Quality Management Overview

Coordinated activities to direct and control an organization with regard to quality.

Walter Shewhart developed the method, which laid the foundation for quality control procedures in laboratories.

They contributed critical thinking and methodologies that advanced quality management concepts.

<p>ISO standards set benchmarks for quality and competence in laboratories.</p> Signup and view all the answers

<p>ISO 15189:2007 and ISO/IEC 17025:2005.</p> Signup and view all the answers

<p>The U.S. military's set of standards for manufacturing served as a model for ISO to develop broader quality standards.</p> Signup and view all the answers

<p>Assessment involves measuring performance against a standard or benchmark.</p> Signup and view all the answers

<p>In the 1940s.</p> Signup and view all the answers

<p>Quality management concepts largely evolved from practices in manufacturing and shop processes.</p> Signup and view all the answers

<p>Galvin's work focuses on micro-scale error reduction.</p> Signup and view all the answers

<p>CLSI stands for Clinical and Laboratory Standards Institute, and its former name was the National Committee for Clinical Laboratory Standards (NCCLS).</p> Signup and view all the answers

<p>CLSI uses a consensus process involving many stakeholders to develop its standards.</p> Signup and view all the answers

<p>The quality management system model developed by CLSI is based on twelve quality system essentials (QSE).</p> Signup and view all the answers

<p>One important document is 'A Quality Management System Model for Health Care; Approved Guideline—Second Edition'.</p> Signup and view all the answers

<p>The CLSI quality management system model is fully compatible with ISO laboratory standards.</p> Signup and view all the answers

<p>The training toolkit is based on both the CLSI quality management system model and the ISO 15189 standard.</p> Signup and view all the answers

<p>National laboratory quality standards are established to apply specifically to laboratories within a country.</p> Signup and view all the answers

<p>Yes, some laboratory standards apply only to specific areas in the laboratory or only to specific tests.</p> Signup and view all the answers

<p>The World Health Organization (WHO) has established standards for some specific programs and areas.</p> Signup and view all the answers

<p>The consensus process is important because it ensures that diverse stakeholder perspectives are considered in standard development.</p> Signup and view all the answers

<p>CLSI/NCCLS.A Quality Management System Model for Health Care; Approved Guideline—Second Edition = Quality management system model CLSI/NCCLS.Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition = Application of quality management system in laboratories ISO 15189 = Standards for quality and competence in medical laboratories ISO laboratory standards = General quality standards for laboratories</p> Signup and view all the answers

<p>CLSI = Develops quality management system models WHO = Establishes standards for specific health care programs ISO = Creates international quality standards applicable to laboratories NCCLS = Former name of CLSI</p> Signup and view all the answers

<p>Quality System Essentials (QSE) = Framework developed by CLSI Consensus process = Involves multiple stakeholders in standards development National laboratory quality standards = Apply specifically within individual countries Laboratory-specific standards = Pertains to certain areas or tests within the laboratory</p> Signup and view all the answers

<p>Country-specific standards = May not be applicable globally Quality management system compatibility = Ensures alignment with ISO standards Stakeholder involvement = Enhances the relevance and acceptance of standards Focus on specific tests = Meets the needs for specialized laboratory procedures</p> Signup and view all the answers

<p>Quality management system model = Foundation for laboratory training Twelve quality system essentials = Core principles guiding laboratory practices Approved guidelines = Standards recognized for compliance Continuous improvement = Ongoing effort to enhance laboratory quality</p> Signup and view all the answers

<p>Quality Control = The process of ensuring products meet quality standards Quality System = The organizational structure needed for implementation Assessment = Measuring performance against a standard or benchmark Quality Management = Coordinated activities to direct and control an organization regarding quality</p> Signup and view all the answers

<p>W. Edwards Deming = Statistical process control methodology Arman Feigenbaum = Total quality control concept Kaoru Ishikawa = Ishikawa diagram for problem-solving Genichi Taguchi = Robust quality design techniques</p> Signup and view all the answers

<p>ISO 9001:2000 = General quality management system requirements ISO 15189:2007 = Quality and competence in medical laboratories ISO/IEC 17025:2005 = Testing and calibration laboratory competence ISO 9000 = Guidance for quality in manufacturing and service industries</p> Signup and view all the answers

<p>1920s = Development of statistical process control by Shewhart 1940s = Application of quality control methods in laboratories 2000s = Release of ISO 9001:2000 addressing laboratory quality 1970s = Introduction of quality circles in manufacturing</p> Signup and view all the answers

<p>ISO = International Organization for Standardization CLSI = Clinical and Laboratory Standards Institute U.S. military = Set standards for manufacturing equipment AABB = Standards for blood and transplant services</p> Signup and view all the answers

<p>Micro-scale error reduction = Galvin's recent work on quality management Total Quality Management (TQM) = Comprehensive approach to long-term success Continual Improvement = Ongoing effort to enhance products and processes Benchmarking = Comparison with best practices in the industry</p> Signup and view all the answers

<p>Resources = Assets necessary for quality control Processes = Activities needed to deliver quality results Procedures = Documented methods for performing tasks Stakeholders = Parties involved in the quality management process</p> Signup and view all the answers

<p>Shewhart = Statistical Process Control Feigenbaum = Quality in the Total System Ishikawa = Quality Circles Taguchi = Quality Loss Function</p> Signup and view all the answers