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[[File:Molecular Diagnostics.jpg|right|426px]]In 2018, the World Health Organization (WHO) noted the following about modern genetic testing<ref name="WHOGenetic">{{cite web |url=https://www.who.int/genomics/professionals/laboratories/en/ |archiveurl=https://web.archive.org/web/20181003114819/http://www.who.int/genomics/professionals/laboratories/en/ |title=Genetic laboratories and clinics |work=Human Genomics in Global Health |publisher=World Health Organization |archivedate=03 October 2018 |accessdate=18 November 2021}}</ref>:
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<blockquote>Prior to the development of modern genetic technologies, genetic services were limited to genetic counselling, where health professionals would attempt to characterize the genetic contribution of diseases based on family histories. With the discovery of DNA, genetic services have dramatically increased in quality and scope. Increasingly sophisticated technologies now permit new methodology and high quality preparations, ensuring greater accuracy in diagnosis.</blockquote>
==''Introduction to Quality and Quality Management Systems''==
{{ombox
| type      = content
| style    = width: 500px;
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
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The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.


A genetic diagnostics lab uses genetic testing to evaluate DNA in the search for a genetic cause for symptoms or a disease. The lab may also have other responsibilities or goals, including interpreting results for physicians, detecting mutations, developing new analytical methods, and improving patient care through its discoveries.<ref name="WHOGenetic" /><ref name="UPennTheGenetic">{{cite web |url=https://genetics.med.upenn.edu/cores/genetic-diagnostic-laboratory/ |title=Genetic Diagnostic Laboratory |work=Genetics - Perelman School of Medicine |publisher=University of Pennsylvania |accessdate=18 November 2021}}</ref>
;1. What is quality?
:''Key terms''
:[[Quality (business)|Quality]]
:[[Quality assurance]]
:[[Quality control]]
:''The rest''
:[[Data quality]]
:[[Information quality]]
:[[Nonconformity (quality)|Nonconformity]]
:[[Service quality]]
;2. Processes and improvement
:[[Business process]]
:[[Process capability]]
:[[Risk management]]
:[[Workflow]]
;3. Mechanisms for quality
:[[Acceptance testing]]
:[[Conformance testing]]
:[[Clinical quality management system]]
:[[Continual improvement process]]
:[[Corrective and preventive action]]
:[[Good manufacturing practice]]
:[[Malcolm Baldrige National Quality Improvement Act of 1987]]
:[[Quality management]]
:[[Quality management system]]
:[[Total quality management]]
;4. Quality standards
:[[ISO 9000]]
:[[ISO 13485]]
:[[ISO 14000|ISO 14001]]
:[[ISO 15189]]
:[[ISO/IEC 17025]]
:[[ISO/TS 16949]]
;5. Quality in software
:[[Software quality]]
:[[Software quality assurance]]
:[[Software quality management]]


The WHO classifies genetic testing into five broad categories<ref name="WHOGenetic" />:
<!--Place all category tags here-->
 
#Carrier identification screening: a test that checks one or more individuals for whether or not they carry a genetic marker for a specific disease (e.g., cystic fibrosis)
#Prenatal diagnostic testing: a series of tests using routine ''in vitro'' fertilization methods when a gestating child is thought to have a genetically caused disease (e.g., Down syndrome)
#Newborn screening: one or more preventative health tests for treating a newborn early when treatment is available (e.g., congenital hypothyroidism)
#Late-onset disorder testing: testing that occurs later in life to determine susceptibility of an individual to a particular disease (e.g., cancer and heart disease)
#Identity testing: testing that "involves profiling the individuals genetic information from DNA test results of genetic markers in order to locate characteristics unique to the individual" (often used in forensic and criminal investigations)
 
As for the techniques used in genetic testing, the American Association for Clinical Chemistry (AACC) has five categories of techniques: [[polymerase chain reaction]] (PCR), DNA sequencing, microarrays, gene expression profiling, and cytogenetics. (For more on cytogenetics, see the following subsection.) The PCR technique is a copying technique that "enables specific genes or regions of interest to be detected or measured." [[DNA sequencing]] (e.g., [[next-generation sequencing]] or NGS) allows scientists to identify changes or variations in the way DNA is arranged that may indicate a disorder. Microarray testing has multiple uses, among them identifying duplications, deletions, or identical sections in DNA, which may indicate a propensity for a particular disease. Gene expression profiling looks at the genes of cells and determines if they are actively making proteins or not for aiding in prognosis, recurrence, and other types of diagnostic indicators for disease.<ref name="AACCGenetic19">{{cite web |url=https://www.testing.com/genetic-testing-techniques/ |title=Genetic Testing Techniques |work=Testing.com |publisher=OneCare Media |date=09 November 2021 |accessdate=18 November 2021}}</ref>
 
==References==
{{Reflist|colwidth=30em}}

Latest revision as of 19:46, 9 February 2022

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Introduction to Quality and Quality Management Systems

This book should not be considered complete until this message box has been removed. This is a work in progress.

The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.

1. What is quality?
Key terms
Quality
Quality assurance
Quality control
The rest
Data quality
Information quality
Nonconformity
Service quality
2. Processes and improvement
Business process
Process capability
Risk management
Workflow
3. Mechanisms for quality
Acceptance testing
Conformance testing
Clinical quality management system
Continual improvement process
Corrective and preventive action
Good manufacturing practice
Malcolm Baldrige National Quality Improvement Act of 1987
Quality management
Quality management system
Total quality management
4. Quality standards
ISO 9000
ISO 13485
ISO 14001
ISO 15189
ISO/IEC 17025
ISO/TS 16949
5. Quality in software
Software quality
Software quality assurance
Software quality management


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