ISO 13485 Lead Auditor - Hong Kong

ISO 13485 Lead Auditor Training Course Outline

Module 1: Introduction to ISO 13485:2016

• Introduction
• What is ISO 13485:2016?
• Benefits of Implementing ISO 13485
• Applications of ISO 13485
• First Steps to ISO 13485:2016 Compliance
• What is a Medical Device?
• Purpose of a Quality Management System
• Importance of ISO 13485
• Basic Principles of ISO 13485
• Exercise

Module 2: ISO 13485 Clauses 1 and 2

• Clause 1 – Scope
• Clause 2 - Normative References

Module 3: ISO 13485 Clauses 3 and 4

• Clause 3 - Terms and Definitions
• Clause 4 - Quality Management System
• Clause 4.1 General Requirements
• Clause 4.2 Document Requirements
• Exercise

Module 4: Requirements and Quality Systems

• Requirements and Quality Systems
• Clause 5 - Management Responsibilities
• Clause 6 - Resource Management
• Clause 7 - Product Realisation
• Clause 8 - Measurement, Analysis, and Improvement
• Exercise

Module 5: Overview of ISO 13485:2016 Requirements

• Requirements of ISO 13485:2016
• General Requirements
• Documentation Requirements
• Management Responsibility
• Resources
• Product Realisation
• Infrastructure
• Risk Management

Module 6: Implementation Phases of the ISO 13485 Frameworks

• Stages to Implementation
• Gap Analysis
• Process Mapping

Module 7: Conducting an ISO 13485 Certification Audit

• Certification Audits
• Exercise

Module 8: Relationship Between ISO 13485 and ISO 9001

• Scope
• Focus
• Continual Improvement
• Terminology
• Differences Between the Standards
• Similarities Between the Standards

Module 9: Internal Auditing

• Internal Auditing
• Internal Audit Objectives
• Auditing Skills
• Steps in Internal Auditing
• Planning, Preparation, and Management of Audits
• Internal Audit – PDCA Cycle
• Types of Audit
• Audit Techniques
• Exercise

Module 10: Internal Audit Plan

• Audit Plan
• Criteria

Module 11: Audit Process

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

Module 12: Internal Audit Evidence and Findings

• Internal Audit Evidence and Findings
• Classification
• Closing Report
• Nonconformities
• Documented Procedure
• Exercise

Module 13: Roles and Responsibilities

• Internal Auditor Responsibilities
• Closing Meetings

Module 14: Resource Management and Product Realisation

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

Module 15: ISO 13485 and Quality Management Systems

• ISO 13485
• Quality Management Systems (QMS)
• Exercise

Module 16: Principles of Quality Management System

• Principles of QMS
• Exercise

Module 17: Fundamentals of Quality Management Systems

• Fundamentals of Quality Management Systems

Module 18: Measurement, Analysis, and Improvement

• Measurement, Analysis, and Improvement
• General Requirements
• Monitoring and Measurement
• Control of Nonconforming Product
• Performance of QMS
• Analysis of Data
• Improvement
• Corrective Action
• Preventive Action
• Identification of Improvement Opportunities

Module 19: Risk Management

• Risk Management
• Risk Management Principle
• Risk Management Process
• Risk Lifecycle
• Risk Management Tools
• Risk Management Culture
• Assessments and Control of Risk Management
• Exercise

Module 20: Key Terms and Definitions of Lead Auditor

• Key Terms Definitions

Module 21: Lead Auditor Responsibilities

• Lead Auditor Responsibilities
• Auditing Organisation
• Auditees

Module 22: Team Leader Skills

• Team Leader Skills
• Exercise

Module 23: Structure and Intent of ISO 13485

• Structure and Intent
• Clause 5 – Management Responsibility
• Clause 6 – Resource Management
• Clause 7 – Product Realisation
• Clause 8 – Measurement, Analysis, and Improvement

Module 24: Medical Devices, Quality, and Auditing Terminology

• Medical Devices
• Quality Management System
• Auditing Terminology
• Exercise

Module 25: Processes, Procedures, and Records

• Processes
• Procedure
• Records

Module 26: Checklist Development

• Purpose
• Completed Checklist Provides
• Process Based Audits
• Checklist
• Process Checklist

Module 27: Planning, Preparation, and Management of Audits

• Planning
• Preparation
• Management of Audits
• Exercise

Module 28: Interviewing Skills

• Key Interviewing Skills
• Star Technique

Module 29: Corrective Action and Verification

• Overview
• Corrective Action
• Documented Procedure
• Process

Module 30: Preventative Action

• Preventive Action: Process
• Exercise and Questions

ISO 13485 Lead Auditor Exam Information

To achieve the ISO 13485 Lead Auditor, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice 
• Total Questions: 30 
• Total Marks: 30 Marks 
• Pass Mark: 50%, or 15/30 Marks 
• Duration: 40 Minutes  
• Open Book/ Closed Book: Closed Book

Who should attend this ISO 13485 Lead Auditor Course?

The ISO 13485 Lead Auditor Course provides the knowledge and skills required to conduct audits of medical device Quality Management Systems against the requirements of ISO 13485. This course can be beneficial for professionals, including:

• Lead Auditors
• Quality Control Managers
• Regulatory Affairs Managers
• Compliance Officers
• Manufacturing Managers
• Quality Assurance Professionals
• Internal Auditors

Prerequisites of the ISO 13485 Lead Auditor Course

There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, some knowledge of Quality Management Systems, auditing techniques, regulatory requirements, and practical experience in medical device manufacturing would significantly benefit the delegates.

ISO 13485 Lead Auditor Training Course Overview

ISO 13485 sets the standards for a Quality Management System (QMS) in scenarios where organisations must consistently demonstrate their ability to provide medical devices and related services that meet customer and regulatory requirements. This training equips learners with the skills required to implement a Quality Management System for medical devices and conduct audits to ensure organisational performance. Acquiring knowledge from this training benefits organisations by streamlining processes and lowering operational challenges. Delegates pursuing this training can improve their expertise and capabilities, opening new career opportunities and potential income growth. Professionals responsible for Quality Management Systems will find mastering ISO 13485 Lead Auditor Training highly advantageous.

The Knowledge Academy provides a 5-day ISO 13485 Lead Auditor Training Course that offers a comprehensive understanding of quality management and the art of auditing systems. Delegates will delve into the implementation phases of ISO frameworks and gain expertise in gap analysis to support various clauses. They will also explore risk management, learning to map identified risks and monitor continuous improvement.

Course Objectives

• To improve the quality of medical devices manufactured by a company
• To promote harmonisation of regulatory requirements for manufacturers
• To provide access and evidence in accordance with regulatory requirements
• To engage management actively and undertake management system activities
• To protect the confidentiality of all documents and information obtained in the audit
• To obtain quality objectives from the manufacturer and pass them to the organisation

After completing this training, delegates can implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to take on responsibilities associated with auditing authority for the management and performance of all audit activities.

What’s included in this ISO 13485 Lead Auditor Course?

• ISO 13485 Lead Auditor Examination
• World-Class Training Sessions from Experienced Instructors
• ISO 13485 Lead Auditor Certificate
• Digital Delegate Pack