13485:2016 Training Products

Select the right 13485:2016 Training topic and method for your organization.

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Internal Auditor Training

13485 Internal Auditor Training  – Learn how to be a professional internal auditor for your company, and conduct audits as required in 13485 Section 8.2.4  This effective and efficient course is available online for beginners and as materials to train new auditors. You will gain the skills for setting up an audit program and schedule, developing audit checklists and plans, and conducting an audit through interviewing personnel and evaluating documents and records.  

Employee Training

ISO 13485 Employee Training – Section 6.2 of 13485:2016 requires that employees understand their role in the QMS, in addition to the Quality Policy and relevant Quality Objectives. This course provides an efficient and effective way to educate ALL of the employees in an organization so they understand their role in meeting the requirements of 13485.  The course covers the fundamentals of 13485, basics of a Quality Management System (QMS), and what is involved in establishing a QMS. The course includes quizzes to ensure comprehension as required by 13485:2016 Sec. 6.2, and a customizable certificate to issue upon satisfactory performance on the quizzes.

12 Employee Newsletters – We also have Employee Newsletter templates in Microsoft Word so you can keep everyone in your organization informed and involved during your implementation project.
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Requirements Training

13485 Requirements Training – This training course is perfect for learning the requirements of 13485:2016.  Learn what you need to do to build an 13485:2016 system, upgrade your current system, or integrate it with another management system. This is a great training tool for your project leader, management, and quality or safety team.
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Risk Training

13485 Risk Management Exercise – These materials can help you identify and prioritize the risk in your processes, as required in 13485:2016 Sec. 6.1 (Actions to address risks and opportunities).

FMEA Training – to manage risk– Failure Mode and Effects Analysis (FMEA) training.  Describes the purpose of FMEA and explain the benefits of using FMEAs in both design and process engineering situations.

Skills Training

Problem Solving Courses – Online – 13485 Section 9.1.3 requires analysis and evaluation of data to improve your performance to meet customer requirements.  These additional problem solving courses are useful training tools to teach you how to correct issues you may discover during an internal audit (continual improvement).  Sharpen and expand your problem solving skills with courses like Root Cause Analysis, FMEA, SPC, PPAP, and more.

We also have a complete database of all trainings you can search by clicking here.

About our Online Training (LMS)

What is an LMS?

Our Learning Management System (LMS) is an easy way to manage the training in your organization.  You can save time by not having to schedule and hold a training, while still meeting record-keeping requirements of 13485:2016.   Users can complete the training 24/7 at their own pace.

Our LMS makes it easy to:
  • Add Learners
  • Assign courses
  • View Activities
    • Did your learners access the course?
    • When did they last access the course?
    • What is the status of their course?
    • What was the score of their completed course?
    • Print their certificate
  • Create different Training Groups
  • Print Reports
Frequently Asked Questions:
  • What % is needed to pass each quiz?
    • Our default is 70%
  • What should they do if they cannot complete the course?
    • Close the course (not the browser) to save the last page they viewed
  • What happens if they fail?
    • They are sent to the beginning of the section
  • What happens when they pass?
    • They are able to print out their certificate

Learning management systems help your company deliver material to the students, administer tests, track your employees’ progress, and manage record-keeping.  You will not have to schedule a time for everyone to be present at the same time, and no one will need to give a presentation.  Users can complete the training anytime within the license period (usually one year, but we also offer extensions).

Already have your own LMS?

We can add custom training content to your LMS so you can integrate training with your existing Learning Management System.

We can tailor the course to meet your organization’s policies. Companies often use an LMS to manage all of their training (safety, policies, etc.). Training can seamlessly integrate with your Learning Management System (LMS) and is compliant with the following international standards:

  • SCORM – The Shareable Content Object Reference Model
    • Lectora has been tested and conforms to the latest SCORM 1.2 and SCORM 2004 Specifications.
  • AICC – The Aviation Industry CBT (Computer-Based Training) Committee
    • Training is an AICC certified Authoring System which has been tested by AICC independent test labs to comply with AICC guidelines and recommendations.
  • LRN – The Learning Resource iNterchange
    • Training publishes to the LRN standard.
  • Accessibility Standards
    • Content created is 508 compliant.

Terms & Options of 13485:2016 Online Training

Online Training courses are available for a one-time purchase, or on a subscription basis.  Prices vary depending on the number of users.  For more information and a comparison chart, click here.