ISO 9001 Auditing Practices Group



| |Document |File name |Change |Date |

| | | | | |

|1. |Global changes |- |New IAF logo |2004-05-05 |

| | | |Revised index list, |2004-05-05 |

| | | |To include the new papers | |

| | | |Revised index list, |2004-09-21 |

| | | |to replace "Value-added auditing" by "How to add value during the audit process" | |

| | | |APG web site transferred to: tc176/ISO9001AuditingPracticesGroup |2004-10-14 |

| | | |Papers re-formatted, so that there is no longer an explanation of the APG and a listing of all the |2004-10-14 |

| | | |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 |2005-12-12 |

| | | |E-mail address for the contact person updated in the information section at the end of each paper |2009-06-05 |

| | | |E-mail address for the contact person updated in the information section at the end of each paper |2009-12-14 |

| | | |All papers converted to PDF format |2010-04-12 |

| | | |All papers reviewed against ISO 9001:2015 |2016-01-13 |

| | | |APG web site transferred to: |2020-02-14 |

| | | | | |

| | | | | |

|2. |APG Web Home page |- |New |2003-12-01 |

| | | |Revisions status list added |2004-05-05 |

| | | |Zip file of all documents added |2004-05-05 |

| | | |Link to TRANSLATIONS added |2005-12-12 |

| | | |Change of IAF Secretariat e-mail address |2011-04-21 |

| | | | | |

|3. |Introduction to the ISO 9001 |APG-Introduction |New |2004-10-14 |

| |Auditing Practices Group | | | |

| | | |Reference to additional papers added |2005-12-12 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | |APG-Introduction2015 |Aligned to ISO 9001:2015 + Removal of the listing of APG documents |2016-01-13 |

| | | | | |

|4. |The need for a 2-stage approach to |APG-2stage |New |2003-12-01 |

| |auditing | | | |

| | | |Revised edition |2009-06-05 |

| |Two stage initial certification |APG-2stage2015 |Re-titled “Two stage initial certification audit” |2016-01-13 |

| |audit | | | |

| | | | | |

|5. |Measuring QMS effectiveness and |APG-Effectiveness |New |2003-12-01 |

| |improvements | | | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |Effectiveness |APG-Effectiveness2015 |Re-titled “Effectiveness” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|6. |Identification of processes |APG-IdentifyProcesses |New |2003-12-01 |

| | | |Section "3. Processes should be analysed, monitored and/or measured, and improved" revised |2004-05-05 |

| | | |Section "5. Is the process approach as described in the 'Introduction' to ISO 9001:2000 a requirement |2004-11-10 |

| | | |of the standard?" revised | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | | | |

| |Processes |APG-Processes2015 |Re-titled “Processes” and aligned to ISO 9001:2015 |2016-01-13 |

| | | |Revised for clarity |Ed2, 2020-07-19 |

| | | | | |

|7. |Understanding the process approach |APG-UnderstandProcessApproach |New |2003-12-01 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Withdrawn | |

| | | | | |

|8. |Determination of the “where |APG-DetermineWhereAppropriate |New |2003-12-01 |

| |appropriate” processes | | | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Withdrawn | |

| | | | | |

|9. |Auditing the “where appropriate” |APG-AuditWhereAppropriate |New |2003-12-01 |

| |requirements | | | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Withdrawn | |

| | | | | |

|10. |Demonstrating conformity to the |APG-DemonstrateConformity |New |2003-12-01 |

| |standard | | | |

| | | |Section " When assessing conformity to the standard, audit checklists may not be sufficient", 3rd |2004-05-05 |

| | | |Paragraph revised | |

| | | |Section "What is adequate sampling", 1st paragraph, 2nd sentence revised |2004-05-05 |

| | | |Section " When assessing conformity to the standard, audit checklists may not be sufficient", 2nd |2004-09-21 |

| | | |Paragraph,1st sentence, "were" replaced by "where". | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |Demonstrate conformity to the |APG-DemonstrateConformity2015 |Re-titled “Demonstrate conformity to the standard” and some limited edits |2016-01-13 |

| |standard | | | |

| | | | | |

|11. |Linking an audit of a particular |APG-AuditofTasktoSystem |New |2003-12-01 |

| |task, activity or process to the | | | |

| |overall system | | | |

| | | |Withdrawn, as it was linked to ISO 9001:2008 | |

| | | | | |

|12. |Auditing continual improvement |APG-AuditContinualImprovement |New |2003-12-01 |

