ISO 9001- Clause 3 Terms and definitions

Clause 3 of the ISO 9001 standard contains the terms and definitions used in the quality management system. The following are the main terms and definitions from this clause:

• Requirements: needs or expectations that are stated, generally implied, or obligatory
• Quality: the degree to which a set of inherent characteristics fulfils the requirements
• Quality management: coordinated activities to direct and control an organization regarding quality.
• Quality management system (QMS): a set of interrelated or interacting elements to establish, implement, maintain, and continually improve quality management.

The following are ISO 9001 Clause 3 Terms and definitions:

• Quality management system: A system to direct and control an organization with regard to quality.
• Policy: A quality policy is a high-level statement of an organization's overall intentions and directions with respect to quality, as expressed by top management.
• Objectives: Quality objectives are goals towards which the organization strives to achieve conformity and satisfy customers and other relevant interested parties.
• Quality manual: A quality manual is a document that outlines an organization's quality management system.
• Procedures: Procedures are written instructions that describe how to carry out activities within the quality management system.
• Work instructions: Work instructions are written instructions that describe how to carry out a specific task.
• Records: Records are documents that provide evidence of activities carried out within the quality management system.

Clause 3 of ISO 9001 defines the term 'quality management system' (QMS) as "the set of policies, processes, and procedures required for planning and execution of the quality management system". The QMS is used by organizations to ensure that their products and services meet the needs of their customers and other stakeholders.

The quality management system defines the framework within which the organization operates. It includes the organizational structure, responsibilities, procedures, processes, and resources. The QMS also provides a basis for continual improvement of the organization's performance.