ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes - Lead Implementer Course

Description

Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes An effective implementation is essential if organizations are to maximize the cost saving, performance, and customer satisfaction benefits of ISO 13485 2016 standards. ISO 13485 2016 lead implementer course is good for those who need an overview on the ISO 13485 2016 standards, or those who will be involved in the implementation of ISO 13485 2016 standards within an organization. ISO 13485 2016 implementation course will guide you through the implementation process by explaining the requirements of ISO 13485 2016 and how they can be applied using international best practices. Using a step-by-step approach, you will learn how to develop an implementation plan, create the necessary documentation, monitor the quality management system, and achieve continual system and quality improvement.

Who Should Attend?

• Anyone responsible for implementing ISO 13485 2016 standard
• Those who want to learn how to interpret the requirements of ISO 13485 2016 standard
• Managers or executives involved in delivering ISO 13485 2016
• Heads of various departments in an organisation
• Jobseekers interested in understanding the best quality management practices followed by the organizations in the medical device value chain
• Anyone looking to gain skills and knowledge in ISO 13485 2016

Key Benefits

• Understand concepts and importance of the ISO 13485 2016 management system principles.
• Grasp the application of risk-based thinking, leadership and process management
• Interpret requirements of ISO 13485 2016 standard and its effective application for managing and improving the functioning of an organization through process approach.
• Understand and develop skills for implementation of management system to manage processes of the organization.
• Build stakeholder confidence by managing processes in line with the latest requirements
• Understand and develop problem solving skills
• Maintain and continually improve your quality management system
• Learn techniques to create and manage documents and records relevant to ISO 13485 2016 quality management system , critical to the products and services delivered and those required to meet customer and regulatory requirements
• Learn skills in human resource management, supplier management, customer management , operations management, inventory management, laboratory management, production planning and logistics management to ensure compliance to ISO 13485 2016 medical device quality management system
• Learn to identify and mitigate internal and external quality issues relevant to businesses
• Learn to identify stakeholder expectations and prepare action plans to fulfill them
• Learn to define and optimize the processes in your organisation
• Understand the methods to develop a customer focus approach in an organisation
• Identify improvement objectives and plans to achieve them
• Understand traceability requirements relevant to products and services
• Develop an effective business communication plan
• Learn to manage design and development activities
• Learn techniques to manage nonconformity in products and services delivered and take corrective actions
• Fill gaps in your professional knowledge

Learning & Evaluation Method

This is  a live and interactive course.  Once you purchase the course, our team will contact you to plan the training. No matter where you are located, we schedule the classes based on your convenience and time zone. You can plan to attend the training in sessions of 4 or 8 hr duration, based on how much time you can spend in a day.

Buy for group Are you planning to buy this course for a group? We have the best prices for you! Select ‘Buy for Group’ option and add to the cart. You will get a discount of 60 – 75% for a group of up to 10 participants. To make a group purchase, create your group name and add individual emails of up to 10 participants. Each participant will get the access to the course materials, exam and the certificate. We will arrange one live-online session for the entire group.