Laboratory Quality Management System Certificate Program, On-Demand Course

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    • Non-member - $750
    • Individual Student - $562.50
    • Individual Associate - $637.50
    • Individual Full Member - $562.50
    • Industry Level III - $375
    • Industry Level II - $450
    • Industry Level I - $150
    • HCPGOV Level III - $375
    • HCPGOV Level II - $450
    • HCPGOV Level I - $150
    • Health System - $150
    • CLSI Staff - Free!

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.

Key:

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INTRODUCTION
Introduction Video
Open to view video.
Open to view video. Introduction video
Appendix IN-A, Logic of the Order of the CLSI Quality System Essentials
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Open to download resource.
Appendix IN-B, CLSI Quality Management System Model
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Open to download resource.
How to Develop a Gap Analysis Tool
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Open to download resource.
Introduction Slide Transcript
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Open to download resource.
Case Study Slides
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Open to download resource.
Introduction Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail Please note that quiz questions may come from ANY of the provided materials, not just the PowerPoint video. You should be familiar with all of the course materials prior to taking the quiz.
QMS01 CLSI Document
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Open to download resource. The QMS01 CLSI Document
Introduction References and Resources
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Open to download resource.
Lesson 1 - QSE Organization and Leadership
Lesson 1 - Organization and Leadership Video
Open to view video.
Open to view video.
Appendix OR-A, Preparing a Rationale for a Quality Management System
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Open to download resource.
Appendix OR-B, Approach for Implementing a QMS
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Open to download resource.
Appendix OR-C, Example of a QSE Policy
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Open to download resource.
Appendix OR-D, example of a QSE Process Document Management Process
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Open to download resource.
Appendix OR-E, Example of a Technical Process Analyzer Set-Up and Run Process
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Open to download resource.
Appendix OR-F, Example of a Quality Procedure Correcting a Paper Record Procedure
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Open to download resource.
Appendix OR-G, Example of a Technical Procedure H&E Staining Procedure
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Open to download resource.
Appendix OR-H, Quality Planning Sequence
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Open to download resource.
Appendix OR-I, Management Review
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Open to download resource.
Lesson 1 Organization Slide Transcript
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Open to download resource.
Lesson 1 References and Resources
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Open to download resource.
Lesson 1, Organization Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Appendix CF-A, Customer Needs Assessment Process
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Open to download resource.
Appendix CF-B, Customer Satisfaction Survey Process
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Open to download resource.
Appendix CF-C, Sample Customer Feedback Form
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Open to download resource.
Lesson 2 - QSE Customer Focus
Lesson 2 - Customer Focus Video
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Open to view video. Lesson 2 - Customer Focus Video
Appendix CF-D, Staff Satisfaction Survey
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Open to download resource.
Customer Focus Slide Transcript
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Open to download resource.
Customer Focus References and Resources
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Open to download resource.
Lesson 2, Customer Focus Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail Please select the best answer for each question.
Lesson 3 - QSE Facilities & Safety Management
Lesson 3 - Facilities & Safety Management Video
Open to view video.
Open to view video. Lesson 3 - Facilities & Safety Management Video
Appendix FS-A, Facility Design Process
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Open to download resource.
Appendix FS-B Hazardous Waste Management Flow Chart
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Open to download resource.
Appendix FS-C, Example Safety Audit
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Open to download resource.
Facilities & Safety Management Slide Transcript
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Open to download resource.
Facilities & Safety Management References and Resources
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Open to download resource.
Lesson 3, Facilities & Safety Management Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Lesson 4 - QSE Personnel Management
Lesson 4, QSE Personnel Management Video
Open to view video.
Open to view video.
Appendix PE-A, Job Description Template
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Open to download resource.
Appendix PE-B, Orientation Program
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Open to download resource.
Appendix PE-C, Laboratory Training Program
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Open to download resource.
Appendix PE-D, Training Guide Form
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Open to download resource.
Appendix PE-E, Written Assessment Form
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Open to download resource.
Appendix PE-F, Training Schedule Form
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Open to download resource.