| | | |Section "How much improvement is enough", |2004-05-05 |

| | | |1st Paragraph, 2nd sentence deleted | |

| | | |Section "Improvement of the process or improvement of the QMS", 1st paragraph, |2004-05-05 |

| | | |4th sentence revised | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Additional text added in the sections on "What sort of information is relevant and where can we find |2009-12-01 |

| | | |it?" and "Improvement of the product, process or improvement of the QMS?" | |

| |Improvement |APG-Improvement2015 |Re-titled “Improvement” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|13. |Auditing a QMS which has minimum |APG-MinDocumentation |New |2003-12-01 |

| |documentation | | | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Withdrawn | |

| | | | | |

|14. |How to audit top management |APG-AuditTopManagement |New |2003-12-01 |

| |processes | | | |

| |Top management |APG-TopManagement2015 |Re-titled “Top management” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|15. |The role and value of the audit |APG-Checklist |New |2003-12-01 |

| |checklist  | | | |

| | | |Amendment to the section “Need for a checklist”, to align with ISO 19011:2011 |2013-01-16 |

| |Checklist |APG-Checklist2015 |Re-titled “Checklist” and a small number of edits made |2016-01-13 |

| | | | | |

|16. |Scope of ISO 9001:2000, Scope of |APG-Scope |New |2003-12-01 |

| |Quality Management System and | | | |

| |Defining Scope of Certification | | | |

| | | |Link to IAF Guidance document added |2004-05-05 |

| | | |Significant re-write of this document, following received comments |2004-11-24 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |Scope of ISO 9001, Scope of Quality|APG-Scope2015 |Title changed to: Scope of ISO 9001, Scope of Quality Management System and Scope of Certification |2016-01-13 |

| |Management System and Scope of | |Substantial revision to align to ISO 9001:2015 | |

| |Certification | | | |

| |Scope and Applicability |APG-Scope_and_Applicability_Ver2_20|Revised edition and re-titled. |2020-02-26 |

| | |20-02 | | |

| | | | | |

|17. |Value-added auditing |- |New |2003-12-01 |

| | | |Replaced by document "How to add value during the audit process" |2004-09-21 |

|18. |How to add value during the audit |APG-HowtoAddValue |New |2004-09-21 |

| |process | |(supersedes the document "Value-added auditing") | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |Adding value |APG-AddingValue2015 |Re-titled “Adding value”, and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|19. |Auditing competence and the |APG-AuditingCompetence |New |2003-12-01 |

| |effectiveness of actions taken | | | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |Competence |APG-Competence2015 |Re-titled “Competence” and aligned to ISO 9001:2015 |2016-01-13 |

| | |APG-Competence |Revised to provide an expanded view in relation to competence requirements throughout the entire body |2022-06-01 |

| | | |of ISO 9001 requirements | |

| | | | | |

|20. |Auditing Statutory and Regulatory |APG-StatutoryRegulatory |New |2004-05-05 |

| |requirements | | | |

| | | |New last Paragraph added |2005-12-12 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |Statutory and Regulatory |APG-StatutoryRegulatory2015 |Re-titled “Statutory and Regulatory requirements” and aligned to ISO 9001:2015 |2016-01-13 |

| |requirements | | | |

| | |APG- StatutoryRegulatory |New edition |2021-06-07 |

| | | | | |

|21. |Auditing the Quality Policy and |- |New |2004-05-05 |

| |Quality Objectives | | | |

| |Auditing Quality Policy, Quality |APG-QualityPolicyandObjectives |New title. |2005-12-12 |

| |Objectives, and Management Review | |Addition of guidance on the auditing of Management Review | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |Policy, objectives and management |APG-PolicyObjectivesManagementRevie|Re-titled “Policy, objectives and management review” and aligned to ISO 9001:2015 |2016-01-13 |

| |review |w2015 | | |

| | | | | |

|22. |Auditing ISO 9001, Clause 7.6 |APG-ISO9001Clause7.6 |New |2004-05-05 |

| |Control of monitoring and measuring| | | |

| |devices equipment | | | |

| | | |Revised edition |2005-12-12 |

| | | |Revised edition |2006-05-15 |

| | | |Re-titled "Auditing ISO 9001, Clause 7.6 Control of monitoring and measuring equipment" |2009-07-30 |

