1. INTRODUCTION

• An introduction for training participants to topics related to the audit process in accordance with the guidelines of ISO 19011:2018. An explanation of what an internal audit is, and a discussion of the types of audit.
• Discussion of terms and definitions related to internal auditing as specified in ISO 19011:2018.
• Characteristics, roles and responsibilities of the audit team and those supporting the audit team:
  • lead auditor,
  • internal auditor,
  • observer,
  • technical expert.
• Presentation and explanation to training participants of the guidelines in ISO 19011:2018 concerning the competence and assessment of management system auditors and audit teams.
• Presentation and explanation of the new auditing principles to training participants. Interpretation of the risk-based approach in the audit process in accordance with the guidelines of ISO 19011:2018.

2. INITIATING THE AUDIT AND PREPARING AUDIT ACTIVITIES IN ACCORDANCE WITH THE GUIDELINES OF ISO 19011:2018

• Familiarising training participants with the stages of an internal audit.
• Presentation of the key elements of an audit:
  • resources,
  • purpose,
  • frequency,
  • scope,
  • criteria. 
• Extended guidelines of ISO 19011:2018 regarding the development of an audit programme:

3. CONDUCTING AUDITS IN ACCORDANCE WITH ISO 19011:2018

• Overview of the purpose of the opening meeting:
  • components of the opening meeting,
  • participants in the opening meeting,
  • duration of the opening meeting.
• Presentation of the principles for conducting an internal audit.
• Discussion of communication during the audit between the auditor and the auditee:
  • appropriate and inappropriate behaviour of the auditor and the auditee during the audit.
• Presentation of audit techniques:
  • methods of gathering information during the audit,
  • conducting audit interviews, formulating questions and using checklists during the audit,
  • reviewing documents and records during the audit,
  • observation during the audit.
• Characteristics of types of non-conformity:
  • discussion of when a non-conformity should be identified and when an observation should be noted.
  • methods of communicating information about a non-conformity or observation to the auditee.
• Presentation of sample audit situations applying audit principles.
• Discussion of the purpose of the closing meeting:
  • elements of the closing meeting,
  • persons attending the closing meeting,
  • duration of the closing meeting.

EXERCISES: Completion of 3 exercises designed to teach the auditee how to apply audit principles.

4. PREPARATION OF THE AUDIT REPORT, CONCLUSION OF THE AUDIT, AND POST-AUDIT ACTIONS IN ACCORDANCE WITH ISO 19011:2018

• Discussion of documents and records resulting from the audit:
  • elements of the audit report,
  • elements of the non-conformity record.
• Discussion of how to report non-conformities and observations:
  • how to prepare an audit report and a non-conformity record,
  • how to formulate conclusions in the audit report and non-conformity record,
  • presentation of a sample audit report,
  • presentation of sample non-conformity records,
  • submission of the audit report and non-conformity records.
• Discussion of post-audit activities.

EXERCISES: Completion of 1 exercise during which training participants will learn to prepare post-audit documentation independently and consolidate the knowledge acquired during Module IV.

5.  REQUIREMENTS OF ISO 9001:2026

• Introduction to ISO 9001:2026:
  • explaining the risk-based approach to auditors,
  • presenting the process-based approach in the standard to auditors,
  • discussing the PDCA cycle,
  • presenting an example explaining how to align the clauses of the standard with the organisation’s processes.
• How to audit management and the person responsible for the QMS in accordance with the requirements of ISO 9001:2026:
  • discussion of the requirements relating to establishing the organisation’s context and carrying out a risk and opportunity analysis,
  • presentation of management’s responsibilities,
  • discussion of the requirements the organisation must meet to properly oversee the quality management system.
• How to audit processes within the company based on the requirements of ISO 9001:2026:
  • explaining to whom audit questions should be directed,
  • discussing how to audit the sales and customer service process,
  • discussing how to audit the design process,
  • discussing how to audit the procurement process and placing orders with suppliers,
  • discussion on how to audit the production process,
  • discussion on how to audit the storage of raw materials, materials and finished products,
  • explanation of the requirements relating to the analysis of risks and opportunities in processes,
  • interpretation of the requirements concerning the provision of resources, communication of competence, awareness and documented information.

EXERCISES: Analysis of audit preparation within a company based on the requirements of ISO 9001:2026.