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At various points in this guide we've talked about various contracts and agreements, but only a little bit about SLAs. Last chapter we said the SLA essentially defines all the responsibility the cloud provider holds, as well as your laboratory, for the supply and use of the CSP's services. This is the "meat and potatoes" of the service paperwork that will cross your eyes. The SLA, in a sense, offers a set of primary legal protections and, ideally, clearly expresses the expectations placed at the feet of both parties. With a well-crafted, signed SLA, neither party can say they were unaware of a stipulation, responsibility, or expectation. By signing the SLA, the laboratory also admits that the document is largely representative of the technological or organizational goals of the lab, and the CSP of its goals.
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SLAs will have numerous components to it addressing both the implementation and use of the service and the management aspects of the service, indicating what services are provided and excluded, the conditions of availability for the provided services, any differing service levels, each party's responsibilities, reporting processes, escalation and dispute procedures, remediation and indemnification methods, cost compromises, and contract change management.<ref name="OverbyWhatIs17">{{cite web |url=https://www.cio.com/article/2438284/outsourcing-sla-definitions-and-solutions.html |title=What is an SLA? Best practices for service-level agreements |author=Overby, S.; Greiner, L.; Paul, L.G. |work=CIO |date=05 July 2017 |accessdate=21 August 2021}}</ref> It would be beyond the scope of this guide to provide broad information about all the elements of an SLA and how to approach them; entire books have been written about the subject over the years.<ref name="WiederService11">{{cite book |title=Service Level Agreements for Cloud Computing |editor=Wieder, P.; Butler, J.M.; Theilmann, W. et al. |publisher=Springer |year=2011 |isbn=9781461416159}}</ref><ref name="RussoTheCloud18">{{cite book |title=The Cloud Service Level Agreement: A Supplement for NIST 800-171 Implementation |author=Russo, M.A. |publisher=Syber Risk |year=2018 |isbn=9781983156533}}</ref> However, let's look at a few of those aspects, from the perspective of the laboratory examining a CSP's SLA.
==''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.


In early 2020, laboratory informatics and scientific consultancy Astrix provided some key insights about SLAs for labs moving to the cloud. Astrix president Dale Curtis emphasized that when examining any SLA, ensure that it's largely addressing "what" questions rather than digging into the minutia of "how" questions; too much "how" and you start losing the other benefits inherent to the SLA.<ref name="CurtisConsid20">{{cite web |url=https://astrixinc.com/considerations-for-cloud-hosting-your-laboratory-informatics-systems/ |title=Considerations for Cloud Hosting Your Laboratory Informatics Systems |author=Curtis Jr., D. |publisher=Astrix, Inc |date=24 January 2020 |accessdate=21 August 2021}}</ref> Does the SLA address "what"<ref name="CurtisConsid20" />:
;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]]


* the specific parameters of the business-significant services offered to your laboratory are, and what happens when those parameters are not met?
<!--Place all category tags here-->
* the ownership rights to service data are for both parties, including discussion of the data request and return processes and their timelines, the format the data will be returned in, the retention times of your data after a CSP closure or contract termination, and the penalties for non-compliance?
* your laboratory's rights to continue and discontinue services are "within and outside of contract renewal timelines," and what the associated costs and penalties may be?
* the standards and regulatory requirements affecting the CSP's cloud service(s) are, giving you any rights to audit the service for compliance?
* the incident resolution process looks like, and how long it will take to complete?
* the change management process for updates and upgrades looks like, including how it will be communicated and scheduled?
* the CSP's disaster recovery process is and what you, the lab, should expect in case of various risks and disasters being realized?
 
==References==
{{Reflist|colwidth=30em}}

Latest revision as of 19:46, 9 February 2022

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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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