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, benefits and structure of ISO 13485:2016, the 7 principles of quality management and the key audit related terminology of the standard. We will also explore the key concepts that underpin ISO 13485:2016, namely: Plan-Do-Check-Act (PDCA) cycle, process approach and risk management.

Module 2 - Introduction to Auditing (Online & Self-Paced)

In this module we will explore the internal audit requirements as specified by ISO 13485:2016, the key terminology associated with the auditing standard ISO 19011:2018, internal audit program management, the audit lifecycle roles & responsibilities of the auditor and desired auditor behaviours.

Module 3 - Audit Initiation and Preparation (Online & Self-Paced)

In this module we will explore the audit objectives, scope and criteria and the criteria for selection of the audit team. We will also expand on the audit lifecycle by exploring the first two phases namely “Initiate the Audit and Prepare Audit Activities” including preparation of the audit plan and development of the audit checklists.

Module 4 - Conducting Audit Activities (Online & Self-Paced)

In this module we will expand on the audit lifecycle by exploring the third phase of the audit lifecycle, namely conducting audit activities. Topics to be covered will include, opening meeting, communication, audit methods, generating audit findings and the process for grading non-conformities.

Module 5 - Audit Report, Close and Follow up the Audit (Online & Self-Paced)

In this module we will explore the final stages of the audit, namely: documenting the identified non-nonconformities and conducting the closing meeting. We will also explore, the last three phases of the audit lifecycle namely: preparing and distributing the audit report, completing the audit and performing follow up audit activities.

Module 6 - Course Introduction (Classroom/Virtual Training)

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

Module 7 - 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 practice the skills required to prepare the necessary documents for the audit including the audit checklist.

Module 8 - Conducting the Audit (Classroom/Virtual Training)

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

Module 9 - Report, Close and Follow-Up the Audit (Classroom/Virtual Training)

In this module we will practice the skills required for conducting the closing meeting, preparing the audit report and verifying that actions taken to address audit findings were effective.