The International Organization for Standardization (ISO) develops globally recognized standards that guide quality, safety, and operational consistency across industries.
In life sciences, ISO standards support structured governance for quality management, risk control, and information security practices used in regulated environments. Many organizations reference ISO principles to standardize SOPs, training, corrective actions, and continuous improvement programs. ISO-aligned systems can strengthen trust with sponsors and partners by demonstrating repeatable, well-controlled processes. While not a clinical trial regulator, ISO standards often complement regulatory expectations for reliable operations and documented oversight.