Terms and Definitions

accreditation
procedure by which an authoritative body gives formal recognition that a body or person is
competent to carry out specific tasks [ISO Guide 2 :1996]

annual joint review
annual review of employee/employer requirements, undertaken to establish mutually acceptable
objectives for a defined period of time

audit
systematic, independent and documented process for obtaining audit evidence and evaluating it
objectively to determine the extent to which audit criteria are fulfilled [ISO 9000:2000]
NOTE
Clinical audit is audit applied to clinical activities

corrective action
action to eliminate the cause of a detected nonconformity or other undesirable situation
NOTE
Corrective action is taken to prevent reoccurrence whereas preventative action is taken to prevent
occurrence [ISO 9000:2000]

department
section of a laboratory in which a single pathology discipline pursues its activities

effectiveness
extent to which planned activities are realised and planned results achieved
[ISO 9000:2000]
NOTE
Clinical effectiveness is effectiveness applied to clinical activities

efficiency
relationship between the result achieved and the resources used [ISO 9000:2000]

examination
set of operations having the object of determining the value or characteristics of a property
NOTE
In some countries and disciplines (e.g. microbiology) examination is the total activity of a number of tests,
observations or measurements [ISO 15189:2003]

laboratory director
competent person(s) with responsibility for, and authority over, a laboratory
[ISO 15189:2003]

laboratory management
person(s) who manage the activities of the laboratory headed by the laboratory director
[ISO 15189:2003]

materials
consumables, calibrators, reagents, calibration material used in the performance of an examination

medical laboratory
clinical laboratory
laboratory for the biological, microbiological, immunological, chemical, immunohaematological,
haematological, biophysical, cytological, pathological or other examination of materials derived
from the human body for the purpose of providing information for the diagnosis, prevention and
treatment of disease in, or assessment of the health of, human beings, and which may provide a
consultant advisory service covering all aspects of laboratory investigation including the
interpretation of results and advice on further appropriate investigation
NOTE These examinations also include procedures for determining, measuring or otherwise describing the
presence or absence of various substances of micro-organisms. Facilities which only collect or prepare
specimens, or act as a mailing or distribution centre, are not considered to be medical or clinical laboratories,
although they may be part of a larger laboratory network or system.
[ISO 15189:2003]

multidisciplinary laboratory
laboratory in which two or more pathology disciplines work in an integrated manner

nonconformity
nonfulfilment of a requirement [ISO 9000:2000]

organisation
group of people and facilities with an arrangement of responsibilities, authorities and relationships
[ISO 9000:2000]

organisational structure
arrangement of responsibilities, authorities and relationships between people
[ISO 9000:2000]

post examination process
post analytical phase
processes following the examination including systematic review, formatting and interpretation,
authorisation for release, reporting and transmission of results and storage of samples of the
examinations [based on ISO 15189:2003]

pre examination process
pre analytical phase
steps starting in chronological order from the clinician’s request, including examination
requisition, preparation of the patient, collection of the primary sample, transportation to and
within the laboratory and ending when the examination procedure starts
[based on ISO 15189:2003]

premises
physical environment in which an organisation carries out particular functions

preventive action
action to eliminate cause of a potential nonconformity or other undesirable potential situation
NOTE
Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent reoccurrence
[ISO 9000:2000]
procedure
specified way to carry out an activity or process [ISO 9000:2000]
NOTE
When the term ‘procedure’ is used in this document a written procedure is required which is subject to
document control, regular review and revision.

quality improvement
part of quality management focused on continually increasing effectiveness and efficiency
NOTE
the term ‘continual quality improvement’ is used when quality improvement is progressive and the
organisation actively seeks and pursues improvement opportunities [based on ISO 9000:2000]

quality management system
management system to direct and control an organisation with regard to quality
[ISO 9000:2000]

quality manual
document specifying the quality management system of an organisation
NOTE
quality manuals may vary in detail and format to suit the size and complexity of an individual organisation
[ISO 9000:2000]
see also www.iso15189.com

quality objective
something sought, or aimed for, related to quality
NOTE
Quality objectives are generally based on the organisation’s quality policy [ISO 9000:2000]

quality planning
part of quality management focused on setting quality objectives and specifying necessary
operational processes and related resources to fulfil quality objectives [ISO 9000:2000]

quality policy
overall intentions and direction of an organisation related to the fulfilment of quality requirements
as specified by laboratory management
NOTE
the quality policy should be consistent with the overall policy of the organisation and should provide a
framework for the setting of quality objectives [based on ISO 9000:2000]

record
document stating results achieved or providing evidence of activities performed
[ISO 9000:2000]

referral laboratory
external laboratory to which a sample is submitted for supplementary or confirmatory examination
procedure and report [ISO 15189:2003]

requirement
need or expectation that is stated, generally implied or obligatory [ISO 9000:2000]

review
activity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of the subject
matter to achieve established objectives [based on ISO 9000:2000]

revision
introduction of all necessary changes to the substance and presentation of a document to ensure its continuing suitability, adequacy, effectiveness to achieve established objectives

user
person or organisation using the services of the laboratory

user dissatisfaction (complaint)
user opinion of the degree to which the service provided has failed to meet their requirements

user satisfaction
user opinion of the degree to which the service provided has met their requirements

validation
confirmation, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled [ISO 9000:2000]

work environment
set of conditions under which work is performed [ISO 9000:2000]