Validation protocols

1. NordVal International protocol for validation of alternative (proprietary) microbiological methods against a reference method

The protocol harmonises with ISO 16140-2:2016.

Note, Jan 2025: Protocol 1 and Appendices are currently under update according to the ISO 16140-2:2016/Amd 1:2024 being under review.

• NordVal Protocol 1  ver. Jan 2022 (pdf) – under update

• Appendix 1 Sensitivity study: NordVal Prot 1 A1 Sensitivity study (xlxs)
• Appendix 2 Qualitative analysis: NordVal Prot 1 A2 ILS Qualitative analysis (xlxs)
• Appendix 3 Quantitative methods: NordVal Prot 1 A3 Quantitative methods plots (xlxs)
• 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 study plan template: Microbiology quantitative methods ver. Apr 2024 

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.

1B. NordVal International protocol for validation of alternative (proprietary) methods for microbiological confirmation and typing procedures

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

• 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)