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ISO 9001 Auditing Practices Group

1.

Document revision status record

Document

File name

Change

Date

Global changes

New IAF logo


Revised index list,
To include the new papers
Revised index list,
to replace "Value-added auditing" by "How to add value during the
audit process"
APG web site transferred to:
www.iso.org/tc176/ISO9001AuditingPracticesGroup
Papers re-formatted, so that there is no longer an explanation of the
APG and a listing of all the guidance notes. Instead, a new separate
paper "Introduction to the APG" has been developed, and limited
informative material now appears at the end of the guidance notes
Correction in footnotes to URL for the ISO 9001 Auditing Practices
Group
E-mail address for the contact person updated in the information
section at the end of each paper
E-mail address for the contact person updated in the information
section at the end of each paper
All papers converted to PDF format
All papers reviewed against ISO 9001:2015

2004-05-05
2004-05-05
2004-09-21

2004-10-14
2004-10-14

2005-12-12
2009-06-05
2009-12-14
2010-04-12
2016-01-13

2.

APG Web Home page

New
Revisions status list added
Zip file of all documents added
Link to TRANSLATIONS added
Change of IAF Secretariat e-mail address

2003-12-01
2004-05-05
2004-05-05
2005-12-12
2011-04-21

3.

Introduction to the
ISO 9001 Auditing
Practices Group

APG-Introduction

New

2004-10-14

APG-Introduction2015

Reference to additional papers added


Aligned to ISO 9001:2008
Aligned to ISO 9001:2015 + Removal of the listing of APG

2005-12-12
2009-06-05
2016-01-13

ISO & IAF 2016 All rights reserved


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ISO 9001 Auditing Practices Group


Document

File name

Document revision status record


Date

Change
documents

4.

5.

6.

7.

8.

The need for a 2stage approach to


auditing

APG-2stage

New

2003-12-01

Two stage initial


certification audit

APG-2stage2015

Revised edition
Re-titled Two stage initial certification audit

2009-06-05
2016-01-13

Measuring QMS
effectiveness and
improvements

APG-Effectiveness

New

2003-12-01

Aligned to ISO 9001:2008


Re-titled Effectiveness and aligned to ISO 9001:2015

2009-06-05
2016-01-13

New

2003-12-01

Section "3. Processes should be analysed, monitored and/or


measured, and improved" revised
Section "5. Is the process approach as described in the 'Introduction'
to ISO 9001:2000 a requirement of the standard?" revised
Aligned to ISO 9001:2008
Re-titled Processes and aligned to ISO 9001:2015

2004-05-05

New

2003-12-01

Aligned to ISO 9001:2008


To be withdrawn, once the transition period for ISO 9001:2008 is
over

2009-06-05

New

2003-12-01

Effectiveness

APGEffectiveness201
5

Identification of
processes

APGIdentifyProcesses

Processes

APG-Processes2015

Understanding the
process approach

APGUnderstandProcessA
pproach

Determination of the
where appropriate

APGDetermineWhereAppr

ISO & IAF 2016 All rights reserved


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2004-11-10
2009-06-05
2016-01-13

ISO 9001 Auditing Practices Group

9.

10.

11.

Document

File name

processes

opriate

Auditing the where


appropriate
requirements

Demonstrating
conformity to the
standard

APGAuditWhereAppropriat
e

APGDemonstrateConformi
ty

Demonstrate
conformity to the
standard

APGDemonstrateConf
ormity2015

Linking an audit of a
particular task, activity
or process to the
overall system

APGAuditofTasktoSystem

Document revision status record


Change

Date

Aligned to ISO 9001:2008


To be withdrawn, once the transition period for ISO 9001:2008 is
over

2009-06-05

New

2003-12-01

Aligned to ISO 9001:2008


To be withdrawn, once the transition period for ISO 9001:2008 is
over

2009-06-05

New

2003-12-01

Section " When assessing conformity to the standard, audit


checklists may not be sufficient", 3rd Paragraph revised
Section "What is adequate sampling", 1st paragraph, 2nd sentence
revised
Section " When assessing conformity to the standard, audit
checklists may not be sufficient", 2nd Paragraph,1st sentence, "were"
replaced by "where".
Aligned to ISO 9001:2008
Re-titled Demonstrate conformity to the standard and some limited
edits

2004-05-05

New

2003-12-01

2004-05-05
2004-09-21

2009-06-05
2016-01-13

To be withdrawn, once the transition period for ISO 9001:2008 is


over
12.

