ISO/IEC 17025:2017 Spreadsheet Validation – the details

Abstract

Spreadsheets are one of the most versatile document formats in use today. They can be used for a multitude of purposes: instructional or informative document, financial analysis, data analysis, charts, numerical calculations, checklists, data entry forms, and information management, to name a few. The list is virtually endless. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories requires spreadsheets to be validated if they affect the quality of the laboratory results. This can occur in three distinct areas – measurement uncertainty budgets, information management, and methods. Failure to validate spreadsheets may result in an assessment/audit nonconformance and ss a calibration accreditation assessor, I have rarely seen spreadsheets validated. This is usually because spreadsheets aren’t looked at as part of the method (calibration procedure) or the information management system. Spreadsheets should be validated for any application and in any industry if they contain calculations that may affect the quality of the organizations product or service. Spreadsheets are required to be validated in organizations regulated by the FDA such as medical devices and pharmaceutical manufacturers. This paper will explain why spreadsheets need to be validated, the applicable sections of ISO/IEC 17025:2017, and the basics on how to validate a spreadsheet.