Editor's Note: Standard, internationally preferred terms and definitions are highlighted in blue. Terms and definitions in black are acceptable, but only if the standard internationally preferred terms and definitions are unacceptable for a certain context. Terms highlighted in red are not acceptable in the international standards community. They appear for educational purposes only. Notes and examples included with definitions are illustrative, and are not to be considered part of the standard definition.

Terms and definitions are often derived from international standards (eg, International Organization for Standardization [ISO] documents). In order to align terms in the Harmonized Terminology Database with their source material, and to ensure that users of the database select the most current terms available, terms may be updated before revision of the CLSI documents in which they appear. This practice does not compromise the utility of the existing CLSI document. For questions regarding this policy, please e-mail standard@clsi.org.

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Quality Glossary


accreditation

process by which an authoritative body gives formal recognition that an organization (eg, a laboratory) is competent to carry out specific tasks

Project: MM19, QMS14, QMS15, MM22, QMS21, QMS25, QMS01, MM24


addendum

information added as an attachment or supplement to a document or record that expands or clarifies the original document or record

Project: QMS26

NOTE: An addended report does not change the original test result(s) or diagnosis.


adverse event

term for any event that is not consistent with the desired, normal, or usual operation of the organization

Project: QMS11


agreement

a contract, order, or understanding between two or more parties, such as between a laboratory and one of its vendors or customers


alternative assessment

system for determining the reliability of tests for which proficiency testing is either not available or not required, including ungraded and/or educational challenges; split sample analysis with reference or other laboratories; split samples with an established in-house method; assayed material; regional pools; clinical validation by chart review; or other suitable and documented means

Project: QMS24


amended report

change made to add or rephrase information, editorial changes, changes made to improve readability or clarity, or additional information that changes the final diagnosis or clarifies the original final diagnosis or interpretation

Project: QMS26, QMS12

EXAMPLE: Amending a final surgical pathology diagnosis arising from a second review of the material.


assessment

systematic process to collect and analyze data to determine the current, historical, or projected status of an organization, person, process, or project

Project: QMS06, QMS14, QMS01

NOTE: Siebels DL, "The Quality Improvement Glossary"


assessor

representative of the assessment organization who determines whether the laboratory meets the assessment organization’s requirements

Project: QMS17

NOTE: An assessor may also be referred to as an inspector, auditor, surveyor, or investigator.


audit

systematic, independent, and documented process to obtain and evaluate evidence objectively to determine the extent to which specified criteria are fulfilled 

Project: QMS06, QMS15, QMS16, QMS21, QMS01


balanced scorecard

a management tool that provides feedback on both internal business processes and external outcomes to continuously improve strategic performance and results

Project: QMS12


benchmark

a standard or measurement that is used to compare with other similar situations

Project: QMS04, QMS12


calibration

comparison of a measurement instrument or system of unverified accuracy to a measurement instrument or system of known accuracy to detect any variation from the required performance specification

Project: QMS07, QMS13, QMS23, QMS24, QMS01


calibration verification

the assaying of calibration materials in the same manner as patient samples to confirm that the calibration of the instrument, kit, or test system has remained stable throughout the measurement range for patient test results

Project: QMS13, QMS23, MM06, POCT04, POCT09, H26, QMS01

NOTE: US CFR 493.2


certification

process by which a qualified third party provides attestation that a system, process, product, or person conforms to specified requirements

Project: QMS04, QMS14, QMS15, QMS21, QMS25


change control

a systematic, documented approach to evaluating, testing, approving, and implementing modifications to products, process, or systems to ensure that adverse affects are minimized and that resources are used efficiently


change management

systematic approach for defining, planning, coordinating, testing, tracking, and communicating a new or revised process and for preparing personnel for the transition to the future state


charter

(v) the granting of authority or rights, stating that the grantor formally recognizes the prerogative of the recipient to exercise the rights specified

Project: QMS14


checklist

tool for organizing and ensuring that all important steps or actions in a process are taken into consideration or acted upon

Project: QMS15


committee

a group of people appointed or chosen to perform a function on behalf of a larger group

Project: QMS14


competence

demonstrated ability to apply knowledge and skills to achieve intended results

Project: QMS03, QMS13, QMS15, QMS01


competence assessment

evaluation of a person’s ability to apply his or her skill, knowledge, and experience to perform assigned laboratory duties correctly

