Glossary · Manufacturing systems
Quality documentation
Also known as: Quality records, QMS documentation
German: Qualitätsdokumentation
In manufacturing, quality documentation is the controlled set of documents and records that describe the quality management system and prove that products and processes meet requirements, such as procedures, work instructions, inspection plans, test records and certificates.
- Manufacturing systems
- Technical documentation
In one sentence
Quality documentation covers QMS procedures, inspection plans and records that prove products and processes meet requirements.
Example
For each batch, the quality documentation includes the inspection plan, measurement results, deviation reports and the release signature.
Explained in context
Context cards connect this term with others to answer one question. Also in British English and German.
How it applies
- Quality system: ISO 9001 calls these documents 'documented information' — maintained (procedures, specifications) or retained (records). Regulated sectors such as medical devices (ISO 13485) and pharma (GMP) add stricter requirements.
- Production: Inspection plans and records are created at the line, increasingly electronically in the MES or quality system. Electronic records need integrity controls and audit trails.
- Documentation: Quality documentation and technical documentation overlap: work instructions, test procedures and product specifications must be consistent. Apply Document control to both, and define which system holds the master of each document type.
Quality documentation vs. technical documentation
Technical documentation describes the product for users, authorities and service. Quality documentation describes and proves how the company ensures quality. A declaration of conformity draws on both.