Auditing continual

APG-

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2003-12-01

New

ISO 9001 Auditing Practices Group

13.

14.

15.

16.

Document

File name

improvement

AuditContinualImprov
ement

Improvement

APGImprovement2015

Auditing a QMS which


has minimum
documentation

APGMinDocumentation

Document revision status record


Change

Date

Section "How much improvement is enough",


1st Paragraph, 2nd sentence deleted
Section "Improvement of the process or improvement of the QMS",
1st paragraph,
4th sentence revised
Aligned to ISO 9001:2008
Additional text added in the sections on "What sort of information is
relevant and where can we find it?" and "Improvement of the
product, process or improvement of the QMS?"
Re-titled Improvement and aligned to ISO 9001:2015

2004-05-05

New

2003-12-01

Aligned to ISO 9001:2008


To be withdrawn, once the transition period for ISO 9001:2008 is
over

2009-06-05

2004-05-05

2009-06-05
2009-12-01

2016-01-13

How to audit top


management
processes
Top management

APGAuditTopManagement

New

2003-12-01

APGTopManagement2015

Re-titled Top management and aligned to ISO 9001:2015

2016-01-13

The role and value of


the audit checklist

APG-Checklist

New

2003-12-01
2013-01-16

Checklist

APG-Checklist2015

Amendment to the section Need for a checklist, to align with ISO


19011:2011
Re-titled Checklist and a small number of edits made

Scope of ISO
9001:2000, Scope of

APG-Scope

New

2003-12-01

ISO & IAF 2016 All rights reserved


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2016-01-13

ISO 9001 Auditing Practices Group


Document

File name

Document revision status record


Change

Date

Link to IAF Guidance document added


Significant re-write of this document, following received comments
Aligned to ISO 9001:2008
Title changed to: Scope of ISO 9001, Scope of Quality Management
System and Scope of Certification
Substantial revision to align to ISO 9001:2015

2004-05-05
2004-11-24
2009-06-05
2016-01-13

New
Replaced by document "How to add value during the audit process"
New
(supersedes the document "Value-added auditing")

2003-12-01
2004-09-21
2004-09-21

Aligned to ISO 9001:2008


Re-titled Adding value, and aligned to ISO 9001:2015

2009-06-05
2016-01-13

New

2003-12-01

Aligned to ISO 9001:2008


Re-titled Competence and aligned to ISO 9001:2015

2009-06-05
2016-01-13

New

2004-05-05

New last Paragraph added


Aligned to ISO 9001:2008
Re-titled Statutory and Regulatory requirements and aligned to ISO

2005-12-12
2009-06-05
2016-01-13

Quality Management
System and Defining
Scope of Certification

Scope of ISO 9001,


Scope of Quality
Management
System and
Scope of
Certification

APG-Scope2015

17.

Value-added auditing

18.

How to add value


during the audit
process

APG-HowtoAddValue

Adding value

APGAddingValue2015

Auditing competence
and the effectiveness
of actions taken

APGAuditingCompetence

19.

20.

Competence

APGCompetence2015

Auditing Statutory and


Regulatory
requirements

APGStatutoryRegulatory

Statutory and

APG-

ISO & IAF 2016 All rights reserved


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ISO 9001 Auditing Practices Group


Document

File name

Regulatory
requirements
21.

22.

23.

Document revision status record


Date

Change

StatutoryRegulato 9001:2015
ry2015

Auditing the Quality


Policy and Quality
Objectives
Auditing Quality
Policy, Quality
Objectives, and
Management Review

New

2004-05-05

APGQualityPolicyandObje
ctives

New title.
Addition of guidance on the auditing of Management Review

2005-12-12

Policy, objectives and


management
review

APGPolicyObjectives
ManagementRevi
ew2015

Aligned to ISO 9001:2008


Re-titled Policy, objectives and management review and aligned to
ISO 9001:2015

2009-06-05
2016-01-13

Auditing ISO 9001,


Clause 7.6 Control of
monitoring and
measuring devices
equipment

APGISO9001Clause7.6

New

2004-05-05

Revised edition
Revised edition
Re-titled "Auditing ISO 9001, Clause 7.6 Control of monitoring and
measuring equipment"

2005-12-12
2006-05-15
2009-07-30

Monitoring and
measuring
resources

APGMonitoringMeasur
ement2015

Making effective use


of ISO 19011

APGEffectiveUseofISO190
11

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And aligned to ISO 9001:2008


Re-titled Monitoring and measuring resources and aligned to ISO
9001:2015

2016-01-13

New

2004-05-05

Aligned to ISO 9001:2008

2009-06-05

ISO 9001 Auditing Practices Group


Document

24.

