Internal audit on Medical Device QMS – ISO 13485:2016

Internal audit on Medical Device QMS – ISO 13485:2016, available at $64.99, has an average rating of 4.34, with 17 lectures, 1 quizzes, based on 850 reviews, and has 2172 subscribers.

You will learn about Conducting an entire internal audit based on ISO 13485:2016 requirements General concepts and principles of auditing Establishing and preparing for the audit Performing the audit (How to conduct a mock audit based on compiled checklist?) Reporting the audit results Post-audit activities and CAPA planning This course is ideal for individuals who are Medical device companies looking to set up their QMS and get ISO 13485:2016 certified or Professionals tasked with overseeing a management system meeting ISO 13485 standards or Professionals tasked with overseeing an internal audit based on ISO 13485 requirements or Quality managers or Risk managers or Medical device practitioners interested in the ISO 13485 framework or Anyone who wishes to be able to properly conduct a mock audit independently It is particularly useful for Medical device companies looking to set up their QMS and get ISO 13485:2016 certified or Professionals tasked with overseeing a management system meeting ISO 13485 standards or Professionals tasked with overseeing an internal audit based on ISO 13485 requirements or Quality managers or Risk managers or Medical device practitioners interested in the ISO 13485 framework or Anyone who wishes to be able to properly conduct a mock audit independently.

Enroll now: Internal audit on Medical Device QMS – ISO 13485:2016

Summary

Title: Internal audit on Medical Device QMS – ISO 13485:2016

Price: $64.99

Average Rating: 4.34

Number of Lectures: 17

Number of Quizzes: 1

Number of Published Lectures: 17

Number of Published Quizzes: 1

Number of Curriculum Items: 18

Number of Published Curriculum Objects: 18

Original Price: $129.99

Quality Status: approved

Status: Live

What You Will Learn

Conducting an entire internal audit based on ISO 13485:2016 requirements
General concepts and principles of auditing
Establishing and preparing for the audit
Performing the audit (How to conduct a mock audit based on compiled checklist?)
Reporting the audit results
Post-audit activities and CAPA planning

Who Should Attend

Medical device companies looking to set up their QMS and get ISO 13485:2016 certified
Professionals tasked with overseeing a management system meeting ISO 13485 standards
Professionals tasked with overseeing an internal audit based on ISO 13485 requirements
Quality managers
Risk managers
Medical device practitioners interested in the ISO 13485 framework
Anyone who wishes to be able to properly conduct a mock audit independently

Target Audiences

Medical device companies looking to set up their QMS and get ISO 13485:2016 certified
Professionals tasked with overseeing a management system meeting ISO 13485 standards
Professionals tasked with overseeing an internal audit based on ISO 13485 requirements
Quality managers
Risk managers
Medical device practitioners interested in the ISO 13485 framework
Anyone who wishes to be able to properly conduct a mock audit independently

Internal audit on Medical Device QMS – ISO 13485:2016 is another course created by Stendard Academy to help you gain the skills, and learn how to be an internal auditor for the ISO 13485:2016 standard.

In the course, we will cover the general principles of auditing, and walk through all the clauses in this standard, to provide a holistic picture of how audits are and can be performed. This will be done as part of a comprehensive mock audit, performed according to an audit checklist we crafted to thoroughly assess each line in the standard.

The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS). It is an essential standard for medical device development companies. Besides being a common regulatory requirement, this standard, when adhered to, provides a Quality Management framework that supports quality products and processes.

You may already have a good understanding of the ISO 13485:2016 standard. However, performing an audit according to the standard is a different matter, with the rigour expected.

Learning these principles and knowing the documents and records required will be useful should you be in a position that requires you to be prepared for external audits, as similar principles apply.

This course has been broken down into:

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

For the purpose of this course, we have also compiled a checklist that we would base our mock audit on. This checklist was put together by our team at Stendard in accordance to ISO 13485:2016. The full checklist is available and you will note that we synced it with requirements according to US FDA 21 CFR Part 820 as well. You can download the Audit Checklist.pdf in Section 3.2. and adapt it for your own organisation’s usage.

Your journey to successfully conducting an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS is only clicks away. We welcome onboard the Stendard Academy, we put quality at the centre of your business and make it easier!

Course Curriculum

Chapter 1: General concepts and principles of auditing

Lecture 1: 1.1: Introduction to the internal auditor course

Lecture 2: 1.2: Understanding Terminology

Lecture 3: 1.3: How to be a good auditor?

Chapter 2: Establishing and preparing for the audit

Lecture 1: 2.1: Introduction to managing the audit

Lecture 2: 2.2: Establishing and preparing for the audit

Chapter 3: Performing the audit (How to conduct a mock audit based on compiled checklist?)

Lecture 1: 3.1: Performing the audit

Lecture 2: Case Study: How to record a non-conformance?

Lecture 3: 3.2: How to conduct a mock audit based on compiled checklist (Clause 1 to 4)?

Lecture 4: 3.3: How to conduct a mock audit based on compiled checklist (Clause 5 to 6)?

Lecture 5: 3.4: How to conduct a mock audit based on compiled checklist (Clause 7)?

Lecture 6: 3.5: How to conduct a mock audit based on compiled checklist (Clause 8)?

Chapter 4: Reporting the audit results

Lecture 1: 4.1: Reporting the audit results

Chapter 5: Post-audit activities and CAPA planning

Lecture 1: 5.1: Following up on post-audit activities

Lecture 2: 5.2: Case study to determine Correction, Corrective Action and Preventive Action

Lecture 3: 5.3: Acceptance of corrective and preventive action

Lecture 4: 5.4: Conclusion

Lecture 5: Bonus Lecture

Instructors

Stendard Academy
The Stendard Academy

Rating Distribution

1 stars: 6 votes
2 stars: 17 votes
3 stars: 103 votes
4 stars: 334 votes
5 stars: 390 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

Menu