EuroGentest - Definitions

The aim of this document is to bring together definitions and explanations of terms related to quality management in genetics.

The formal definitions from "ISO 9000:2005: Quality management systems - Fundamentals and vocabulary" are preferred. Where useful or necessary, these are complemented by definitions from other sources and/or interpretations by EuroGentest experts of terms, in the context of genetics.

Accreditation

"Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks." (ISO guide2)

Formal recognition of technical competence, as well as compliance to a quality management system. Central to accreditation are two features: the principle of external review, with regular external audits carried out by an independent body; and to fulfil the requirements of standards, most importantly ISO 15189 or ISO 17025.

See also: certification , which requires external audit of compliance to a QMS, but not of technical competence; and licensing , which is usually mandatory and government-imposed and which may or may not involve criteria of quality.

Audit

"A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled" (ISO 9000:2005 3.9.1)

Review of procedures as defined by the QMS: aspects of the structure, processes, and outcomes are selected and systematically evaluated against explicit criteria (for example, the requirements of an accreditation standard). Where indicated, changes are implemented and further monitoring is used to confirm improvement.

Auditee

Auditor

"A person with the demonstrated personal attributes and competence to conduct an audit" (ISO 9000:2005 3.9.9)

Audit team

"One or more auditors conducting an audit, supported if needed by technical experts" (ISO 9000:2005 3.9.10)

CAPA

Certification

"Procedure by which a third party gives written assurance that a product, process or service conforms to specific requirements" (ISO guide2)

Formal recognition of compliance to a quality management system, most commonly ISO 9001.

See also: accreditation , which adds requirements of technical competence to those of compliance to a QMS; and licensing , which is usually mandatory and government-imposed and which may or may not involve criteria of quality.

Continual improvement

"A part of quality management focused on increasing the ability to fulfil quality requirements" (ISO 9000:2005 3.2.12)

Continual improvement is a set of activities that an organization routinely carries out in order to enhance its ability to meet requirements. Continual improvement can be achieved by carrying out internal audits, performing management reviews, analysing data, and implementing corrective and preventive actions (Praxiom).

Corrective action

"An action to eliminate the cause of a detected non-conformity or other undesirable situation" (ISO 9000:2005 3.6.5)

Corrective actions are steps that are taken to remove the causes of an existing non-conformity or to make quality improvements. Corrective actions address actual problems. In general, the corrective action process can be thought of as a problem-solving process (Praxiom).

External audit

"External audits include those generally termed second-and third-party audits. Second-party audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf. Third-party audits are conducted by external, independent auditing organizations, such as those providing certification of conformity to ISO 9001" (ISO 9000:2005 3.9.1)

Review of procedures by auditors, external to the organization, such as from a national accreditation body.

External quality assessment (EQA)

"A system of objectively assessing the laboratory performance by an outside agency. EQA is a system whereby a set of reagents and techniques are assessed by an external source and the results of the testing laboratory are compared with those of an approved reference laboratory The main objective of external quality assessment is to establish inter-laboratory compatibility" (WHO 1981)

"External Quality Assessment" (EQA) and "Proficiency testing" (PT) are often used interchangeably. The difference between EQA and PT is not always clear. EQA is more used in Europe and PT in the US. EQA is more focused on education and continuous improvement; PT is focused on satisfactory performances and authorization.

Horizontal audit

"This examines one element in a process on more than one item. It is a detailed check of a particular aspect of the documentation and implementation of the quality management system or examination processes" (Burnett 2002)

Example: Examine a number of laboratory reports, to evaluate whether appropriate interpretation and suggestions for follow-up of abnormal results had been provided.

Internal audit

"Sometimes called first-party audits, are conducted by, or on behalf of, the organization itself for management review and other internal purposes, and may form the basis for an organization's declaration of conformity. In many cases, particularly in smaller organizations, independence can be demonstrated by the freedom from responsibility for the activity being audited" (ISO 9000:2005 3.9.1)

Internal audits are carried out by your personnel. Internal quality audits examine the elements of a quality management system in order to evaluate how well these elements comply with quality system requirements (Praxiom).

Internal quality control (IQC)

"The set of procedures undertaken by the staff of a laboratory for continuously assessing laboratory work and the emergent results, in order to decide whether they are reliable enough to be released. It is meant to allow laboratory technicians to check their own performance and help them to monitor the reliability of their technique. The main objective of internal quality control is to ensure day-to-day consistency" (WHO 1981)

International standard

"A standard that is adopted by an international standardizing/standards organization and made available to the public" (ISO Guide2)

International standards include ISO 15189, ISO 17025 (accreditation) and ISO 9001 (certification).

