Quality Management System Lead Auditor based on ISO 9001:2015

Quality Management System Lead Auditor Course Based on ISO 9001:2015

The Quality Management System Lead Auditor Course Based on ISO 9001:2015 is designed to train individuals to become proficient lead auditors for quality management systems. This course focuses on the skills and knowledge required to plan, conduct, report on, and follow up audits of a quality management system based on ISO 9001:2015 standards. It is intended for those who aspire to lead audit teams and ensure compliance with the ISO 9001:2015 standard.

Course Overview:

1- Introduction to ISO 9001:2015

• Overview of ISO 9001:2015: Understanding the purpose, scope, and benefits of the ISO 9001:2015 standard.
• Quality Management Principles: Recap of the principles that underpin the standard, including customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.
• Structure and Requirements: Detailed review of the standard’s requirements and their implications for the quality management system (QMS).

2- Lead Auditor Responsibilities and Skills

• Role of the Lead Auditor: Understanding the responsibilities and expectations of a lead auditor in managing the audit process.
• Skills and Competencies: Developing the skills necessary for effective auditing, including communication, leadership, and problem-solving.

3- Planning the Audit

• Audit Planning:
  • Audit Objectives and Scope: Defining the objectives and scope of the audit.
  • Audit Plan Development: Creating an audit plan that includes the schedule, resources, and methodology.
  • Preparation: Reviewing relevant documentation and preparing for the audit.
• Risk Assessment: Identifying potential risks associated with the audit and planning mitigation strategies.

4- Conducting the Audit

• Audit Execution:
  • Opening Meeting: Conducting the opening meeting to confirm the audit scope, objectives, and schedule with the auditee.
  • Data Collection: Techniques for collecting and evaluating evidence through interviews, document reviews, and observations.
  • Audit Sampling: Selecting samples to review in order to gather representative evidence.
• Auditing Techniques:
  • Questioning Techniques: Using effective questioning techniques to gather information and assess compliance.
  • Observation Skills: Observing processes and activities to assess conformity with ISO 9001:2015 requirements.
  • Evidence Evaluation: Analyzing collected evidence to determine whether it meets the audit criteria.

5- Reporting and Follow-Up

• Audit Reporting:
  • Findings and Nonconformities: Documenting audit findings, including any nonconformities or areas for improvement.
  • Audit Report: Preparing a clear and concise audit report that summarizes findings, conclusions, and recommendations.
• Follow-Up:
  • Corrective Actions: Reviewing and verifying corrective actions taken in response to audit findings.
  • Closing Meeting: Conducting the closing meeting to present the audit findings and discuss corrective actions with the auditee.

6- Management of the Audit Program

• Audit Program Management:
  • Audit Program Development: Creating and managing an audit program to ensure comprehensive coverage of the QMS.
  • Resource Management: Allocating and managing resources for audits, including team members and tools.
• Continuous Improvement:
  • Audit Effectiveness: Evaluating the effectiveness of the audit process and making improvements as necessary.
  • Feedback and Learning: Gathering feedback from audits and incorporating lessons learned into future audit activities.

7- Compliance and Best Practices

• Adherence to Standards: Ensuring that audits are conducted in accordance with ISO 19011 (guidelines for auditing management systems) and other relevant standards.
• Best Practices: Applying best practices for auditing to enhance the effectiveness and efficiency of the audit process.

Course Learning Outcomes:

• Understand and apply the requirements of ISO 9001:2015 in the context of quality management system audits.
• Plan, conduct, and manage audits effectively as a lead auditor.
• Prepare and present comprehensive audit reports and follow-up on corrective actions.
• Ensure compliance with ISO 19011 guidelines and industry best practices for auditing.
• Drive continuous improvement within the organization by leveraging audit findings and implementing effective corrective actions.

Target Audience:

• Quality Managers and Coordinators: Individuals responsible for overseeing quality management and audit activities.
• Internal Auditors: Auditors seeking to advance their skills to lead audit teams.
• Compliance Officers: Professionals involved in ensuring adherence to quality standards and regulations.
• Senior Management: Executives interested in understanding the audit process and supporting effective quality management.

Certification:

Upon successful completion of the course, participants will receive certification as a Lead Auditor for ISO 9001:2015, demonstrating their competence in leading audits and managing the quality management system according to ISO 9001:2015 standards.