Medical Devices
ISO 13485:2016 Internal Auditor Course (certified by Exemplar Global)
INTRODUCTION
This course enables you to learn the application of key principles and practices in accordance with ISO 13485:2016 Guidelines for auditing management system”.
Course Objectives
This course is designed to enhance the level of understanding of those actively utilizing and engaging in 1st Party Assessments. Our expert tutors give you the necessary skills to perform internal audits on an organization’s Quality Management Systems (QMS) for Medical Devices to the requirements of ISO 13485:2016 and to contribute to their continual improvement.
Course Outline
- Practical use of ISO13485:2016
- Principles of auditing, the audit cycle, and audit objectives
- Auditing skills and techniques
- Planning - Use of checklists, resources, and timing
- Selection of audit teams and training
- Interviewing and evaluation of information and findings
- Observation / Opportunities for Improvements – objective evidence
- Evaluating the significance of nonconformities
- Communicating and presenting audit reports
- Corrective actions and effective follow-up programs
- Effective improvement – planning, monitoring, and results
How you learn?
Course Approach
Frequently Asked Questions
Who should attend?
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Kiwa International Certifications(M) Sdn Bhd
2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor
+603-3884 7813
info@kiwacert.com
Services
Accredited to ISO/IC 17021:2015
ACB QMS 28
ACB OSH 17
ACB EMS 20
ACB GMP 06
ACB FSMS 13
ACB HACCP 08
ACB MDMS 05
Kiwa International Certifications(M) Sdn Bhd
2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor
+603-3884 7813
info@kiwacert.com
Services
Accredited to ISO/IC 17021:2015
ACB QMS 28
ACB OSH 17
ACB EMS 20
ACB GMP 06
ACB FSMS 13
ACB HACCP 08
ACB MDMS 05
