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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 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
2.2 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
3. Choosing laboratory informatics software for better ISO/IEC 17025 compliance
3.1 Evaluation and selection
3.1.1 Technology considerations Laboratory informatics options 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
3.2 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)
4. Resources for selecting and implementing informatics solutions
4.1 LIMS vendors
4.2 Consultants
4.3 Other resources
4.3.1 ISO/IEC 17025 accreditation bodies
4.3.2 ISO/IEC 17025 reference and resource library
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
5.5 LIMSpec in Microsoft Word format
6. Closing remarks