An ISO 13485 Lead Auditor is a trained professional responsible for auditing and ensuring compliance with ISO 13485, the global standard for medical device quality management systems. This certification provides expertise in leading and managing audits effectively. Implementing ISO 13485 is crucial for companies to establish a robust quality system, ensuring regulatory compliance, product safety, and customer trust while enabling global market access. The training enhances your ability to conduct medical device audits, ensuring adherence to international standards and improving career opportunities in the industry. A Lead Auditor's role includes preparing audit reports, interviewing employees, reviewing company policies, and testing controls to maintain compliance and quality assurance in medical device manufacturing and distribution.

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ISO 13485 Lead Auditor

 ISO 13485 Lead Auditor Training Course Syllabus 

Module 1: Introduction to ISO 13485:2016  

  • Overview of ISO 13485:2016 
  • Purpose and Benefits of ISO 13485 Implementation 
  • Applications and Initial Compliance Steps 
  • Understanding Medical Devices and Quality Management Systems 
  • Key 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  
    • 4.1 General Requirements 
    • 4.2 Documentation Requirements  
  • Practical Exercise 

Module 4: Quality Systems and Requirements  

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

Module 5: ISO 13485:2016 Key Requirements  

  • General and Documentation Requirements 
  • Management Responsibility and Resource Allocation 
  • Product Realization and Risk Management 

Module 6: ISO 13485 Implementation Stages  

  • Implementation Phases 
  • Conducting Gap Analysis 
  • Process Mapping 

Module 7: ISO 13485 Certification Audit  

  • Certification Audit Process 
  • Practical Exercise 

Module 8: ISO 13485 vs. ISO 9001  

  • Scope and Focus Comparison 
  • Continual Improvement and Terminology Differences 
  • Key Similarities and Differences 

Module 9: Internal Auditing Fundamentals  

  • Objectives and Key Auditing Skills 
  • Steps in Internal Auditing 
  • Audit Planning, Preparation, and Execution 
  • Internal Audit and PDCA Cycle 
  • Audit Techniques and Types 
  • Practical Exercise 

Module 10: Internal Audit Planning  

  • Audit Plan Development 
  • Audit Criteria and Scope 

Module 11: Audit Process Execution  

  • Conducting Process Audits 
  • Scope, Criteria, and Reporting Findings 

Module 12: Audit Evidence and Findings  

  • Internal Audit Evidence Classification 
  • Closing Reports and Nonconformities 
  • Documented Procedures 
  • Practical Exercise 

Module 13: Roles and Responsibilities  

  • Internal Auditor Responsibilities 
  • Conducting closing Meetings 

Module 14: Resource Management and Product Realization  

  • Resource Allocation 
  • Infrastructure and Product Development Planning 

Module 15: ISO 13485 and Quality Management Systems (QMS)  

  • Understanding ISO 13485 in QMS Context 
  • Practical Exercise 

Module 16: Principles of Quality Management Systems  

  • Core Principles of QMS 
  • Practical Exercise 

Module 17: Fundamentals of QMS  

  • Essential Components of Quality Management Systems 

Module 18: Measurement, Analysis, and Improvement  

  • Monitoring and Measurement Strategies 
  • Handling Nonconforming Products 
  • Data Analysis and QMS Performance Improvement 
  • Corrective and Preventive Actions 

Module 19: Risk Management in ISO 13485  

  • Principles, Process, and Lifecycle of Risk Management 
  • Tool and Risk Culture Development 
  • Risk Assessments and Controls 
  • Practical Exercise 

Module 20: Key Lead Auditor Terms and Definitions  

  • Essential Terminology for Lead Auditors 

Module 21: Lead Auditor Responsibilities  

  • Key Duties of a Lead Auditor 
  • Auditing Organizations and Auditees 

Module 22: Team Leadership Skills  

  • Core Skills for Leading an Audit Team 
  • Practical Exercise 

Module 23: 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  

  • Understanding Medical Devices and QMS 
  • Auditing Terminology 
  • Practical Exercise 

Module 25: Processes, Procedures, and Records  

  • Understanding and Managing Processes, Procedures, and Records 

Module 26: Audit Checklist Development  

  • Purpose and Components of an Effective Checklist 
  • Process-Based Audits 

Module 27: Audit Planning and Management  

  • Audit Planning, Preparation, and Execution 
  • Practical Exercise 

Module 28: Interviewing Skills for Audits  

  • Key Interviewing Techniques 
  • STAR Technique Application 

Module 29: Corrective Actions and Verification  

  • Corrective Action Planning and Execution 
  • Documented Procedures and Verification 

Module 30: Preventive Actions and Continuous Improvement  

  • Preventive Action Process 
  • Exercises and Q&A Session  

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 from PECB 

• 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

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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 medical 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 Taiwan 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 Taiwan 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 Taiwan provides individuals with comprehensive knowledge of auditing principles, practices, techniques, leadership skills, and the ability to manage audit programs.  

Lead Auditor 13485 training in Taiwan 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 Taiwan contributes to organizational excellence by producing auditors capable of driving improvements, ensuring regulatory compliance, and enhancing overall quality.  

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