COURSE DESCRIPTION
OBJECTIVE
To provide participants with the knowledge and skills to lead first, second, and third party audits of quality management systems, meeting the criteria of ISO 9001 in accordance with ISO 17021 and ISO 19011.
REQUIREMENTS
Knowledge about quality management and the seven principles, PDCA cycle, the relationship between customer satisfaction and quality management, terms and definitions from ISO 9000:2015, and the structure and content of ISO 9001:2015.
PROGRAM CONTENT
MODULE 1 — INTRODUCTION
1.1 — Introduction
IRCA and the auditor registration scheme. ISO 17024. Course Objectives and Program Assessment Methodology and Criteria for Approval.
MODULE 2 — QUALITY MANAGEMENT SYSTEM
2.1 — Quality Management
• Concept of Quality, Quality Control, Quality Assurance, and Continuous Improvement: PDCA Cycle, Customer Satisfaction;
• Process Approach and Quality Management Principles: Benefits of a Quality Management System;
• The ISO 9000, ISO 9001, and ISO 9004 standards: terms, definitions, scope, and use by organizations.
2.2 — Foundations in ISO 9000:2015 and Requirements of ISO 9001:2015
• Management System Model, Scope and Application: The processes of an Organization;
• Principles, definitions, and requirements of the Context of the Organization, Leadership, Planning, Support, Operation, Evaluation, and Improvement;
• Understand the processes involved in establishing, implementing, operating, monitoring, reviewing, maintaining, and improving the QMS;
• Understand the QMS requirements and relevant documented information;
2.3 — Audit Situations Study
— Case studies evaluating conformity with ISO 9001:2015
MODULE 3 — CERTIFICATION MODULE
3.1 — Certification Process
• Types of Audits: First, second, and third party; Pre-audit;
• Certification Phase 1 and Phase 2, Monitoring, and Recertification;
• Explain the benefits for the organization and interested parties of third-party certification of the QMS;
• Accrediting Body and Certification Body: ISO 17021; IAF;
• Auditor Qualification and Registration: Role of Lead Auditor and Auditor, EAC, NACE;
• Audit and Non-Conformity Cycle;
• Suspension, Cancellation of Certificate;
• Complaint and Appeal.
MODULE 4 — AUDIT MODULE
4.1 — Audit as an Evaluation Instrument
• Audit Customer, Lead Auditor, and Auditee;
• The role of the Auditor, Specialist, Auditor in Training, and Guide;
• Strategic Analysis and Sampling: Risk and materiality assessment, priority selection, data and information sampling;
• The objectives of the Audit. The purpose and importance of scope and criteria;
• Different Audit methods: on-site activities and remote activities.
• Audit of activities requiring human interaction;
• Competence of the Audit Team: Skills, education, training, and experience.
4.2 — Audit Process
• Audit Program: ISO 17021, ISO 19011, Internal Auditor;
• Initial Contact and Audit Team Selection;
• Audit Planning: responsibility matrix, documentation study, and requirement establishment, audit plan preparation, checklists, and action plans;
• Communication;
• Conducting the Audit: Opening Meeting, Evidence Search, Guides, Notes and Time Control, Evaluation by the Audit Team, Deviation Recording and Classification, Closing Meeting;
• Confirm the adequacy of the implementation, operation, monitoring, critical review, maintenance, and improvement of the QMS and the role of the auditor in assessing the organization's ability to meet customer, statutory, and regulatory requirements for the product and those
4.3 — Mock Audit
• Conduct the Mock Audit by participating in different roles within the Audit Team.
MODULE 5 — CONCLUSION
5.1 — Sample Exam
• Conduct a Sample Exam promoting correction and discussion.
5.2 — Conclusion and Evaluation by the Participant
• Confidentiality and Ethics;
• Auditor's Code of Conduct;
• Continuous Assessment Results;
• Compliance with IRCA;
• Evaluation by the Participants.
5.3 — Final Exam
• Conduct the final exam.
The Quality Management System Lead Auditor Exam is the exam required by GLOBAL as part of the Certification process for Individuals in this Qualification. The Exam Program meets the GLOBAL Certification Program PC01-01, in accordance with the ISO 17024 standard, and fulfills the requirements of IRCA.
DURATION
40 HOURS
