ISO 13485 as an integrator of unified quality management system of medical devices production in accordance with the European standards and Technical Regulations requirements. The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices, including IVD (In Vitro Diagnostic).
The standard can be used by an organization for the design, development, production, installation and servicing of medical devices as well as for the design, development and provision of related services
Gain the confidence to effectively audit a MDMS in accordance with internationally recognized best practice techniques. Demonstrate your commitment to quality by transforming existing auditor skills to ISO. Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business.
You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”. Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO audit and satisfy third-party
certification. You’ll acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance
Upon the completion of the course, participants will be able to:
• Understand the requirements and scope of ISO 13485
• How to meet ISO 13485 requirements and achieve accreditation
• Design, plan and implement an ISO 13485 quality management system
• How to increase efficiency and improve operational standards
• How to increase efficiency and improve your auditing skills
• Quality Concept
• Introduction to ISO 9001: 2015 & ISO 13485: 2016
• The relation between ISO 9001: 2015 to ISO 13485: 2016
• ISO 13485: 2016 requirements
• Cross-reference to ISO 14971: 2012 (Application of risk management to medical devices)
• Quality Management System
• Management Responsibility
• Resource Management
• Product Realization
• Measurement, analysis and improvement
• Understand the roles & responsibilities of the auditor.
• Apply ISO 19011 definitions, Concepts & Guidelines.
• Recognize the principles practices and types of audits.
• Conduct all phases of Internal Audit.
• Prepare and presents effective reports.
• How to plan audits
• Conduct audit team selection
• Initiate the audit and conducting open meetings
• Understand audit team responsibilities
• Communicate effectively during the team.
• Conduct onsite activities
• Prepare audit conclusions
• Presentation of good practice examples by experts and student
• Concepts, Techniques and Sharing Practical Experience
• Brainstorming (Perception Activity)
• Visual Aid (Videos Simulation)
• Case Studies, Self-Questioner and Real World Scenarios
NES-EURO CERT. Partner has qualified and expert surveyors, engineers, chemists, auditors & trainers responsible for the company. Our team has big experience at different fields to gain customer confidence and satisfactions at the Arab Republic of Egypt Gulf & Middle East Area.
• Teamwork based on a competitive spirit
• Credibility to guarantee our results
• Innovation to seek out the best methods
• Dedication to customer needs and desire
Our training solutions are developed by subject matter experts to help organizations and individuals improve personal competence and skills – core enablers of sustainable business development and competitive advantage.
Our Solutions meets the learning needs of wide Varity of Global Industries and subject areas,
Our Courses cover Quality and safety Improvement, Compliance, Sustainability, Health & Safety, Risk Management, Business Management Development, Functional and Industrial Training.
