Validation protocols

NordVal International Protocol 1: Validation of alternative (proprietary) microbiological methods against a reference method

NordVal International Protocol 1 harmonises with ISO 16140-2:2016 and has together with Appendix 1-3 been updated 29.06.2026 according to ISO 16140-2:2016/Amd 1:2024.

Download the files here:

• NordVal International Protocol 1 (new June 2026): NordVal Protocol No 1_Micro_June 2026 (pdf)
• Appendix 1 Sensitivity study (new June 2026): Statistics on qualitative results according to ISO 16140 2 amd 1(xlsx)
• Appendix 2 Qualitative analysis (new June 2026): Statistics on qualitative results according to ISO 16140 2 amd 1(xlsx)
• Appendix 3 Quantitative methods (new June 2026): NordVal-Prot-1_A3_Quantitative-methods-plots(xlsx)
• Appendix 4 Accuracy profile multiple comparison study: A4 AP calculation tool MCS (xlxs)
• Appendix 5 Accuracy profile interlaboratory study: A5 AP calculation tool ILS (xlxs)

• NordVal International study plan template: Microbiology quantitative methods ver. Apr 2024 (docx) 

Water samples

We offer reviewing alternative methods for quantitative analyses in microbiology of drinking water samples according to EN ISO 17994 as required for alternative methods by (EU) 2020/2184.

NordVal International Protocol 1B: Validation of alternative (proprietary) methods for microbiological confirmation and typing procedures

The protocol harmonises with ISO/DIS 16140-6 2017-12-15.

Download the file here:

• NordVal Protocol 1B  ver. Jan 2019 (pdf)

Evaluation forms for reviewers

Evaluation forms for validation of alternative microbiological methods can be downloaded here:

• Qualitative evaluation form (doc)
• Quantitative evaluation form (doc)