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Developing and Maintaining a Laboratory Quality Management System



Course Description:
Updated in 2020, this self-study course is designed to guide the student through a series of lessons on laboratory quality management system and quality assurance/quality control (QA/QC) procedures.

Participants will learn the basic elements required for an effective laboratory quality program and what is required to implement a QA/QC program system that is compliant with ISO/IEC 17025:2017 and the requirements of accreditation bodies like AIHA Laboratory Accreditation Programs (AIHA LAP, LLC).

The information presented will assist participants 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.

Those laboratories seeking accreditation should be certain to review all current requirements of the accreditation body prior to applying for accreditation since requirements may change.

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

Learning Outline:

  1. Laboratory Quality Management System
  2. General Requirements and Structural Requirements
  3. Resource Requirements: General, Personnel, Facilities and Environmental Conditions, and Equipment
  4. Resource Requirements: Metrological Traceability and Externally Provided Products and Services.
  5. Process Requirements: Review of Requests, Tenders and Contracts and Selection, Verification, and Validation of Methods
  6. Process Requirements: Sampling, Handling of Test or Calibration Items, and Technical Records
  7. Elementary Statistics
  8. Process Requirements: Evaluation of Measurement Uncertainty, Ensuring the Validity of Results, and Reporting of Results
  9. Process Requirements: Complaints, Nonconforming Work and Control of Data and Information Management
  10. Management System Requirements: Options, Management System Documentation, Control of Management System Documents, and Control of Records
  11. Management System Requirements: Actions to Address Risks and Opportunities, Improvement, and Corrective Actions
  12. Management System Requirements: Internal Audits and Management Reviews

Contact Hours:
40 Hours

Learning Level:
Intermediate

Intended Audience:
  • Industrial hygienists
  • Laboratory bench chemists
  • Laboratory quality staff
  • Laboratory management
Course Authors:
Ronald H. Peters, CIH