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Instrument interfaces (discussed later in this chapter) are typically a non-trivial monetary investment for laboratories<ref name="John3504HL7_11">{{cite web |url=https://community.spiceworks.com/topic/175107-hl7-interface-cost-and-maintenance |title=HL7 Interface cost and maintenance |author=John3504 |work=Spiceworks |date=07 December 2011 |accessdate=25 April 2020}}</ref> as the developer has to take into account compliance requirements, the required analytical outcomes, and the instrument itself, as well as its available connections.<ref name="StraussConnect18">{{cite web |url=https://www.labmanager.com/laboratory-technology/connecting-lab-instruments-interface-strategies-depend-upon-compliance-requirements-2034 |title=Connecting Lab Instruments: Interface Strategies Depend Upon Compliance Requirements |author=Strauss, D. |work=Lab Manager |date=08 July 2018 |accessdate=30 April 2020}}</ref> Yet a laboratory informatics vendor with experience has likely already set up interfaces to the instruments used in testing COVID-19 and other respiratory illnesses. RT-PCR systems like Hologic's Panther Fusion<ref name="HologicPantherFusion20">{{cite web |url=https://www.hologic.com/coronavirus-test |title=Hologic’s Molecular Test for the Novel Coronavirus, SARS-CoV-2, Receives FDA Emergency Use Authorization |author=Hologic |publisher=Hologic, Inc |date=17 March 2020 |accessdate=30 April 2020}}</ref> and Abbot's RealTime m2000<ref name="AbbottRealTime20">{{cite web |url=https://www.molecular.abbott/us/en/products/infectious-disease/RealTime-SARS-CoV-2-Assay |title=Abbott RealTime SARS-CoV-2 Assay |author=Abbott |publisher=Abbott Laboratories |accessdate=30 April 2020}}</ref> represent a few of the systems being used to test for COVID-19 right now. Is the laboratory informatics system able to interface with these and other lab-based and point-of-care (POC) instruments you may require, at a reasonable cost? If so, also ensure the ease of assigning those instruments to specific tests or samples in the system. You should also be able to document well numbers for the analysis, as well as later view which samples are associated with a particular instrument. (In some cases, an instrument may be solely allocated to one specific test type.)
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==References==
==''Introduction to Quality and Quality Management Systems''==
{{Reflist|colwidth=30em}}
{{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.
}}
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 (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]]
 
<!--Place all category tags here-->

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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