Laboratory Quality Management Research Articles

Effect of accreditation schemes on the setting of quality specifications by laboratories

In the future, there will be a universal standard for quality management in medical laboratories: ISO 15189. This standard follows the basic principles of ISO 17025, the general standard for test laboratories, but also adds several specific aspects. A comparison between these standards is given. The language of ISO 15189 is designed to be understood by medical laboratory professionals. As this standard is applicable to all medical laboratory fields, requirements are given in general terms requiring the laboratory to implement them correctly. Because it is essential that information provided by laboratory results is useful for healthcare, the requirements covered by ISO 15189 are compared with those needed for providing good medical laboratory services. The capabilities of the personnel at the laboratory-clinic interface are the most difficult to assess and evaluate in an adequate quality management system.

Survey of Analytical Methods and Winery Laboratory Proficiency

Results of a survey of methods of analysis for five basic measurements of wine composition (pH, titratable acidity, volatile acidity, ethanol, and residual sugar) used in commercial winery laboratories are reported. A laboratory proficiency test was conducted with cooperating wineries for the same measurements. The proficiency test showed satisfactory results for the analysis of pH and ethanol in wine with coefficients of variation between wineries of 1.2% and 1.8%, respectively. Less than 20% of the wineries were proficient in measuring titratable acidity or volatile acidity. The range of reported volatile acidity concentrations varied more than two-fold. The analysis for residual sugar yielded unsatisfactory results, with a coefficient of variation of 140% and reported values ranging from 0.01 to 4.0 g/L. The results of this preliminary proficiency test suggested a need for improved laboratory quality management systems, especially with respect to analytical method standardization and validation, and for the establishment of proficiency testing program for American wineries. An "ASEV Winery Laboratory Quality Systems" CD-ROM was developed to guide wineries from the first steps of setting up a quality management system all the way to winery lab accreditation, and a continuous and frequent inter-laboratory proficiency testing scheme has been established.

Third European Conference on Quality Management in Clinical Laboratories: "QUALITY (R)EVOLUTION IN CLINICAL LABORATORIES", 30-31 October 1997, Antwerp, Belgium

Third European Conference on Quality Management in Clinical Laboratories: "QUALITY (R)EVOLUTION IN CLINICAL LABORATORIES", 30-31 October 1997, Antwerp, Belgium

Second European Conference on Quality Management in Clinical Laboratories: "QUALITY (R)EVOLUTION IN CLINICAL LABORATORIES"

Second European Conference on Quality Management in Clinical Laboratories: "QUALITY (R)EVOLUTION IN CLINICAL LABORATORIES"

Total Quality Management for Clinical Laboratories: A Need or a New Fashion?

SummaryIn most European countries, concepts of quality management in medical laboratories have been proposed. These concepts are based on general standards for test laboratories (EN 45001, ISO 25) or specific adapted standards. Improvement of quality lays on the foundation of the implementation of quality systems in medical laboratories. This new approach will have consequences on management style and on working conditions. Efficacy on the implementation can only be tested by external audits. During this audit, not only the quality system and analytical competence must be examined, but also if there is a real contact between pathologists and clinicians and if laboratory results are clinically validated (clinical audit).This new vision on quality in medical laboratories will ask a reconsideration of the tasks, duties and knowledge of clinical pathologists.

First European conference on quality management in clinical laboratories: "Quality (r)evolution in clinical laboratories", 12-13 November 1995, Antwerp, Belgium

First European conference on quality management in clinical laboratories: "Quality (r)evolution in clinical laboratories", 12-13 November 1995, Antwerp, Belgium

Quality Control and Quality Management of Alternate-Site Testing

Quality is an important attribute of clinical laboratory results; however, methods for defining acceptable quality may not be entirely agreed upon. In addition, confusion over quality is added when laboratory testing is moved to alternate sites. As quality parameters are designed for novel laboratory delivery systems, it will be best to use novel approaches that build on already well-defined principles of laboratory quality management.

Quality management and practice: Evaluation of the QUASIMEME questionnaire

A questionnaire was completed by 89 participating laboratories in the EU-QUASIMEME project to determine the current practices in Quality Management in marine chemistry laboratories. The results are discussed in relation to the developing QUASIMEME programme. Sixty-four percent of laboratories recognized that current quality management (QM) measures are inadequate and that there is a need for development of quality manuals and standard operating procedures to cover all procedures. A structured improvement in quality management and control in all areas of information gathering is necessary, from the storage, preparation and analyses of samples to the data recording and archiving. Comparison of reported precision of data (as indicated from the questionnaire) and the actual precision shown from the 1993 laboratory performance studies indicates significant differences implying that laboratories do not have a true measure of their real capabilities.

Laboratory Quality Management

Laboratory Quality Management