Online & On-Demand ISO 13485:2016 Internal Auditor Training | Exemplar Global Certified

Module 1 - Introduction to ISO 13485:2016

• Purpose, Benefits & Structure of ISO 13485:2016
• Key Terms & Definitions
• Principles of Quality Management
• Relationship with ISO 9001
• Key Revisions of ISO 13485
• Key Concepts (PDCA, Process Approach, Risk Management)

Module 2 - Establishing a QMS

• QMS Processes
• QMS Documentation
• Document Control
• Record Control

Module 3 - Management Responsibility

• Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control),
• Responsibility
• Authority and Communication
• Management Review

Module 4 - Resource Management

• Resource Planning
• Human Resources
• Infrastructure
• Work Environment and Contamination Control

Module 5 - Product Realization, Part 1

• Planning of Product Realization & ISO 14971
• Customer related Processes
• Design & Development

Module 6 - Product Realization, Part 2

• Purchasing
• Production & Service Provision
• Control of Monitoring & Measuring Equipment

Module 7 - Measurement, Analysis and Improvement

• Monitoring & Measurement (feedback, complaint handling, regulatory reporting & internal audit, process and product monitoring & measuring)
• Control of Non-Conforming Product
• Analysis of Data
• Improvement (CAPA)

Module 8 - Introduction to QMS Auditing

• Internal Audit Requirements
• Introduction to ISO 19011:2018
• Onsite & Remote Audits
• Principles of Auditing
• Audit Lifecycle
• Auditor Roles & Responsibilities
• Desired Auditor Behaviour

Module 9 - Audit Initiation and Preparation

• Audit Planning
• Audit Scope, Objectives and Criteria
• Initiating the Audit
• Selection of Audit Team
• Document Review
• Preparing Audit Activities
• Internal Audit Plan
• Audit Checklist

Module 10 - Conducting Audit Activities

• Audit Activities Workflow
• Conducting the Audit
• Opening Meeting
• Communication during an Audit
• Collecting & Verifying Information
• Generating Audit Findings
• Non-Conformity Grading

Module 11 - Audit Report, Close and Following Up the Audit

• Non-Conformity Reporting
• Closing Meeting
• Audit Report & Distribution
• Completing the Audit
• Audit Follow Up Activities