laboratory quality management system online course

Last Updated on August 8, 2022 by Team College Learners

Learn about a Laboratory Quality Management System for your lab. We created this course to help you manage your lab efficiently and effectively. It is an easy to understand and comprehensive course that gives you all the tools you need to start managing a laboratory in a professional and credible manner. Are you sick and tired of an antiquated, poorly designed and inefficient quality management system?

On-Demand Course: Laboratory Quality Management System Certificate Program

This online, self-paced Laboratory Quality Management System Certificate Program describes the skills needed for successful implementation and sustainment of a quality management system (QMS) in your laboratory.

This program focuses on providing a systematic, process-oriented approach to meeting quality objectives, and delivering consistent, high-quality, cost-effective laboratory services through the implementation of a QMS.

Upon completion of this online training course, participants will be able to ensure that their laboratories:
• Meet accreditation quality requirements.
• Run with the highest efficiency and productivity.
• Provide the highest quality test results to their patient population.

Intended Audience: Quality Officers and Managers, Laboratory Managers, Laboratory Technical Staff

Earn 13 P.A.C.E.® CE Credits.
CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.

All materials in this course are copyrighted.
©2020 Clinical and Laboratory Standards Institute. All rights reserved.

$225.00 – $750.00 Purchase

Items Included in the Purchase of this Course

Introduction Section: 1 Presentation 1 Assessment 1 Link 6 DocumentsLesson 1 – QSE Organization and Leadership Section: 1 Presentation 1 Assessment 11 DocumentsLesson 2 – QSE Customer Focus Section: 1 Presentation 1 Assessment 6 DocumentsLesson 3 – QSE Facilities and Safety Management Section: 1 Presentation 1 Assessment 5 DocumentsLesson 4 – QSE Personnel Management Section: 1 Presentation 1 Assessment 8 DocumentsLesson 5 – QSE Supplier and Inventory Management Section: 1 Presentation 1 Assessment 6 DocumentsLesson 6 – QSE Equipment Management Sectin: 1 Presentation 1 Assessment 6 DocumentsLesson 7 – QSE Process Management Section: 1 Presentation 1 Assessment 5 DocumentsLesson 8 – QSE Documents and Records Management Section: 1 Presentation 1 Assessment 9 DocumentsLesson 9 – QSE Information Management Section: 1 Presentation 1 Assessment 4 DocumentsLesson 10 – QSE Nonconforming Event Management Section: 1 Presentation 1 Assessment 5 DocumentsLesson 11 – QSE Assessments Section: 1 Presentation 1 Assessment 6 DocumentsLesson 12 – QSE Continual Improvement Section: 1 Presentation 1 Assessment 9 DocumentsSummary and Conclusion Section: 1 Presentation 2 DocumentsFinal Examination Section: 1 AssessmentCourse Evaluation Survey: 9 questionsCLSI Laboratory Quality Management System Certificate Program Certificate: 0/28 Course items completedCLSI Quality Glossary Link: CLSI Quality GlossarySlides for Introduction in pdf. Document: Slides for Introduction in pdf.Slides for Lesson 1 in pdf. Document: Slides for Lesson 1 in pdf.Slides for Lesson 2 in pdf. Document: Slides for Lesson 2 in pdf.Slides for Lesson 3 in pdf. Document: Slides for Lesson 3 in pdf.Slides for Lesson 4 in pdf. Document: Slides for Lesson 4 in pdf.Slides for Lesson 5 in pdf. Document: Slides for Lesson 5 in pdf.Slides for Lesson 6 in pdf. Document: Slides for Lesson 6 in pdf.Slides for Lesson 7 in pdf. Document: Slides for Lesson 7 in pdf.Slides for Lesson 8 in pdf. Document: Slides for Lesson 8 in pdf.Slides for Lesson 9 in pdf. Document: Slides for Lesson 9 in pdf.Slides for Lesson 10 in pdf. Document: Slides for Lesson 10 in pdf.Slides for Lesson 11 in pdf. Document: Slides for Lesson 11 in pdf.Slides for Lesson 12 in pdf. Document: Slides for Lesson 12 in pdf.Slides for Summary and Conclusion in pdf. Document: Slides for Summary and Conclusion in pdf.

CLSI eLearning Programs

CLSI offers high-quality eLearning programs that allow you to access the best training anywhere and anytime.

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Laboratory Quality Management System (LQMS) Certificate Program

Do you know how to ensure that your lab:

  • Meets accreditation quality requirements?
  • Runs with the highest efficiency and productivity?
  • Provides the highest quality test results for your patient population?