Project: QMS16, POCT04, QMS03

NOTE: This includes all aspects of testing, from specimen collection to result reporting, and it is usually done with specimens containing known amounts of the analyte(s) for which the specimens are being tested.


competencies

the capability to apply or use a set of related knowledge, skills, and abilities required to successfully perform “critical work functions” or tasks in a defined work setting

Project: QMS16


complaint

any concern about the laboratory’s operation

Project: QMS21

EXAMPLES: Quality of testing, unlabeled specimens, unethical practices, confidentiality of patient information, laboratory qualification, and responsibility issues.


compliance

successful fulfillment of a rule such as a specification, standard, policy, regulation, or law

Project: QMS17, QMS01


confidentiality

the entrustment of information form one party to another for that party's exclusive use not imparted to others

NOTE: "Confidentiality" is not synonymous with "privacy" 


conflict of interest

situation that has the potential to undermine the impartiality of an individual because of the possibility of differences between the individual’s self-interest and professional interest or public interest

Project: QMS05


conformance

fulfillment of a requirement

Project: QMS01, QMS02


consumable materials

materials that are used and then disposed, become incorporated into other materials and lose their identity, or cannot be used for their intended purpose without obliterating or transforming their substance

Project: QMS21

EXAMPLES: Disposable pipettes, pipette tips, test tubes, instrument cuvettes; reagents and controls; label stock.


continual improvement

recurring activity to enhance performance (ISO 9000)

Project: QMS19, QMS06, EP23, MM20, QMS14, QMS15, QMS11, QMS01

NOTE 1: Also known as continuous improvement; NOTE 2: Continual improvement includes the actions taken throughout an organization to increase the effectiveness and efficiency of activities and processes in order to provide added benefits to the customer and organization.


corrected report

a change in a previously issued examination report intended to correct an inaccuracy, including changes in examination results, patient identification, reference intervals, interpretation, or other content

Project: QMS26


corrective action

action(s) to eliminate the cause and prevent recurrence of a nonconformity or other undesirable situation (ISO 9001)

Project: QMS06, QMS11, QMS13, QMS14, QMS15, QMS17, QMS19, QMS24, QMS01

NOTE: There can be more than one cause for a nonconformity or undesirable situation.


customer

person or organization that could or does receive a product or a service that is intended for or required by this person or organization (ISO 9000)

Project: QMS14, QMS15, QMS16, QMS19, QMS21, QMS06, QMS01

EXAMPLES: Consumer, client, end user, retailer, receiver of product or service from an internal process, beneficiary, and purchaser (modified from ISO 9000); NOTE 1: A customer can be internal or external to the organization (ISO 9000); NOTE 2: Employees may be regarded as internal customers; NOTE 3: A customer can be internal or external to the organization and can include patients and health care providers, eg, physicians, nurses, laboratory staff.


data

facts used as a basis for reasoning, discussion, or calculation

Project: QMS12, QMS26, QMS01


document

(noun) information and the medium on which it is contained (ISO 9000)

Project: QMS06, QMS14, GP26, QMS02, QMS15, QMS16, QMS26, QMS21, QMS25, QMS01

NOTE: Documents may be paper based or electronic.


document

(verb) the action of creating a record

Project: I/LA33, QMS26


effectiveness

extent to which planned activities are realized and planned results are achieved (ISO 9000)

Project: GP26, QMS06, QMS14, QMS15, QMS12, QMS01


equipment

single apparatus or set of devices or apparatuses needed to perform a specific task (adapted from IEV 151-11-25)

Project: QMS13, QMS01

NOTE 1: For the purpose of QMS13, equipment includes general purpose devices; NOTE 2: For the purpose of QMS01, equipment includes general purpose devices, analytical systems, and computer system hardware and software.


establish

define, document (in writing or electronically), and implement

Project: GP26, QMS01


examination

set of operations having the object of determining the value or characteristics of a property (ISO 15189)

Project: QMS02, GP26, QMS06, QMS11, QMS13, GP33, GP44, POCT07, POCT10, QMS14, GP23, QMS25, QMS22, QMS01, EP35

NOTE 1: In some disciplines (eg, microbiology), an examination is the total activity of a number of tests, observations, or measurements (ISO 15189); NOTE 2: In CLSI document QMS02, the term “examination” replaces the term “test”; however, for the purposes of this guideline, readers can consider the terms equivalent; NOTE 3: Laboratory examinations that determine a value of a property are called quantitative examinations; those that determine the characteristics of a property are called qualitative examinations (ISO 15189); NOTE 4: In clinical chemistry, laboratory examinations have been called assays or tests (ISO 18113-1); NOTE 5: Examination has replaced terms such as test, assay, and analysis in CLSI document POCT07. Subsequently, the adjectives preexamination and postexamination have replaced the adjectives preanalytical and postanalytical; NOTE 6: Laboratory examinations are also often called assays or tests (ISO 15189); NOTE 7: In EP35, examinations are also called measurement procedures.


