For further information please contact your TÜV Rheinland branch offices on site or use the contact form on this web page. However, if you do not meet these requirements, you can expect to struggle with the Program. This will help you and your organisation to identify gaps in your quality management system as a basis for improvement of regulatory compliance and system effectiveness. Training on-site minimizes the cost-per-student, reduces travel expenses, and ensures that the content is specific to your exact needs. You will receive a certificate once you comply with all the requirements related to the selected credential.
Lecture: Developing Process-Based Management Systems 13:45 15:00 9. Certification Examinations: 36 hours approx. Quality directors, regulatory managers and professionals responsible for managing internal, corporate, supply chain or registration audit programs may also benefit from the program. Selection of Auditors and Subject Matter Experts 3. This course will give you a good understanding of how to perform quality audits in your organisation and at your suppliers.
You will learn how to apply the concept of human factors to your management system and address the standard requirements. Workshops reinforce key topics including documentation of audits, opening and closing meetings, auditor interpretations, listening and questioning techniques, checklists, and nonconformance reports. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. The Examinations are open-book you can have the Standard and other notes open beside you , time-limited and taken on-line. All Modules have full resume and scaling capabilities.
Workshop: Corrective Action 17:15 17:45 21. What else will I need to become a competent auditor? Students gain necessary auditing skills through a balance of formal classroom tutorials, role playing, group workshops, and open forum discussions. This course is delivered by expert auditors with wide experience of the medical device industry and will give you the skills required to perform internal, supplier or notified body audits. Just send an e-mail to or, for other options, see Contact Us. Successfully completing the course examinations satisfies the training requirements for certification by Exemplar Global as an internal auditor. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.
We offer comprehensive support tools including detailed instructor guides to ensure a consistent training experience throughout the organization. Writing clear nonconformity statements Break out Exercise 4 1. Development of the Internal Audit Program 1. Her experience includes leading international initiatives for the U. It also indicates that you understand the importance of the safety and performance of medical devices and how a medical devices quality management system can assure just that, consequently leading to customer satisfaction. Who can I contact for more information? With an emphasis on hands-on training, this course features workshops tailored to the working environment of the medical device industry. There are no extra costs involved.
Visit for upcoming training dates and locations. Early bird discounts are obtained by reserving a place and paying the discounted fee at the time of booking or invoice date. Improvements in the new version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements and a greater focus on post-market surveillance including complaint handling. Strict new requirements for Clinical Data, risk management, postmark surveillance, and supplier management. Lecture: Quality Standards Including 13485 11:30 12:00 3. It was one of the first organizations granted general consultative status with the United Nations Economic and Social Council.
For Course Content details see below. Development and Maintenance of the Audit Schedule The Internal Audit Process Management System Audit Planning and Preparation 1. Creating an Organizational Culture that Supports Quality. Two for less discounts are available for two or more people from the same organisation attending the same course, making the reservation at the same time and paying the discounted fee by the invoice date. You do not have to provide us with any evidence of you qualifications and experience. Additional Notes Note: Due to stringent international standards guidelines, a maximum course enrollment is strictly enforced.
The course includes hands-on workshops that allow you to replicate the working environment of the medical device industry. With the standard applicable to so many types of products, the revision was no easy task. Her expertise is in sterile disposable medical devices. Note:Pricing is dependent on location and may vary. This five-day course is recognised by regulatory agencies as the qualification for auditors and quality managers and gives you the same qualification as your notified body assessor. Organizations that are striving for continuous improvement will benefit from this standard by being able to provide safe and competent medical devices and achieve the trust of customers.