ISO 13485 Lead Auditor - United States

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 5 - Management Responsibilities
• Clause 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 - Management Responsibilities
• Clause 6 - Resource Management
• Clause 7 - Product Realization
• 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 Realization
• 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 Audits
• 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 Realization

• 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 Organization
• 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 Realization
• 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

• Overview
• Preventive Action: Process
• Exercise and Questions