| | | | | |

| | | |And aligned to ISO 9001:2008 | |

| |Monitoring and measuring resources |APG-MonitoringMeasurement2015 |Re-titled “Monitoring and measuring resources” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|23. |Making effective use of ISO 19011 |APG-EffectiveUseofISO19011 |New |2004-05-05 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Significant revision of section “Competence and evaluation of auditors”, to align with ISO 19011:2011 |2013-01-16 |

| |Effective use of ISO 19011 |APG-ISO19011_2015 |Re-titled “Effective use of ISO 19011” |2016-01-13 |

| | |APG-ISO_19011_2018 |Edited to align with ISO 19011:2018 |2020-09-21 |

| | | | | |

|24. |Auditing Customer Feedback |APG-CustomerFeedback |New |2004-05-05 |

| |processes | | | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |Customer Feedback |APG-CustomerFeedback2015 |Re-titled “Customer Feedback”, and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|25 |Documenting a Nonconformity |APG-DocumentNonconformity |New |2004-11-24 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |Nonconformity – Documenting |APG-DocumentNonconformity2015 |Re-titled “Nonconformity – Documenting” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|26 |Review of Actions in response to a |- |New |2004-11-24 |

| |Nonconformity | | | |

| |Guidance for reviewing and closing |APG-ReviewNonconformity |Revised, re-titled and re-focussed |2005-02-10 |

| |nonconformities | | | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Paragraphs on systemic versus one-off nonconformities and the text and table on the "5 Whys" added |2010-12-01 |

| |Nonconformity – Review and closing |APG-ReviewNonconformity2015 |Re-titled “Nonconformity – Review and closing” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|27 |Auditing Internal Communications |APG-InternalCommunications |New |2005-02-10 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Revision of section 2.3 |2010-07-12 |

| | | |Amendment of section 2.3 |2011-04-21 |

| |Internal communication |APG-InternalCommunication2015 |Re-titled “Internal communication” and aligned with ISO 9001:2015 |2016-01-13 |

| | | |Edited and cross references updated |Ed2, Amd1 |

| | | | |2020-07-19 |

| | | | | |

|28 |Auditing Preventive Action |APG-PreventiveAction |New |2005-02-10 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Revision of section 2.2a) bullets 9 and 10 |2010-07-12 |

| | | |Revision of section 2.2a) |2011-04-21 |

| | | |Withdrawn | |

| | | | | |

|29 |Auditing service organizations |APG-AuditingServiceOrganizations |New |2005-07-30 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |Service organizations |APG-ServiceOrganizations2015 |Re-titled “Service organizations” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|30 |THIRD PARTY Auditor impartiality |APG-AuditorImpartiality |New |2005-07-30 |

| |and | | | |

| |conflict of interest | | | |

| |Impartiality |APG-Impartiality2015 |Re-titled “Impartiality” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|31 |Auditing the effectiveness of the |APG-InternalAuditEffectivness |New |2005-07-30 |

| |internal audit | | | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Revision of section 2.2 |2010-07-12 |

| | | |Revision of section 2.2 |2011-04-21 |

| |Internal audit |APG-InternalAudit2015 |Re-titled “Internal audit” and aligned to ISO 9001:2015 |2016-01-13 |

| | | |Edited and Cross references updated |Ed1, Amd1 |

| | | | |2020-07-19 |

| | | | | |

|32 |Auditing Electronic-Based |APG-AuditingElectronicBasedMS |New |2005-08-25 |

| |Management Systems (EBMS) | | | |

| |Electronic documented information |APG-DocumentedInformation2015 |Re-titled “Electronic documented information systems” and aligned to ISO 9001:2015 |2016-01-13 |

| |systems | | | |

| | | |Withdrawn. Superseded by the paper on Digital Processes |2020-09-21 |

| | | | | |

|33 |Auditing the Management of |APG-ManagementOfResources |New |2005-12-12 |

| |Resources | | | |

| |Resources |APG-Resources2015 |Re-titled “Resources” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|34 |Auditing of Customer Communications|APG-CustomerCommunications |New |2005-12-12 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Revision of section 2.4 |2010-07-12 |

| | | |Revision of section 2.4 |2011-04-21 |

| |Customer Communications |APG-CustomerCommunications2015 |Re-titled “Customer Communications” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|35 |Auditing the Design and Development|APG-Design&Development |New |2006-05-15 |

| |Process | | | |

| | | |Significant revision of Introduction section. |2006-12-08 |

| | | |Correction to Fig 1, to show link between Verification and input, not planning. | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Reference to ISO 9000, clause 3.4.1 corrected to 3.5.1 |2009-06-30 |

