Quality management glossary for everyday work

Key quality management terms

Quality management system (QMS)

The combination of processes, responsibilities and rules used to manage quality. Software supports this system but does not replace its actual implementation and application by people.

Document control

Governs the creation, review, approval, distribution and revision of documented information. The aim is for the right people to work with valid instructions. See document control.

Record or evidence

Documents what actually happened, such as a check or a training session. A completed record differs from a template that only describes what should be recorded in the future.

Revision

A specific editing state of a document. A new revision is not automatically approved; version control and approval status need to be considered separately.

Deviation

An observed difference between a requirement and the actual situation. Describe the facts, impact and affected process before investigating causes and deciding which actions are appropriate.

Correction

Removes a specific observed problem, such as a wrongly labelled file. On its own it does not demonstrate that the cause has been removed or recurrence prevented.

CAPA

Corrective and Preventive Action: a structured approach to causes, actions and effectiveness. A closed task alone is not evidence of effectiveness. See the CAPA process.

Effectiveness check

Assesses against previously agreed criteria whether an action achieved its intended outcome. The timing, assessment method and verifiable observations should be documented so others can understand the conclusion.

Internal audit

A planned and traceable assessment against defined criteria. Independence, suitable evidence and documented findings matter more than simply ticking boxes on an audit checklist.

Audit trail

A traceable sequence of recorded system events. It can show who changed something and when. A technical change history does not, by itself, demonstrate regulatory conformity.

Competence

The ability to apply knowledge and skills to a particular activity. Attending training and demonstrating competence are different types of evidence and should not be treated as interchangeable.

Risk

The effect of uncertainty on an objective. Quality management evaluates potential impacts and suitable actions in a specific process context; a numerical score does not replace a reasoned professional assessment.

Apply terminology within your process

Agree clear terms for instructions, evidence and status within your team. Use our guides for practical steps and the standards overview for context. Record organisation-specific definitions where people can find them when carrying out their work.