as criteria that all QMS auditors, consultants or practitioners
have to follow.
The items listed under "QMS auditing topics" below have papers and
presentations associated with them. Simply click on one of the links to
view and download the relevant document.
Feedback from users will be used by the ISO 9001 Auditing Practices Group
to determine whether additional guidance documents should be developed, or if
these current ones should be revised. Comments on the papers or presentations
can be sent to the following email address: charles.corrie@bsigroup.com.
A sister web
page for the Accreditation
Auditing Practices Group has been established to provide guidance to
accreditation auditors.
QMS auditing topics
Introduction
to the ISO 9001 Auditing Practices Group
The
need for a 2-stage approach to auditing
Measuring
QMS effectiveness and improvements
Understanding
the process approach
Determination
of the “where appropriate” processes
Auditing
the “where appropriate” requirements
Demonstrating
conformity to the standard
Linking
an audit of a particular task, activity or process to the overall system
Auditing
continual improvement
Auditing
a QMS which has minimum documentation
How
to audit top management processes
The
role and value of the audit checklist
Scope
of ISO 9001, Scope of Quality Management System and Defining Scope of
Certification
How
to Add Value during the audit process
Auditing
competence and the effectiveness of actions taken
Auditing
Statutory and Regulatory requirements
Auditing
Quality Policy, Quality Objectives, and Management Review
Auditing
ISO 9001, Clause 7.6 Control of monitoring and measuring equipment
Making
effective use of ISO 19011
Auditing
Customer Feedback processes
Guidance
for reviewing and closing nonconformities
Auditing
Internal Communications
Auditing
Service Organizations
Third
Party Auditor Impartiality and Conflict of Interest
Auditing
the Effectiveness of the Internal Audit
Auditing
Electronic Based Management Systems
Auditing
the Management of Resources
Auditing
Customer Communications
Auditing
the Design and Development Process
Auditor
Code of Conduct and Ethics
Guidance
on Cultural Aspects of Auditing
Auditing
the Procurement and Supply Chain Processes
Added
Value Audits versus Consultancy
Approach
to Demonstration of Traceability of Measurement Results
Zip
file of all the above documents
[TRANSLATIONS
– Links to translations of the above documents]
Disclaimer
The contributions on this website have not been subject
to an endorsement process by the International Organization for Standardization
(ISO), ISO Technical Committee 176 or the International Accreditation Forum
(IAF).
The information contained on this website is available to the public for
educational and communication purposes and the ISO 9001 Auditing Practice
Group does not take responsibility for any errors, omissions or other
liabilities that may arise from the provision or subsequent use of such
information.
Abbreviations and Definitions
On this website the following
abbreviations are commonly used:
Auditee = the organization being audited
CRB = Certification/registration body
NCR = Non-conformity report
QMS = Quality management system
Further reading:
ISO and IAF have published several
documents related to QMS and auditing, which are listed below. These are
available from ISO or the IAF, or from your national ISO member body or IAF
member body.
[1] ISO 9000:2005, Quality
management systems - Fundamentals and vocabulary
[2] ISO 9001:2008, Quality
management systems - Requirements
[3] ISO 9004:2000, Quality
management systems - Guidelines for performance improvements
[4] "ISO 9000
Introduction and Support Package" guidance documents from ISO/TC 176 SC2:
N524 - Guidance on ISO
9001:2008, Clause 1.2 'Application'
N525 - Guidance on the
Documentation requirements of ISO 9001:2008
N526 - Guidance on the
Terminology used in ISO 9001:2000 and ISO 9004:2000
N544 - Guidance on the
Concept and Use of the Process Approach
N630 - Guidance on Outsourced
Processes
N836 - Implementation
guidance for ISO 9001:2008
(These may be downloaded, for
free, from the ISO or ISO/TC 176/SC 2 web sites)
[5] ISO/IEC 17000:2004,
Conformity assessment - Vocabulary and general principles
[6] ISO 19011:2002,
Guidelines for quality and/or environmental management systems auditing
[7] ISO/IEC 17021:2006,
Conformity assessment - Requirements for bodies providing audit and
certification of management systems
[8] ISO Handbook:2002, ISO 9001:2000 for small businesses - What to do,
Advice from ISO/TC 176
[9] ISO 9001:2000 - What does
it mean in the supply chain?
[10] IAF mandatory documents
which may be downloaded, for free, from the IAF
web site:
IAF
MD 1:2007 Certification of Multiple Sites Based on Sampling
IAF
MD 2:2007 Transfer of Accredited Certification of Management Systems
IAF
MD 3:2008 Advanced Surveillance and Recertification Procedures (ASRP)
IAF
MD 4:2008 Use of Computer Assisted Auditing Techniques ("CAAT") for
Accredited Certification of Management Systems
IAF
MD 5:2009 Duration of QMS and EMS Audits
Useful web sites:
http://www.iaf.nu/ International Accreditation Forum (IAF)
http://www.iso.org/ International Organization
for Standardization (ISO)
http://www.tc176.org/ ISO Technical
Committee no. 176, Quality Management and Quality Assurance (ISO/TC 176)
www.iso.org/tc176/sc2 ISO/TC 176,
Sub-committee no.2, Quality Systems (ISO/TC 176/SC 2)
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