ISO 13485 establishes the standards for a Quality Management System (QMS) in contexts where organizations must consistently demonstrate their capability to deliver medical devices and related services that comply with customer and regulatory requirements. This training in India provides learners with the essential skills needed to implement a quality management system for medical devices and conduct audits to ensure organizational effectiveness.Gaining knowledge from this ISO 13485 Training helps organizations streamline their processes and minimize operational difficulties. Individuals in India who pursue this training can enhance their expertise and skills, leading to new career opportunities and potential income growth. Professionals responsible for quality management systems should aim to excel in ISO 13485 Lead Auditor training. Mindbel's 5-day ISO 13485 Lead Auditor Training Course in India provides a thorough understanding of quality management and the principles of auditing systems. Participants will explore the implementation phases of ISO frameworks and develop expertise in conducting gap analyses to support various clauses. They will also learn about risk management, including how to identify, map, and monitor risks while fostering continuous improvement.

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ISO 13485 Lead Auditor

ISO 13485 Lead Auditor Training Course Outline

Module 1: Introduction to ISO 13485:2016

  • Course Overview
  • Definition of ISO 13485:2016
  • Advantages of Implementing ISO 13485
  • Applications of ISO 13485
  • Initial Steps for ISO 13485:2016 Compliance
  • Understanding Medical Devices
  • Purpose of a Quality Management System
  • Significance of ISO 13485
  • Fundamental Principles of ISO 13485
  • Practical 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
  • Practical Exercise

Module 4: Requirements and Quality Systems

  • Overview of Requirements and Quality Systems
  • Clause 5 - Management Responsibilities
  • Clause 6 - Resource Management
  • Clause 7 - Product Realization
  • Clause 8 - Measurement, Analysis, and Improvement
  • Practical Exercise

Module 5: Overview of ISO 13485:2016 Requirements

  • Key Requirements of ISO 13485:2016
  • General Requirements
  • Documentation Requirements
  • Responsibilities of Management
  • Resource Management
  • Product Realization
  • Infrastructure Considerations
  • Risk Management

Module 6: Implementation Phases of the ISO 13485 Framework

  • Steps for Implementation
  • Conducting a Gap Analysis
  • Process Mapping Techniques

Module 7: Conducting an ISO 13485 Certification Audit

  • Overview of Certification Audits
  • Practical Exercise

Module 8: Relationship Between ISO 13485 and ISO 9001

  • Scope Comparison
  • Areas of Focus
  • Emphasis on Continual Improvement
  • Key Terminology
  • Differences Between the Standards
  • Commonalities Between the Standards

Module 9: Internal Auditing

  • Fundamentals of Internal Auditing
  • Objectives of Internal Audits
  • Essential Auditing Skills
  • Steps in Internal Auditing
  • Planning, Preparation, and Management of Audits
  • Internal Audit – PDCA Cycle
  • Types of Audits
  • Audit Techniques
  • Practical Exercise

Module 10: Internal Audit Plan

  • Developing an Audit Plan
  • Establishing Criteria

Module 11: Audit Process

  • Overview of the Audit Process
  • Conducting Process Audits
  • Defining Scope
  • Establishing Criteria
  • Reporting Audit Findings

Module 12: Internal Audit Evidence and Findings

  • Gathering Evidence and Findings from Internal Audits
  • Classification of Findings
  • Preparing Closing Reports
  • Addressing Nonconformities
  • Documented Procedures
  • Practical Exercise

Module 13: Roles and Responsibilities

  • Responsibilities of Internal Auditors
  • Conducting Closing Meetings

Module 14: Resource Management and Product Realization

  • Provision of Necessary Resources
  • Infrastructure Management
  • Planning and Development of Products

Module 15: ISO 13485 and Quality Management Systems

  • Overview of ISO 13485
  • Understanding Quality Management Systems (QMS)
  • Practical Exercise

Module 16: Principles of Quality Management System

  • Key Principles of QMS
  • Practical Exercise

Module 17: Fundamentals of Quality Management Systems

  • Core Concepts of Quality Management Systems

Module 18: Measurement, Analysis, and Improvement

  • Overview of Measurement, Analysis, and Improvement
  • General Requirements
  • Monitoring and Measurement Techniques
  • Control of Nonconforming Products
  • Performance Evaluation of QMS
  • Data Analysis
  • Improvement Strategies
  • Corrective Actions
  • Preventive Actions
  • Identifying Opportunities for Improvement

Module 19: Risk Management

  • Overview of Risk Management
  • Principles of Risk Management
  • Risk Management Process
  • Understanding the Risk Lifecycle
  • Risk Management Tools
  • Cultivating a Risk Management Culture
  • Assessments and Control of Risk Management
  • Practical Exercise

Module 20: Key Terms and Definitions for Lead Auditors

  • Definitions of Key Terms

Module 21: Lead Auditor Responsibilities

  • Responsibilities of the Lead Auditor
  • Interactions with the Auditing Organization
  • Responsibilities towards Auditees

Module 22: Team Leader Skills

  • Essential Skills for Team Leaders
  • Practical Exercise

Module 23: Structure and Intent of ISO 13485

  • Understanding the Structure and Intent of ISO 13485
  • 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

  • Overview of Medical Devices
  • Understanding Quality Management Systems
  • Key Auditing Terminology
  • Practical Exercise