external assessment

systematic process conducted by an organization external to the laboratory to collect and analyze data to determine compliance with specified requirements

Project: QMS17, QMS01

NOTE 1: External assessment may also be referred to as an audit, inspection, site visit, or survey; NOTE 2: For the purposes of QMS17, proficiency testing is excluded; NOTE 3: The terms “mock inspection” or “self-assessment” may be used when a laboratory assesses itself for compliance using an external assessment organization’s requirements. In this case, the laboratory is doing an “internal” assessment of itself.


flow chart

diagram, often using geometric symbols, showing the sequence of activities and decisions made in a process

Project: QMS18, QMS02, QMS01


form

a paper or electronic document on which information, data, or results are recorded

Project: QMS06, GP26, QMS02, QMS15, QMS26, QMS25, QMS01

NOTE: When completed, a form becomes a record.


gap analysis

a process to determine actions to take to move an entity from its current state to a desired future state

Project: QMS19, QMS01

NOTE 1: Also called need-gap analysis, needs analysis, and needs assessment; NOTE 2: Gap analysis consists of 1) listing of characteristic factors (such as attributes, competencies, performance levels) of the present situation (“what is”), 2) listing factors needed to achieve future objectives (“what should be”), and then 3) highlighting existing gaps that need to be filled.


goal

broad statement describing a desired future condition or achievement without describing specific parameters

Project: QMS06, QMS14, QMS16, QMS03, QMS12, QMS01

NOTE 1: An example is “improve laboratory service”; NOTE 2: “Goal” is not synonymous with “objective.”


information

data shaped into a form that is meaningful and useful to support decision-making, coordination, and control in an organization

Project: QMS26, QMS22, QMS12, QMS01


installation qualification

a set of formal checks and records that confirms the equipment or process and its components, including any integral hardware or software, were supplied as ordered and properly installed in the laboratory or other environment

Project: QMS18, MM17, QMS01

NOTE: Installation qualification can be performed by the manufacturer’s technical service engineer.


management

coordinated activities to direct and control an organization (ISO 9000)

Project: QMS11, QMS01

NOTE 1: Management can include establishing policies and objectives and processes to achieve these objectives (ISO 9000); NOTE 2: The word “management” sometimes refers to people, ie, a person or group of people with authority and responsibility for the conduct and control of an organization (ISO 9000).


management review

periodic, formal evaluation by leadership of the status, adequacy, and effectiveness of the quality system

Project: QMS11, QMS01


nonconforming event

an occurrence that does not conform to the laboratory’s policies, processes, and/or procedures or with applicable regulatory or accreditation requirements or has the potential to affect (or has affected) patient, donor, or personnel safety

Project: QMS11, QMS01


objective

a statement of future expectations with measurable parameters and an indication of when the expectations should be achieved

Project: QMS03, QMS06, QMS14, QMS15, QMS12, QMS01

EXAMPLE: Reduce turnaround time of stat test results to the emergency department by 30% within six months; NOTE 1: “Objective” is not synonymous with “goal”; NOTE 2: Objectives are derived from goals and clarify what must be accomplished.


operational qualification

process to confirm that the equipment or process conforms to the manufacturer’s specifications for its intended use

Project: QMS18, MM17, QMS01

NOTE: Operational qualification can be performed by the manufacturer’s technical service engineer.


opportunity for improvement

condition that, when improved, should result in significant enhancement of organizational efficiency and effectiveness and/or customer satisfaction

Project: QMS06, QMS14, QMS15, QMS01


organization

person or group of people that has its own functions with responsibilities, authorities, and relationships to achieve its objectives (ISO 9000)

Project: QMS01, QMS15


path of workflow

sequential processes that transform an order into the information contained in the report of results, including preexamination, examination, and postexamination procedures

Project: QMS06, QMS07, QMS14, QMS25, QMS15, GP23, QMS16, QMS21, QMS03, QMS01


performance qualification

process to confirm that the equipment or process will perform to the organization’s own specified needs and intended use, producing acceptable results under normal operating conditions

