Standard Operating Procedure (SOP)

Standard Operating Procedure (SOP) is the controlled-document artifact-type that describes the recurring way a process step is to be performed in a regulated environment — manufacturing, laboratory, clinical, or quality. SOPs are the everyday currency of QMS audits and the most-cited document type in 21 CFR 820, ISO 13485, and ISO 9001 audits.

What it covers

• Scope, purpose, and applicability of the procedure.
• Roles and responsibilities for who performs each step.
• Stepwise procedure with required equipment, materials, and reference documents.
• Records and forms generated by following the SOP (the audit evidence chain).
• Revision control and periodic review per the QMS.

Relationships (see sidebar)

• Supports Quality Management, Manufacturing Execution, and Regulatory Submission.
• Implemented by PLM/QMS platforms including Siemens Teamcenter, PTC Windchill, Aras Innovator (Aras Quality Management), and PTC Arena (Arena QMS).
• Linked to the QMS document hierarchy.