Licensing (US: Licensure)

"The permission, permit from a governmental agency to operate a laboratory"(OECD)

Licensing of health care facilities is distinct from accreditation and certification, and is usually mandatory and government-imposed (example: French " agrément"). Licensing does not necessarily require any evaluation of quality management or technical competence.

Management review

"An activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives" (ISO 9000:2005 3.8.7)

The purpose of a management review is to evaluate the overall performance of an organization's quality management system and to identify improvement opportunities. These reviews are carried out by the organization's top managers and are done on a regular basis (praxiom).

National standard

"A standard that is adopted by a national standards body and made available to the public" (ISO Guide2)

National standards include Clinical Pathology Accreditation, CPA (UK) and Coördinatie Commissie ter bevordering van de Kwaliteitsbeheersing van het Laboratoriumonderzoek op het gebied van de Gezondheidszorg, CCKL (The Netherlands).

Non-conformity

A non-conformity is a failure or a refusal to meet a requirement of the quality management system or the relevant standard. Non-conformities and their causes require corrective actions.

Although the terms are commonly used interchangeably, non-conformity is not synonymous with "non-compliance", which is a failure to meet the requirements of a law, regulation, or other requirement.

Preventive action

"An action to eliminate the cause of a potential non-conformity" (ISO 9000:2005 3.6.4)

Preventive actions are steps that are taken to remove the causes of potential non-conformities or to make quality improvements. Preventive actions address potential problems, ones that have not yet occurred. In general, the preventive action process can be thought of as a risk analysis process (Praxiom).

Procedure

"A detailed procedure defines the work that should be done, explains how it should be done, who should do it, and under what circumstances. In addition, it explains what authority and what responsibility has been allocated, which supplies and materials should be used, and which documents and records must be used to carry out the work" (Praxiom)

A quality management system is based on its standard operating procedures (SOPs), which are detailed, written instructions designed to achieve uniformity of the performance of a specific function. SOPs cover not only laboratory procedures (tests) but all aspects of the QMS.

Proficiency testing (PT)

Quality

"A degree to which a set of inherent characteristics fulfils requirements" (ISO 9000:2005 3.1.1)

In short, a quality is a desirable characteristic. However, not all qualities are equal. Some are more important than others. The most important qualities are the ones that customers want... So providing quality products and services is all about meeting customer requirements (Praxiom).

In the context of genetics services, where progress can be very rapid and where "customers" (typically, referring doctors) cannot be expected to have full knowledge of the services available, a more appropriate definition of quality would be:

Products and services that meet or exceed customers' expectations (after Professor Kano).

Quality assurance (QAu)

"A part of quality management focused on providing confidence that quality requirements will be fulfilled" (ISO 9000:2005 3.2.11)

Quality assurance (QAu) is defined as a set of activities whose purpose is to demonstrate that an entity meets all quality requirements. QAu activities are carried out in order to inspire the confidence of both customers and managers, confidence that all quality requirements are being met (after Praxiom).

Effective QAu must include all activities from design, development, production, installation, and servicing through to documentation, and is based on the existence and effectiveness of procedures that attempt to ensure, in advance, that required levels of quality will be reached.

We propose the abbreviation "QAu" rather than the commonly-used "QA", which is more commonly used for "Quality assessment".

Quality control (QC)

"A part of quality management focused on fulfilling quality requirements" (ISO 9000:2005 3.2.10)

Quality control is defined as a set of activities or techniques whose purpose is to ensure that all quality requirements are being met. In order to achieve this purpose, processes are monitored and performance problems are solved (Praxiom).

Quality management

"Coordinated activities to direct and control an organization with regard to quality" (ISO 9000:2005 3.2.8)

Quality management includes all the activities that managers carry out in an effort to implement their quality policy. These activities include quality planning, quality control, quality assurance, and quality improvement (Praxiom).

Quality manager

Individual with "delegated responsibility and authority to oversee compliance with the requirements of the quality management system, who shall report directly to the level of laboratory management at which decisions are made on laboratory policy and resources;" (ISO 15189:2005 4.1.5)

The formal designation of the quality manager is an essential first step in the development and implantation of a quality management system.

Quality management system (QMS)

"System to establish a quality policy and quality objectives and to achieve those objectives." (ISO 9000:2005)

A quality management system (QMS) is a web of interconnected processes, designed to ensure consistency and improvement of working practices, which in turn should provide products and services that meet customer's requirements.

The design and implementation of a QMS will vary depending on the type, size and products of the organisation, but always includes quality planning, quality assurance and quality control.

