SOP & Compliance Glossary
Plain-English definitions of the terms and standards you'll encounter while writing SOPs, running quality programs, and navigating audits.
SOP
(Standard Operating Procedure)A documented, step-by-step process for performing a routine business task consistently and safely.
ISO 9001
The international standard for quality management systems, requiring documented procedures, continuous improvement, and risk-based thinking.
HACCP
(Hazard Analysis and Critical Control Points)A food safety management system that identifies biological, chemical, and physical hazards and defines controls to prevent them.
HIPAA
(Health Insurance Portability and Accountability Act)US federal law requiring covered entities to protect patient health information through documented policies, procedures, and training.
GMP
(Good Manufacturing Practice)Regulatory requirements ensuring pharmaceutical, medical device, and food products are consistently produced to quality standards.
CAPA
(Corrective and Preventive Action)A structured process for investigating quality problems, implementing fixes, and preventing recurrence. Core to ISO 9001 and FDA quality systems.
SOX
(Sarbanes-Oxley Act)US law requiring public companies to document and test internal controls over financial reporting. Applies to any SOP that affects financial data.
Root Cause Analysis
(RCA)A structured investigation method that identifies the underlying cause of a problem rather than treating its symptoms.
PPE
(Personal Protective Equipment)Protective clothing, helmets, gloves, and equipment designed to protect workers from workplace hazards. Required by OSHA and most regulators.
Risk Assessment
A documented process for identifying hazards, evaluating likelihood and severity, and determining appropriate controls.