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ISO 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 standard. The SO 13485 Lead Auditor course in Estonia typically covers topics such as the principles of auditing, the structure and content of the ISO 13485 standard, and the techniques used to assess the effectiveness of a QMS. Upon completion of the SO 13485 Lead Auditor course, participants should be able to plan, conduct, and report on audits of medical device organizations in accordance with ISO 13485:2016.

Training Calendar for International Organization for Standardization (ISO)

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International Organization for Standardization (ISO) 13485 Lead Auditor

1: Overview of ISO 

• Brief introduction to the International Organization for Standardization (ISO) 

• Explanation of ISO's mission and purpose 

• List of some of the most widely recognized ISO standards 

2: ISO 13485 Standard 

• Explanation of the ISO 13485 standard and its purpose 

• Benefits of implementing ISO 13485 

• Common misconceptions about ISO 13485 

3: ISO 13485 Lead Auditor 

• Explanation of the ISO 13485 Lead Auditor certification and its purpose 

• Benefits of becoming an ISO 13485 Lead Auditor 

• Overview of the role of an ISO 13485 Lead Auditor 

4: Certification Process 

• Overview of the certification process for ISO 13485 Lead Auditor 

• Requirements for becoming an ISO 13485 Lead Auditor 

• Differences between certification and compliance 

5: Course Details 

• Course duration and format for ISO 13485 Lead Auditor training 

• Course objectives and learning outcomes 

• Prerequisites for taking the course 

6: Benefits of ISO 13485 Lead Auditor 

• Advantages of becoming an ISO 13485 Lead Auditor 

• Career opportunities for those with ISO 13485 Lead Auditor certification 

• Relationship between ISO 13485 Lead Auditor and other ISO standards 

7: Role of an ISO 13485 Lead Auditor 

• Detailed explanation of the role and responsibilities of an ISO 13485 Lead Auditor 

• Key skills required for the role 

• Importance of an ISO 13485 Lead Auditor in an organization 

8: ISO 13485 Audit 

• Explanation of the ISO 13485 audit process 

• Key steps in the audit process 

• Importance of preparing for an ISO 13485 audit 

9: Implementing ISO 13485 

• Overview of the process of implementing ISO 13485 

• Key steps in the implementation process 

• Importance of effective implementation in achieving ISO 13485 certification 

10: Conclusion 

• Summary of key points covered in the presentation

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

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DURATION

Online Instructor-led (5 days) English

EXAM

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Benefits of International Organization for Standardization (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 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.

International Organization for Standardization (ISO) 13485 Lead Auditor Training FAQs

ISO 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 course format may vary, but it typically includes lectures, group discussions, and hands-on exercises.
The course 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 ISO 13485 standard, 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 trainingis 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 trainingprovides individuals with comprehensive knowledge of auditing principles, practices, techniques, leadership skills, and the ability to manage audit programs.  

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

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

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

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