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
• This course is assessed by 1-hour multiple-choice open book assessment by end of the training day.
• Trainees will receive A4 Certificate from NES.
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.