Project: QMS18, MM17, QMS23, QMS01

NOTE 1: Performance qualification needs to be performed by laboratory personnel before use in testing and examinations; NOTE 2: Performance qualification should incorporate test cases and protocols to evaluate the full range of intended use; NOTE 3: Performance qualification represents the final qualification of the equipment; NOTE 4: Performance qualification must be performed by the organization’s personnel.


personnel

collective group of employees and contractors hired by an organization

Project: QMS16, QMS01


plan

written account of intended future course of action aimed at achieving a specific goal(s) or objective(s) within a specific time frame that explains in detail what needs to be done, when, how, and by whom

Project: GP26, QMS06, QMS15, QMS16, QMS21, QMS14, QMS25, QMS01

NOTE: May be referred to as an action plan.


policy

intentions and direction formally expressed within an organization and endorsed by laboratory leadership

Project: QMS02, QMS06, QMS14, QMS15, QMS16, QMS21, QMS25, QMS01


postexamination processes

processes following the examination, including review, release, reporting, and retention of results and retention, storage, and disposal of clinical material (modified from ISO 15189)

Project: GP26, QMS25, GP23, QMS22, QMS01


preexamination processes

processes that include, in chronological order, the request for examination, preparation and identification of the patient, collection of the specimen, transportation to and within the laboratory, and preparation of the specimen for examination, and end when the examination begins (modified from ISO 15189)

Project: QMS06, GP44, QMS25, GP48, GP23, QMS22, QMS01

NOTE: For pathologists and cytotechnologists, preexamination activities extend from the time the tissue is removed or collected to the point where the slides are prepared and ready for diagnostic interpretation.


preventive action

action to eliminate the cause of a potential nonconformity or other potential undesirable situation (ISO 9000)

Project: GP26, QMS11, QMS06, QMS13, EP18, EP23, QMS01

NOTE 1: There can be more than one cause for a potential nonconformity (ISO 9000); NOTE 2: Preventive action is taken to prevent occurrence whereas corrective action is taken to reduce or eliminate recurrence (modified from ISO 9000).


procedure

specified way to carry out an activity (modified from ISO 9000)

Project: QMS06, QMS15, QMS03, QMS02, QMS14, QMS07, QMS21, I/LA33, QMS25, GP26, GP23, C57, QMS16, QMS21, QMS25, GP48, QMS01

NOTE 1: Procedures can be documented or not (ISO 9000); NOTE 2: When a procedure is documented, the term “written procedure” or “documented procedure” is frequently used. The document that contains a procedure can be called a “procedure document” (ISO 9000); NOTE 3: For a quality management system, a procedure is a set of instructions that describes the stepwise actions taken to complete activities identified in processes; NOTE 4: A series of tasks usually performed by one person according to instructions.


process

set of interrelated or interacting activities that transforms inputs into outputs (modified from ISO 9000)

Project: GP26, QMS02, QMS15, POCT05, POCT05, GP23, QMS16, QMS14, QMS06, QMS07, QMS08, I/LA33, QMS18, QMS21, QMS25, QMS03, QMS01

NOTE 1: A process may be documented as a flow chart or table that describes operations in the laboratory’s path of workflow or activities within a quality system essential; NOTE 2: A process is a set of related tasks and activities that accomplishes a work goal; NOTE 3: A process is a naturally occurring or designed sequence of changes in time of properties or attributes of an object or a system. For example, G(t) is the process of glucose fluctuations over a specified period of time; NOTE 4: Whether the “intended result” of a process is called output, product, or service depends on the context of the reference (ISO 9000); NOTE 5: Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes (ISO 9000).


process control

mechanisms for maintaining the output of a specific process within desired parameters

Project: QMS01


proficiency testing

evaluation of participant performance against preestablished criteria by means of interlaboratory comparisons (ISO/IEC 17043)

