Medical Devices
ISO 13485:2016 Medical Devices Management System Lead Auditor Course (certified by Exemplar Global)
INTRODUCTION
This 5-days Lead Auditor Course focuses on the application of key principles and practices in accordance with ISO 13485:2016 and ISO19011 “Guidelines for auditing management system”. This course is designed to enhance the level of understanding for those actively utilizing and engaging in 3rd Party Assessments. Our expert tutors give you the necessary skills to perform 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 Objectives
By the end of this practical and interactive course, delegates are able to plan, conduct, report, and follow up a QMS audit, and evaluate any corrective and preventive actions arising from the audit.
Course Outline
- Practical use of ISO13485:2016 and its requirements
- 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
Our learning style is interactive lectures, which means I talk a little and you talk a little. In addition to this, we have group discussions and activities with interactive feedback and then there will be real-time representative assessments.
Exemplar Global certified
International Recognized Qualification
This certificate enables successful candidates to apply to Exemplar Global for certification as a provisional auditor upon passing the examination. Participants who choose not to submit the assessment and fail to pass the examination will be issued a 'Certificate of Attendance'
Frequently Asked Questions
Who should attend?
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Can I participate if I don't have the basic knowledge ?
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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
