Kvalitetsdokumentation

Kvalitetsdokumentation refers to the set of documents that describe and support an organization's quality management system (QMS). The documentation makes it possible to plan, perform, monitor and improve processes so that products and services meet defined requirements and customer expectations.

Core elements typically include the quality policy and objectives, the quality manual, documented processes and procedures, work instructions, forms and records, as well as records for training, internal audits, nonconformities, corrective and preventive actions, supplier quality and calibration. Documentation provides a consistent basis for how work is performed and how quality is verified.

Many industries follow formal standards that shape kvalitetsdokumentation. The ISO 9001 standard for quality management requires a documented QMS and controlled documents. Sector-specific standards such as ISO 13485 (medical devices) or GMP/GxP compliance in life sciences impose additional documentation requirements, including validation, traceability and change control.

Document control is central: documents are approved, versioned, accessible to authorized personnel, and kept for a defined retention period. Changes are managed through change requests, impact assessments, and re-approval. Records are retained as evidence of conformance and performance.

Effective kvalitetsdokumentation supports risk management, supplier management, training, and continuous improvement. Common challenges include keeping documents up to date, avoiding unnecessary documentation, and ensuring accessibility across locations or systems. When well managed, it provides audit readiness, transparency, and a basis for process optimization.