Work Instruction

In a quality management system, a work instruction defines the detailed steps necessary to carry out a procedure. Work instructions are used only where they are needed to ensure the quality of the product or service.

Validation

Substantiation by examination and provision of objective evidence that verified processes, methods, and/or procedures are fit for their intended use.

System owner

The person responsible for the availability, and maintenance of a computerised system and for the security of the data residing on that system.

Standard (document)

A standard (industry, national, government, or international standard; a norme) is a document that describes the processes and methods that must be performed in order to achieve a specific technical or management objective, or the methods for evaluation of any of these.

Quality manual

The quality manual is the document that describes the quality management policy of an organization with respect to a specified conformance standard.

Procedure

A procedure describes a specific process for implementing all or a portion of a policy.

Preventive action

Preventive action is something done to prevent the possible future occurrence of a nonconformance, even though such an event has not yet happened.

Policy

A policy defines and sets out the basic objectives, goals, vision, or general management position on a specific topic