ISO 13485:2016 INTERNAL AUDIT TRAINING
INTRODUCTION FOR ISO 13485:2016 INTERNAL AUDIT TRAINING
This course provide the participants with the knowledge and skills to conduct the internal audits of the QMS based on the relevant audit criteria like ISO 13485:2016. Participants will learn how to use risk based approach in the internal audit and learn how to report on the effective implementation and maintenance of management system in accordance with ISO 19011.
The training provides:
• Understand the guidelines of QMS auditing accordance to ISO 19011:2011 and internal audit process from initiating, preparing, conducting audit activities, preparing and distributing the audit report
• Understand the application of the risk-based approach in medical device QMS and implement during the internal audit
• To handle the non-conformance effectively
• To Develop your knowledge of how the requirements of respective standard like ISO 13485:2016 are fulfilled and help the organization to fulfil the regulatory requirements.
HOW YOU WILL BENEFIT
• Prepare, conduct and follow up on respective standard like ISO 13485:2016 audit activities
• The role of internal audit in maintaining and improving QMS with reference to the Plan, Do, Check, Act (PDCA) cycle
• Gain the skill to assess an organization’s capability to manage its QMS by using risk- based approach
• Handle the non-conformity effectively based on the real life example from the auditor perspective
This course has been designed for management representatives, ISO 13485 QMS Steering Committee members, lead QMS auditors, internal QMS auditors, personnel responsible for legal requirements updating, and ISO conformance
• This course can be run in-company around the world
• We can tailor the content to focus on your requirements.
• This approach makes perfect sense for groups of 4+ delegates, enhancing cost effectiveness as well as team bonding.
• Classroom accompanied by Lectures, real Experience Sharing, Role-plays, Interactive Group Activities, Experiences, Simulation Activities and Feedback
• Delegate manuals and certificates of Attendance will be provided
SCHEDULE AND HOURS
This course runs from 9:00am – 1:00pm periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
Module 1: Introduction to Auditing
- Potential benefits of internal auditing from the auditor perspective
- Understand the auditor competence and responsibilities
Module 2: The Process Approach and Process Auditing
- Understanding and meeting the requirements
- Looking at process in terms of added value and Obtaining results of process performance
Module 3: Non-conformity management
- Understanding the standard requirement based on the real-life example of non-conformity
- Case study
Module 4: Managing audit program
- Understand the Plan, Do, Check, Act cycle
Module 5: Practical internal audit
- Applying the risk-based approach in audit
- Testing the understanding on the standard requirement
- Prepare audit conclusion and report
- Conduct audit follow up
- Q&A session