ISO 13485 2016 Medical devices — Quality Management System — Requirements for Regulatory Purposes - Internal Auditor 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 ISO 13485 2016 internal auditor course will help you learn how to initiate an audit, prepare and conduct audit activities, compile and distribute audit reports and complete follow-up activities. On successful completion of this course, you will be able to optimize your auditing skills with the internationally recognized ISO 13485 2016 standard and boost your audit capabilities. Also gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary. ISO 13485 2016 internal auditor training course develops the necessary skills to assess and report on the conformance and implementation of processes based on ISO 13485 2016.

Who Should Attend?

• Anyone involved in the planning, implementing, maintaining, supervising or auditing of an ISO 13485 2016 quality management system
• Those who like to handle the role of an ISO 13485 2016 internal auditor in an organisation
• Employees of any organisation who wish to audit their organisation’s quality management system
• Those involved in second party audits such as vendor audits
• Personnel who wish to pursue career as an ISO 13485 2016 internal auditor

Key Benefits

• Gain the skills to plan, conduct, report and follow up first and second party audits in accordance with ISO 19011
• Learn skills to lead an internal audit team
• Identify the aims and benefits of an ISO 13485 2016 audit
• Interpret ISO 13485 2016 requirements for audit application
• Grasp the application of risk-based thinking, leadership and process management
• Acknowledge the correlation between ISO 13485 2016 and other standards and regulatory frameworks
• Learn the latest techniques in ISO 13485 2016 internal auditing
• Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business

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.