ISO13485:2016   Lead Auditor

Course Content                                                                                                    
Module 1              Fundamentals of Quality & QMS and Aligning ISO 13485 to core business objectives. 

Module 2  Process Management to manage and improve the business. 

Module 3  Establishing Key Performance Indicators (KPI’s) and Measuring process performance. 

Module 4 Introduction to Quality Auditing. 

Module 5 Planning the audit programme. 

Module 6 Scheduling audit programme. 

Module 7 Selecting internal and external auditors. 

Module 8 Audit preparation and looking at the critical success factors for your organisation. 

Module 9 Understanding the organisation and its key processes. 

Module 10  Using Checklists. 

Module 11  Audit Lifecycle. 

Module 12 Participants carry out either a live audit in an organisation or a detailed virtual audit. 

Module 13 Guidelines for productive Opening and Closing meetings. 

Module14 Carrying out the audit. 

Module 15 Objective Evidence. 

Module 16 Audit findings and Classification. 

Module 17 Writing the Audit Report. 

Module 18 Corrective action and effectiveness. 

Module 19 How to deal with external auditors. 

Course Objectives: • Describe the purpose of a QMS and explain the 8 principles of quality management. 

• Explain the purpose, content of ISO13485:2016 

• Interpret requirements of ISO 13485:2016 in the context of an audit. 

• Manage an audit programme. 

• Understand the different types of audits. 

• Describe the roles and responsibilities of auditors and lead auditors. 

• Plan and conduct an audit in accordance with ISO 19011, demonstrate ability to Plan and prepare effectively. 

• Gather objective evidence, through effective interviewing, observation, sampling and note taking. 

• Analyse and interpret information in order to determine conformance with requirements. 

• Report the audit, including writing valid, factual and value-adding non-conformity reports. 

• Undertake audit follow-up activities, including evaluating the effectiveness of corrective action. 

• Professionally liaise with external auditors.