Basic Essentials and Applications of Quality Management System (QMS) in Biomedical Sciences

Although the essentials of the quality management system (QMS) were introduced in the 1920s, its implementation in the laboratory was started in the 1940s. Quality in the laboratory means to have a traceable and accurate test results. Accordingly, any level of inaccuracy should be avoided. On the other hand, in the field of biomedical product manufacturing, achieving a safe and efficient product needs implementing all of the aspects of the quality in the manufacturing process [1, 2].

[1]  Inês Hexsel Grochau,et al.  A process approach to ISO/IEC 17025 in the implementation of a quality management system in testing laboratories , 2012, Accreditation and Quality Assurance.

[2]  Horace Gumba,et al.  Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research , 2018, Wellcome open research.

[3]  A. Weckenmann,et al.  Quality management – history and trends , 2015 .

[4]  George Munchus,et al.  International Journal of Health Care Quality Assurance Managerial process improvement : a lean approach to eliminating medication delivery , 2016 .

[5]  K. Freeman,et al.  Quality Documentation Challenges for Veterinary Clinical Pathology Laboratories , 2008, Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc.

[6]  J. Mountford,et al.  Good Manufacturing Practice (GMP) Translation of Advanced Cellular Therapeutics: Lessons for the Manufacture of Erythrocytes as Medicinal Products. , 2018, Methods in molecular biology.

[7]  L. Berte Laboratory quality management: a roadmap. , 2007, Clinics in laboratory medicine.

[8]  Erica Iacob,et al.  Experience of accreditation in a surface science laboratory , 2016, Accreditation and Quality Assurance.

[9]  Raffaella Ravinetto,et al.  The Art of Writing and Implementing Standard Operating Procedures (SOPs) for Laboratories in Low-Resource Settings: Review of Guidelines and Best Practices , 2016, PLoS neglected tropical diseases.

[10]  T. Suzuki-Nishimura Clinical Trials and Good Clinical Practice , 2010 .

[11]  A. Picarillo Introduction to quality improvement tools for the clinician , 2018, Journal of Perinatology.

[12]  Vivek Nanda Quality Management System Handbook for Product Development Companies , 2005 .

[13]  Ali Elbireer,et al.  Improving laboratory data entry quality using Six Sigma. , 2013, International journal of health care quality assurance.

[14]  Max Salfinger,et al.  Practical Guidance for Clinical Microbiology Laboratories: Implementing a Quality Management System in the Medical Microbiology Laboratory , 2018, Clinical Microbiology Reviews.

[16]  John Keenan Taylor Quality Assurance of Chemical Measurements , 1981 .

[17]  Sten A Westgard,et al.  Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control. , 2017, Clinics in laboratory medicine.

[18]  Alba N. Zaretzky,et al.  Quality management systems from the perspective of organization of complex systems , 2008, Math. Comput. Model..

[19]  Katsuo Kubono,et al.  [Quality management system in the medical laboratory--ISO15189 and laboratory accreditation]. , 2004, Rinsho byori. The Japanese journal of clinical pathology.

[20]  H. Ingason Best Project Management Practices in the Implementation of an ISO 9001 Quality Management System , 2015 .

[21]  Lynn C Allen,et al.  Role of a quality management system in improving patient safety - laboratory aspects. , 2013, Clinical biochemistry.

[22]  F. Geijo Quality management in analytical R&D in the pharmaceutical industry: Building quality from GLP , 2000 .

[23]  Roger Williams,et al.  Quality Management: The New Challenges , 2006 .

[24]  Simon Knowles,et al.  Lean management systems: creating a culture of continuous quality improvement , 2013, Journal of Clinical Pathology.

[25]  S. Karapetrovic,et al.  On the effectiveness of quality management system audits , 2004 .

[26]  A. Yahaya,et al.  Implementation of the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation , 2016, African journal of laboratory medicine.

[27]  Shengwei Wang,et al.  Energy efficient design and control of cleanroom environment control systems in subtropical regions – A comparative analysis and on-site validation , 2017 .

[28]  Robert Ivor John,et al.  Good Laboratory Practice for optimization research , 2016, J. Oper. Res. Soc..