Lesson 4, Personnel Management Slide Transcript
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Open to download resource.
Lesson 4, Personnel Management References and Resources
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Open to download resource.
Lesson 4, Personnel Management Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Lesson 5, QSE Supplier & Inventory Management
Lesson 5, QSE Supplier & Inventory Management Video
Open to view video.
Open to view video.
Appendix SI-A, Approved Supplier List
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Open to download resource.
Appendix SI-B, Process to Select a Referral Laboratory
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Open to download resource.
Appendix SI-C, Approved Referral Laboratories List
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Open to download resource.
Appendix SI-D, Kanban Cards
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Open to download resource.
Lesson 5, Supplier & Inventory Management Slide Transcript
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Open to download resource.
Lesson 5, Supplier & Inventory Management References and Resources
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Open to download resource.
Lesson 5, Supplier & Inventory Management Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Lesson 6, QSE Equipment Management
Lesson 6, Equipment Management Video
Open to view video.
Open to view video.
Appendix EQ-A, List of Laboratory Equipment and Instruments
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Open to download resource.
Appendix EQ-B, Equipment Master File History Form
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Open to download resource.
Appendix EQ-C, Information for PQ Protocol
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Open to download resource.
Appendix EQ-D, Equipment Decommissioning Plan
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Open to download resource.
Lesson 6, Equipment Management Slide Transcript
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Open to download resource.
Lesson 6, Equipment Management References and Resources
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Open to download resource.
Lesson 6, Equipment Management Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Lesson 7, QSE Process Management
Lesson 7, QSE Process Management Video
Open to view video.
Open to view video.
Appendix PM-A, Validation Plan Outline
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Open to download resource.
Appendix PM-B, Quality Control Plan Development
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Open to download resource.
Appendix PM-C, Total Process Control
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Open to download resource.
Lesson 7, Process Management Slide Transcript
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Open to download resource.
Lesson 7, Process Management References and Resources
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Open to download resource.
Lesson 7, Process Management Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Lesson 8, QSE Documents and Records Management
Lesson 8, QSE Documents and Records Management Video
Open to view video.
Open to view video.
Appendix DR-A, Flow Chart Construction
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Open to download resource.
Appendix DR-B, Template Contents for Laboratory Documents
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Open to download resource.
Appendix DR-C, Document Review Checklist
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Open to download resource.
Appendix DR-D, Document Management Form
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Open to download resource.
Appendix DR-E, Document Management Rules
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Open to download resource.
Appendix DR-F, Records Management Process
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Open to download resource.
Appendix DR-G, Example of a Records Retention Schedule
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Open to download resource.
Lesson 8, Documents and Records Slide Transcript
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Open to download resource.
Lesson 8, Documents and Records References and Resources
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Open to download resource.
Lesson 8, Documents and Records Management Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Lesson 9, QSE Information Management
Lesson 9, QSE Information Management Video
Open to view video.
Open to view video.
Appendix IM-A, Flow of Laboratory Information
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Open to download resource.
Appendix IM-B, Formula Verification Worksheet
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Open to download resource.
Lesson 9, Information Management Slide Transcript
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Open to download resource.
Lesson 9, Information Management References and Resources
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Open to download resource.
Lesson 9, Information Management Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Lession 10, QSE Nonconforming Event Management
Lesson 10, QSE Nonconforming Event Management Video
Open to view video.
Open to view video.
Appendix NC-A, Common Nonconforming Events
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Open to download resource.
Appendix NC-C, Process for Manufacturer's Recall
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Open to download resource.
Lesson 10, Nonconforming Event Management Slide Transcript
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Open to download resource.
Lesson 10, Nonconforming Event Management References and Resources
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Open to download resource.
Lesson 10, Nonconforming Event Management Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Lesson 11, QSE Assessments
Lesson 11, Assessments Video
Open to view video.
Open to view video.
Appendix AS-A, Laboratory External Assessment Process
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Open to download resource.
Appendix AS-B, Proficiency Testing Process
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Open to download resource.
Appendix AS-C, Elements of a Laboratory Internal Audit Report
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Open to download resource.
