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  |title=Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research
  |title=Introduction to Quality and Quality Management Systems
  |subtitle=2020 Edition
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  |cover-image=Time-Quality-Money.png
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==''Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research'', 2020 Edition==
==''Introduction to Quality and Quality Management Systems''==
'''Title''': ''Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research'', 2020 Edition
{{ombox
 
| type      = content
'''Author for citation''': Shawn E. Douglas and Alan Vaughan
| style    = width: 500px;
 
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
}}
 
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.
'''Publication date''': TBD
 
Insert description of book here.
 
:[[User:Shawndouglas/sandbox/sublevel2|1. Introduction to medical diagnostics and research laboratories]]
::1.1 Medical diagnostics lab
:::1.1.1 Pathology
::::1.1.1.1 Anatomical vs. clinical pathology
::::1.1.1.2 Forensic pathology
:::1.1.2 Physician office lab
:::1.1.3 Integrative medicine lab
::1.2 Public health lab
::1.3 Toxicology lab
::1.4 Blood bank and transfusion lab
::1.5 Central and contract research lab
:::1.5.1 Medical and other research in academia
::1.6 Genetic diagnostics lab
:::1.6.1 Cytogenetics lab
::1.7 Medical cannabis testing lab
 
:[[User:Shawndouglas/sandbox/sublevel3|2. Choosing laboratory informatics software for your lab]]
::2.1 Evaluation and selection
:::2.1.1 Technology considerations
:::2.1.2 Features and functions
:::2.1.3 Cybersecurity considerations
:::2.1.4 Regulatory compliance considerations
:::2.1.5 Cost considerations
::2.2 Implementation
:::2.2.1 Internal and external integrations
::2.3 MSW, updates, and other contracted services
::2.4 How a user requirements specification fits into the entire process (LIMSpec)
 
:3. Additional resources for selecting and implementing informatics solutions
::[[User:Shawndouglas/sandbox/sublevel4|Part 1: Laboratory informatics vendors]]
::3.1 Laboratory informatics vendors
:::3.1.1 LIMS vendors
:::3.1.2 LIS vendors
:::3.1.3 ELN vendors
:::3.1.4 Middleware vendors
::[[User:Shawndouglas/sandbox/sublevel5|Part 2: Other vendors and service providers]]
::3.2 Medical diagnostics instrumentation vendors
::3.3 EHR vendors
::3.4 Laboratory workflow and business intelligence solution vendors
::3.5 Laboratory billing service providers
::[[User:Shawndouglas/sandbox/sublevel6|Part 3: Industry and community resources]]
::3.6 Trade organizations and events
::3.7 User communities
::3.8 Books and journals
::3.9 Standards
::3.10 LIMSpec
 
:[[User:Shawndouglas/sandbox/sublevel37|4. Taking the next step]]
::[https://www.lablynxpress.com/index.php?title=4.1_Develop_a_specification_document_(LIMSpec)_tailored_to_your_lab%27s_needs 4.1 Develop a specification document (LIMSpec) tailored to your lab's needs]
::[https://www.lablynxpress.com/index.php?title=4.2_Issue_the_specification_as_a_request_for_information_(RFI) 4.2 Issue the specification as a request for information (RFI)]
::[https://www.lablynxpress.com/index.php?title=4.3_Acquire_information_and_proposals_from_vendors 4.3 Acquire information and proposals from vendors]
:::[https://www.lablynxpress.com/index.php?title=4.3.1_The_value_of_demonstrations 4.3.1 The value of demonstrations]
 
:[[User:Shawndouglas/sandbox/sublevel38|5. Closing remarks]]


: Appendix 1. Blank LIMSpec template for medical diagnostics and research labs
;1. What is quality?
::[[LII:LIMSpec/Introduction and methodology|A1.1 Introduction and methodology]]
:''Key terms''
::[[LII:LIMSpec/Primary Laboratory Workflow|A1.2 Primary Laboratory Workflow]]
:[[Quality (business)|Quality]]
::[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations|A1.3 Maintaining Laboratory Workflow and Operations]]
:[[Quality assurance]]
::[[User:Shawndouglas/sandbox/sublevel39|A1.4 Specialty Laboratory Functions]]
:[[Quality control]]
::[[LII:LIMSpec/Technology and Performance Improvements|A1.5 Technology and Performance Improvements]]
:''The rest''
::[[LII:LIMSpec/Security and Integrity of Systems and Operations|A1.6 Security and Integrity of Systems and Operations]]
:[[Data quality]]
::[[LII:LIMSpec/Putting LIMSpec to use|A1.7 Putting LIMSpec to Use]]
:[[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]]


: Appendix 2. Completed example of LIMSpec for medical diagnostics and research labs
<!--Place all category tags here-->
::[[User:Shawndouglas/sandbox/sublevel40|A2.1 Primary Laboratory Workflow]]
::[[User:Shawndouglas/sandbox/sublevel41|A2.2 Maintaining Laboratory Workflow and Operations]]
::[[User:Shawndouglas/sandbox/sublevel42|A2.3 Specialty Laboratory Functions]]
::[[User:Shawndouglas/sandbox/sublevel43|A2.4 Technology and Performance Improvements]]
::[[User:Shawndouglas/sandbox/sublevel44|A2.5 Security and Integrity of Systems and Operations]]

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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