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 Romania 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.
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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
Training Delivery Modes
Mindbel learning offers 4 learning modes to choose
Classroom Training
Interactive sessions by expert and accredited trainers in classroom
Online Training
Industry experienced trainers led online sessions
Corporate group training for corporates
Flexible delivery methods are available depending on your learning style.
Focused One to One training
You will learn from qualified, accredited, certified and highly experienced trainers in classroom
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 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
What is ISO 13485 Lead Auditor course?
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.
Who should attend ISO 13485 Lead Auditor course?
What is the objective of ISO 13485 Lead Auditor course?
How long does the ISO 13485 Lead Auditor course last?
What are the prerequisites for attending ISO 13485 Lead Auditor course?
What are the course topics covered in ISO 13485 Lead Auditor course?
What is the format of the ISO 13485 Lead Auditor course?
How is the ISO 13485 Lead Auditor course evaluated?
What is the benefit of attending ISO 13485 Lead Auditor course?
Is ISO 13485 Lead Auditor certification recognized internationally?
Why is ISO 13485 Lead Auditor training important?
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.
How does ISO 13485 Lead Auditor training prepare individuals for audit leadership roles?
ISO 13485 Lead Auditor trainingprovides individuals with comprehensive knowledge of auditing principles, practices, techniques, leadership skills, and the ability to manage audit programs.
How does ISO 13485 Lead Auditor training enhance risk assessment skills?
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.
How do ISO 13485 Lead Auditors manage audit teams effectively?
ISO 13485 Lead Auditors manage audit teams by assigning roles and responsibilities, coordinating activities, providing guidance, and ensuring efficient communication among team members.
How does ISO 13485 Lead Auditor training contribute to organizational excellence?
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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