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Standard Operating Procedure

What is Standard Operating Procedure?

A documented set of step-by-step instructions for completing routine operations consistently, efficiently, and in compliance with standards.

Governance

What the standards actually require on standard operating procedure

Requirements naming standard operating procedure across 6 standards, quoted from the control text.

A testing facility must have SOPs in writing setting forth nonclinical study methods that management is satisfied are adequate to ensure quality and integrity of data generated.

58.81 · Standard Operating Procedures →
ISO 22398:20133 controls

Top management should review the after-action report, comparing the exercise performance objectives with the results; follow up that corrective actions are implemented and commitments to them met;

iso-22398-2013::6.3 · Management review and corrective action →

Include policy and guidance documents: standard operating procedures, a metadata standard or data dictionary, data quality standards and assurance processes, and auditing and monitoring practices.

australian-government-data-governance-framework-2025::A.3.4 · A.3.4 Policy and guidance documents →

Applies to units storing hazardous waste munitions and explosives (264.1200). Storage units must be designed and operated with containment, controls and monitoring that minimise detonation and releases to soil, ground water, surface water and air;

epa-rcra-hazardous-waste-management::264-SubpartEE · Part 264 Subpart EE: Hazardous waste munitions and explosives storage →

A computerized system validation plan is produced for each GxP regulated system, centred on patients, product quality and the integrity of data, summarizing the system and project, identifying measures of success and defining criteria for final acceptance and...

gamp-5-good-automated-manufacturing-practice::M1 · Appendix M1 Validation Planning →

Questions people ask about standard operating procedure

What is Standard Operating Procedure?
A documented set of step-by-step instructions for completing routine operations consistently, efficiently, and in compliance with standards.
Why is Standard Operating Procedure important for compliance?
Standard Operating Procedure is a key concept in Governance. Understanding standard operating procedure helps organizations meet regulatory requirements, reduce risk, and demonstrate due diligence during audits. Our compliance platform maps 1,016 frameworks with 316K cross-framework control mappings.
Which compliance frameworks address Standard Operating Procedure?
Standard Operating Procedure appears in the requirement text of New Zealand Information Security Manual (NZISM), 21 CFR Part 58 - Good Laboratory Practice (GLP), ISO 22398:2013, Australian Government Data Governance Framework (2025), EPA RCRA Hazardous Waste Management. Across these standards we have identified 11 controls that name it directly, each linked to the control text on the compliance platform.
Where can I learn more about Standard Operating Procedure?
Explore our compliance framework pages to see how standard operating procedure applies across different standards and regulations. Our implementation guides provide step-by-step guidance, and the compliance platform offers AI-powered analysis of how this concept maps across 1,016 frameworks.

See how Standard Operating Procedure applies across compliance frameworks

Our platform maps 1,016 frameworks with 316K cross-framework control mappings. Explore how this concept is addressed across standards.

Written and maintained by Gerard Blokdyk, The Art of Service.