Difference between revisions of "User:Shawndouglas/sandbox/sublevel1"

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Table 3 lists the major vendors developing and selling PCR, isothermal amplification, and NGS supplies, instruments, and software for both clinical diagnostics and life science research. "Research use only" equipment like Siemens Healthcare's Fast Track Cycler was ignored for completing the table. The vendor list was largely compiled from vendors identified in a handful of online market reports on PCR, with an added sprinkling of a few additional reagent vendors (e.g., Jena Bioscience, LGC, and New England BioLabs) who address isothermal amplification supplies in addition to PCR. Note that this is not an endorsement for any particular vendor.
{{Saved book
{|
  |title=Introduction to Quality and Quality Management Systems
| STYLE="vertical-align:top;"|
  |subtitle=
{| class="wikitable sortable" border="1" cellpadding="5" cellspacing="0" width="90%"
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  |cover-color=#fffccc
  ! style="background-color:white; text-align:left; font-weight: normal; padding-left:10px; padding-right:10px;" colspan="13"|'''Table 3.''' Major players operating in the global diagnostic PCR, isothermal amplification, and NGS market
  | setting-papersize = A4
  |-
  | setting-showtoc = 1
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Vendor
  | setting-columns = 1
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Shop all products
}}
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|PCR machines
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Nucleic acid extraction<br />and purification machines
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Immunoassay analyzers<br />and assays
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|PCR and qPCR assays
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|PCR and qPCR enzymes<br />and master mixes
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|DNA/RNA purification,<br />quantitation, and<br />amplification supplies
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|LAMP assays
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Isothermal amplification<br />enzymes and <br />master mixes
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|NGS supplies
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Supporting labware<br />and supplies
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Software
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Abbott
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.molecular.abbott/us/en/offerings/products Abbott products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
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  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
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  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  |-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Agilent Technologies
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.agilent.com/en-us/products Agilent products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  |-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Becton, Dickinson and Company
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.bd.com/en-us/offerings/capabilities BD products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  |-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Bio-Rad Laboratories, Inc.
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.bio-rad.com/en-us/life-science-research?ID=1100 Bio-Rad products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  |-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|bioMérieux SA
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.biomerieux-usa.com/az bioMérieux products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
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  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  |-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Danaher Corporation and its companies
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cepheid.com/ Cepheid products],<br />[https://www.beckmancoulter.com/en/products Beckman Coulter products], and<br />[https://www.beckman.com/ Beckman Life Sciences products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|F. Hoffmann-La Roche AG
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.roche.com/products/diagnostics-portfolio.htm Roche Diagnostics products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Jena Bioscience GmbH
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.jenabioscience.com/ Jena Bioscience products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|LGC Limited and its companies
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.lucigen.com/products.html Lucigen products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Merck KGaA
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.sigmaaldrich.com/US/en/life-science/covid Sigma-Aldrich products] and<br />[https://www.emdmillipore.com/US/en/products/vMqb.qB.GdEAAAE_Mhd3.Lxj,nav Millipore Sigma products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|New England BioLabs, Inc.
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.neb.com/products NEB products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Promega
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.promega.com/products/ Promega products] and [https://www.promega.com/products/catalog/ catalog]
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|QIAGEN N.V.
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.qiagen.com/us/products/ QIAGEN products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Siemens Healthcare GmbH
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.siemens-healthineers.com/products-services Siemens Healthcare products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Thermo Fisher Scientific, Inc.
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.thermofisher.com/us/en/home/order.html Thermo Fisher products] and<br />[https://www.fishersci.com/us/en/browse/90217008/pcr-equipment-and-supplies Fisher Scientific products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
|-
|}
|}


The "Software" column of Table 3 represents whether or not the vendor offers laboratory informatics software such as a LIMS or LIS. Those vendors' solutions may or may not be tailored to handle the specific requirements of a clinical diagnostic or virology lab handling COVID-19 and other viruses. (See the next chapter for more in-depth information about working an informatics solution into COVID-19 and other viral testing workflow.) A non-endorsed, representative example of vendors who do include:
==''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.
}}
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.