Project: GP26, QMS11, GP23, QMS24, MM17, QMS01

NOTE 1: For the purposes of ISO 17043, the term “proficiency testing” is taken in its widest sense and includes, but is not limited to: a) quantitative scheme – in which the objective is to quantify one or more measurands of the proficiency test item; b) qualitative scheme – in which the objective is to identify or describe one or more characteristics of the proficiency test item; c) sequential scheme – in which one or more proficiency test items are distributed sequentially for testing or measurement and returned to the proficiency testing provider at intervals; d) simultaneous scheme – in which proficiency test items are distributed for concurrent testing or measurement within a defined time period; e) single occasion exercise – in which proficiency test items are provided on a single occasion. It may be advantageous to pilot the change to evaluate its effectiveness before implementing a full-scale change; f) continuous scheme – in which proficiency test items are provided at regular intervals; g) sampling – in which samples are taken for subsequent analysis; and h) data transformation and interpretation – in which sets of data or other information are furnished and the information is processed to provide an interpretation (or other outcome); NOTE 2: Some providers of proficiency testing in the medical area use the term “external quality assessment” for their proficiency testing schemes, or for their broader programs, or both; NOTE 3: The requirements of ISO 17043 cover only those external quality assessment activities that meet the definition of proficiency testing (ISO 17043); NOTE 4: In some countries, the proficiency testing programs for medical laboratories are called “external quality assessment” programs (modified from ISO/IEC 17043); NOTE 5: Commonly, a program periodically sends multiple specimens or samples to members of a group of laboratories for analysis and/or identification; the program then compares each laboratory’s results with those of other laboratories in the group and/or with an assigned value and reports the results to the participating laboratory and others; NOTE 6: Other forms of proficiency testing include data transformation exercises, single-item testing (in which one item is sent to a number of laboratories sequentially and returned to the program at intervals), and one-off exercises (in which laboratories are provided with a test item on a single occasion); NOTE 7: Proficiency testing is sometimes referred to as “external quality assessment.”


program

group of interrelated activities to accomplish specific outcomes on a continuing basis

Project: GP26, QMS15, QMS16, QMS14, QMS25, QMS01

EXAMPLE 1: Safety program, quality control program, training program; EXAMPLE 2: Actions and related documents that constitute a safety program, quality control program, or training program; NOTE: A program is directed at accomplishing a clear objective, including detailed activities to take, by whom, when, and what means or resources to use.


quality

degree to which a set of inherent characteristics fulfills requirements (modified from ISO 9000)

Project: QMS15, GP26, QMS06, EP23, QMS14, GP23, QMS16, QMS25, QMS01


quality assurance

part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000)

Project: GP26, QMS06, EP23, POCT01, VET03, M23, H42, H43, C34, EP18, POCT09, H26, POCT07, I/LA28, QMS01, QMS15, MM19, NBS05, POCT10, QMS14, POCT12, VET01, POCT14, MM22, GP23, H52, POCT13, M52, QMS21, POCT04, QMS24, VET06, GP48, M02, M07, NBS04, M11, M24, NBS09, MM24

NOTE 1: The practice that encompasses all procedures and activities directed toward ensuring that a specified quality of product or service is achieved and maintained. In the testing environment, this process includes monitoring of raw materials, supplies, instruments, and procedures; specimen collection/transport/storage/processing; recordkeeping; calibration and maintenance of equipment; quality control procedures; proficiency testing; training of personnel; and all else involved in the production of the data reported; NOTE 2: These activities include monitoring, evaluating, taking preventive and corrective actions, if necessary, and monitoring the corrective actions for the preexamination, examination, and postexamination phases; NOTE 3: Quality assurance is a comprehensive set of policies, procedures, and practices used to monitor the laboratory’s entire testing process and ensure that the testing site’s results are reliable; NOTE 4: Quality assurance is also described as a planned and systematic set of quality activities; NOTE 5: Quality assurance includes monitoring, evaluating, and taking corrective actions, if necessary, based on evaluations, and monitoring the corrective actions for preexamination, examination, and postexamination activities. These activities include but are not limited to recordkeeping, calibration and maintenance of equipment, quality control, proficiency testing, and training; NOTE 6: Quality assurance may be said to comprise internal quality assurance and external quality assurance and is interrelated with quality control; NOTE 7: A comprehensive set of policies, procedures, and practices used to monitor the laboratory’s entire testing process and ensure that the testing site’s results are reliable.


quality control

the set of procedures designed to monitor the test method and the results to ensure appropriate test system performance

Project: QMS01, QMS06, QMS07, QMS13, QMS14, QMS15, QMS21, QMS23, QMS24

NOTE: Quality control includes testing quality control materials and charting and analyzing the results.


quality indicator

observations, statistics, or data defined by the organization or service that typify the performance of a given work process and provide evidence that the organization or service is meeting its quality intentions

