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

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Now that the demonstrations have been conducted and more questions asked, you should be close to finalizing your requirement specifications with one ore more vendors. In fact, you may have taken LIMSpec, chosen a few critical requirements from it, added them to a few unique requirements of your own, and included them as part of an RFI or question and answer session with vendors. You then likely took those responses and added them to your wider overall specification (e.g., LIMSpec), along with your own notes and observations from interacting with the vendor. This may have been repeated for several vendors and their offerings.  
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At this point, you're likely ready to either have those vendors complete the rest of the responses for their corresponding URS, or you may even be ready to narrow down your vendor selection. This all likely depends on what the initial fact finding revealed. How well did the vendors respond to your laboratory's unique set of needs? Were there critical areas that one vendor could address with their off-the-shelf solution but another vendor would have to address with custom coding? Did any of the vendors meet your budget expectations? Have you followed up on any references and customer experiences the vendors provided to you?
==''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.


It may be that several vendors are appealing at this point, meaning it's time to have them respond to the rest of the URS. This makes not only for good due diligence, to better ensure most requirements can be met, but also a reviewable option for any "tie-breaker" you have between vendors. In reality, this tie-breaker scenario would rarely come up; more often, some other aspect of the software, company, or pricing will be a stronger limiter. However, you still want to get all those vendor responses, even if you've early on filtered your options down to one vendor.
;1. What is quality?
 
:''Key terms''
Ultimately, your specification document may look similar to the LIMSpec, or it may have a slightly different format. Many prospective buyers will develop a requirement specification in Microsoft Excel, but that has a few minor disadvantages. Regardless of format, you'll want to give plenty of space for vendors to submit a response to each requirement. For your convenience, a Microsoft Word version of Appendix 1's LIMSpec for medical diagnostics and research labs is also included as part of this guide (see A1.8 LIMSpec in Microsoft Word format). That document is editable, giving end users and vendors the flexibility to remove information and enlarge columns.
:[[Quality (business)|Quality]]
 
:[[Quality assurance]]
Additionally, remember that often is the case that after the URS is completed and final questions asked, no single vendor can meet all your needs. Be ready for this possibility, whether it be a functionality requirement or a budget issue. Know ahead of time where your laboratory is willing to be flexible, and how much flex you have. After all of your lab's preparation, and with a little luck, you've found a vendor that fits the bill, even if a few minor compromises had to be made along the way.
:[[Quality control]]
 
:''The rest''
 
:[[Data quality]]
==Citation information for this chapter==
:[[Information quality]]
'''Chapter''': 6. Taking the next step
:[[Nonconformity (quality)|Nonconformity]]
 
:[[Service quality]]
'''Title''': ''Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research''
;2. Processes and improvement
 
:[[Business process]]
'''Edition''': 2022 Edition
:[[Process capability]]
 
:[[Risk management]]
'''Author for citation''': Shawn E. Douglas and Alan Vaughan
:[[Workflow]]
 
;3. Mechanisms for quality
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
:[[Acceptance testing]]
 
:[[Conformance testing]]
'''Publication date''': January 2022
:[[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]]


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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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