ISO 13485:2016 Implementation & Internal Audit

The training provides:

• Understanding the guidelines of QMS auditing accordance to ISO 19011:2018 and internal audit process from initiating, preparing, conducting audit activities, preparing and distributing the audit report
• To handle the non-conformance effectively and help the client understand the clause of standard requirements
• To Develop your knowledge of how the requirements of respective standard are fulfilled and help the organization to fulfil the regulatory requirements.

The proposed course program is as follow:

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: Post internal audit   

• Applying the process-based approach in audit
• Testing the understanding on the standard requirement
• Prepare audit conclusion and report
• Conduct audit follow up
• Q&A session

Content

This course is designed for individuals in the medical device industry who are involved in the development and maintenance of a quality management system based on company apply ISO standard. No prerequisites are necessary for this course.