Quality Policy
Quick facts
| Category | Leadership's formal commitment to quality |
|---|---|
| Used by | Manufacturing, medical devices, pharmaceuticals, aerospace, automotive and other regulated industries |
| Also called | None widely standardized |
| Related standards | ISO 9001, ISO 13485, AS9100, IATF 16949 |
| Related processes | Quality objectives, quality manual, management review |
| Semantic match | quality policy, ISO 9001 clause 5.2, quality management commitment statement, top management quality policy |
What is Quality Policy?
A quality policy is a brief, high-level statement, set by an organization's top management, expressing its commitment to quality. It typically includes a commitment to satisfying applicable requirements, whether from customers, regulations or the standard the organization follows, and a commitment to continually improving the quality management system.
Unlike a procedure, a quality policy is not meant to describe how specific tasks are performed. It is closer to a mission statement for the quality system, setting the overall direction that quality objectives, later established under the policy, must align with.
Because the quality policy is meant to guide the entire organization, it must be documented, actively communicated so employees understand and can apply it to their roles, and made available to relevant interested parties, such as customers or regulators, where appropriate.
Why is Quality Policy important?
A meaningful quality policy sets a unified direction for the entire quality management system, ensuring that quality objectives and day-to-day decisions align with a consistent overall commitment rather than operating without clear direction.
Because the policy must be communicated and understood by employees, it plays a role in building a genuine quality culture, rather than existing only as a framed document that few people ever reference.
A well-crafted quality policy also demonstrates to auditors, customers and regulators that leadership has genuinely committed to quality, rather than delegating it entirely to a quality department without visible top-level ownership.
How does Quality Policy work?
Establishing and maintaining a quality policy typically involves:
- Drafting. Top management develops a policy appropriate to the organization's purpose and context.
- Commitment statements. Include commitments to satisfying applicable requirements and continual improvement.
- Approval. Formalize the policy through top management approval.
- Documentation. Maintain the policy as controlled, documented information.
- Communication. Ensure employees understand the policy and how it applies to their roles.
- Review. Revisit the policy periodically, particularly during management review, to confirm it remains appropriate.
Quality Policy vs. Quality Objectives
| Comparison | Quality Policy | Quality Objectives |
|---|---|---|
| Level | High-level statement of commitment and direction | Specific, measurable goals |
| Set by | Top management | Relevant functions and levels, consistent with the policy |
| ISO 9001 reference | Clause 5.2 | Clause 6.2 |
Real-world examples of Quality Policy
A medical device manufacturer's quality policy commits to meeting customer and regulatory requirements while continually improving product safety and effectiveness, communicated to all employees during onboarding.
An aerospace supplier reviews its quality policy during an annual management review, confirming it remains aligned with the company's current strategic direction and market position.
A growing manufacturer revises its quality policy after expanding into a new regulated market, updating the statement to reflect its broader commitment to the additional applicable requirements.
Regulations and standards related to Quality Policy
ISO 9001 Clause 5.2 requires top management to establish, implement and maintain a quality policy that is appropriate to the organization's purpose and context, provides a framework for setting quality objectives, includes a commitment to satisfy applicable requirements, and includes a commitment to continual improvement of the QMS.
The policy must also be maintained as documented information, communicated and understood within the organization, and made available to relevant interested parties as appropriate. ISO 13485, AS9100 and IATF 16949 carry closely aligned requirements for a documented quality policy.
Required by
How QT9 helps with Quality Policy
QT9 QMS quality policy capabilities
- Maintain the quality policy as a controlled, version-tracked document.
- Distribute and communicate the policy to all employees automatically.
- Link the quality policy to quality objectives for clear alignment.
- Support periodic review of the policy during management review.
- Maintain complete revision history for audit readiness.
- Make the current approved policy instantly accessible organization-wide.
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Common mistakes with Quality Policy
Common mistakes include writing a quality policy that simply restates the standard's requirements verbatim rather than reflecting the organization's own genuine commitment and context.
Other problems include treating the policy as a static document posted once and forgotten, rather than periodically reviewing it to confirm it remains appropriate as the organization's context and strategic direction evolve.
Frequently asked questions
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