ISO 13485:2016 Overview
This course has been designed to give participants the necessary skills and knowledge to carry out internal audits of Quality Management Systems (QMS) for Medical Devices of an organization as per the requirements of 13485:2016 standards.
The successful participants of this training will become the auditors (internal-external) and can give their effective contribution to the overall development of EN ISO 13485 standards and quality management system.
Lead Auditor Virtual Training Schedule – Evening Batch
| Course Name | Start Date | End Date |
|---|---|---|
| ISO 13485:2016 – Evening batch | 24thSep’24 | 28thSep’24 |
Learning Mode
E- learning (Online / Self-paced)
Virtual Live training (Online / Tutor-led)
In company training (Onsite)
Who Can Eligible
There are no specific requirements needed to study the Lead Auditor course, this qualification is ideal for individuals from all kinds of industrial sectors worldwide.
ISO 13485:2016 Medical Device Quality Management System Objective
ISO 13485:2016 – Medical Device Quality Management System Certification training aims at educating the participants about EN ISO 13485: 2016 Medical Devices Quality Management Systems and giving them essential skills to groom them as competent auditors delivering their active responsibilities in the audits based on the standards.
Equips learners with an understanding of the requirements for an effective Quality Management System (QMS) and associated documentation.- Skills to perform internal quality system audits.
- Plan and prepare for internal audits.
- Knowledge of the role of internal audits in improving and sustaining management systems.
- Review the recognised criteria related to auditing and initiate the steps to audit with practical applications.
- Explains the purpose of a quality management system, quality management systems standards, management system audit and third-party certification.
Who are the target people for ISO 13485:2016 Course?
This course can be taken by any medical device professional and persons responsible for implementing a quality management system based on ISO 13485:2016. This includes:
- Management representatives.
- Quality directors, managers, and engineers.
- Consultants.
- Founders or CEOs of medical device companies.
- QMS documentation specialists.
- Material suppliers.
- Purchasing teams and Operational team members.
- And many…
Benefits of the ISO 13485:2016 course
Recognition
-
- A most valuable and recognised credential.
- International qualification for quality management systems for medical device manufacturing.
Skills
- Demonstrates your expertise in performing and leading a management system audit.
- Provides competence in improving work processes.
- Skills to develop safer and more efficient medical devices.
Career Growth
- Improved number of job opportunities.
- Your expertise on the standard adds value to your profile and maximizes your earning potential.
FAQ for ISO Lead Auditor Course
How does ISO 45001 2018 Lead Auditor Training help an organization to succeed?
With ISO 45001 2018 Lead Auditor Training, organizations can cultivate a firm safety culture within the workplace, where it ensures its adherence to the health and safety standards, mitigate risks and incidents, and improve its reputation, thus enhancing its operational efficiency and maintaining its success.
What are the prerequisites for ISO 45001 2018 Lead Auditor Training?
There are no formal requisites for this training. However, the participants of the training are expected to possess prior knowledge or experience in occupational health and safety management systems to get the most from ISO 45001 2018 Lead Auditor Training.
What are the career scopes with ISO 45001 2018 Lead Auditor Online Training?
Successful candidates of ISO 45001 2018 Lead Auditor Training will have a promising scope of career opportunities that include internal auditors, consultants, lead auditors, or become managers maintaining occupational health and safety management within organizations. You can also become an independent auditor and cater to various clients.
Is ISO 45001 2018 Lead Auditor Training accepted all over the world?
Yes, ISO 45001 2018 Lead Auditor Training carries worldwide acceptance and is an internationally recognized certification that lines up with the needs of ISO 45001, an international standard for occupational health and safety management systems.
What is the duration of the ISO 45001 2018 Lead Auditor Course?
The time duration for ISO 45001 2018 Lead Auditor Course varies; however, it typically covers a few days to weeks, where the learning blends theoretical learning, practical exercises, and assessments.
What are the learning outcomes of ISO 45001 2018 Lead Auditor Training?
On successful completion of ISO 45001 2018 Lead Auditor Certification Training, you will gain insights on:
ISO 45001 standard , Auditing principles & techniques , Risk assessment , Regulatory compliance and Best practices to manage occupational health and safety.
What are the Course Fees for the ISO Lead Auditor course online in Dubai, UAE?
The Course fees of ISO 45001:2018 may vary based on different factors such as location, learning mode and others. To learn more about ISO Course Fees, you can contact our course advisor in UAE for accurate information.