25

26

27

Document revision status record

File name

Change

Effective use of ISO


19011

APG-ISO19011_2015

Significant revision of section Competence and evaluation of


auditors, to align with ISO 19011:2011
Re-titled Effective use of ISO 19011

Auditing Customer
Feedback processes

APGCustomerFeedback

Customer Feedback

APGCustomerFeedba
ck2015

Documenting a
Nonconformity

APGDocumentNonconfor
mity

Date
2013-01-16
2016-01-13

New

2004-05-05

Aligned to ISO 9001:2008


Re-titled Customer Feedback, and aligned to ISO 9001:2015

2009-06-05
2016-01-13

New

2004-11-24

Aligned to ISO 9001:2008


Re-titled Nonconformity Documenting and aligned to ISO
9001:2015

2009-06-05
2016-01-13

Nonconformity
Documenting

APGDocumentNonco
nformity2015

Review of Actions in
response to a
Nonconformity
Guidance for
reviewing and closing
nonconformities

New

2004-11-24

APGReviewNonconformity

Revised, re-titled and re-focussed

2005-02-10

Aligned to ISO 9001:2008


Paragraphs on systemic versus one-off nonconformities and the text
and table on the "5 Whys" added
Re-titled Nonconformity Review and closing and aligned to ISO
9001:2015

2009-06-05
2010-12-01

New

2005-02-10

Nonconformity
Review and closing

APGReviewNonconformity
2015

Auditing Internal
Communications

APGInternalCommunicatio

ISO & IAF 2016 All rights reserved


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2016-01-13

ISO 9001 Auditing Practices Group


Document

File name

Document revision status record


Change

Date

Aligned to ISO 9001:2008


Revision of section 2.3
Amendment of section 2.3
Re-titled Internal communication and aligned with ISO 9001:2015

2009-06-05
2010-07-12
2011-04-21
2016-01-13

New

2005-02-10

Aligned to ISO 9001:2008


Revision of section 2.2a) bullets 9 and 10
Revision of section 2.2a)
To be withdrawn, once the transition period for ISO 9001:2008 is
over

2009-06-05
2010-07-12
2011-04-21

New

2005-07-30

Aligned to ISO 9001:2008


Re-titled Service organizations and aligned to ISO 9001:2015

2009-06-05
2016-01-13

ns

28

29

30

31

Internal
communication

APGInternalCommuni
cations2015

Auditing Preventive
Action

APG-PreventiveAction

Auditing service
organizations

APGAuditingServiceO
rganizations

Service organizations

APGServiceOrganizati
ons2015

THIRD PARTY Auditor


impartiality and
conflict of interest
Impartiality

APGAuditorImpartiality

New

2005-07-30

APG-Impartiality2015

Re-titled Impartiality and aligned to ISO 9001:2015

2016-01-13

Auditing the
effectiveness of the
internal audit

APGInternalAuditEffectivn
ess

New

2005-07-30

Aligned to ISO 9001:2008


Revision of section 2.2
Revision of section 2.2

2009-06-05
2010-07-12
2011-04-21

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ISO 9001 Auditing Practices Group

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33

34

35

Document revision status record

Document

File name

Change

Internal audit

APGInternalAudit2015

Re-titled Internal audit and aligned to ISO 9001:2015

Date
2016-01-13

Auditing ElectronicBased Management


Systems (EBMS)
Electronic
documented
information systems

APGAuditingElectronicBas
edMS
APGDocumentedInformati
on2015

New

2005-08-25

Re-titled Electronic documented information systems and aligned to


ISO 9001:2015

2016-01-13

Auditing the
Management of
Resources
Resources

APGManagementOfResou
rces
APG-Resources2015

New

2005-12-12

Re-titled Resources and aligned to ISO 9001:2015

2016-01-13

Auditing of Customer
Communications

APGCustomerCommunicat
ions

New

2005-12-12

Aligned to ISO 9001:2008


Revision of section 2.4
Revision of section 2.4
Re-titled Customer Communications and aligned to ISO 9001:2015

2009-06-05
2010-07-12
2011-04-21
2016-01-13

New

2006-05-15

Significant revision of Introduction section.


