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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 bolikhamxai in Laos 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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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
Interactive sessions by expert and accredited trainers in classroom
Industry experienced trainers led online sessions
Flexible delivery methods are available depending on your learning style.
You will learn from qualified, accredited, certified and highly experienced trainers in classroom
Average Salary
$110K
per annum
Expected Job growth rate
25%
Companies Hiring
Job Roles
Benefits
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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