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Revision as of 20:12, 16 January 2023
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Title: LIMS Selection Guide for ISO/IEC 17025 Laboratories
Edition: First Edition
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: ???
Description of this book goes here ...
The table of contents for LIMS Selection Guide for ISO/IEC 17025 Laboratories is as follows:
- 1. Introduction to ISO/IEC 17025
- 1.1 History of ISO/IEC 17025
- 1.2 ISO/IEC 17025 vs. ISO 9001
- 1.3 How we benefit from ISO/IEC 17025 laboratories
- 2. How ISO/IEC 17025 affects and benefits laboratories
- 2.1 Types of labs affected by ISO/IEC 17025
- 2.1.1 Analytical and regulatory testing labs
- 2.1.1.1 Product development and manufacturing labs
- 2.1.2 Basic and applied research labs
- 2.1.3 Reference measurement and calibration labs
- 2.1.4 A note about clinical laboratories
- 2.1.1 Analytical and regulatory testing labs
- 2.2 What ISO/IEC 17025 asks of laboratories
- 2.2.1 Competence, impartiality, and consistent operations
- 2.2.2 Demands on the laboratory
- 2.2.3 Addressing gaps in ISO/IEC 17025
- 2.3 How laboratories benefit from ISO/IEC 17025 compliance
- 2.1 Types of labs affected by ISO/IEC 17025
- 3. Choosing laboratory informatics software for better ISO/IEC 17025 compliance
- 3.1 Evaluation and selection
- 3.1.1 Technology considerations
- 3.1.1.1 Laboratory informatics options
- 3.1.1.2 LIMS, quality management, and the QMS
- 3.1.2 Features and functions for ISO/IEC 17025 compliance
- 3.1.3 Cybersecurity considerations
- 3.1.4 Regulatory compliance considerations
- 3.1.5 System flexibility
- 3.1.6 Cost considerations
- 3.1.1 Technology considerations
- 3.2 Implementation
- 3.2.1 Internal and external integrations
- 3.3 MSW, updates, and other contracted services
- 3.4 How a user requirements specification fits into the entire process (LIMSpec)
- 3.1 Evaluation and selection
- 4. Resources for selecting and implementing informatics solutions
- 4.1 LIMS vendors
- 4.2 Consultants
- 4.3 Professional
- 4.3.1 Trade organizations
- 4.3.2 Conferences and trade shows
- 4.4 LIMSpec
- 5. Taking the next step
- 5.1 Conduct initial research into a specification document tailored to your lab's needs
- 5.2 Issue some of the specification as part of a request for information (RFI)
- 5.3 Respond to or open dialogue with vendors
- 5.3.1 The value of demonstrations
- 5.4 Finalize the requirements specification and choose a vendor
