Hepatitis B virus (HBV) DNA measurement plays an important role in the diagnosis and management of patients with chronic HBV infection, because the treatment strategy is formulated based on either the absolute HBV DNA level, or the relative change in HBV DNA level. To obtain the results with high quality, assay, performance characteristics must be verified and statistical quality control methods must be planned. In this study, systematic and random error values of plasma HBV DNA were determined. Performance of the method was examined by employing a normalized operational process specifications (OPSpecs) chart. The systematic error at low and high control levels were 0.33 and 0.22 log (IU/ml) respectively. At both levels, the standard deviations (SD) of the assay were 0.17 log (IU/ml). In addition, a single rule of 1_2.5s with 2 control measurements was selected as a candidate quality control method. Results showed that the assay performed well and was acceptable for clinical use. Further improvement might be attained by switching to automated purification methods. The well-established discipline of statistical quality control was applied to a real-time quantitative polymerase chain reaction (PCR). It was concluded that by employing sigma-metrics statistical quality control (QC) methods which utilized long-term controls, critical changes in the measurement system could be detected. Sigma metrics and OPSpecs chart could examine the performance of the method and whether the quality control scheme planed was appropriate. Therefore, these methods were practical for assisting laboratory choose the proper measurement method and select correct quality control scheme.