5S see LEAN
Accreditation Certification by a duly recognized body of the facilities, capability, objectivity, competence, and integrity of an agency, service or operational group or individual to provide the specific service(s) or operation(s) needed.
Accident An undesirable or unfortunate event that occurs unintentionally.
AFNOR National Institute of France. Association Francaise de Normalization AFNOR is France's national standards-setting organization.
ASQ American Society for Quality
Analytical Phase 1. Activities and steps related to performing laboratory examinations. 2. A set of operations having the object of determining the value or characteristics of a property to describe these processes. 3. One phase of the three-phase framework for the total testing process to describe issues related to the quality of laboratory testing. See Pre- and Postanalytical.
ANSI American National Standards Institute.
Audit Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

Balanced Scorecard A management system that which uses financial data, operational measures, customer satisfaction, internal processes and the organization’s innovation and improvement activities. This allows the monitoring of present performance, but also tries to capture information about how well the organization is positioned to perform well in the future.
Belts A term used to describe the levels of Six Sigma intense training. Moving up the belt ladder denotes increased experience and the successful completion of courses and projects. See Green Belt, Black Belt, Champion (management executive), Master Black Belt.
Bias The difference between the average value of all measurements and the reference value. A numerical value used to measure accuracy.
Black Belt (BB) Full-time team leader responsible for implementing process improvement projects—define, measure, analyze, improve and control (DMAIC) or define, measure, analyze, design and verify (DMADV)—within the business to drive up customer satisfaction levels and business productivity. See Green Belt. Six Sigma term.
Brainstorming A group decision-making technique designed to generate a large number of creative ideas through an interactive process. Brainstorming is used to generate alternative ideas to be considered in making decisions.
BSI British Standards Institute.

CAP College of American Pathologists. See CLIA.
Cause An identified reason for the presence of a defect or problem.
Cause and Effect Diagram See Ishikawa Diagram.one of the "seven tools of quality."
Certification The procedure and action by a duly authorized body of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures, or items in accordance with applicable requirements.
Champion A business leader or senior manager who ensures that resources are available for training and projects, and who is involved in project tollgate reviews; also an executive who supports and addresses Six Sigma organizational issues.
Checklist A tool used to ensure all important steps or actions in an operation have been taken. Checklists contain items important or relevant to an issue or situation. See check sheets.
Check Sheet A simple data recording device. The check sheet is custom designed by the user, which allows him or her to readily interpret the results. The check sheet is one of the "seven tools of quality." See ckecklist.
CLIA In the USA, the Centers for Medicare and Medicaid Services (CMS) regulates all laboratory testing under the Clinical Laboratory Improvement Amendments (CLIA). Certificate of Accreditation is issued to a laboratory by approved accrediting organizations such as CAP, Commission on Laboratory Accreditation (COLA), and the Joint Commission on Accreditation of Health Care Organizations (JCAHO).
Closed-loop corrective action (CLCA) A sophisticated engineering system designed to document, verify and diagnose failures, recommend and initiate corrective action, provide follow-up and maintain comprehensive statistical records.
CLSI Clinical and Laboratory Standards Institute. Uses consensus process in developing standards.
CLSI GP26 Application of a Quality Management System Model for Laboratory Services (Quality document).
CLSI HS1 A Quality Management System Model for Health Care (Quality document).
CMPT (Clinical Microbiology Proficiency Testing Program) A university-based, Canadian external quality assessment program for clinical microbiology, mycology, enteric parasitology, and water testing laboratories. Estb. 1982. See EQA.
COLA Commission on Laboratory Accreditation (USA)
Competence Demonstrated ability to apply knowledge skills.
Compliance An affirmative indication or judgment that the supplier of a product or service has met the requirements of the relevant specifications, contract, or regulation; also the state of meeting the requirements.
Conformitè Europeënne Mark (CE Mark) Conformity European Union mark. The European Union created the CE Mark to regulate the goods sold within its borders. The mark represents a manufacturer's declaration products comply with the EU's New Approach Directives. These directives apply to any country that sells products within the EU.
Continual/Continous Improvement The cornerstone of quality management systems, allows the laboratory to gain insights from setting objectives, monitoring through audit and management review, addressing complaints and nonconformities, and performing client satisfaction surveys. A recurring activity to increase the ability to fulfill requirements: Plan, Do, Check, Act.
Continuous Quality Improvement (CQI) A philosophy and attitude for analyzing capabilities and processes and improving them repeatedly to achieve the objective of customer satisfaction.
Control Chart A chart with upper and lower control limits on which values of some statistical measure for a series of samples or subgroups are plotted. The chart frequently shows a central line to help detect a trend of plotted values toward either control limit.
Controlled Documentation A system for maintaining and ensuring the proper use of time or version sensitive documents.
Correction Action to eliminate a detected nonconformity.
Corrective Action Plan A plan to eliminate the cause of a detected nonconformity or other undesirable situation.
Corrective Action Recommendation (CAR) The full cycle corrective action tool that offers ease and simplicity for employee involvement in the corrective action/process improvement cycle.
CQA Certified Quality Auditor.
CQMgr Certified Quality Manager.
CSA Canadian Standards Association.
CTQ Critical to quality.
Cultural Resistance A form of resistance based on opposition to the possible social and organizational consequences associated with change.
Culture Change A major shift in the attitudes, norms, sentiments, beliefs, values, operating principles and behavior of an organization.
Customer Organization or person that receives a product.
Customer Satisfaction Customer's perception of the degree to which the customer's requirements have been fulfilled. It can vary from high satisfaction to low satisfaction. If customers believe that you've met their requirements, they experience high satisfaction. If they believe that you've not met their requirements, they experience low satisfaction.