Learn the skills needed for successful implementation and sustainment of a quality management system (QMS) in your lab. The Laboratory Quality Management System (LQMS) Certificate Program focuses on providing a systematic process-oriented approach to meeting quality objectives and delivering consistent, high-quality, cost-effective lab services through the implementation of a QMS. This online learning program imparts the knowledge and skills necessary for successful implementation and sustainment of a QMS in your lab. The program consists of 12 modules, each representing one of the 12 quality system essentials.

Already registered? Log in here.

EP23 Online Workshop: Risk-Based Tools to Meet IQCP Requirements

Is your lab feeling the pressure of establishing an IQCP? Let CLSI help you streamline the process with the EP23™ Online Workshop: Risk-Based Tools to Meet IQCP Requirements.

As the current equivalent quality control in the CLIA guidance will soon not be an acceptable option for compliance, the EP23 Online Workshop is an invaluable tool to guide users through the process of establishing an IQCP.

This fun and interesting online workshop allows for anyone, anywhere, anytime to learn about IQCP, EP23, and its intent to help simplify QC based on risk management.

Already registered? Log in here.

Implementing the Cost of Quality in the Laboratory Certificate Program

This online training course will help your laboratory determine how much it spends on supporting good quality, resolving problems and errors, and preventing poor quality from occurring. It will help your organization improve profitability and enhance your ability to provide better patient care. This is the only training program that truly implements the steps needed to determine the existing cost of quality in your laboratory.

Intended Audience: Quality Officers and Managers, Laboratory Managers, Laboratory Technical Staff, Laboratory Administration

Already registered? Log in here.

Overview of Risk Management for the Laboratory

Understand the answers to these critical questions to help your organization improve profitability—and enhance your ability to provide better patient care—with our online learning program Implementing the Cost of Quality in the Laboratory Certificate Program. 

Enroll in the only program that discusses the steps needed to determine the existing cost of quality in your lab.

This online course allows participants to understand the general concepts of risk assessment and performing a Failure Mode and Effects Analysis (FMEA). The course includes information from relevant ISO and CLSI standards to provide a basic understanding of risk analysis. This course is intended for laboratory personnel who have not performed a formal risk analysis before and is relevant for audiences anywhere in the world. It does not address US CLIA requirements for IQCP; please see CLSI course EP23/IQCP for that information.

Upon completion of this training workshop, participants will be able to:

  • Create a plan for the risk assessment
  • Identify risks and potential hazards in laboratory processes
  • Analyze the likelihood and severity of the identified risks
  • Determine the priorities for risk mitigation and control
  • Implement actions for risk control
  • Monitor the risk management program over time

Intended Audience: Laboratory Administration, Quality Managers and Officers, Laboratory Managers, Laboratory Technical Staff

Already registered? Log in here.

The 7 Best Online Quality Management Training Courses in 2020

Be 100% ready for your next audit with our complete guide

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Quality management issues are responsible for an unfathomable amount of lost revenue. From production delays to recalls, product quality problems can eat up every bit of the profits your organization can generate — in a hurry.

Too many companies invest in software, consultants, or systems — but fail to invest in their #1 resource, their people. At the end of the day, if your team doesn’t understand the value of quality and how to implement it at your company, you won’t succeed.

There’s a lot on the line for life sciences companies. If you want to meet your revenue goals, it’s time to look at investing in quality management training for your employees in 2020.

Online training courses can be a great place to start. Here are some of the best in the industry.

7 Top Online Quality Management Training Courses

Investing in quality management training can help your company avoid the revenue loss associated with quality failures, rework, recalls, and delays getting your product to marketing.

Consider the following online courses to help you train your team and implement your new quality systems.


The Association for the Advancement of Medical Instrumentation (AAMI) was created to address the needs of today’s busy professionals. Their online training specializes in areas related directly to medical devices and technologies and was developed in close consultation with regulators, industry leaders, and subject matter experts.

