User:Shawndouglas/sandbox/sublevel17

From LIMSWiki
Jump to navigationJump to search

Sandbox begins below

Daily Operations in the Core Lab Aboard USNS Comfort (49826052293).jpg

Title: What are the key elements of a LIMS to better comply with ISO/IEC 17025?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: TBD

Introduction

This article will turn to LIMSpec—a laboratory informatics requirements specification document that has evolved significantly over the years—for input into what the base and specialty requirements of a LIMS are in regards to better complying with ISO/IEC 17025. With the current version of LIMSpec having at its core standards such as ASTM E1578-18 Standard Guide for Laboratory Informatics and ISO/IEC 17025 Testing and calibration laboratories, the LIMSpec makes for a durable requirements document that, when used to acquire an informatics solution, can better help a laboratory choose appropriate functionality based upon current standards, regulations, guidance, and more. In particular, this article will look at the touch points of ISO/IEC 17025 with LIMSpec and highlight their importance.

LIMS and quality management

Base LIMS requirements

Specialty LIMS requirements

Conclusion

References