Project: QMS01, QMS12, QMS19, QMS12, GP23, GP26, QMS06, QMS14

NOTE 1: Also referred to as “key performance indicator” or “quality metric”; NOTE 2: Also referred to as “key performance indicator” or “quality metric” and may be reported in various formats, such as a dashboard or scorecard.


quality manual

description of an organization’s quality management system (modified from ISO 9000)

Project: QMS01, QMS14

NOTE: Quality manuals can vary in detail and format to suit the size and complexity of an individual organization (ISO 9000).


quality planning

activity of setting quality goals and objectives and identifying related processes and resources (modified from ISO 9000)

Project: QMS06, QMS01, QMS14, QMS15

NOTE: Establishing quality plans can be part of quality planning (ISO 9000).


quality policy

overall intentions and direction of an organization related to quality as formally expressed by organizational leadership (modified from ISO 9000)

Project: QMS14, QMS01, GP26, QMS16

NOTE 1: Generally, the quality policy is consistent with the overall policies of an organization and provides a framework for setting quality objectives (modified from ISO 9000); NOTE 2: Quality management principles presented in ISO 9000 can form a basis for the establishment of a quality policy.


quality system essentials

the components of a management infrastructure necessary to support any health care organization’s or service’s path of workflow

Project: GP26, QMS14, QMS01, QMS06, QMS06, QMS07, GP23


record

(noun) evidence of results achieved or activities performed (modified from ISO 9000)

Project: QMS14, QMS02, QMS01, QMS06, QMS14, QMS15, QMS17, GP26, QMS16, QMS26, QMS03

NOTE 1: Records can be used, for example, to demonstrate traceability and to provide evidence of verification or corrective action (modified from ISO 9000); NOTE 2: Generally, records need not be under revision control (ISO 9000); EXAMPLES: Proficiency testing results, completed temperature charts, completed forms.


record

(verb) the action of documenting in a recoverable medium the activities performed or results achieved

Project: QMS02, QMS01, QMS26


requirement

need or expectation that is stated, generally implied, or obligatory (ISO 9000)

Project: QMS01, QMS14, QMS16, QMS17, QMS21

NOTE 1: A specified requirement is one that is stated, for example, in documented information (ISO 9000); NOTE 2: “Generally implied” means that it is custom or common practice for the organization and interested parties that the need or expectation under consideration is implied (ISO 9000); NOTE 3: A qualifier can be used to denote a specific type of requirement, eg, product requirement, quality management requirement, customer requirement, quality requirement (ISO 9000); NOTE 4: Requirements can be generated by different interested parties or by the organization itself (ISO 9000); NOTE 5: It can be necessary for achieving high customer satisfaction to fulfill an expectation of a customer even if it is neither stated nor generally implied or obligatory (ISO 9000).


risk

combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51)

Project: QMS01, M29, HS11, GP40, EP18, EP23, QMS14, QMS16, GP47, QMS21, EP31

NOTE 1: In EP18, the combination of frequency of occurrence and severity is also risk; NOTE 2: A potential hazard or quality deficiency associated with a process, product, or service.


risk management

systematic application of management policies, processes, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (modified from ISO 14971)

Project: QMS01, EP18, EP23, GP47


root cause analysis

systematic approach for identifying the causal factor(s) underlying a problem or condition

Project: QMS01, GP26, GP33

NOTE: Regulatory bodies may require use of the term “root cause analysis” to ensure confidentiality of root cause analysis documents.


specification

any requirement with which a product, process, service, or other activity must conform (21 CFR 820)

Project: QMS01, QMS21


supplier

organization or person that provides a product or a service (modified from ISO 9000)

Project: QMS01, GP26, QMS14

EXAMPLES: Producer, distributor, retailer, or vendor of a product, or a provider of a service or information (modified from ISO 9000); NOTE 1: A supplier can be internal or external to the organization (modified from ISO 9000); NOTE 2: In a contractual situation, a supplier is sometimes called a “contractor” (modified from ISO 9000).


traceability

ability to trace the history, application, or location of that which is under consideration (modified from ISO 9000)

Project: QMS01, GP26, I/LA28

NOTE: When considering a product or a service, traceability can relate to the origin of materials and parts, the processing history, and the distribution and location of the product after delivery (modified from ISO 9000).


training

process to provide instruction for performing or improving a job function

Project: QMS01, QMS16, QMS03


uncertainty

(of measurement) non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used (JCGM 200:2012)