| |Design and Development Process |APG-Design&Development2015 |Re-titled “Design and Development Process”, aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|36 |Auditor Code of Conduct and Ethics |APG-Code-of-Conduct-&-Ethics |New |2006-05-15 |

| |Code of Conduct and Ethics |APG-Code-of-Conduct-&-Ethics2015 |Title changed to: Code of Conduct and Ethics, and other very minor editorial changes |2016-01-13 |

| | | | | |

|37 |Guidance on Cultural Aspects of |APG-CulturalAspects |New |2006-12-08 |

| |Auditing | | | |

| |Cultural Aspects |APG-CulturalAspects2015 |Title changed to: Cultural Aspects, and minor editorial changes |2016-01-13 |

| | | | | |

|38 |Output Matters |APG-OutputMatters |New |2006-12-08 |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| | | |Withdrawn | |

| | | | | |

|39 |Auditing the Procurement and Supply|APG-AuditProcurement&SupplyChain |New |2007-07-02 |

| |Chain Processes | | | |

| | | |- New paragraph inserted prior to the Introduction |2007-07-13 |

| | | |- Introduction edited | |

| | | |Aligned to ISO 9001:2008 |2009-06-05 |

| |External providers |APG-ExternalProviders2015 |Re-titled “External providers”, and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|40 |Added Value Audits versus |APG-ADDED_VALUE_AUDITS_VS_CONSULTAN|New |2008-07-15 |

| |Consultancy |CY | | |

| | |APG-ValueVsConsultancy2015 |Aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|41 |Writing Audit Reports |APG-WritingAuditReports |New |2009-03-20 |

| | | |Small amendment to section 3a), to align to ISO 19011:2011 |2013-01-16 |

| |Audit Reports |APG-AuditReports2015 |Re-titled “Audit reports” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|42 |Audit Trail |APG-AuditTrail.doc |New |2009-12-10 |

| | |APGAuditTrail2015 |One correction made |2016-01-13 |

| | | |Withdrawn |2022-05-09 |

| | | | | |

|43 |Approach to Demonstration of |APG-MeasurementTraceability |New |2009-12-10 |

| |Traceability of Measurement Results| | | |

| |Measurement traceability |APG-MeasurementTraceability2015 |Re-titled “Measurement traceability” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|44 |Deployment of the Expected Outcomes|APG-ExpectedOutcomes |New |2010-08-20 |

| |documents | | | |

| |Expected Outcomes |APG-ExpectedOutcomes2015 |Title changed to: Expected Outcomes. |2016-01-13 |

| | | |References to “product” changed to “products and services” | |

| | | | | |

|45 |How to deal with Consultants |APG-Consultants |New |2010-12-01 |

| |Deal with consultants |APG-Consultants2015 |Re-titled “Deal with Consultants” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|46 |Auditing Customer Complaints |APG-CustomerComplaints |New |2011-04-21 |

| |Customer Complaints |APG-CustomerComplaints2015 |Re-titled “Customer Complaints” and edited to be consistent with ISO 9001:2015 |2016-01-13 |

| | | | | |

|47 |Using Technical Experts on an audit|APG-TechnicalExperts |New |2011-04-21 |

| |team | | | |

| |Technical Experts |APG-TechnicalExperts2015 |Title changed to: Technical experts, and some minor editing |2016-01-13 |

| | | | | |

|48 |Audit Evidence collection |APG-EvidenceCollection |New |2013-01-16 |

| |Evidence collection |APG-EvidenceCollection2015 |Re-titled “Evidence collection” and aligned to ISO 9001:2015 |2016-01-13 |

| | | | | |

|49 |Context |APG-Context2015 |New |2016-01-13 |

| | | | | |

|50 |Organizational Knowledge |APG-OrganizationalKnowledge2015 |New |2016-01-13 |

| | | | | |

|51 |Risk Based Thinking |APG-RiskBasedThinking2015 |New |2016-01-13 |

| | | | | |

|52 |Audit Planning |APG-Audit_Planning |New |2017-01-13 |

| | | | | |

|53 |Remote Audits |APG-Remote_Audits |New |2020-04-16 |

| | | | | |

|54 |Digital Processes |APG-Digital_Processes |New |2020-09-21 |

| | | | | |

|55 |During disruptive events |APG-Disruptive_event |New |2021-01-21 |

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