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Medical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the FDA. Medical research labs provide many different analytical and consulting services, including (but not limited to)<ref name="MAGIDefinition04">{{cite web |url=https://www.magiworld.org/FdaGcpRecords?Pkey=1134 |title=Definition of Central Laboratory |work=FDA Good Clinical Practice (GCP) Q&A |publisher=Model Agreements & Guidelines International |date=19 April 2004 |accessdate=18 November 2021}}</ref><ref name="MinorHandbook06">{{cite web |url=https://books.google.com/books?id=RmrLBQAAQBAJ&printsec=frontcover |title=Handbook of Assay Development in Drug Discovery |editor=Minor, L.K. |publisher=CRC Press |year=2006 |pages=488 |isbn=9781420015706}}</ref>:
{{Saved book
|title=Introduction to Quality and Quality Management Systems
|subtitle=
|cover-image=Time-Quality-Money.png
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* clinical studies
==''Introduction to Quality and Quality Management Systems''==
* bioequivalence studies
{{ombox
* study design and management
| type      = content
* high-volume specimen testing
| style    = width: 500px;
* custom assay development
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
* test kit development and supply
}}
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.


Medical research can happen in the private, government, and academic sectors. Private medical research labs are most often referred to as "central laboratories," which are contracted by pharmaceutical companies and medical device manufacturers. Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term "central laboratory." However, it gets used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a "central" lab handling sample analysis) performed at medical institutions.<ref name="MAGIDefinition04" /><ref name="KarelinSelecting13">{{cite web |url=https://www.contractpharma.com/issues/2013-05/view_features/selecting-a-central-laboratory/ |title=Selecting a Central Laboratory |author=Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. |work=Contract Pharma |publisher=Rodman Media, Inc |date=06 May 2013 |accessdate=18 November 2021}}</ref> These central labs may also be contracted out to provide "courier services for delivering lab kits and biosamples from/to medical institutions where diagnostics and treatment of patients is performed."<ref name="KarelinSelecting13" /> Analytical testing and other services at a central or contract lab include anatomic pathology, digital pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.<ref name="CovanceClinical">{{cite web |url=https://drugdevelopment.labcorp.com/services/clinical-testing/central-laboratory-services/core-laboratory-testing-services.html |title=Global Network and Core Services |publisher=Labcorp Drug Development |accessdate=18 November 2021}}</ref><ref name="ACMCentral">{{cite web |url=https://www.acmgloballab.com/central-lab-services |title=Central Lab Services |publisher=ACM Global Laboratories |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]]


==References==
<!--Place all category tags here-->
{{Reflist|colwidth=30em}}

Latest revision as of 19:46, 9 February 2022

Introduction to Quality and Quality Management Systems
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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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