SOPkrav

SOPkrav is a term used in organizational governance to denote the formal requirements that govern the creation, approval, distribution, and maintenance of standard operating procedures (SOPs) within an organization. It defines how SOPs must be written, structured, and controlled to ensure consistency, traceability, and regulatory compliance.

Scope and applicability: SOPkrav applies across domains such as manufacturing, healthcare, laboratories, and service operations. It typically covers document control, versioning and revision history, access controls, roles and responsibilities, training and competence, and retention policies.

Core components often required by SOPkrav include a defined scope and purpose, the procedure steps, responsibilities, references, appendices, risk considerations, and performance indicators. It emphasizes change control, approval workflows, and archival of superseded versions.

Implementation and impact: Organizations implement SOPkrav through quality management systems, aligning with standards such as ISO 9001, ISO 13485, or GMP. Digital platforms are commonly used to enable centralized storage, automatic versioning, and audit trails. Compliance is typically assessed via internal audits, management reviews, and staff training records.

See also: Standard operating procedure; document control; quality management system; regulatory compliance.