Spring 2013 Newsletter
Q: What is a Quality Management System?
A: Your Assurance of Accurate Test Results!
By Lou Samudio, Quality Manager

The ADDL Quality Management System (QMS) is written to be in compliance with the AAVLD Accreditation Requirements. These are a set of guidelines set forth by the American Association of Veterinary Laboratory Diagnosticians stating the format which all veterinary labs seeking accreditation through their organization should follow when implementing a QMS. The ISO definition for QMS is, “the organizational structure, procedures, processes and resources needed to implement a quality control and quality assurance program.” Sounds simple enough, but just what is quality control, quality assurance, what is the difference between the two, why are they important to accreditation and why are they important to you?

The ISO definition for Quality Control (QC) is, “the part of quality management focused on providing evidence that the quality requirements of products or services have been fulfilled.” The ADDL fulfills this quality requirement during testing of your samples by running, when appropriate, positive/negative controls, preparing and running lab spiked samples, lab method blanks, calibration curves, etc. So, quality control is a review of the product or service either during or after the fact. The result is that if the QC’s are not what we anticipated, there will be some rework or re-inspection that takes place to accept the results of your analyses, to insure you of accurate results.

The ISO definition for Quality Assurance (QA) is “the planned and system wide activities implemented within the QMS, that demonstrates as needed, and which provides adequate confidence, that each step or task will fulfill requirements for making quality product or services.” For us at the ADDL, this is our SOP’s and controlled document system, our training, the internal audits, corrective action process, etc. The result is confidence that your test results will be accurate.

The ultimate result of a QC process will be suitable results for our clients. If work has to be performed again, there is a loss of time, resources and wasted effort that must be accounted. On the other hand, QA defines successful processes and systems upfront, provides a means for training staff to these systems, provides means for correcting when these systems need updating, and requires that these processes are periodically reviewed to determine sustained conformance. When implemented successfully, QA Programs result in successful QC inspection results, and successful testing.

The ADDL QMS is a modern day approach to putting quality into a process to assure or maximize the potential for obtaining accurate QC results the first time through. It is a system that continually evolves through internal audits, corrective action, review and updates to SOP’s, and training to new and/or updated procedures to drive continuous improvement efforts.

Indiana ADDL, 406 S University St, West Lafayette, IN 47907. (765) 494-7440
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