Correction to Fig 1, to show link between Verification and input, not
planning.
Aligned to ISO 9001:2008
Reference to ISO 9000, clause 3.4.1 corrected to 3.5.1
Re-titled Design and Development Process, aligned to ISO
9001:2015

2006-12-08

Customer
Communications

APGCustomerCommu
nications2015

Auditing the Design


and Development
Process

APGDesign&Development

Design and
Development

APGDesign&Develop

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2009-06-05
2009-06-30
2016-01-13

ISO 9001 Auditing Practices Group


Document
Process

File name

Document revision status record


Change

Date

ment2015

Auditor Code of
Conduct and Ethics
Code of Conduct and
Ethics

APG-Code-ofConduct-&-Ethics
APG-Code-ofConduct-&Ethics2015

New

2006-05-15

Title changed to: Code of Conduct and Ethics, and other very minor
editorial changes

2016-01-13

Guidance on Cultural
Aspects of Auditing
Cultural Aspects

APG-CulturalAspects

New

2006-12-08

APGCulturalAspects2015

Title changed to: Cultural Aspects, and minor editorial changes

2016-01-13

38

Output Matters

APG-OutputMatters

New
Aligned to ISO 9001:2008
To be withdrawn, once the transition period for ISO 9001:2008 is
over

2006-12-08
2009-06-05

39

Auditing the
Procurement and
Supply Chain
Processes

APGAuditProcurement&Su
pplyChain

New

2007-07-02

- New paragraph inserted prior to the Introduction


- Introduction edited
Aligned to ISO 9001:2008
Re-titled External providers, and aligned to ISO 9001:2015

2007-07-13

New

2008-07-15

Aligned to ISO 9001:2015

2016-01-13

36

37

40

External providers

APGExternalProviders
2015

Added Value Audits


versus Consultancy

APGADDED_VALUE_AUD
ITS_VS_CONSULTA
NCY
APGValueVsConsultancy2

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10

2009-06-05
2016-01-13

ISO 9001 Auditing Practices Group


Document

File name

Document revision status record


Change

Date

New

2009-03-20

Small amendment to section 3a), to align to ISO 19011:2011


Re-titled Audit reports and aligned to ISO 9001:2015

2013-01-16
2016-01-13

New
One correction made

2009-12-10
2016-01-13

015
41

Writing Audit Reports

APGWritingAuditReports

Audit Reports

APGAuditReports2015

42

Audit Trail

APG-AuditTrail.doc
APGAuditTrail2015

43

Approach to
Demonstration of
Traceability of
Measurement Results
Measurement
traceability

APGNew
MeasurementTraceabi
lity

2009-12-10

APGRe-titled Measurement traceability and aligned to ISO 9001:2015


MeasurementTraceabi
lity2015

2016-01-13

Deployment of the
Expected Outcomes
documents
Expected Outcomes

APGExpectedOutcomes

New

2010-08-20

APGExpectedOutcomes20
15

Title changed to: Expected Outcomes.


References to product changed to products and services

2016-01-13

How to deal with


Consultants
Deal with consultants

APG-Consultants

New

2010-12-01

APG-Consultants2015

Re-titled Deal with Consultants and aligned to ISO 9001:2015

2016-01-13

Auditing Customer
Complaints
Customer Complaints

APGCustomerComplaints
APGCustomerComplaints2

New

2011-04-21

Re-titled Customer Complaints and edited to be consistent with ISO


9001:2015

2016-01-13

44

45

46

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11

ISO 9001 Auditing Practices Group


Document

File name

Document revision status record


Change

Date

015
Using Technical
Experts on an audit
team
Technical Experts

APGTechnicalExperts

New

2011-04-21

APGTechnicalExperts2015

Title changed to: Technical experts, and some minor editing

2016-01-13

Audit Evidence
collection
Evidence collection

APGEvidenceCollection
APGEvidenceCollection20
15

New

2013-01-16

Re-titled Evidence collection and aligned to ISO 9001:2015

2016-01-13

49

Context

APG-Context2015

New

2016-01-13

50

Organizational
Knowledge

APGOrganizationalKnowle
dge2015

New

2016-01-13

51

Risk Based Thinking

APGRiskBasedThinking20
15

New

2016-01-13

47

48

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