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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
- 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
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
- Overview
- Corrective Action
Module 30: Preventative Action
- Overview
- Preventive Action: Process
- Exercise and Questions
Prerequisites
There are no formal prerequisites for attending this ISO 13485 Lead Auditor Training course.
Audience
This course is designed for everyone who wishes to advance their knowledge of implementing quality management systems for medical devices and managing auditing to improve the overall performance of an organisation.
ISO 13485 Lead Auditor Training Course Overview
ISO 13485 defines the requirements for a Quality Management System (QMS) in situations where an organisation must demonstrate its ability to consistently offer medical devices and related services that fulfil customer and applicable regulatory requirements. Studying this training provides learners with the implementation of a quality management system for medical devices and methods to conduct auditing activities to ensure the overall performance of an organisation. Obtaining knowledge of this training assists organisations in eliminating problems and reducing the work burden. Individuals who pursue this training can better acquire the knowledge and abilities that will ultimately expand their employment options and raise their income.
The Knowledge Academy’s 5-day ISO 13485 Lead Auditor Training course provides delegates with comprehensive knowledge of quality management and how to audit the system. During this training, delegates will learn about the implementation phases of ISO frameworks and the gap analysis for support information for several clauses. They will also learn about risk management for mapping identified risks and monitoring continuous improvement. This course will be led by our highly skilled and knowledgeable instructor with years of experience teaching ISO courses.
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 will be able to 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 Training Course?
This training course includes:
- The ISO 13485 Lead Auditor Examination
- The Knowledge Academy ISO 13485 Lead Auditor Manual
- Certificate
- Experienced ISO Instructor
- Refreshments
ISO 13485 Lead Auditor Exam
In order to complete this ISO 13485 Lead Auditor 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