Developing and Maintaining a Laboratory Quality Management System 

Revised and Updated in 2009!

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6.68 IH CM Points, 4.0 CEUs and 4.0 COCs

Revision Author: Ronald H. Peters, CIH, Peters Consulting, Inc.

Course Level
Intermediate  

Who Will Benefit

  • Industrial hygienists
  • Laboratory bench chemists
  • Laboratory QA/QC supervisors
  • Laboratory management

Prerequisites
 A basic knowledge of laboratory analytical procedures and an introduction to statistics or mathematics.

Learning Outcomes:
Upon completion, students will better be able to:

  • Explore the concepts of quality assurance and quality control
  • Describe basic elements required for an effective laboratory QA/QC program
  • Determine requirements to implement and evaluate a QA/QC program
  • Identify requirements for laboratory accreditation
  • Discuss how defined principles affect analytical data

Course Specifics

This self-study is designed to guide the student through a series of lessons on laboratory quality management system and assurance/quality control (QA/QC) procedures. The student will learn the basic elements required for an effective laboratory QA/QC program and what is required to implement a QA/QC program. Information is presented to assist the student in applying the QA/QC procedures to each phase of data production from preparation for sample collection through receipt of a final report in order to reduce or eliminate errors in the process. The course also includes information for ongoing evaluation of laboratory QA/QC programs that help ensure continued improvement in the program.

The program is divided into 12 chapters dealing with different aspects of the QA/QC process. Each chapter contains modules designed to teach a specific concept. The course includes a Student Manual, Reading Materials, and a final exam. The Student Manual contains information designed to introduce the student to the topics essential to a well-designed laboratory quality system that is compliant with ISO/IEC 17025 and the American Industrial Hygiene Association (AIHA) Laboratory Accreditation Programs (AIHA-LAP, LLC) requirements. The Student Manual includes learning objectives, and competency exercises designed to reinforce the material presented in the course and is designed to lead the student through the learning process. The Reading Materials include ISO/IEC 17025:2005, selected AIHA-LAP, LLC policy modules, attachments, and appendices. The attachments included and referenced in the chapters of the Student Manual are mandatory reading and the student may be tested on the contents of these attachments.  The appendices are suggested reading and for reference purposes only.  The student will not be tested on the contents of the appendices.   

Course Outline

1.   Laboratory Quality Management System
2.   Organization and Management System
3.   Document Control through Complaints
4.   Non-conforming Testing Work through Preventative Action
5.   Control of Records, Internal Audits, and Management Review
6.   General, Personnel, and Accommodation and Environment
7.   Elementary Statistics
8.   Test Methods and Method Validation
9.   Estimation of Uncertainty of Measurement and Control of Data
10. Equipment and Traceability of Measurement
11. Sampling and Handling of Test Items
12. Assuring the Quality of Tests, Data Reduction and Validation, and Reporting the Test Results 
 

Time to Complete
This course will take approximately 40 hours to complete. Students will have up to 6 months from their enrollment date to complete it. 

Course Components
Student manual, reading materials and a final exam. 

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