Online ISO 13485:2016 Internal Auditor Theory Training
This fully online training course is ideal for anyone that wants to gain an in-depth understanding of the process for performing internal audits of part of their QMS (based on ISO 13485:2016), in accordance with ISO 19011:2018.
If you are interested in this course, we recommend having a look at our online ISO 13485:2016 introduction course. Check it out today!
- 6 Hours
Some Companies that have used Comply Guru™
The Numbers - How We Are Doing
Our Pass Rate
Would Recommend Comply Guru
Gave us 4/5 Stars or higher Overall Training Experience
Would Recommend Online or Blended Training over Classroom Training
Module 0 - Course Introduction
In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.
Module 1 - Introduction to Quality Management Systems (QMS)
In this module we will explore the purpose, benefits and structure of ISO 13485:2016, the 7 principles of quality management and the key audit related terminology of the standard. We will also explore the key concepts that underpin ISO 13485:2016, namely: Plan-Do-Check-Act (PDCA) cycle, process approach and risk management.
Module 2 - Introduction to Auditing
In this module we will explore the internal audit requirements as specified by ISO 13485:2016, the key terminology associated with the auditing standard ISO 19011:2018, internal audit program management, the audit lifecycle roles & responsibilities of the auditor and desired auditor behaviours.
Module 3 - Audit Initiation and Preparation
In this module we will explore the audit objectives, scope and criteria and the criteria for selection of the audit team. We will also expand on the audit lifecycle by exploring the first two phases namely “Initiate the Audit and Prepare Audit Activities” including preparation of the audit plan and development of the audit checklists.
Module 4 - Conducting Audit Activities
In this module we will expand on the audit lifecycle by exploring the third phase of the audit lifecycle, namely conducting audit activities. Topics to be covered will include, opening meeting, communication, audit methods, generating audit findings and the process for grading non-conformities.
Module 5 - Audit Report, Close and Follow up the Audit
In this module we will explore the final stages of the audit, namely: documenting the identified non-nonconformities and conducting the closing meeting. We will also explore, the last three phases of the audit lifecycle namely: preparing and distributing the audit report, completing the audit and performing follow up audit activities.
This course is fully certified by Comply Guru™.
Successful completion will entitle each Learner to receive a certificate of completion.
What each Learner should know before completing this course:We recommend that each Learner have the following prior knowledge before completing this course:
- The Plan, Do, Check, Act (PDCA) Cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.
- Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
- Knowledge of the requirements is a key pre-requisite in attending this course as without a good understanding, the course & final examination may be very challenging.
Printed Copy of ISO 13485:2016
- Each participant should have a printed copy of the standard to reference while completing this course. This is not provided by Comply Guru.
E-Learning System RequirementsThe below are the recommended requirements for each Learner in wishing to complete any of our online training courses or modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well.
Recommended Operating SystemsWindows 7/10, Mac OSX Sierra, iPad IOS10
Mobile DevicesComply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.
Internet SpeedWe recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content
Recommended Internet Browsers
- Google Chrome 32 bit version 50 or later
- Safari 10 or later
Recommended SettingsWe recommend that the following settings are enabled:
- Pop-ups (in both Internet Browser and security software)
- Latest Version of Adobe Flash Player
- Latest Version of Adobe Acrobat Reader