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ISO 13485 Internal Auditor - Romania
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ISO 13485 Internal Auditor course is a training program designed to provide participants with the knowledge and skills necessary to perform internal audits of a medical device quality management system (QMS) in accordance with the requirements of the ISO 13485:2016 standard. The ISO 13485 Internal Auditor course in chelina in Romania covers topics such as the principles of auditing, the structure and content of the ISO 13485 standard, and the steps involved in performing an internal audit. Upon completion of the ISO 13485 Internal Auditor course, participants should have a good understanding of the requirements of the ISO 13485 standard and the ability to perform internal audits that assess the effectiveness of a medical device QMS. The ISO 13485 Internal Auditor course is intended for professionals who are involved in the maintenance and improvement of a medical device QMS, including quality managers, quality assurance personnel, and internal auditors.
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ISO 13485 Internal Auditor
1. Introduction to ISO 13485
• Understanding the basics
• Understanding the purpose
• Scope of ISO 13485
2. Overview of ISO 13485
• Exploring the main components
• Exploring the main updates
3. ISO 13485 requirements
• Specific criteria
• Specific expectations
4. Learn about audit definitions, types, and concepts
• Fundamental definitions
• Various types of audits
• Key concepts
5. Prepare the audit report and checklists
• Understanding the process
• Understanding the methodologies
6. Follow-up procedures for internal audit
• Exploring post-audit procedures
• Follow up actions
• Corrective measures
• Effectiveness
7. Roles and responsibilities of an internal auditor
• Defining the specific duties
• Defining the specific roles
• Defining the specific skills
Target Audience
- Quality Managers
- Quality Assurance Personnel
- Personnel Auditors
- Internal Auditors
IT Includes
- 2 days interactive instructor-led training
- Training provided by highly qualified, certified, and accredited trainers from PECB
- Certificate of ISO 13485 Internal 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 Internal Auditor training with Mindbel
Average Salary
$110K
per annum
Expected Job growth rate
25%
Companies Hiring
Job Roles
- Quality Managers and Leaders
- Internal Auditors
- Regulatory Affairs Professionals
- Medical Device Professionals
- Compliance Officers
- Risk Management Personnel
- Quality Assurance Teams
- Process Improvement Professionals
- Professionals Transitioning to ISO 13485
- Management Representatives
Benefits
- Gain a thorough comprehension of the ISO 13485 standard, focusing on the specific requirements for quality management systems in the medical device industry.
- Develop strong auditing skills, enabling you to effectively plan, conduct, report, and follow-up on internal audits within your organization.
- Acquire knowledge to ensure your organization's compliance with international standards, fostering confidence among stakeholders and regulatory bodies.
- Learn to apply a risk-based approach to internal auditing, identifying and addressing critical areas that impact the quality management system.
- Enhance your ability to assess and improve quality management processes, contributing to increased efficiency and product/service quality.
- Develop skills to identify non-conformities, recommend corrective actions, and verify the implementation of solutions, ensuring continual improvement.
- Facilitate collaboration across departments by understanding how different functions contribute to the overall effectiveness of the quality management system.
- Attain a globally recognized certification that demonstrates your competence as an internal auditor, enhancing your professional credibility.
ISO 13485 Internal Auditor Training FAQs
What is ISO 13485 Internal Auditor Course?
ISO 13485 Internal Auditor course is a training program designed to provide participants with the knowledge and skills necessary to perform internal audits of a medical device quality management system (QMS) in accordance with therequirements of the ISO 13485:2016 standard.
Who is the target audience for ISO 13485 Internal Auditor Course?
What is the objective of ISO 13485 Internal Auditor Course?
How long does the ISO 13485 Internal Auditor Course last?
What are the prerequisites for attending ISO 13485 Internal Auditor Course?
What are the course topics covered in ISO 13485 Internal Auditor Course?
What is the format of the ISO 13485 Internal Auditor Course?
How is the ISO 13485 Internal Auditor Course evaluated?
What is the benefit of attending ISO 13485 Internal Auditor Course?
Is ISO 13485 Internal Auditor certification recognized internationally?
How can ISO 13485 Internal Auditor training benefit organizations?
ISO 13485 Internal Auditor training can benefit organizations by ensuring they have in-house expertise to conduct effective internal audits, identify non-conformities, and implement corrective actions.
What are the typical challenges faced by ISO 13485 Internal Auditors?
Challenges include understandingcomplex processes, conducting objective assessments, managing potential conflicts of interest, and maintaining up-to-date knowledge of the ISO 13485 standard.
How does ISO 13485 address risk-based auditing?
ISO 13485 promotes a risk-based approach to auditing, where auditors focus on areas with higher risk and potential impact on the quality and safety of medical devices.
How does an ISO 13485 Internal Auditor assess compliance with regulatory requirements?
ISO 13485 Internal Auditorsassess compliance with regulatory requirements by comparing the organization's quality management system to both the ISO 13485 standard and relevant medical device regulations.
How does ISO 13485 Internal Auditor training support career development?
ISO 13485 Internal Auditor training enhances an individual's auditing skills, which are highly valued in the medical device industry and can lead to career advancement and increased responsibilities.
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