Internal audit on Medical Device QMS - ISO 13485:2016

Name: Internal audit on Medical Device QMS - ISO 13485:2016
Rating: 4.4 (1509 reviews)

Successfully conduct an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS

Bestseller

Created byStendard Academy

Last updated 5/2021

English

Arabic [Auto],English

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

Course content

5 sections • 17 lectures • 1h 41m total length

1.1: Introduction to the internal auditor course6:02
Learn to design and execute a compliant internal audit program for ISO 13485:2016, mastering QMS checks, audit planning, and practical clause-based audits across first-, second-, and third-party assessments.
1.2: Understanding Terminology4:43
Identify core audit terminologies for ISO 13485:2016 medical device QMS, including audit team roles, technical experts, observers, and artifacts like program, plan, scope, criteria, evidence, findings, conformity, and non-conformity.
1.3: How to be a good auditor?4:28
Learn how to be a good auditor by applying seven attributes—integrity, fair presentation, due professional care, confidentiality, independence, evidence-based and risk-based approaches—to deliver reliable, actionable audit information that improves performance.

2.1: Introduction to managing the audit2:25
Learn how to manage an internal audit program for medical device QMS ISO 13485:2016, covering audit objectives, scope, criteria, resources, risks, and the five-step process from planning to post-audit follow-up.
2.2: Establishing and preparing for the audit8:32
Establish and prepare your ISO 13485:2016 internal audit program by defining objectives, scheduling priorities, assigning auditors, developing checklists, and performing a documentation audit.

3.1: Performing the audit11:00
Conduct the audit by executing the plan with an opening meeting, interviewing staff, observing processes, and reviewing records to identify non-conformities and collect objective evidence for ISO 13485:2016 QMS.
Case Study: How to record a non-conformance?0:39
Explore recording a non-conformance and documenting findings during internal audits, citing ISO 13485:2016 clause 8.2.6 on monitoring and measurement, and ensuring personnel identity is available for implantable medical device inspections.
How to correctly record a non-conformance when conducting an audit?
3.2: How to conduct a mock audit based on compiled checklist (Clause 1 to 4)?9:38
Perform a practical mock audit using a compiled ISO 13485:2016 checklist (clauses 1–4) aligned with 21 CFR part 820 to verify the quality manual, process interactions, and audit evidence.
3.3: How to conduct a mock audit based on compiled checklist (Clause 5 to 6)?5:25
Assess how to perform a mock audit of the medical device QMS by evaluating management responsibility, policy, training, and management review records, plus infrastructure and work environment controls.
3.4: How to conduct a mock audit based on compiled checklist (Clause 7)?23:31
Conduct a mock audit of clause 7 product realization, examining planning, requirements, design and development, supplier controls, production, and traceability with emphasis on verification and validation.
3.5: How to conduct a mock audit based on compiled checklist (Clause 8)?10:08
Conduct a mock audit of a medical device qms aligned with ISO 13485:2016, using clause 8 to examine measurement, analysis, improvement, internal audit, CAPA, and reporting to regulatory authorities.

5.1: Following up on post-audit activities1:57
Following up on post-audit activities, initiate and accept the CAPA plan proposed by the auditee, with auditors reviewing it by non-conformity severity, then implement, monitor effectiveness, verify results, and close.
5.2: Case study to determine Correction, Corrective Action and Preventive Action2:07
Explore how to distinguish correction, corrective action, and preventive action in a non-conformance using the capa process, identifying immediate fixes, root-cause actions, and preventive checks from a spill scenario.
5.3: Acceptance of corrective and preventive action3:49
Explore the CAPA acceptance process for nonconformities, including immediate corrections, third-party calibration, preventive actions, and monitoring to verify effectiveness within the medical device QMS.
5.4: Conclusion1:59
Learn auditing principles, craft an audit program, and manage follow-up for internal and external audits, while emphasizing documentation and using Stendard Solution to stay audit-ready.
Bonus Lecture1:26
Explore ISO 13485:2016 and the medical device quality management system, its clauses, and how to set up and maintain the QMS to align with customer expectations.

Requirements

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

Description

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

Internal audit on Medical Device QMS - ISO 13485:2016

What you'll learn

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Course content

General concepts and principles of auditing3 lectures • 15min

Establishing and preparing for the audit2 lectures • 11min

Performing the audit (How to conduct a mock audit based on compiled checklist?)6 lectures • 1hr

Reporting the audit results1 lecture • 4min

Post-audit activities and CAPA planning5 lectures • 11min

Requirements

Description

Who this course is for: