ISO 13485 Certification Courses

This ISO 13485 Lead Auditor Certification course covers concepts and topics from ISO 13485 Foundation, ISO 13485 Internal Auditor, and ISO 13485 Lead Implementer Certifications. 

In this ISO 13485 Lead Auditor Certification course, you will learn advanced concepts to ensure the quality of medical devices and implement quality measures according to the ISO 13485 standard. This course also covers the roles and responsibilities of the Lead Auditor and audit team, including:

Course Outline:

Module 1: Key Terms and Definitions of Lead Auditor

Module 2: Lead Auditor Responsibilities

Module 3: Team Leader Skills

Module 4: ISO 13485 Clauses 1 and 2

Module 5: ISO 13485 Clauses 3 and 4

Module 6: Structure and Intent of ISO 13485

Module 7: Medical Devices, Quality, and Auditing Terminology

Module 8: Processes, Procedures, and Records

Module 9: Checklist Development

Module 10: Planning, Preparation, and Management of Audits

Module 11: Interviewing Skills

Module 12: Corrective Action and Verification

This ISO 13485 Lead Implementer Certification covers the essential principles and requirements for implementing the ISO 13485 standard in your organisation. This course also helps you in seamless quality control of the medical device’s manufacturing. This ISO 13485 Lead Implementer certification also covers ISO 13485 Foundation and Internal Auditor Certification. 

Course Outline:

Module 1: ISO 13485 and Quality Management Systems

Module 2: Principles of Quality Management System

• Customer and Regulatory Focus
• Leadership and Involvement
• Define Process Approach
• Common Tools
• Decision Making
• Supplier and System Management
• Continuous Improvement

Module 3: Fundamentals of Quality Management Systems

Module 4: Requirements and Quality Systems

Module 5: Measurement, Analysis, and Improvement

• Monitoring and Measurement
• Control of Non-Conforming Products
• Performance of the QMS
• Analysis of Data
• Improvement of Quality
• Corrective Action
• Preventive Action
• Identifying Improvement Opportunities

Module 6: Risk Management

• Principles of Risk Management 
• Process of Risk Management
• Risk Lifecycle
• Risk Management Tools and Culture
• Assessments and Control of Risk Management

During this ISO 13485 Internal Auditor certification, you will learn various advanced topics such as introduction to Internal Audit plan, responsibilities of Internal Auditor, scope and criteria of Internal Audit. This ISO 13485 Internal Auditor certification also covers the concepts used in ISO 13485 Foundation certification. Attending this course will provide you with knowledge of both Foundation and Internal Auditor levels of ISO 13485. 

Course Outline:

Module 1: Internal Auditing

• Objectives of Internal Audit
• Auditing Skills
• Planning, Preparation, and Management of Audits
• PDCA cycle
• Types of Audit
• Audit Techniques

Module 2: Introduction to Internal Audit Plan

• Audit Plan
• Criteria

Module 3: Audit Process

• Conducting Process Audits
• Internal Audit Scope and Criteria
• Reporting Audit Findings

Module 4: Internal Audit Evidence and Findings

• Classification
• Define Closing Report
• Documented Procedure

Module 5: Roles and Responsibilities

• Responsibilities of Internal Auditor
• Closing Meeting
• Responsibilities of Management

Module 6: Resource Management and Product Realisation

• Provision of Resources
• Infrastructure
• Planning and Development of Products