Quality Policy
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A formal statement issued by senior management describing an organization’s overall intentions and direction with respect to quality. It establishes the framework within which quality objectives are set, communicates management commitment, and is typically reviewed for continued suitability during management review.
The quality policy is usually a short, high-level document — often a single page — signed by the site or corporate senior executive, expressing commitment to patient safety, regulatory compliance, and continual improvement. It is deliberately brief because it is meant to be understood and communicated across the whole organization, not just the quality function.
Under ICH Q10, an explicit, visible quality policy is one of the ways senior management demonstrates accountability for the pharmaceutical quality system, and it is expected to be communicated to and understood by personnel at all levels, often via training and posted communications.
A quality policy that is written once, filed, and never referenced again is a common inspection finding — assessors will ask staff at any level whether they can describe the organization’s quality commitments, so the policy must be genuinely disseminated.
- —Issued and owned by senior management
- —Sets the framework within which quality objectives are established
- —Must be communicated to and understood by personnel at all levels
- —Reviewed periodically, typically at management review, for continued suitability
ISO 9001:2015 Clause 5.2 (Quality policy); ICH Q10
Frequently asked questions
What is Quality Policy?
A formal statement issued by senior management describing an organization’s overall intentions and direction with respect to quality. It establishes the framework within which quality objectives are set, communicates management commitment, and is typically reviewed for continued suitability during management review.
Which regulations cover Quality Policy?
ISO 9001:2015 Clause 5.2 (Quality policy); ICH Q10