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ISO 9001 And ISO 37301 Lead Auditor

Overview:

Introduction:

The PECB ISO 9001 and  ISO 37301 Lead Auditor training course enables you to develop the necessary competence to perform quality management system (QMS) audits by applying widely recognized audit principles, procedures, and techniques. Many organizations seek competent auditors to determine whether their policies, procedures, and controls adhere to ISO 37301 and ISO 9001 requirements. This training course aims to help you complete these tasks successfully and intends to reflect the importance of effective CMS audits. In addition, this training course aims to strengthen your knowledge and skills to plan and carry out CMS audits based on the guidelines for auditing management systems provided in ISO 19011 and the certification process described in ISO/IEC 17021-1. 

Course Objectives:

At the end of this course the participants will be able to:

  • Explain the fundamental concepts and principles of a quality management system (QMS) based on ISO 9001

  • Interpret the ISO 9001 requirements for a QMS from the perspective of an auditor

  • Evaluate the QMS conformity to ISO 9001 requirements, in accordance with the fundamental audit concepts and principles

  • Plan, conducted, and close an ISO 9001 compliance audit, in accordance with ISO/IEC 17021-1 requirement, ISO 19011 guidelines, and other best practices of auditing

  • Manage an ISO 9001 audit program

  • Understand the main concepts of a compliance management system (CMS) and its processes based on ISO 37301

  • Acknowledge the relationship between ISO 37301 and other standards and regulatory frameworks

  • Understand the auditor’s role in planning, leading, and following up on a CMS audit in accordance with ISO 19011

  • Interpret the requirements of ISO 37301 in the context of a CMS audit

  • Plan an audit, lead a team of auditors, draft nonconformity reports, and follow up on an audit

  • Act with due professional care during an audit

Targeted Audience:

  • Auditors seeking to perform and lead CMS audits

  • Managers or consultants seeking to master the CMS audit process

  • Individuals responsible for maintaining conformity to ISO 37301 and ISO 19011 requirements in an organization

  • Technical experts seeking to prepare for a CMS audit

  • Expert advisors and compliance officers

Course Outlines:

Unit 1: 

  • Training course objectives and structure

  • Standards and regulatory frameworks

  • Certification Process

  • Introduction to compliance and CMS based on ISO 37301

  • An overview of ISO 37301 requirements — Clauses 4 to 10

Unit 2: 

  • Introduction to the quality management system (QMS) and ISO 9001

  • Audit principles and the preparation for and initiation of an audit

  • On-site audit activities

  • Closing of the audit

  • Certification exam

Unit 3: 

  • Fundamental audit concepts and principles

  • The impact of trends and technology in auditing

  • Evidence-based auditing

  • Risk-based auditing

  • Initiation of the audit process

  • Stage 1 audit

Unit 4:

  • Fundamental principles and concepts of a quality management system

  • Quality management system (QMS) requirements

  • Fundamental audit concepts and principles

  • Preparation of an ISO 9001 audit

  • Conducting an ISO 9001 audit 

Unit 5: 

  • Drafting audit findings and nonconformity reports

  • Audit documentation and quality review

  • Closing of the audit

  • Evaluation of action plans by the auditor

  • Beyond the initial audit

  • Managing an internal audit program

  • Closing of the training course

Unit 6:

  • Managing an ISO 9001 audit program

  • Reviewing documented information
  • Following up on nonconformities

  • Beyond the initial audit

  • Conducting an on-site audit

Unit 7:

  • Beyond the initial audit

  • Managing an internal audit program
  • Competence, evaluation and closing the training
  • Leading an audit team

Unit 8:

  • Stage 2 audit

  • Communication during the audit
  • Audit procedures
  • Drafting audit findings and nonconformity reports

Unit 9:

  • Explain the fundamental concepts and principles of a quality management system (QMS)

  • Interpret the ISO 9001 requirements for a QMS from the perspective of an auditor
  • Evaluate the QMS conformity to ISO 9001 requirements

Unit 10:

  • Plan, conduct, and close an ISO 9001 compliance audit

  • ISO 19011 guidelines, and other best practices of auditing
  • Manage an ISO 9001 audit program

 

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