Project: GP26, QMS21, POCT05, POCT05, C43, POCT07, MM06, GP34, EP24, C51, MM20, C40, H60, C62, EP05, C57, EP19, QMS24, C24, EP34, MM17, QMS01

NOTE 1: Measurement uncertainty includes components arising from systematic effects, such as components associated with corrections and the assigned quantity values of measurement standards, as well as the definitional uncertainty. Sometimes estimated systematic effects are not corrected for but, instead, associated measurement uncertainty components are incorporated (JCGM 200:2012); NOTE 2: The parameter may be, for example, a standard deviation called standard measurement uncertainty (or a specified multiple of it), or the half-width of an interval, having a stated coverage probability (JCGM 200:2012); NOTE 3: Measurement uncertainty comprises, in general, many components. Some of these may be evaluated by Type A evaluation of measurement uncertainty from the statistical distribution of the quantity values from series of measurements and can be characterized by standard deviations. The other components, which may be evaluated by Type B evaluation of measurement uncertainty, can also be characterized by standard deviations, evaluated from probability density functions based on experience or other information (JCGM 200:2012); NOTE 4: In general, for a given set of information, it is understood that the measurement uncertainty is associated with a stated quantity value attributed to the measurand. A modification of this value results in a modification of the associated uncertainty (JCGM 200:2012); NOTE 5: The parameter may be, eg, a standard deviation (or a given multiple of it), or the half-width of an interval, having a stated level of confidence (ISO 15195).


validation

confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled (ISO 9000)

Project: AUTO13, QMS07, QMS01, MM09, I/LA34, MM07, M33, H54, GP26, QMS13, MM13, MM10, MM03, H49, EP07, I/LA02, MM12, C24, MM01, GP40, AUTO10, AUTO08, EP10, C49, M50, C50, H58, POCT02, POCT05, MM11, I/LA21, H57, I/LA33, M55, GP33, H26, MM06, I/LA28, GP34, C58, C56, MM20, POCT05, MM22, H60, C62, AUTO11, C57, MM23, MM21, EP33, POCT14, POCT17, QMS21, POCT04, QMS24, I/LA20, M58, EP31, C63, QMS22, EP32, QMS23, MM24

NOTE 1: The word “validated” is used to designate the corresponding status (ISO 9000); NOTE 2: The use conditions for validation can be real or simulated (ISO 9000); NOTE 3: A term used by the FDA for a study used to determine whether a test system meets user needs (modified from 21 CFR Part 820); NOTE 4: Validation is also defined as the action (or process) of proving that a procedure, process, system, equipment, or method used works as expected and achieves the intended result; NOTE 5: The components of validation are quality control, proficiency testing, validation of employee competency, instrument calibration, and correlation with clinical findings; NOTE 6: Examples include validation of the process to use a new diagnostic tool, such as a new mammography instrument, automated laboratory test system or information system, automated medication dispensing system, or a new pulmonary function assessment device; information system; or evidence-based medicine; NOTE 7: a) Example: Validation of the performance of a new diagnostic tool such as an internally developed, analyte-specific method or reagents, or a laboratory-developed information system; b) Manufacturers are required to validate instruments and methods before market release (eg, FDA approval or European CE mark); NOTE 8: Manufacturers are required to validate instruments and methods before market release, eg, FDA approval or European CE mark; Example: Validation of the performance of a new diagnostic tool or a laboratory-developed information system; NOTE 9: Manufacturers are required to validate equipment before market release, eg, FDA approval or European CE mark; NOTE 10: Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (FDA); NOTE 11: Some of the components of validation are performance characteristics (eg, linear range, reproducibility, recovery, accuracy), quality control, proficiency testing, validation of employee competency, instrument calibration, and correlation with clinical findings; NOTE 12: Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled (FDA Quality System Regulation, 21 CFR 820.3); NOTE 13: As used in CLSI document I/LA21, validation includes performance verification; NOTE 14: Includes determination of performance characteristics (ie, accuracy, precision, sensitivity, specificity); NOTE 15: A one-time process completed to determine or confirm test performance characteristics before the test system is used for patient testing; NOTE 16: For the purpose of this guideline, validation is defined as establishing recorded evidence that provides a high degree of assurance that a specified process will consistently produce an outcome meeting its predetermined specifications and quality attributes; NOTE 17: In the context of CLSI document H26, and within the clinical laboratory environment, validation is primarily a manufacturer’s responsibility to ensure that design goals are met and performance claims are stated; NOTE 18: In the United States, the FDA has defined validation of a finished medical product in the context of the Quality System Regulation, 21 CFR § 820, as follows: 21 CFR § 820.3(z):Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. (1) Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. (2) Design validation means establishing by objective evidence that device specifications conform to user needs and intended use(s).”; NOTE 19: Examples include validation of the process to use a new diagnostic tool, such as an automated laboratory test system; information system; or evidence-based medicine; NOTE 20: It is primarily the manufacturer’s responsibility to ensure that design goals are met and performance claims are stated for a commercially developed assay or device, and a laboratory’s responsibility for a laboratory-developed test; NOTE 21: For the purpose of MM09, validation refers to the determination of performance characteristics; NOTE 22: The process of demonstrating that the system under consideration meets, in all respects, the specification of that system; NOTE 23: Examples include validation of the process to use a new diagnostic tool, such as an automated laboratory test system or information system; NOTE 24: Validation is also defined as the action (or process) of proving that a procedure, process, system, equipment, or method used works as expected and achieves the intended result; NOTE 25: For the purposes of C63, establishment of the performance of a measurement procedure through the provision of objective evidence; NOTE 26: The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents (ISO 9000); NOTE 27: The action (or process) of proving that a procedure, process, system, equipment, or method used works as expected and achieves the intended result; NOTE 27: Validation is the establishment and/or confirmation, through extensive testing, of the analytical and/or clinical performance characteristics of the measurement procedure.


