ISO 13485 Foundation Training - One day - Virtual Classroom
2 Feb 2020
This online training is designed specifically for those who are new to ISO 13485, or are scheduled to attend our IRCA Approved Internal / Lead Auditor training courses.
Facilitated by experts working in the Quality Management, for many years, this is an excellent opportunity to listen and ask all the questions you may have in relation to the standard or your upcoming IRCA Approved Internal / Lead Auditor training.
This course aims to provide learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry with a detailed understanding of the standard and its implementaion/maintenance. It also covers the context of the requirements of ISO 13485 which is compatible with IMDRF members medical device regulators individual country standards.
This course provides a basis for learners who wish to go on to complete CQI and IRCA Certified MD-QMS Auditor Training courses which also embody mandatory IMDRF country regulatory requirements not specifically covered by ISO 13485.
By the end of the training, participants will be able to:
Explain the purpose of a medical device medical device quality management system.
Explain medical device quality management systems standards and business benefits of improved performance.
Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents.
Explain the specific quality management related requirements of ISO 13485.
Outline the processes involved in establishing, implementing, operating, monitoring, measuring, analysing, evaluating, reviewing, maintaining, and improving a medical device quality management system, including the significance of these for MD-QMS auditors.
Explain the terms and definitions defined and used in ISO 9000:2015 Medical Device Quality Management Systems – fundamentals and vocabulary and those specific to ISO 13485.
Outline the structure and content of ISO 13485, and its relationship with ISO 9001 including key differences.
Outline, with reference to the PDCA cycle and the model of a process- based medical device quality management system, the structure and content of ISO 13485.
Making reference to the seven quality principles, explain the relationship between ISO 13485 requirements and ISO 9000.
Explain the specific medical device quality management related requirements of ISO 13485.
Explain some of the key concepts and interelapionships, including:
adoption of risk-based approach
quality policy - quality objectives - management review
top management, leadership, commitment and accountability
Control of design and development process from inception to transfer to manufacturing.
Resources, customer satisfaction and conformity to product and service requirements.
Monitoring, measurement, analysis and evaluation of the medical device quality management system performance against planned objectives and the internal audit.
Compliance with customer and regulatory requirements, improvement and the importance of the management review to these processes.
Recommend prior knowledge *:
• The Plan, Do, Check, Act (PDCA) cycle
• The core elements of a management system and the interrelationship between scope, top management commitment, policy, planning, objectives, performance evaluation, measurement, review and continual improvement.
• The fundamental concepts and the seven quality management principles (see ISO 9000)
• The relationship between quality management, regulatory compliance and satisfying customer requirements.
Quality management terms and definitions
• The commonly used quality management terms and definitions (see ISO 13485 and ISO 9000).