ISO 9001:2015 Lead Auditor Course

This course aims to provide students with the skills necessary to plan, lead, conduct, execute, audits and to be able to write effective audit reports and associated nonconformity reports.  Successful completion of the course will provide a basis for students who wish to go on to apply for IRCA registration as a QMS Lead or Principal Auditor.

Learning objectives describe what students will know and be able to do by the end of the course. On completion, successful students will be able to:

• Explain the process-based quality management system model for ISO 9001, and the role of audits in the maintenance and improvement of quality management systems;
• Describe the purpose of third party certification;
• Explain the role and responsibilities of an auditor to plan, conduct, report and follow up a quality management system audit, in accordance with ISO 19011;
• Plan, conduct, report and follow up an audit as part of a quality management system based on ISO 9001, and in accordance with ISO 19011.

In order for students to achieve the overall learning objectives, they will need to acquire and develop specific knowledge. This is specified below as ‘enabling objectives’ and can be considered as steps to the achievement of the learning objectives stated above. Students will be able to:

• With reference to the Plan, Do, Check, Act cycle, explain the process-based quality management system model for ISO 9001, and the role of internal audit in the maintenance and improvement of quality management systems;
• Explain the purpose of a quality management system and the business benefits of improving the effectiveness of a quality management system;
• State requirements for QMS documentation, and explain the difference between documents, documented procedures and records;
• Explain the role and responsibilities of an auditor to plan, conduct, report and follow up an internal quality management system audit, in accordance with ISO 19011;
• Explain the purpose of and differences between first-party, second-party and third party certification audit of management systems, including the role of the QMS auditor in assessing an organisation’s ability to meet customer, statutory and regulatory requirements applicable to the product, and the organisation’s own requirements;
• Explain the benefits of third-party accredited certification of quality management systems for organisations and stakeholders;
• Describe the role and responsibilities of the auditor at each stage of the audit process
• Plan, conduct, report and follow up an internal audit of part of a quality management system based on ISO 9001, and in accordance with ISO 19011 Skills (to be practised and tested through tasks and in real or simulated audit situations;
• Explain the audit process, making reference to similarities and differences in the process between first-party, second-party and third-party certification audit;
• The purpose of a stage 1 audit, including the documentation review, and describe a typical stage 1 audit process and outputs;
• Prepare for a stage 2 audit, including preparing an audit plan;
• Conduct on-site audit activities, including preparing working documents, conducting audit meetings, gathering audit evidence, preparing and approving and distributing the audit report, and conducting the audit follow up.