DAP Diagnostic Accreditation Program in British Columbia. A new accreditation program is under development by the DAP that will focus on clients and quality improvement from a systems perspective consistent with the recommendations made by the newly created Provincial Laboratory Coordinating Office (PLCO).
Deming Cycle for Continuous Improvement A visualization of the CQI process usually consisting of four points - Plan, Do, Check, Act -- linked by quarter circles. The cycle was first developed by Dr. Walter A. Shewhart but was popularized in Japan in the 1950 by Dr. W. Edwards Deming.
Deming's 14 Principles The foundation of Deming's philosophy. The points are a blend of leadership, management theory, and statistical concepts that highlight the responsibilities of management while enhancing the capacities of employees.
DMADV (Define, measure, analyze, design and verify)
DMAIC (Define opportunities, Measure performance, Analyze opportunity, Improve performance, Control performance) A methodology used by Six Sigma.
Document Information and its supporting medium; digital or physical. ISO identifies five types of documents: specifications, quality manuals, quality plans, records, and procedure documents.
Documentation Written material defining the process to be followed.
DPMO Defects per million opportunities. See Six Sigma.
EA European national accreditation bodies have joined to form the European Accreditation (EA) to achieve uniformity of accreditation throughout Europe as well as internationally working in partnership with the International Laboratory Accreditation Cooperation.
Error A deviation from truth, accuracy or correctness; a mistake; a failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.
Event An occurrence of some importance and frequently having antecedent cause.
Examination See Analytical phase, pre- and postanalytical phase.
External Quality Assessment (EQA) The external challenge of the effectiveness of a laboratory’s quality system with samples of known but undisclosed content. It checks for accurate, timely and clinically useful process output. EQA is a tool to provide management with an insight into the quality of the routine laboratory work. See Proficiency Testing.

14 Points W. Edwards Deming's 14 management practices to help companies increase their quality and productivity.
Facilitator A specifically trained person who functions as a teacher, coach and moderator for a group, team or organization.
Fishbone Chart See Ishikawa Diagram.
Flowchart A graphical representation of the flow of a process. A useful way to examine how various steps in a process relate to each other, to define the boundaries of the process, to identify customer/supplier relationships in a process, to verify or form the appropriate team, to create common understanding of the process flow, to determine the current "best method" of performing the process, and to identify redundancy, unnecessary complexity and inefficiency in a process.
FMEA Method (FMECA) Failure Mode and Effect (and Criticality) Analysis. A tool of risk assessment and failure analysis for use in risk management and product liability control. The systematic method of identifying and preventing service, process or product failures before they occur.
FOCUS-PDSA Find, Organize, Clarify, Understand, Select—Plan, Do, Study, Act (Quality improvement tool)Form A paper or electronic document on which information or results are captured; once completed becomes a record.
Form A paper or electronic document on which information or results are captured; once completed becomes a record.

