Quality Policy

‍A Quality Policy is a document established by an organization's top management that sets forth the overall intentions and direction regarding quality.

The Quality Policy is the formal, declarative statement of an organization's mission and commitment to quality. It serves as the primary guidance document for the entire Quality Management System (QMS), outlining the commitment to meeting requirements, enhancing customer satisfaction, and ensuring continual improvement.

The Quality Policy is an explicit requirement of major quality management standards, including the FDA's Quality System Regulation (QSR) and the ISO 9001 standard.

Management Responsibility and Commitment

The establishment of the Quality Policy is a primary responsibility of management with executive responsibility.

Establishment and Commitment: Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality.

Definition: The Quality Policy represents the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.

Requirements (ISO 9001:2015): The Quality Policy must be developed, implemented, and maintained by top management, ensuring it is:

• Appropriate to the purpose and context of the organization and supports its strategic direction.
• Consistent with the overall strategic direction of the organization and the quality objectives.
• Includes a commitment to satisfy applicable requirements.
• Includes a commitment to continual improvement of the quality management system.
• Used as a framework for setting quality objectives.

Communication and Implementation

A key function of the Quality Policy is to communicate the organization's quality commitment both internally and externally.

Internal Communication: Management must ensure that the Quality Policy is understood, implemented, and maintained at all levels of the organization.

Documentation and Availability: The Quality Policy shall be available and be maintained as documented information. It should be communicated, understood, and applied within the organization.

External Use: It should be readily available to relevant interested parties, as appropriate. Since it is often used for promotional purposes, a clear and short Quality Policy is convenient and general practice. The policy is often displayed on the organization's premises and posted on websites.

Personnel Awareness: Personnel working under the organization's control must be made aware of the quality policy as part of their training and awareness procedures.

Role within the Quality Management System (QMS)

The Quality Policy sits at the top of the QMS documentation hierarchy and provides the ultimate reference for decision-making.

Documentation Hierarchy: In the traditional QMS document structure, the Quality Policy is at the top, followed by the Quality Manual, procedures, work instructions, and records.

Framework for Objectives: The Quality Policy is critical because it defines the quality objectives to which the organization strives, turning management's commitment into specific, measurable quality goals.

Management Review Input: Management reviews must ensure that the QMS satisfies the manufacturer's established quality policy and objectives.

Mandatory Document: The Quality Policy is one of the four mandatory documents (along with the scope, quality objectives, and supplier selection criteria) that organizations certified to ISO 9001:2015 must maintain.

Analogy for Understanding the Quality Policy

If a Quality Management System (QMS) is the detailed rulebook for running a business, the Quality Policy is the organization's founding constitutional statement or motto. It does not tell anyone how to perform a task (that's the procedure), but it declares the fundamental principles that govern all actions, such as: "We are committed to satisfying customer needs and achieving zero defects." This commitment, established by the highest level of leadership, ensures that every subsequent rule (procedure) and every specific goal (quality objective) is aimed toward fulfilling that core declaration.

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