Quality manual

"A document specifying the quality management system of an organization" (ISO 9000:2005 3.7.4)

A quality manual documents an organization's Quality Management System. It can be a paper manual or an electronic manual (Praxiom).

Recommendation

Commonly made in an audit report, recommendations suggest actions that could improve the QMS but which are not formal corrective actions to observed non-conformities.

Regional standard

"A standard that is adopted by a regional standardizing/standards organization and made available to the public" (ISO Guide2)

Requirement

"need or expectation that is stated, generally implied or obligatory" (ISO 9000:2005 3.1.2)

Scope of accreditation

"The scope of accreditation of a testing laboratory is the formal and precise statement of the activities which the laboratory is accredited for. It is as such the result of a combination of information (scope parameters) concerning the testing field, the type of test (describing the measurement principle), the product/object tested and the methods and procedures used for the test" (EA-2/05)

The scope of accreditation provides a precise description of the specific tests for which the laboratory is deemed competent and, generally, requires an evaluation of the laboratory's competence for each new test that is added to the scope. This scope is typically available in the national accreditation registry.

Recently, some accreditation bodies permit the use of "Flexible accreditation scopes", in the context of which laboratories have the opportunity to make changes within the testing field and within the accreditation conditions, without an additional audit of the accreditation body.

Standard

"A document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context" (ISO Guide2)

A standard is a document. It is a set of rules that control how people develop and manage materials, products, services, technologies, processes, and systems. ISO's standards are agreements. ISO refers to them as agreements because its members must agree on content and give formal approval before they are published. ISO standards are developed by technical committees. Members of these technical committees come from many countries. Therefore, ISO standards tend to have very broad support (Praxiom).

Standard Operating Procedure (SOP)

Technical expert

"A person who provides specific knowledge or expertise to the audit team" (ISO 9000:2005 3.9.11)

The audit team for accreditation of genetics services consists of a lead auditor, a technical auditor and/or a technical expert with appropriate genetics expertise.

Traceability

"The ability to trace the history, application or location of that which is under consideration" (ISO 9000:2005 3.5.4)

Traceability refers to the completeness of the information about every step in a process chain. The term is used in different contexts, for example:

- To refer to an unbroken chain of measurements relating an instrument's or a reagent's measurements to a known (higher) standard.

- To describe the history of a sample (via an electronic or "paper trail"), to relate it reliably to the original sample and request, to all tests performed and to their results and reports.

Validation

"Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled" (ISO 9000:2005 3.8.5)

Accreditation standards require that methods and procedures be evaluated and found to give satisfactory results, before being used for medical examinations. The validations shall be as extensive as are necessary (after ISO15189).

Validation must be applied to methods developed or modified in the laboratory, and may also be applied to commercial kits for diagnostic use.

Verification

"Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled" (ISO 9000:2005 3.8.4)

Accreditation standards require that methods and procedures be evaluated and found to give satisfactory results, before being used for medical examinations.

Verification is typically applicable to procedures designed for diagnostic use (e.g. commercial kit for diagnostic use), to verify that the kit performs according to its defined specifications. It is not sufficient for tests developed or modified in-house, but only for those received "with specified requirements".

Vertical audit

"Examines more than one element in a process, on one item. It is a detailed check that all elements associated with a chosen examination (test) are implemented. In any single audit, one or a number of examinations that have recently passed through the laboratory are randomly selected" (Burnett 2002)

Example: Select a sample and its associated request form (input), and follow every element of the process to the report (output). This simultaneously audits the process and the traceability.

Witness audit

Audit by observation of a procedure (for example, laboratory test or sample reception and registration). Witness audits commonly combine aspects of both vertical and horizontal audits, and may include checks on reagent traceability, instrument maintenance and calibration, and document control. As well as auditing the procedure, witness audits allow a check that an individual has received comprehensive training and has a thorough understanding of the work they perform.

Collected by EuroGentest Unit 1

References

D. Burnett, A practical guide to accreditation in laboratory medicine, ACB Venture Publications, 2002

European co-operation for Accreditation (EA), EA-2/05 - The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing, 2001
http://www.european-accreditation.org/n1/doc/EA-2-05.pdf Exit EuroGentest website

International Organization for Standardization (ISO),
ISO Guide2 - General terms and their definitions concerning standardization and related activities, 1996
ISO 9000:2005 - Quality management systems - Fundamentals and vocabulary
ISO 15189:2005 - Medical laboratories - Particular requirements for quality and competence
http://www.iso.org/ Exit EuroGentest website

World Health Organization (WHO), External Assessment of Health Laboratories, 1981
http://www.who.int/ Exit EuroGentest website

Lab Quality

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Definitions

Collected by EuroGentest Unit 1

References