Gantt Chart A type of bar chart used in process planning and control to display planned work and finished work in relation to time.
Gap / GAP Analysis Planning tool used to compare present/current state with future desired state. Basis for development of action plans to address high priority gaps. See Spider Diagram.
Green Belt (GB) A business team leader responsible for managing projects and implementing improvement in his or her organization. An employee of an organization who has been trained on the improvement methodology of Six Sigma and will lead a process improvement or quality improvement team as part of his or her full-time job. See Black Belt.
Groupthink A situation in which critical information is withheld from the team because individual members censor or restrain themselves, either because they believe their concerns are not worth discussing or because they are afraid of confrontation.

Histogram A graphic summary of variation in a set of data. The pictorial nature of the histogram lets people see patterns that are difficult to detect in a simple table of numbers. The histogram is one of the "seven tools of quality."
Hoshin Planning (hoshin kanri) The organization-wide strategic planning system used widely in Japanese companies.

IATA International Air Transport Association.
ILAC International Laboratory Accreditation Cooperation See EA.
ILAC-G13:2000 Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes.
Incident An individual occurrence of brief duration or secondary importance.
Incremental Improvement Improvements that are implemented on a continual basis.
Indicators Established measures used to determine how well an organization is meeting its customers' needs as well as other operational and financial performance expectations.
Infrastructure Buildings, workspaces, equipment, hardware, software, utilities, and support services such as transportation and communication.
Inspection Activities, such as measuring, examining, testing, gaging one or more characteristics of a product or service, and comparing these with specified requirements to determine conformity.
Instant Pudding A term used to illustrate an obstacle to achieving quality or the supposition that quality and productivity improvement are achieved quickly through an affirmation of faith rather than through sufficient effort and education. W. Edwards Deming used this term, which was initially coined by James Bakken of Ford Motor Co., in his book Out of the Crisis.
IOM Institute of Medicine see Healthcare and Quality.
Internal Audits Internal audits are examinations performed usually by your own staff for internal organizational determine the degree that your organizaton is adhering to your internal quality management requirements.
Internal Quality Control The processes carried out to check that the laboratory instruments, kits, reagents, calibrators and equipment are performing within specifications.
Ishikawa Diagram A graphic tool used to explore and display all the factors that may influence or cause a given outcome. Developed by Kaoru Ishikawa.
ISO International Organization for Standardization.
ISO Standards A set of international standards providing guidance for quality in manufacturing and service industries; developed to help companies effectively document the quality system elements to be implemented to maintain an efficient quality system. The standards, initially published in 1987, are not specific to any particular industry, product or service; broad applicability, many kinds of organizations can use. The standards were developed by ISO. See CLSI.
ISO 9001:2000 Standard The most important and internationally recognized series of standards for Quality Management are referred to as the ISO 9000 series. The most recent iteration was written in 2000, and thus is referred to as ISO 9000:2000. A series of policy statements.
ISO 17025:1999 Standard for testing and calibration laboratories.
ISO 15189:2003 Standard for medical laboratories. A series of policy statements.
ISO/IEC Guide 43 Proficiency testing by inter-laboratory comparisons.

Joint Committee for the Accreditation of Healthcare Organizations (JCAHO) JCAHO sets standards for, evaluates and accredits nearly 18,000 healthcare organizations and programs in the United States.
Just-in-time Training The provision of training only when it is needed to all but eliminate the loss of knowledge and skill caused by a lag between training and use.

