Eurachem: guide to the life cycle and qualification of analytical equipment — from user requirements to decommissioning
On 19 December 2025 Eurachem published the guide “The Fitness for Intended Use of Analytical Equipment and Systems”, prepared by its Analytical Equipment and System Qualification Working Group. It describes the whole life cycle of instruments: design, installation, operational and performance qualification, maintaining the qualified state and decommissioning.
- Equipment is defined more narrowly than in clause 6.4.1 of ISO/IEC 17025: measuring instruments or instrument systems including control and data-processing units, auxiliary equipment and computerised systems with software that can influence results.
- The guide runs from design and production by the manufacturer through purchasing (design qualification and user requirement specifications), prearrangements before delivery, installation (IQ), operational (OQ) and performance qualification (PQ) to requalification — time-dependent and event-driven — and decommissioning.
- It takes into account ISO 9001, ISO/IEC 17025, ISO 17034, ISO 15189 and ISO 10012 as well as GMP and GLP, pharmacopoeias and the Codex Alimentarius; it also covers software categories, metrological and procedural traceability, risk assessment and documentation requirements.
- It focuses on laboratory equipment but also applies to field measurement equipment, and its principles may be applied to in-line and on-line analysers permanently installed in plants. The editor is Ernst P. Halder (Eurachem Switzerland); ISBN 978-0-948926-41-9.
Source: Eurachem — New Guide to Analytical Equipment and System Qualification (19.12.2025)