PECB ISO 13485 Lead Implementer - Mastery of ISO 13485 Implementation
Register for the ISO 13485 Lead Implementer training with BCloud. Master the ISO 13485 standard for medical devices. Available in Morocco and Africa. Quality education delivered by our experts.
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- Duration : 5 Days
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About The Course PECB ISO 13485 Lead Implementer
The ISO 13485 Lead Implementer training provided by BCloud is designed to offer professionals an in-depth understanding of the concepts, requirements, and best practices to implement and manage a Quality Management System for Medical Devices (QMSMD) in accordance with the ISO 13485 standard. This intensive training covers the following key topics:
- Understand the correlations between ISO 9001 and other standards and regulations.
- Master the principles, methods, and tools used to effectively establish and manage a Quality Management System (QMS).
- Describe the requirements of the ISO 9001:2015 standard in the specific case of an organization.
- Be able to guide a company in planning, implementing, managing, monitoring, and maintaining a QMS.
- Develop a sufficient level of expertise to advise a company on good quality management practices.
- Pass the ISO 9001 Lead Implementer exam and obtain one of the 4 associated PECB certifications.
Prerequisites
A basic understanding of quality management concepts and the ISO 13485 standard is recommended to make the most of this training. Prior experience in implementing or managing quality management systems in the medical device sector will also be beneficial.
Who Should Attend This Course?
The ISO 13485 Lead Implementer training is designed to prepare individuals to establish, manage, and maintain a Quality Management System (QMS) for medical devices in accordance with the ISO 13485 standard. This training focuses on the practical implementation of the standard within an organization.
The ISO 13485 Lead Implementer training is suitable for:
Quality Managers: Those who are responsible for establishing or improving a QMS for medical devices within their organization.
Medical Device Professionals: Individuals involved in the design, manufacturing, distribution, or maintenance of medical devices who want to ensure that their organization complies with international quality requirements.
Consultants: Those who assist companies in designing, implementing, and improving their QMS in accordance with ISO 13485.
Regulatory Affairs Professionals: Individuals who need to ensure that the company complies with applicable regulations and standards.
Internal Auditors: While their primary role is auditing, having a thorough understanding of the implementation of the standard can help perform more effective audits.
Senior Executives: Those who need to understand the implications and benefits of a QMS compliant with ISO 13485.
The main objective of this training is to provide participants with the knowledge and skills needed to successfully implement ISO 13485. This includes understanding the requirements, planning the implementation, managing associated risks, and ensuring continuous improvement of the QMS.
Course Program
Day 1: Introduction to an ISMS and ISO 27001 Standard
- The regulatory and legal framework related to an Information Security Management System (ISMS)
- Fundamental principles of an Information Security Management System (ISMS)
- Functioning of the Information Security Management System
- Key points of the ISO 27001:2013 standard
- Initialization of the ISMS implementation
Day 2: Planning ISMS Implementation
- Analysis of the company's structure and definition of information security objectives
- Evaluation of the current management system
- Conducting and approving the ISMS project
- Coverage and policies of the ISMS
- Organizational structure and information security management
Day 3: ISMS Implementation
- Definition of a document management process
- Development of controls, writing policies, and development of specific procedures
- Communication plan
- Training and awareness plan
- Risk management
- Operations management
Day 4: Monitoring, Continuous Improvement, and ISMS Audit Preparation
- Monitoring, measurement, analysis, and evaluation
- Internal audit process
- Management review
- Treatment of non-conformities
- Continuous improvement process
- Preparation for ISMS certification audit
- Skills and evaluation of those responsible for implementation
Last Half-day:
- ISO 27001 Lead Implementer certification exam (duration: 3 hours)
- Note: The exam and PECB ISO 27001 Lead Implementer course material are available in English and French.
Why Choose Our Course?
By choosing BCloud for your training, you will benefit from the following advantages:
Expert and experienced trainers: Our trainers are seasoned experts in the field of medical device quality management. They have in-depth knowledge of the ISO 13485 standard and practical experience in implementing quality management systems in the medical device industry.
Comprehensive and up-to-date training material: Our training material is specially designed to cover all the requirements of the ISO 13485 standard. It is regularly updated to reflect the latest developments and best practices in medical device quality management. You will have access to presentations, practical guides, case studies, and exercises to facilitate your learning.
Guidance and support: Throughout your training, our instructional team is there to support you and answer your questions. You will receive personalized support to understand and apply the key concepts of the ISO 13485 standard, as well as practical advice to overcome specific challenges related to implementing a quality management system in the medical device sector.
Extended network of professionals and experts: By joining the ISO 13485 Lead Implementer training with BCloud, you will have the opportunity to connect with other professionals and experts in the medical device industry. You can share experiences, exchange ideas, and benefit from a strong network to support your professional development.
Geographical flexibility: Our ISO 13485 Lead Implementer training is available in different regions, offering geographical flexibility for participants. You can choose the location and dates that suit you best, making it easy for you to participate in the training.
Invest in your career and develop your skills in medical device quality management with BCloud, a leader in ISO 13485 training. Register now to start your journey toward ISO 13485 Lead Implementer certification.
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What Our Customers Say
Ahmed Ben hammida
The ISO 13485 Lead Implementer training was a very rewarding experience. The knowledge and skills acquired allowed me to understand ISO 13485 in detail and its practical application in the field of medical devices. The instructors were extremely knowledgeable, providing real real-world examples that made the content more tangible and easy to understand. The interactive sessions and practical case studies reinforced my learning and gave me the confidence to implement these standards in my organization. highly recommends this training to anyone involved in the implementation and quality management of medical devices.