Radar Chart See Spider Diagram.
Random Sampling A commonly used sampling technique in which sample units are selected so that all combinations of n units under consideration have an equal chance of being selected as the sample.
Records Information captured on worksheets, forms, and charts.
Red Bead Experiment An experiment developed by W. Edwards Deming to illustrate it is impossible to put employees in rank order of performance for the coming year based on their performance during the past year because performance differences must be attributed to the system, not to employees.
Registrar Accreditation Board (RAB) A board that evaluates the competency and reliability of registrars (organizations that assess and register companies to the appropriate ISO 9000 series standards and to the ISO 14000 environmental management standard). RAB provides ISO course provider accreditation.
Referral Laboratory External laboratory to which a sample is submitted for a supplementary or confirmatory examination procedure and report.
Requirement An expression of customers, including assessment providers, of need or expectation.
Review Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives.
Right the First Time A term used to convey the concept that it is beneficial and more cost effective to take the necessary steps up front to ensure a product or service meets its requirements than to provide a product or service that will need rework or not meet customer needs. In other words, an organization should engage in defect prevention rather than defect detection.
Risk The combination of severity of harm and probability of occurrence of that harm.
Risk Analysis The systematic use of available information to identify hazards and estimate the risk.
Risk Assessment Identifying potential failure modes, determining severity of consequences, identifying existing controls, determining probabilities of occurrence and detection, and evaluating risks to identify essential control points.
Risk Evaluation The process of comparing the estimated risk against risk criteria to determine the risk acceptability.
Risk Management The identification, analysis and economic control of those risks which can threaten the assets or earnings of an enterprise.
Risk Priority Number (RPN) The risk priority number of a failure mode and its effect(s) before improvement.
Root Cause That which has the most impact on the problem being tackled.
Root Cause Analysis A tool designed to help identify not only what and how an event occurred, but also why it happened.Safety Those processes implemented to protect laboratory workers, visitors, the public, and environment.

Scatter Diagram A graphical technique to analyze the relationship between two variables. s one of the "seven tools of quality."
SCC Standards Council of Canada.
Scorecard A scorecard is an evaluation device, usually in the form of a questionnaire, that specifies the criteria customers will use to rate your business's performance in satisfying their requirements.
Seven Tools of Quality Tools that help organizations understand their processes to improve them. The tools are the cause and effect diagram, check sheet, control chart, flowchart, histogram, Pareto chart and scatter diagram.
Shall/Should Statements See Quality Management Standards.
SHEA Society for Healthcare Epidemiology of America
sigma 's' Denotes standard deviation.
Sigma 'S' Denotes the process Sigma.
SIPOC chart/ diagram A tool used by a team to identify all relevant elements of a process improvement project before work begins. It helps define a complex project that may not be well scoped, and is typically employed at the Measure phase of the Six Sigma DMAIC methodology. It is similar and related to Process Mapping and 'In/Out Of Scope' tools, but provides additional detail. Suppliers (the 'S' in SIPOC) of your process, the Inputs (the 'I') to the process, the Process (the 'P') your team is improving, the Outputs (the 'O') of the process, and the Customers (the 'C') that receive the process outputs. In some cases, Requirements of the Customers can be appended to the end of the SIPOC for further detail.
Six Sigma A quality process that measures defects in parts per million.; stands for Six Standard Deviations (Sigma is the Greek letter “s” used to represent standard deviation in statistics) from mean. Six Sigma methodology provides the techniques and tools to improve the capability and reduce the defects in any process by constantly reviewing and re-tuning the process. To achieve this, Six Sigma uses a methodology known as DMAIC.
Special and Common Cause System of Variation The collection of variables that produce both common cause variation and special cause variation and the interaction of those variables.
Spider Diagram A visual report card for the performance of a number of indicators on a single chart. Also know as a "radar chart" and a "gap analysis" tool, this diagram makes visible the gaps between the current and desired performance.
.Standard Standards are documents, most often reached through the process of consensus of expert opinions that have been authorized by recognized bodies as best practices. A document rises to the level of a standard when an agency with authority states that adherence to the document is required to develop and manage materials, products, services, technologies, processes, and systems. See Quality Management Standards.
Standards Vocabulary
Horizontal Standards Horizontal standards are said to be very broad, but not deep or specific on many points.   Horizontal standards tend most commonly to set down principles or systems such as quality management systems.
Vertical Standards Vertical standards are often referred to as technical standards on a specific subject.  They do not tend to cover a broad range of subjects or topics, but provide a large amount of specific detail. 
Normative statements In international standards statements the described required action include the term “shall”.  In less formal standards the word “must” or “required” may be used.
Normative standards may be found in the body of the document or may be within an annex.
Informative statements In all standards, statements that clarify, or give examples, or give caution are usually included.  Such statements are intended to provide information only and are not required to be enacted. 
Statistical Process Control (SPC) A statistical technique used to monitor processes, usually involving the use of control charts. Traditional SPC standards call for improving defect levels measured in percentages (parts per hundred).
Statistical Tools Methods and techniques used to generate, analyze, interpret, and present data.
Statistical Process Control (SPC) A statistical technique used to monitor processes, usually involving the use of control charts. Traditional SPC standards call for improving defect levels measured in percentages (parts per hundred).
Statistical Tools Methods and techniques used to generate, analyze, interpret, and present data.
Supplier Organization or person that provides a product or service.
Survey The act of examining a process or of questioning a selected sample of individuals to obtain data about a process, product or service.
SWOT Analysis Strengths, Weaknesses, Opportunities, Threats. SWOT analysis headings provide a good framework for reviewing strategy, position and direction of a company or business proposition, or any idea.

