Sawgrass Nutra Labs — QMS Policy

Document Control (Metadata)

Field	Value
Effective Date	3/1/2026
Status	Implemented
Document ID	QMS-POLICY-001
Version	v1.0
Owner	Quality Unit (QU)
Approver	Quality Unit Director
Controlled System of Record	GitHub
Change Control	QMS-1347
Last Review Due	03/01/2026
Next Review Due	03/01/2027

Sawgrass Nutra Labs Quality Management System (QMS) Policy

Sawgrass Nutra Labs is committed to the manufacture, packaging, testing, storage, and distribution of dietary supplements that consistently meet applicable regulatory requirements and internal quality standards for identity, purity, strength, composition, and safety.

Sawgrass Nutra Labs establishes, implements, and maintains a comprehensive Quality Management System (QMS) to ensure compliance with applicable laws, regulations, and recognized standards, including but not limited to 21 CFR Part 111 and NSF/ANSI 455-2, and to support continual improvement of GMP-relevant processes and system effectiveness.

Authority & Governance Model (Architecture-Aligned): The Quality Unit (QU) is the final quality authority and retains independent, non-delegable decision rights for product quality, regulatory compliance, and data integrity. The QMS provides the governance framework that controls how quality processes operate and how effectiveness is monitored. Quality Control (QC) defines controlled acceptance criteria and specifications used to evaluate conformance.

Operations execute GMP activities under approved procedures.
QA administers and executes the quality system processes under QU authority.
QU retains final disposition/release authority; quality decisions shall not be overridden.
QMS governs execution and oversight; it does not independently set acceptance criteria or make disposition decisions.

The Quality Unit is granted independent authority and responsibility to ensure product quality, regulatory compliance, and data integrity. Quality decisions made under QU authority shall not be overridden by operational or commercial considerations.

All personnel are responsible for understanding and complying with applicable QMS requirements. No activity that may impact product quality, patient/consumer safety, or regulatory compliance may be performed outside approved procedures, controlled documentation, qualified personnel, and documented controls.

Sawgrass Nutra Labs is committed to maintaining data integrity consistent with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) and to meeting electronic record and signature requirements under 21 CFR Part 11 where applicable.

Sawgrass Nutra Labs is committed to continuous improvement and effective risk management through objective evidence, management review, internal audits, deviation/investigation management, corrective and preventive actions (CAPA), and controlled change management.

Senior management is accountable for providing the leadership, resources, and support necessary to implement, maintain, and continuously improve the effectiveness of the QMS.