ISO 13485 Lead Implementer - Hong Kong

ISO 13485 Lead Implementer​ 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

ISO 13485 Lead Implementer Exam Information

To achieve the ISO 13485 Lead Implementer, 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 Implementer Course?

The ISO 13485 Lead Implementer Course gives employees the knowledge and skills they need to lead the implementation and management of an ISO 13485-based Quality Management System for medical devices. Below are some professionals who can benefit from this course:

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

Prerequisites of the ISO 13485 Lead Implementer Course

There are no formal prerequisites for this ISO 13485 Lead Implementer. However, prior experience in medical device manufacturing or regulatory compliance will greatly benefit the delegates.

ISO 13485 Lead Implementer Training Course Overview

ISO 13485 Lead Implementer Training is a course that introduces delegates to managing quality in the medical device industry. ISO 13485 Certification is a globally recognised standard that establishes Quality Management System requirements for medical device organisations. Understanding its relevance is crucial to ensuring that organisations consistently meet customer and regulatory requirements in the medical device field.

Mastering ISO 13485 is essential for anyone responsible for implementing and managing Quality Management Systems in the medical device industry. It provides a valuable credential for individuals dedicated to quality assurance and regulatory compliance, opening opportunities for high-profile jobs and enhanced earnings. Its importance lies in improving an organisation's overall performance and mitigating risks associated with medical devices.

The 3-day ISO 13485 Lead Implementer Training Course equips delegates with the knowledge and skills to effectively implement a Quality Management System for medical devices. Participants will gain an in-depth understanding of the auditing process, enabling them to obtain and evaluate audit evidence objectively. They will also learn how to control nonconforming products identified during the inspection process.

Course Objectives

• To evaluate the expectations and requirements of the customers
• To improve the quality of medical devices manufactured by a company
• To promote harmonisation of regulatory requirements for manufacturers
• To enhance the credibility and image of a company to represent compliance
• To engage management actively and undertake management system activities
• To design and develop consultancy for a respiratory inhaler manufacturer

At the end of this training, delegates can implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to analyse the data and implement identified opportunities for improvement.

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

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