- Knowledge of the following ISO 13485:2016 principles and concepts:
- - The model of a process-based MDSM the structure and content of ISO13485:2016
- Knowledge of the requirements of ISO 13485:2016
- Medical Devices Quality system auditors
- Medical Devices Quality management practitioners
- Employees conducting Medical Devices Quality audits within their own organizations (internal audits).
PR017: ISO 13485:2016 (Medical Devices Quality Management System) Auditor/ Lead Auditor
This program is designed to give you the relevant skills and knowledge to carry out audits of Medical Devices Quality management system against the ISO 13485:2016 requirements. This course was created to help you build your auditing practice and expand your competence.
The objective of this course is to provide Learners with the knowledge and skills required to perform first, second and third-party audits of Medical Devices Quality management against the ISO 13485:2016 in accordance with ISO 19011 and ISO 17021, where appropriate.
- Explain the purpose of Medical Devices Quality management system.
- the purpose, scope and requirements of ISO 13485:2016
- Explain the role of an auditor to plan, conduct, report and follow up Medical Devices Quality management system audit in accordance with ISO 19011 and ISO 17021-1
- The roles and responsibilities of auditors and lead auditors.
- Plan and prepare effectively for an audit.
- Analyze and interpret information in order to determine conformance with requirements.
- Report the audit, including writing valid, factual and value-adding nonconformity reports.
- undertake audit follow-up activities, including evaluating the effectiveness of corrective action.
This course is certified by Exemplar Global.
BIQS is Exemplar Global Approved Training Provider.
- Lectures 0
- Quizzes 0
- Duration 40 hours
- Skill level Expert
- Language English
- Students 0
- Assessments Self