The AAMI’s online training programs include a blend of live and on-demand webinars on topics such as:

  • Guidance on the use of AGILE practices in the development of medical device software
  • Principles for Medical Device Security—Risk Management
  • Applying Novel Sterilization Processes to Healthcare Products
  • Assurance Cases for Medical Devices: Annual Updates from FDA and Industry Practitioners
  • Building for the Future: Construction and Renovation of Sterile Processing Facilities, Part I: New Construction

2. 13485 Store

The ISO 13485 Store features a robust selection of online training options, including online courseswebinarsvirtual training, and PowerPoint presentations. Topics available include:

  • What are the regulatory implications of Brexit?
  • Validation and Verification, are you clear on the requirements?
  • Understanding Changes to EN-60601 and How to Maintain MDD Compliance
  • Unannounced Audits: The Requirements, BSI’s model, implementation, and feedback
  • Technical Documentation requirements under MDR, including requirements for your legacy files

Related Reading: What An ISO 13485 Quality Manual For Medical Devices Should Look Like


The International Society for Pharmaceutical Engineering (ISPE) offers a wide array of training options for pharmaceutical professionals.

ISPE’s online training includes Recorded SessionsExpanded Online TrainingGeneral Industry KnowledgeGMPFundamental Industry Knowledge Online, and Online Learning Webinars.

Topics covered include:

  • Product Quality Lifecycle Implementation (PQLI®): Focusing on Q10
  • Introduction to Process Analytical Technology
  • HVAC and Utilities: Special Requirements
  • The ISPE Quality Metrics Initiative
  • A GAMP Interpretation – Annex 11

4. Udemy

Udemy gives you the ability to hand-select the specific course options that you need for just about any topic.

You can enjoy training provided directly from industry experts on quality management topics such as:

  • ISO 9001:2015 Quality Management System Auditor Course
  • Quality Management for Business Excellence
  • Process Validation (101) in ISO 9001/Quality/Risk Management
  • Certified Quality Engineer Training
  • SAP Quality Management – SAP QM – Training Course

5. PDA

The Parenteral Drug Association (PDA) strives to advance the industry through strong relationships and communication with regulatory bodies around the world.

PDA offers a wide variety of online training programs on topics such as:

  • ICH Q7 GMP for APIs
  • 2019 PDA Data Integrity Workshop
  • Root Cause Investigation for CAPA
  • Global Regulatory and CGMPs for Sterile Manufacturing
  • Strategies for Reducing Human Error Nonconformances

6. Alison

Alison prides itself on being a socially conscious free learning platform that seeks to be a catalyst for positive change and prosperity for everyone.

Their courses are free, but certifications and diplomas are provided at an additional charge.

Courses include:

  • ISO 13485:2016 – Quality Management Systems for Medical Devices
  • Fundamentals of Quality Standards – Revised 2018
  • ISO Management System Audit Techniques and Best Practices
  • Diploma in Quality Management – Revised 2017
  • Introduction to Quality Management

Related Reading: The 9 Core Elements of a Quality Management System


The Academy of Applied Pharmaceutical Sciences (AAPS) offers an online Pharmaceutical Quality Assurance and Quality Control Diploma Program. This course is designed to give students comprehensive knowledge and skills in the fields of Pharmaceutical Analysis, Regulatory Affairs, and Quality Assurance.

The program is taken in three phases over 12 months and includes courses on:

  • Good Manufacturing Practices
  • Pharma Lab Testing
  • Workplace Hazardous Material Information Systems (WHMIS)
  • Dissolution Testing
  • Regulatory Affairs

Free Qualio Resources

We’ve developed free, downloadable quality management resources which can give your team a jump start on the path to quality excellence.

  • The Perfect Quality Assurance Plan for Pharmaceutical Companies: In this guide, you’ll learn how to create a perfect quality assurance plan for your pharmaceutical organization which safeguards your company from compliance issues and the reputational and financial damage which comes with product problems and recalls.
  • 7 Ways to Improve Medical Device Quality: In this guide, we answer some crucial questions, including: What can I do to improve review processes? How do I identify where quality standards are not being met? How do I establish and use feedback loops successfully? How can I ensure our documents are in order? Can I guarantee that my team is trained appropriately?

How to Track Quality Management Training in an eQMS

Training your team and building a culture of quality is about more than just teaching them essential quality assurance and control. You also need to make sure that each staff member understands their roles inside your company.

That’s why we’ve built quality management training functionality into the core of our enterprise quality management system (eQMS). Qualio’s training center allows you to create custom training routines for your employees. You can assign them to groups or individuals and easily track progress throughout your organization. Multiple-choice assessments within each training also help you ensure that they mastered the material presented.

Your Next Step: Schedule a demo of the Qualio training center and see for yourself how you can implement and report on training in your business. You already know that quality is important or you wouldn’t have read this far. It’s time to let us help you put quality first and claim your competitive advantage.

Robert FentonQualio Founder & CEO. Helping healthcare organizations launch life-saving products faster.