Appendix AS-D, Developing, Evaluating, and Monitoring a Single Laboratory Quality Indicator
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Open to download resource.
Appendix NC-B, NCE Report Form Components
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Open to download resource.
Lesson 11, Assessments Slide Transcript
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Open to download resource.
Lesson 11, Assessments References and Resources
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Open to download resource.
Lesson 11, Assessments Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Lesson 12, QSE Continual Improvement
Lesson 12, Continual Improvement Video
Open to view video.
Open to view video.
Appendix CI-A, Continual Improvement Program
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Open to download resource.
Appendix CI-B, Continual Improvement Process Questions
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Open to download resource.
Appendix CI-C, Identify Opportunities for Improvement
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Open to download resource.
Appendix CI-D, Models and Tools
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Open to download resource.
Appendix CI-E, Plan-Do-Check-Act Template
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Open to download resource.
Appendix CI-F, Quality Implementation Plan
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Open to download resource.
Appendix CI-G, Close Out Template
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Open to download resource.
Lesson 12, Continual Improvement Slide Transcript
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Open to download resource.
Lesson 12, Continual Improvement References and Resources
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Open to download resource.
Lesson 12, Summary and Conclusion Slide Transcript
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Open to download resource.
Lesson 12, Continual Improvement Quiz
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
10 Questions  |  Unlimited attempts  |  8/10 points to pass  |  Graded as Pass/Fail
Lesson 13, Summary and Conclusion
Lesson 13, Summary and Conclusion Video
Open to view video.
Open to view video.
Case Study Slides, Final Examination, Course Evaluation, and P.A.C.E. Certificate
Case Study Slides
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Open to download resource.
LQMS Final Examination
37 Questions  |  10 attempts  |  30/37 points to pass
37 Questions  |  10 attempts  |  30/37 points to pass
Course Evaluation
5 Questions
5 Questions Course evaluation
Laboratory Quality Management System Certificate Program P.A.C.E. Continuing Education Certificate
Live Viewing: 13.00 P.A.C.E. credits and certificate available
Live Viewing: 13.00 P.A.C.E. credits and certificate available
Slides for all Lessons in PDF
Introduction Slides
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Open to download resource.
Lesson 1 Organzation Slides
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Open to download resource.
Lesson 2 Customer Focus Slides
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Open to download resource.
Lesson 3 Facilities and Safety Slides
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Open to download resource.
Lesson 4 Personnel Slides
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Open to download resource.
Lesson 5 Supplier and Inventory Management
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Open to download resource.
Lesson 6 Equipment Management Slides
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Open to download resource.
Lesson 7 Process Management slides
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Open to download resource.
Lesson 8 Documents and Records Management Slides
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Open to download resource.
Lesson 9 Information Management Slides
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Open to download resource.
Lesson 10 Nonconforming Event Management Slides
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Open to download resource.
Lesson 11 Assessments Slides
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Open to download resource.
Lesson 12 Continual Improvement Slides
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Open to download resource.
Lesson 13 Summary and Conclusion Slides
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Open to download resource.
Introduction Voiceover Script
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Open to download resource.
Voiceover Files
Lesson 1 Organization Voiceover Script
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Open to download resource.
Lesson 2 Customer Focus Voiceover Script
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Open to download resource.
Lesson 3 Facilities and Safety Voiceover Script
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Open to download resource.
Lesson 4 Personnel Voiceover Script
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Open to download resource.
Lesson 5 Supplier and Inventory Management Voiceover Script
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Open to download resource.
Lesson 6 Equipment Voiceover Script
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Open to download resource.
Lesson 7 Process Management Voiceover Script
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Open to download resource.
Lesson 8 Documents and Records Management Voiceover Script
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Open to download resource.
Lesson 9 Information Management Voiceover Script
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Open to download resource.
Lesson 10 Nonconforming Event Management Voiceover Script
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Open to download resource.
Lesson 11 Assessments Voiceover Script
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Open to download resource.
Lesson 12 Continual Improvement Voiceover Script
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Open to download resource.
Lesson 13 Summary and Conclusion Voiceover Script
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Open to download resource.