Course details
This five-day intensive course enables participants to develop the necessary expertise to support an organization in implementing and managing Medical Devices Quality Management System (MDQMS) based on ISO 13485:2016. Participants will also gain a thorough understanding of best practices used to implement quality processes based on requirements from ISO 13485. This training is consistent with the project management practices established in ISO 10006 (Quality Management Systems - Guidelines for Quality Management in Projects).Learning objectives
- To understand the implementation of Medical Devices Quality Management System in accordance with ISO 13485
- To gain a comprehensive understanding of the concepts, approaches, standards, methods and techniques required for the effective management of Medical Devices Quality Management System
- To understand the relationship between the components of a Quality Management System and the compliance with customer and regulatory requirements
- To acquire necessary expertise to support an organization in implementing, managing and maintaining MDQMS as specified in ISO 13485
- To acquire necessary expertise to manage a team implementing ISO 13485
- To develop knowledge and skills required to advise organization on best practices in the management of quality
- To improve the capacity for analysis and decision making in the context of quality management
- To prepare an organization for an ISO 13485 audit
- Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485 and initiation of MDQMS
- Introduction to management systems and the process approach
- Normative frameworks and methodologies related to Quality and Medical Devices
- Understanding the requirements of ISO 13485:2016
- Fundamental principles of Quality and Medical Devices
- Initiating the MDQMS implementation
- Planning the implementation of MDQMS based on ISO 13485
- Writing a business case and a project plan for the implementation of MDQMS
- Definition of the scope of the MDQMS
- Development of MDQMS policy
- Implementing MDQMS based on ISO 13485
- Implementation of a document management framework
- Design of controls and writing of procedures
- Development of a training and awareness program and communicating about the quality
- Product realization processes
- Operations management of MDQMS
- Controlling, monitoring and measuring MDQMS and the certification audit of MDQMS in accordance with ISO 13485
- Controlling and monitoring MDQMS
- ISO 13485 Internal Audit
- Management review of MDQMS
- Implementation of an improvement program
- Preparing for an ISO 13485 certification audit
- Certification Exam
- Sessions of lectures illustrated with examples based on real cases
- Practical exercises based on a full case study including role playing and oral presentations
- Review exercises to assist the exam preparation
- Practice test similar to the certification exam
- Benefit from the practical exercises, the number of training participants is limited
- Domain 1: Fundamental principles and concepts of quality and medical devices
- Domain 2: Medical Devices Quality Management System Best Practice based on ISO 13485
- Domain 3: Planning MDQMS based on ISO 13485
- Domain 4: Implementing MDQMS based on ISO 13485
- Domain 5: Performance evaluation, monitoring and measurement of MDQMS based on ISO 13485
- Domain 6: Maintaining the effectiveness of MDQMS based on ISO 13485
- Domain 7: Preparing for MDQMS certification audit
Eligibility / Requirements
ISO 13485 Foundation Certification or a basic knowledge of ISO 13485 is recommended
Job roles this course is suitable for:
Invest in yourself and elevate the trajectory of your career. In today's competitive market , specialised knowledge sets you apart from the pack. Make an impact statement that shows you are dedicated to taking your risk management skills to the highest standards.Course Location
About Optimizer Middle East
Introduction:
Optimizer Middle East is a professional organization located in Business village, Deira, Dubai, UAE and active in the MENA countries. The core business of the organization encompass services and consultancies in accounting management systems based on international standards and professional training including technical, management and accounting with the objective of developing personnel skills.
We have executed various professional development projects the Gulf region and North Africa till date targeting to be a leader for Training and development in the area.
Vision:
We Optimizer Middle East shall become the professional umbrella for all the training and development professionals in MENA regions.
Mission:
Develop, organize, sustain through providing professional services, consultancies and training with the objective of disseminating standardized and developed professional practices to individuals and private as well as governmental organizations in MENA region.
Our Objectives:
- Provision of knowledge as skills
- Empowering individuals and organizations in MENA region with the latest professional advanced tools
- Introduction of conceptual practices in the organizational activities
- Qualifying professional experts in the government and private sector
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