Module 25: Processes, Procedures, and Records

  • Overview of Processes
  • Understanding Procedures
  • Importance of Records

Module 26: Checklist Development

  • Purpose of Checklists
  • Benefits of a Completed Checklist
  • Process-Based Audits
  • Checklist Examples
  • Process Checklist Development

Module 27: Planning, Preparation, and Management of Audits

  • Audit Planning Techniques
  • Preparation Strategies
  • Management of Audits
  • Practical Exercise

Module 28: Interviewing Skills

  • Key Skills for Effective Interviews
  • STAR Technique

Module 29: Corrective Action and Verification

  • Overview of Corrective Actions
  • Documented Procedures for Corrective Actions
  • Processes for Implementation

Module 30: Preventive Action

  • Overview of Preventive Actions
  • Preventive Action Processes
  • Practical Exercises and Questions 

Target Audience

• Quality professionals 

• Auditors 

• Medical device professionals 

• Management Representative

IT Includes

• 5 days interactive instructor-led training 

Training provided by highly qualified, certified, and accredited trainers fromPECB 

• Certificate of ISO 13485 Lead Auditor course by PECB 

Certification

Exam Format

• Number of questions: 12 

• Exam Mode: Online/Web-based open book 

• Duration: 180 mins

• Exam format: Essay type

ACCREDITED BY

Authorised Governing Body and Mindbel

DURATION

Online Instructor-led (5 days) English

EXAM

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Benefits of ISO 13485 Lead Auditor training with Mindbel

Average Salary

$110K

per annum

Expected Job growth rate

25%

Companies Hiring

Job Roles

  • Quality Professionals
  • Auditors and Lead Auditors
  • Regulatory Compliance Specialists
  • Internal Auditors
  • Consultants
  • Quality Assurance and Regulatory Affairs Professionals
  • Senior Management
  • Manufacturing and Production Managers
  • Healthcare and Medical Professionals
  • Professionals Transitioning to Medical Device Industry

Benefits

• Gain in-depth knowledge of the ISO 13485 standard, focusing on quality management systems specific to the medical device industry. 

• Achieve certification as an ISO 13485 Lead Auditor, validating your competency in leading and conducting audits in compliance with international standards.

• Develop advanced auditing skills, including planning, conducting, and reporting on audits, ensuring a thorough understanding of the audit process.

• Acquire skills in identifying and assessing risks associated with medica device quality management systems, contributing to effective risk management practices.  

• Ensure that your organization is in compliance with ISO 13485 standards, promoting the delivery of safe and effective medical devices to the market.

• The ISO 13485 standard is globally recognized, providing you with expertise that is applicable internationally and opening doors to opportunities worldwide. 

• The iso 13485 Lead Auditor certification enhances your professional profile, making you a valuable asset to organizations seeking experts in medical device quality management.  

• Learn to lead audit teams and contribute to the continuous improvement of quality management systems.  

• As a certified ISO 13485 Lead Auditor from Mindbel, you gain from the reputation of a premier training institute, adding credibility to your expertise in the medical device industry.

ISO 13485 Lead Auditor Training FAQs

13485 Lead Auditor course is a training program designed to provide participants with the knowledge and skills necessary to perform audits of medical device quality management systems (QMS) against the requirements of the ISO 13485:2016 standard.

The target audience for the course are quality professionals, auditors, medical device professionals, and management representatives who are involved in the audit of medical device QMS.

The objective of the course is to provide participants with the knowledge and skills necessary to plan, conduct, and report on audits of medical device organizations in accordance with ISO 13485:2016.

The duration of the course varies, but it typically 5 days.

The prerequisites for attending the course vary, but participants typically should have a good understanding of quality management principles and the medical device industry, as well as experience in auditing or quality management.

The course topics covered typically include the principles of auditing, the structure and content of the ISO 13485 standard, and the techniques used to assess the effectiveness of a QMS.

The 13485 Lead Auditor course format may vary, but it typically includes lectures, group discussions, and hands-on exercises.

The 13485 Lead Auditor course in Ethiopia is evaluated through assessments, exams, or practical exercises, which may be used to test participants' knowledge and understanding of the course material.

The benefits of attending the course include gaining a better understanding of the requirements of the 13485 Lead Auditor course, developing the knowledge and skills necessary to audit medical device QMS effectively, and improving the overall quality of a medical device organization's QMS.

Yes, ISO 13485 Lead Auditor certification is recognized internationally and is a highly sought-after certification in the medical device industry.

ISO 13485 Lead Auditor training in Ethiopia is important because it equips individuals with the skills, knowledge, and techniques required to lead and manage effective audits of medical device quality management systems.  

ISO 13485 Lead Auditor training in Ethiopia provides individuals with comprehensive knowledge of auditing principles, practices, techniques, leadership skills, and the ability to manage audit programs.  

Lead Auditor 13485 training in Ethiopia teaches individuals to assess risks associated with medical device quality management systems, enabling them to focus audits on high-risk areas.  

Lead Auditor 13485 manage audit teams by assigning roles and responsibilities, coordinating activities, providing guidance, and ensuring efficient communication among team members.  

ISO 13485 auditor training in Ethiopia contributes to organizational excellence by producing auditors capable of driving improvements, ensuring regulatory compliance, and enhancing overall quality.  

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