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 Haiti 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 Haiti, 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)
Filter By Month:
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 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
What is ISO 13485 Lead Auditor course?
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 in Haiti?
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.
What is the objective of ISO 13485 Lead Auditor course?
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.
How long does the ISO 13485 Lead Auditor course last?
The duration of the course varies, but it typically 5 days.
What are the prerequisites for attending ISO 13485 Lead Auditor course in Haiti?
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.
What are the course topics covered in ISO 13485 Lead Auditor course?
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.
What is the format of the ISO 13485 Lead Auditor course?
The 13485 Lead Auditor course format may vary, but it typically includes lectures, group discussions, and hands-on exercises.
How is the ISO 13485 Lead Auditor course evaluated?
The 13485 Lead Auditor course in Haiti is evaluated through assessments, exams, or practical exercises, which may be used to test participants' knowledge and understanding of the course material.
What is the benefit of attending ISO 13485 Lead Auditor course?
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.
Is ISO 13485 Lead Auditor certification recognized internationally?
Yes, ISO 13485 Lead Auditor certification is recognized internationally and is a highly sought-after certification in the medical device industry.
Why is ISO 13485 Lead Auditor training important?
ISO 13485 Lead Auditor training in Haiti 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.
How does ISO 13485 Lead Auditor training prepare individuals for audit leadership roles?
ISO 13485 Lead Auditor training in Haiti provides 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?
Lead Auditor 13485 training in Haiti 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?
Lead Auditor 13485 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 auditor training in Haiti contributes to organizational excellence by producing auditors capable of driving improvements, ensuring regulatory compliance, and enhancing overall quality.
Top
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
Popular Certification Courses
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.