Online & Blended ISO 13485:2016 Lead Auditor Training (CQI & IRCA Certified)

Module 0 - Course Introduction (Online & Self-Paced)

In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.

Module 1 - Introduction to Quality Management Systems (QMS) (Online & Self-Paced)

In this module we will explore the purpose and benefits of a QMS and an overview of the ISO 13485:2016 standard will be provided.

Module 2 - Key Concepts of ISO 13485:2016 (Online & Self-Paced)

In this module an introduction to the key concepts that underpin ISO 13485 including the PDCA cycle, process-based approach, risk based thinking and management commitment and the significance of these for the QMS Auditor.

Module 3 - Introduction to QMS Auditing (Online & Self-Paced)

In this module an introduction to QMS auditing including coverage of the certification audit process will be provided.

Module 4 - Planning the Audit (Online & Self-Paced)

In this module we will explore the initial audit planning steps including determination of the audit objectives, scope and criteria and selection of the audit team.

Module 5 - Audit Initiation and Preparation (Online & Self-Paced)

In this module we will explore the activities associated with the first two phases of the audit lifecycle including establishing contact with the auditee and development of the audit plan and audit work documents.

Module 6 - Conducting the Audit (Online & Self-Paced)

In this module we will explore the opening meeting, the need for effective communication and the methods available to the QMS auditor for collecting information and audit evidence.

Module 7 - Generating Audit Findings and Closing Meeting (Online & Self-Paced)

In this module we will explore the process for generating the audit findings, agenda for the final audit team meeting and the closing meeting.

Module 8 - Audit Reporting, Completion and Follow-Up (Online & Self-Paced)

In this module we will explore the final three phases of the audit lifecycle including coverage of the audit report, steps required to complete the audit and requirements for following-up on the audit.

Module 9 - Course Introduction [Classroom/Virtual Training]

In this module, an introduction to the classroom/virtual training element of the blended course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & training delivery.

Module 10 - Planning the Audit [Classroom/Virtual Training]

In this module we will explore the key steps that are required to plan the audit using a risk-based approach. We will also conduct a document review in preparation for the audit and practice the skills required to prepare the necessary documents for the audit including the audit checklist.

Module 11 - Conducting the Audit [Classroom/Virtual Training]

In this module we will practice the skills required to effectively conduct an audit using a sample QMS case study. A variety of audit methods will be practiced during this session including interview, document review and data analysis.

Module 12 - Generating Audit Findings and Closing Meeting [Classroom/Virtual Training]

In this module we will practice the skills required to write and grade non-conformities and determine audit conclusions. We will also practice the skills required to conduct a closing meeting

Module 13 - Audit Report and Follow Up Activities [Classroom/Virtual Training]

In this module we will practice the skills required to prepare the audit report and to evaluate audit responses including differentiating between a correction and corrective action.