Document ID: L00-QMS-CHARTER
Version: 1.0
Effective Date: ____________________
Approved By: ____________________
Next Review Due: ____________________
This Quality Charter establishes the foundational intent, authority, and commitment of Sawgrass Nutra Labs to operate and maintain an effective Quality Management System (QMS).
The Charter defines WHY the QMS exists and WHO holds ultimate authority for quality, compliance, and data integrity. It represents the highest level of quality intent within the organization and serves as the anchor from which all QMS governance, structure, and execution are derived.
This document does not define rules, procedures, or methods. All governance rules and operational requirements are defined in lower-level QMS documents.
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.
Executive Leadership affirms that quality and regulatory compliance are fundamental business obligations and shall not be compromised by operational, financial, or commercial considerations.
The QMS is established and maintained to align with applicable laws, regulations, and recognized standards, including but not limited to:
This Charter affirms alignment at the intent level only. Detailed regulatory mappings and interpretations are maintained in controlled governance and crosswalk documents.
The Quality Unit (QU) is granted independent authority and responsibility to govern the QMS and make final decisions related to product quality, regulatory compliance, and data integrity across the enterprise.
The QU has non-delegable authority over, at a minimum:
Quality decisions made by the QU shall not be overridden by Operations, Management, production schedules, cost considerations, or commercial pressures.
For clarity of authority, governance, and execution, the Quality Management System is structured using distinct but interrelated functions:
Execution of operational activities and generation of quality data may be performed by trained personnel within business functions under controlled procedures. Independence is not required for execution. Independent authority is applied at the level of review, evaluation, escalation, and disposition. Final, non-delegable quality decision authority is retained by Quality Control Operations (QCO).
This authority model is definitive. No procedure, specification, work instruction, training material, or business process document may redefine, dilute, or conflict with the roles, authorities, or decision boundaries established in this section. Any proposed change to this model requires approval by Quality Control Operations (QCO) through formal QMS change control.
Senior Management is accountable for providing the leadership, resources, and support necessary to implement, maintain, and continuously improve the effectiveness of the QMS.
Management retains ultimate accountability for:
This Charter applies enterprise-wide to all activities that may impact product quality, regulatory compliance, or data integrity.
All QMS documents, processes, and records shall inherit authority and intent from this Charter. No lower-level document may contradict or override the principles established herein.
Detailed governance rules, system requirements, procedures, work instructions, and records are defined in subordinate QMS documents and controlled systems.
This Quality Charter is approved by Executive Leadership and the Head of the Quality Unit and is reviewed periodically to ensure continued suitability, effectiveness, and alignment with regulatory expectations.
Approved By: __________________________
Title: __________________________
Date: __________________________