Internal audit on Medical Device QMS - ISO 13485:2016

🏥 Internal Audit on Medical Device QMS - ISO 13485:2016 📜

Course Overview:

At Stendard Academy, we're proud to present our comprehensive course designed to empower you with the necessary skills and knowledge to successfully conduct internal audits in compliance with the requirements of ISO 13485:2016 for Medical Device Development and Quality Management Systems (QMS).

What You'll Learn:

• General Concepts and Principles of Auditing: Understanding the core principles that underpin any successful audit. 🔍
• Establishing and Preparing for the Audit: Learn how to set up your audit environment and prepare all necessary documentation. 📑
• Performing the Audit: Master the art of conducting a mock audit using our meticulously crafted checklist, ensuring every aspect of ISO 13485:2016 is assessed. 🕵️‍♂️
• Reporting the Audit Results: Gain confidence in effectively communicating your findings and recommendations post-audit. 📈
• Post-Audit Activities and CAPA Planning: Understand the critical follow-up steps to take after an audit, including the implementation of Corrective and Preventive Actions (CAPA). 🛠️

Course Structure:

1. General concepts and principles of auditing
2. Establishing and preparing for the audit
3. Performing the audit (How to conduct a mock audit based on compiled checklist?)
4. Reporting the audit results
5. Post-audit activities and CAPA planning

Why This Course?

• Practical Application: You'll engage in a mock audit using our tailored checklist, which aligns with both ISO 13485:2016 and the US FDA 21 CFR Part 820.
• Regulatory Alignment: Understand how this course prepares you for external audits, as similar principles apply.
• Downloadable Resources: Access our comprehensive Audit Checklist.pdf in Section 3.2., which can be adapted for your organization's use.

Your Journey Begins Here:

Embark on your journey to mastering internal audits for medical device QMS with ISO 13485:2016. By enrolling in this course, you're choosing to align your practices with the highest standards of quality management. 🚀

Join Us at Stendard Academy:

We're committed to placing quality at the heart of your business and simplifying the process for you. With our expertly designed curriculum, you'll be well-equipped to navigate the complexities of internal audits with confidence. 🎓

Enroll now and take the first step towards excellence in Medical Device QMS auditing with Stendard Academy - where quality is not just a standard, but the cornerstone of success.