Technical Report No. 01/ 2024
October2024
Guidelinesfor themanagement ofdigitalised systemsinlaboratoriesaccredited toISO/IEC17025
Author:Edouard SalingrosGembloux Agro-BioTech University of Liege 5030 Gembloux Belgium
Impressum
“Guidelines for the management of digitalised systems in laboratories accredited to EUROLABTechnicalReport 1/2024ISO/IEC17025"
October 2024
EUROLAB General SecretariatRueduCommerce20-221000 BrusselsBELGIUM
Phone: 32 2 511 50 65e-Mail:info@ URL:
Table of contents
Foreword....1.Introduction and scope 41.1 Introduction.... 51.2 Scope .. 52. Normative references ....3.Definitions.4. Risk assessment. 454.1 Risk-based classification .... .475. ldentified risks .495.1 Selection of a system module or related service unfit for purpose ... 495.2 Improper use and handling.... ..495.3 Cyberattacks and insider attacks. ...505.4 Physical failure due to natural wear and tear ... 5.5 Service discontinuation .51 515.6 Disaster. . 525.7 Skill obsolescence or loss.. . 535.8 Unexpected behaviour due to development errors or unsuitable design... ..535.9 Delivery of erroneous data or delivery of data to unauthorised third parties .. .. 546.Controls ..546.1 Documented procedures and technical records. ..546.2 Technical documentation..... ...566.3 User requirements procurement and design qualification ...6.4 Development . 616.5 Acceptance testing - ..62 .. 656.7 General inventory and logbooks. 6.6 Maintenance.. ..666.8 Environmental conditions... .676.9 Redundancy of facilities.. 686.10 File format . .696.11 Change control .696.12 Indexing - . 706.13 Access control.6.14 Archiving and disposal . .746.15 Backups... .766.16 Digital signatures .. 77
6.17 Electronic Document Management Systems (EDMS) 776.18 Personnel. 786.19 Event reporting.. .. 796.20 Internal audits. 807.Appendices 827.1 Appendix A.... 827.2 Appendix B. 7.3 Appendix C. E8References. 84 86
Foreword
EUROLAB (the European Federation of National Associations of Measurement Testing and AnalyticalLaboratories) is a not-for-profit organisation representing laboratories coordinating their efforts to sas uszueao apamouy ueus Aq saged pooe aosod pue salualeup uosoo ssaeand working groups; and publishing position papers technical reports and newsletters.
The present guidelines have been reviewed by EUROLAB members and a special thanks are addressed to Anton Bloth (convenor of the Digitalisation working group VUP) other VUP members Tobias Pflockand Alexander Frenzl (Audittrails) and to Christian Mueller-Schoell(Metler-Toledo) for their feedback.
Comments and feedback for the next edition can be sent to the following e-mail addresses:
edouard.salingros@uliege.besecretariat@eurolab-aisbl.eu
