Quality Management System Development

A strong Quality Management System (QMS) is the foundation of a competent and accredited laboratory. Our Quality Management System Development service helps laboratories design, implement, and strengthen quality systems that align with the requirements of ISO/IEC 17025, Good Laboratory Practice (GLP), and AOAC accreditation programs.

This service supports laboratories at any stage of quality system maturity. Whether your laboratory is establishing a quality management system for the first time or refining an existing framework to meet accreditation requirements, we provide structured guidance to ensure the system is compliant, practical, and sustainable for long-term operation.

We work closely with laboratory leadership, quality managers, and technical personnel to establish clear policies, procedures, and documentation that support reliable laboratory operations. Our goal is not only to meet accreditation requirements, but also to create a quality system that integrates smoothly into daily laboratory activities and supports consistent, defensible analytical results.

Our approach emphasizes clarity, efficiency, and long-term maintainability. Rather than developing excessive documentation that is difficult to maintain, we help laboratories implement streamlined quality systems that are well-organized, easy to follow, and aligned with real laboratory workflows.

Through this service, laboratories gain a structured quality framework that supports technical competence, traceability, documentation control, and continual improvement, ensuring they are well prepared for accreditation body assessments.

Typical Engagement Range

$8,000 – $40,000

Pricing varies depending on laboratory size, testing scope, number of methods, and the level of quality management system development required.

What This Service Includes

Quality Management System Framework Development
Design or refinement of a structured laboratory Quality Management System aligned with ISO/IEC 17025 management and technical requirements.

Quality Policy and Quality Manual Development
Creation or improvement of the laboratory’s quality policy and quality manual structure to clearly define quality objectives, organizational responsibilities, and system oversight.

Alignment with ISO/IEC 17025, GLP, and AOAC Requirements
Evaluation and alignment of laboratory procedures and processes with internationally recognized quality and accreditation standards.

Development of Standard Operating Procedures (SOPs)
Guidance in establishing or refining SOPs that support consistent laboratory practices, method implementation, equipment management, and documentation control.

Document and Record Control Structure
Implementation of a practical system for managing controlled documents, laboratory records, training documentation, and traceability of activities.

Implementation of Quality System Controls
Guidance for establishing key quality system elements including:
• Training and competency programs
• Corrective and preventive action processes
• Internal audit programs
• Risk-based thinking and process monitoring
• Management review procedures

Documentation and Traceability Framework
Development of systems that ensure laboratory activities are traceable, well documented, and able to withstand accreditation assessments.

Long-Term Quality System Sustainability
A practical roadmap for maintaining, monitoring, and continually improving the laboratory quality management system after implementation.

Outcomes for Your Laboratory

By the completion of this service, your laboratory will have:

• A structured and compliant Quality Management System aligned with ISO/IEC 17025
• Clearly defined policies, procedures, and documentation supporting laboratory operations
• Improved operational consistency and traceability
• Greater confidence when preparing for accreditation assessments
• A scalable quality framework capable of supporting future laboratory growth