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 ISO 13485 Lead Auditor course in Luxembourg 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 ISO 13485 Lead Auditor course in Luxembourg, participants should be able to plan, conduct, and report on audits of medical device organizations in accordance with ISO 13485:2016.

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ISO 13485 Lead Auditor

1. Introduction to ISO 13485

• What is ISO 13485:2016?

• Importance of ISO 13485

2. Overview of ISO 13485:2016

• General requirements

• Documentation requirements

• Management responsibility

• Resources

• Product realisation

• Infrastructure

• Risk management

3. Implementation Phases of the ISO 13485 Frameworks

• Stages to implementation

• Gap analysis Process mapping

4. Conducting an ISO 13485 Audit

• Certification audits

5. Relationship Between ISO 13485 and ISO 9001

• Scope

• Focus

• Continual improvement

• Terminology

• Differences between the standards

• Similarities between ISO 13485 and ISO 9001

6. Internal Auditing

• Internal audit objectives

• Auditing skills

• Internal audit objectives

• Internal audit objectives

• Records and follow-ups

• Using correct procedures in reference to the 9001:2015 standard

7. Procedures

• Definition of scope, objectives, and policies of a QMS

• Analysing implementation methodologies

• Methods to operate a QMS efficiently

• Planning, selecting and reviewing the implementation process

• Different ways to detect problems

• Roles and responsibilities of a Lead Implementer and quality team

8. Implementation process based on ISO 9001

• Report reconciliation and documentation

• How to maintain QMS structure through compliance policies

• Sequential operation process

• Measurement, monitoring and controlling of errors

9. Lead Auditor Training

• Roles and responsibilities of a Lead Auditor

• Lead Auditor requirements, scope, and procedures

• Report preparation, findings, reconciliation, and conclusions

10. On-Site Lead Audit Techniques

• Team selection and planning

• Interactive meetings

• Opening meeting

• Daily discussion meetings

• Closing meeting

• Objective of an Audit Report

• Presentation of reports

• Techniques and processes of an audit

11. Closure of Audit

• Prevention of errors

• Rectifying errors efficiently

• Reviewing audit strategies and plans

• Follow ups

• Checklist closure

• Surveillance audit

12. Methods of Collecting Information

• Visual observation

• Examination of records

• Employee interviews

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

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

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

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