TDG Transportation of Dangerous Goods.
TDGR Transportation of Dangerous Goods Regulations. Learn about the Transport of Dangerous Goods Act from Transport Canada .
Team A group of individuals organized to work together to accomplish a specific objective.
Test Determination of one or more characteristics according to a procedure.
Theory of Constraints (TOC) Also called constraints management, it is a set of tools that examines the entire system for continuous improvement. The current reality tree, conflict resolution diagram, future reality tree, prerequisite tree and transition.
Time to Result Length of time that a sample’s first result may be issued orally (e.g. telephoned) or written (e.g. faxed) to the ordering physician.
Total Quality Management Any management system that addresses all areas of an organization, emphasizes customer satisfaction, and uses continuous improvement methods and tools.
Toyota Production System see LEAN.
Traceability Ability to trace the history, application or location of that which is under consideration. Task: A specific, definable activity to perform an assigned piece of work, often finished within a certain time.
Tree Diagram A tool to expand a proposed change from a general idea to a specific series of concepts or actions. Used to systematically map out in increasing detail the full range of paths and tasks that need to be accomplished to achieve a primary goal and related sub-goals.
Turn Around Time Length of time that a sample’s final result may be issued to the ordering physician.

Ultimate Customer The person or unit who receives the output from a series of processes and for whom these processes are designed. Without the ultimate customer, there would be no need for the intermediate processes to exist.
Unfreezing Reassessing old values and behaviors and becoming open to the acceptance of a new culture.
Universal Precautions An approach to infection control in which all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other blood-borne pathogens.

Validation Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
Value Added The parts of the process that add worth from the perspective of the external customer.
Value Based Management (VBM) A series of measures of companywide adherence to defined values, as opposed to result-oriented processes.
Verification Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
Vision An overarching statement of the way an organization wants to be; an ideal state of being at a future point.

Waste Any activity that consumes resources and produces no added value to the product or service a customer receives.
Wheel-within-a-Wheel See nested PDSA.
WHMIS Workplace Hazardous Materials Information System.
Work Environment All the factors that influence work; these include social, cultural, psychological, physical, and environmental conditions. The term work environment includes lighting, temperature, and noise factors, as well as the whole range of ergonomic influences. It also includes things like supervisory practices as well as reward and recognition programs. All of these things influence how work is performed.
World-class Quality A term used to indicate a standard of excellence: best of the best.

Zero Defects A performance standard and methodology developed by Philip B. Crosby that states if people commit themselves to watching details and avoiding errors, they can move closer to the goal of zero.