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Abstract Background and Objective: Every organization requires ongoing evaluation of existing conditions. The purpose of this study is to assess and analyze the standards and criteria that each Laboratory system is required to observe and upgrade them, to determine the gap between the ideal and the current status and finally to present the strategy and executive plan in order to achieve the desirable status. Material and Methods: This study was performed in a medical diagnostic laboratory in Gorgan by using the quality system checklist related to medical diagnostic laboratories, which was revised in 2009. Internal evaluation matrix (Internal Factor Evaluation) was used to examine the main factors in the context of establishing a quality management system in a clinical laboratory.After examining the factors, determining the laboratory status, recording the results of monitoring (in terms of strengths and weaknesses) and determining the gap between existing and desirable status, we provided the appropriate and effective solutions in line with defined standard. Results: of 164 items thatshould have been done in the first assessment, 111 (67.7%) items are in performed group and 53 (32.3%) are not in. After compiling and running a plan, 147 (89.6%) are performed, 15 (9.2%) needed to be modified and 2 (1.2%) still not performed. It is evident that a significant difference (p< 0.05) and a tangible improvement in current problems are seen after establishing the qualitysystem in the laboratory. The lab equipment, lab space and facilities, pre-examination process, testing process and post-examination process are considered .Regarding the health and safety in the laboratory, lab equipment, lab space and facilities, pre-examination process, testing process and post-examination process, no significant difference is observed between before and after the implementation of the program. Conclusion:after establishing the quality system in laboratory, a significant difference and tangible improvement in the current problems are observed. It is implied the importance of pre-planned responses to problems and the performance of strategic planning. Keywords: Strategic Planning, Medical Diagnostic Laboratory, Quality Control

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Background and Objectives: Quality control (QC) is a crucial tool in the clinical laboratory for error identification and correction. While IQC ensures daily precision and accuracy, EQAS ensures long-term accuracy by providing external verification. The objective of this study was to evaluate our laboratory’s performance in the EQAS program and assess the impact of corrective actions on EQAS performance improvement.
Methods: The retrospective observational study was undertaken in the tertiary care hospital. The Biochemistry department of the laboratory participated in the monthly clinical chemistry EQA program administered by CMC Vellore EQAS. Nineteen parameters were assessed using structured approach to analyze deviating EQAS results. Monthly performance was analyzed in terms of the SDI (Standard Deviation Index) and VIS (variance index score) for the period of October 2019 to September 2021.
Results: Among the nineteen parameters assessed in EQAS program, most showed ‘excellent’ performance between October 2019 and September 2021 based on mean SDI. Some improvement was observed in the SDI values between the two cycles after implementing a structured approach in root cause analysis and indicates an enhanced level of performance in the EQAS program. The VIS analysis revealed that 89.47% of parameters in the October 2019 to September 2020 period and 94.73% in the October 2020 to September 2021 achieved scores classified as ‘very good’ performance.
Conclusion: Adopting a structured approach to analyze deviating EQAS results enables the evaluation of laboratory performance and offers opportunities for improvement. Consequently, EQAS plays a significant role as a cornerstone in the accreditation process.