* [[Abbott Informatics Corporation]] - [https://www.starlims.com/us/en/covid19-testing-and-reporting/starlims-covid19 STARLIMS LIMS]
;1. What is quality?
* [[AgileBio]] - [https://labcollector.com/solutions/applications/lp-covid19-pack/ COVID-19 LC]
:''Key terms''
* [[Autoscribe Informatics, Inc.]] -  [https://www.autoscribeinformatics.com/lims/matrix-covid-lims Matrix Covid LIMS]
:[[Quality (business)|Quality]]
* [[BioSoft Integrators, LLC]] - [https://biosoftintegrators.com/covid-19/ LabOptimize LIMS for COVID-19]
:[[Quality assurance]]
* [[CloudLIMS.com, LLC]] - [https://cloudlims.com/industries/covid-19-lims-software.html CloudLIMS for COVID-19]
:[[Quality control]]
* [[Common Cents Systems, Inc.]] - [https://resources.apollolims.com/blog/covid-19-testing-and-the-important-role-of-a-lims Apollo LIMS for COVID-19]
:''The rest''
* [[Comp Pro Med, Inc.]] - [https://www.comppromed.com/covid-19-rapid-deployment-lis/ COVID-19 Rapid Deployment LIS]
:[[Data quality]]
* [[Illumina, Inc.]] - [https://blog.software.illumina.com/2020/04/14/efficient-accurate-lab-management-for-covid-19-research/ BaseSpace Clarity LIMS for COVID-19]
:[[Information quality]]
* [[Junction Concepts, Inc.]] - [https://qbench.net/qbench-covid-19-lims-laboratory-information-management-system/ QBench]
:[[Nonconformity (quality)|Nonconformity]]
* [[LabLynx, Inc.]] - [https://www.covidlims.com/ COVIDLiMS]
:[[Service quality]]
* [[LabVantage Solutions, Inc.]] - [https://www.labvantage.com/your-lab-type/labvantage-covid-19-lims/ LabVantage COVID-19 LIMS]
;2. Processes and improvement
* [[Physion, LLC]] - [https://www.ovation.io/covid-19/ Ovation LIMS for COVID-19]
:[[Business process]]
* [[Sunquest Information Systems, Inc.]] - [https://www.sunquestinfo.com/docs/sunquest-covid19-mitogen-lims-product-focus.pdf Mitogen LIMS for COVID-19] (PDF)
:[[Process capability]]
* [[Third Wave Analytics, Inc.]] - [https://thirdwaveanalytics.com/covid19/ Lockbox LIMS for SARS-CoV-2 Clinical Testing]
:[[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]]


Additionally, when in-house knowledge is lacking, a consultant may be required. These consultants are meant to be representative examples of those laboratory consulting firms indicating they have the knowledge to help a laboratory with COVID-19-related testing and other issues. This list is not an endorsement for any particular consultant:
<!--Place all category tags here-->
 
* [https://www.aruplab.com/consulting ARUP Laboratories] (Utah)
* [https://www.colaborate.com/covid-19-lab-consulting/ Colaborate] (Florida)
* [https://elitediagnostics.com/verticals/infectious-disease/ Elite Diagnostics] (North Carolina)
* [https://www.freedassociates.com/news/freed-associates-launches-a-covid-19-consulting-service-for-health-care-organizations/ Freed Associates] (California)
* [https://www.lighthouselabservices.com/consulting/infectious-disease/ Lighthouse Lab Services] (North Carolina)
* [https://optimumhit.com/ehr-services/covid-19-support/ Optimum Healthcare IT] (Florida)
* [https://thecovidconsultants.com/ The COVID Consultants] (Colorado)
* [https://www.triumvirate.com/coronavirus Triumverate Environmental] (Massachusetts)

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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