Management with adaptable practices
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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
- Clauses 1 - Scope
- Clauses 5 - Management Responsibility
- Clauses 6 - Resource Management
- 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
- Clause 6
- Clause 7
- Clause 8
- 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
Prerequisites
There are no formal prerequisites for attending this ISO 13485 Lead Implementer course.
There are no formal prerequisites for attending this ISO 13485 Lead Implementer course.
- Anyone involved in defining, planning, or Lead Implementer an ISO 13485 based Quality Management System
- Management representatives
- Implementation team members
ISO 13485 Lead Implementer Training Course Overview
ISO 13485 establishes quality management system requirements for organisations that must consistently demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements. The lead implementer of this standard is responsible for developing, implementing, maintaining, and monitoring a quality management system for medical devices and enhancing an organisation's overall performance. Studying this training allows learners to implement a quality management system for medical devices and strategies for mitigating the risk associated with them. Adding management skills for medical devices to the profile will help individuals to get high-profile jobs in globally recognised corporations and claim upgraded earnings.
This 3-day ISO 13485 Lead Implementer Training course provides delegates with a thorough understanding of managing quality and implementation of respective systems. During this training, delegates will become familiar with the auditing process for obtaining audit evidence and evaluating it objectively. They will also get acquainted with the control of nonconforming products detected through the inspection process. Our highly skilled and professional trainer with years of experience teaching ISO courses will conduct this training.
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 development consultancy for a respiratory inhaler manufacturer
At the end of this training, delegates will be able to 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 Training Course?
This training course includes:
- The ISO 13485 Lead Implementer Examination
- The Knowledge Academy ISO 13485 Lead Implementer Manual
- Certificate
- Experienced Instructor
- Refreshments
ISO 13485 Lead Implementer Exam
In order to complete this ISO 13485 Lead Implementer training course, delegates will need to pass the associated examination. The exam is:
- Multiple choice questions
- Duration of 40 minutes
- 50% pass mark
- Closed book