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 Anguilla 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.
Filter By Month:
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.
Mindbel
#73, Karnataka Layout HBCS, 2nd Stage, 3rd Main Road, Bangalore 560079, India
Call Us
+91-7483337319
Email Address
support@mindbel.com
Join Us
As a Trainer
DISCLAIMER: The following disclaimer outlines the terms and conditions of use for the Mindbel Online Training Portal. By accessing and using our website, you agree to comply with the terms and conditions set forth in this disclaimer. If you do not agree to the terms and conditions, you should not use this website.
The names, trademarks, logos, and brands displayed on the Mindbel Online Training Portal are the property of their respective owners. The use of these names, trademarks, logos, and brands does not imply endorsement or affiliation with Mindbel, unless explicitly stated. The use of these names, trademarks, logos, and brands is solely for the purpose of identifying the products and services offered by their respective owners.
The content, information, and materials on the Mindbel Online Training Portal are provided for informational purposes only. We make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is therefore strictly at your own risk.
Mindbel shall not be liable for any loss or damage arising out of or in connection with the use of the Mindbel Online Training Portal or any information, products, services, or related graphics contained on the website. This includes without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website.
The Mindbel Online Training Portal may contain links to other websites which are not under the control of Mindbel. We have no control over the nature, content, and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.
The Mindbel Online Training Portal is provided on an "as is" basis without any representations or warranties, express or implied. Mindbel makes no representations or warranties in relation to the Mindbel Online Training Portal or the information and materials provided on the website.