Welcome to the advISO SOP Writing Guide

Release: 0.1 [2026-01-19]

The following pages have been developed to provide comprehensive guidance on the writing and implementation of Standard Operating Procedures (SOPs) for organisations working toward accreditation under the ISO 15189 (medical laboratories) and ISO 17025 (testing and calibration laboratories) standards.

This guide explains in detail how an SOP should be structured and what content must be included to meet international requirements. It offers practical advice, examples, and frameworks that enable laboratories to create SOPs which not only comply with ISO standards but also serve as clear, reliable evidence of quality and competence.

A Glossary of ISO terms is also provided, offering definitions and bioinformatics-specific translations to facilitate clear communication and shared understanding between both wet lab and dry lab teams. This glossary is intended to bridge disciplinary language gaps and promote collaboration across different areas of expertise.

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This documentation was developed as part of the Wellcome Trust–funded project: “ISO in a Box: Developing a framework to enable the development of end-to-end genomics-based ISO 15189 and ISO 17025 accredited services, anywhere in the world” (Grant Reference: 228162/Z/23/Z)