ISO 13485 Lead Auditor - Philippines

ISO 13485 Lead Auditor Course Outline

The following subjects will be taught during this course

Module 1: Introduction to ISO 13485:2016

• What is ISO 13485:2016?
• Importance of ISO 13485 for an organisation

Module 2: A Overview of ISO 13485:2016 Requirements

• General requirements
• Documentation requirements
• Management responsibility
• Resources
• Product realisation
• Infrastructure
• Risk management

Module 3: Implementation Phases of the ISO 13485 Frameworks

• Stages to implementation
• Gap analysis
• Process mapping

Module 4: Conducting an ISO 13485 Certification Audit

• Certification audits

Module 5: The Relationship Between ISO 13485 and ISO 9001

• Scope
• Focus
• Continual improvement
• Terminology
• Differences between the standards
• Similarities between ISO 13485 and ISO 9001

Module 6: Internal Auditing

• Internal audit objectives
• Auditing skills
• Planning, preparation, and management of audits
• Internal audit – PDCA cycle
• Types of audit
• Audit techniques

Module 7: The Internal Audit Plan

• The audit plan
• Criteria

Module 8: The Audit Process

• Conducting process audits
• Internal audit scope and criteria
• Reporting audit findings

Module 9: Internal Audit Evidence and Findings

• Classification
• The closing report
• Nonconformities
• Documented procedure

Module 10: Roles and Responsibilities

• Internal Auditor responsibilities

• Closing meeting
• Management responsibilities

Module 11: Resource Management and Product Realisation

• Provision of resources
• Infrastructure
• Planning and development of products

Module 12: ISO 13485 and Quality Management Systems

Module 13: Principles of Quality Management System

• Customer and regulatory focus
• Leadership
• Involvement
• The process approach
• Common tools
• Decision making
• Supplier management
• System management
• Continuous improvement

Module 14: The Fundamentals of Quality Management Systems

Module 15: Requirements and Quality Systems

Module 16: Measurement, Analysis, and Improvement

• Monitoring and measurement
• Control of non-conforming products
• The performance of the QMS
• Analysis of data
• Improvement of quality
• Corrective action
• Preventive action
• Identification of improvement opportunities

Module 17: Risk Management

• Risk management principles
• The risk management process
• Risk lifecycle
• Risk management tools
• Risk management culture
• Assessments and control of risk management

Module 18: Key Terms and Definitions of Lead Auditor

Module 19: Lead Auditor Responsibilities

• Roles, responsibilities, and authorities

Module 20: Team Leader Skills

Module 21: ISO 13485 Clauses 1 and 2

Module 22: ISO 13485 Clauses 3 and 4

Module 23: Structure and Intent of ISO 13485

Module 24: Medical Devices, Quality, and Auditing Terminology

Module 25: Processes, Procedures, and Records

Module 26: Checklist Development

Module 27: Planning, Preparation, and Management of Audits

Module 28: Interviewing Skills

Module 29: Corrective Action and Verification