Internal audit on Medical Device QMS - ISO 13485:2016
What you'll 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
- Owning the ISO 13485:2016 standard is optional but recommended
- Attending our "Medical Devices Quality Management System - ISO 13485:2016" course is optional, but recommended for beginners
- Familiarising with compiled audit checklist (included in this course resource
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!
Who this course is for:
- 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
At Stendard, we believe that quality is everyone’s business because it takes a team to consistently deliver and uphold great standards that build confidence with customers, partners and the community. We are a regulatory consultancy and technology company that helps businesses implement international standards, streamline business processes across the organisation, and accelerate global growth. Our vision is to put quality at the centre of your business and make it easier.
In the past years, the team at Stendard has been internationally involved with more than 400 companies working to attain the ISO 13485, ISO 22000, ISO 27001 and many more certification standards.