⭐ 100% Online and Self-Paced
⭐ Exemplar Global Recognized Training Provider
⭐ Ready-to-use templates and materials
⭐ Internationally Recognized Certificate
⭐ No Prior Experience in Auditing and Management Systems Required
This course is designed for those who seek to develop, implement, improve, manage, or audit against multiple disciplines and are interested in becoming an external auditor, continuing their career as auditors across various industries and organizations.
This course provides a comprehensive and practical understanding on how to conduct a successful audit, either as part of an audit team or as the team lead. This course will give participants a thorough knowledge of the audit process, integrated management systems, team management, standards fundamentals, and risk-based approach methodologies.
This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”
By enrolling in this course you will access to the course materials and ready-to-use templates such as:
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Explanation of ISO 13485 and workshops
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ISO 13485 audit checklist
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ISO 13485 documentation requirements
- ISO 14971:2019 Overview of structure and contents
- Clean room technologies and validation
- Biological evaluation of medical devices
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Process approach guide
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Risk management guide
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Risk-based thinking guide
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Sample audit plan
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Sample audit report
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Auditor meeting guide
Exemplar Global recognized certificate (formerly RABQSA).
International in This Course
- ISO 19011:2018
- ISO 13485:2016
Qualification
- Exemplar Global – TL Management Systems Lead Auditors
- Exemplar Global – AU Auditing Management Systems – ISO 19011:2018
- Exemplar Global-MD- Medical Devices ISO 13485:2016