verification

provision of objective evidence that a given item fulfills specified requirements (JCGM 200:2012)

Project: QMS01, MM13, EP25, C34, I/LA33, C43, H26, MM06, H02, M53, MM19, C51, EP17, EP27, EP09, EP26, C40, I/LA26, EP06, POCT06, EP19, H48, C64, EP34, MM17, QMS22, C49, M24, NBS09, NBS05, EP35

EXAMPLE 1: Confirmation that a given reference material as claimed is homogeneous for the quantity value and measurement procedure concerned, down to a measurement portion having a 10 mg mass (JCGM 200:2012); EXAMPLE 2: Confirmation that performance properties or legal requirements of a measuring system are achieved (JCGM 200:2012); EXAMPLE 3: Confirmation that a target measurement uncertainty can be met (JCGM 200:2012); EXAMPLE 4: Results obtained from using an examination method exactly as validated by the manufacturer without any deviation; NOTE 1: When applicable, measurement uncertainty should be taken into consideration (JCGM 200:2012); NOTE 2: The item may be, eg, a process, measurement procedure, material, compound, or measuring system (JCGM 200:2012); NOTE 3: The specified requirements may be, eg, that a manufacturer’s specifications are met (JCGM 200:2012); NOTE 4: Verification in legal metrology, as defined in VIML (OIML V1:2000), and in conformity assessment in general, pertains to the examination and marking and/or issuing of a verification certificate for a measuring system (JCGM 200:2012); NOTE 5: Verification should not be confused with calibration. Not every verification is a validation (JCGM 200:2012); NOTE 6: In chemistry, verification of the identity of the entity involved, or of activity, requires a description of the structure or properties of that entity or activity (JCGM 200:2012); NOTE 7: For the purposes of I/LA33 and C64, verification is defined as confirmation by examination and provision of objective evidence that specified requirements have been met; NOTE 8: In the context of CLSI document H26, verification is the end-user laboratory’s responsibility to ensure that manufacturers’ claims are correct; NOTE 9: A one-time process completed to determine or confirm test performance characteristics before the test system is implemented; NOTE 10: An activity completed to determine or confirm examination performance characteristics before the examination system is used for examinations; NOTE 11: A one-time process completed to determine or confirm test performance characteristics before the test system is used for patient testing; NOTE 12: For a laboratory measurement procedure, verification is the confirmation through testing that the performance characteristics of the measurement procedure are consistent with established label claims. Verification is normally performed by the end user before measurement procedure implementation for routine use in the laboratory; NOTE 13: Although “verification” may be used to describe actions performed by either the end user or the manufacturer, eg, to demonstrate acceptable performance specifications, EP19 uses verification to refer to confirmation of acceptable performance by the end user of a measurement procedure; NOTE 14: The verification of an extended measuring interval is performed through testing in the laboratory implementing the measurement procedure; NOTE 15: Confirming the performance of a regulatory organization–cleared or –approved assay is a “verification” process; NOTE 16: The ongoing process that confirms specified requirements (predetermined by validation) are fulfilled.


 

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