Internal Audits & Compliance Reviews

Internal audits are a critical component of maintaining an effective laboratory quality management system and ensuring ongoing compliance with accreditation requirements. Our Internal Audits & Compliance Review service provides laboratories with an independent and objective evaluation of their quality systems, technical activities, and operational practices against the requirements of ISO/IEC 17025, Good Laboratory Practice (GLP), Good Documentation Practices (GDP), and AOAC accreditation programs.

Accreditation bodies require laboratories to conduct periodic internal audits to verify that their quality management systems are functioning as intended and that laboratory activities remain compliant with established procedures and accreditation standards. However, internal audits conducted by internal staff may sometimes overlook systemic issues or areas that could present challenges during an external accreditation assessment.

Our service provides laboratories with an experienced, independent perspective, allowing potential compliance gaps to be identified and addressed before they become findings during accreditation body evaluations.

During the audit process, we conduct structured assessments designed to closely simulate the experience of an accreditation assessment. This includes reviewing documentation, evaluating laboratory practices, interviewing personnel, and assessing the implementation of quality system elements across the organization.

The goal of our internal audit process is not only to identify gaps or nonconformities, but also to provide practical recommendations that strengthen laboratory processes, improve documentation quality, and enhance the overall effectiveness of the quality management system.

By identifying potential issues early and providing clear guidance for corrective actions, laboratories can approach accreditation assessments with greater confidence and a stronger, more reliable quality system.

Typical Engagement Range

$3,000 – $15,000

Pricing varies depending on laboratory size, scope of testing, number of methods evaluated, and the complexity of the laboratory’s quality management system.

What This Service Includes

Comprehensive Internal Audit of the Quality Management System
Independent evaluation of the laboratory’s Quality Management System to determine whether policies, procedures, and practices align with ISO/IEC 17025 requirements and accreditation expectations.

Review of Laboratory Procedures and Technical Activities
Detailed review of laboratory Standard Operating Procedures, quality documentation, analytical methods, and operational practices to verify consistency with documented processes.

Evaluation Against GLP, GDP, ISO/IEC 17025, and AOAC Requirements
Assessment of laboratory activities against recognized quality and accreditation standards to determine whether systems are properly implemented and maintained.

Identification of Nonconformities and Compliance Gaps
Systematic identification of areas where laboratory practices may not fully meet accreditation requirements, including potential nonconformities that could be identified during an external assessment.

Observations and Opportunities for Improvement
Identification of areas where laboratory processes, documentation, or system implementation could be strengthened to improve operational efficiency and quality system performance.

Detailed Written Audit Report
Delivery of a comprehensive audit report outlining findings, including areas of compliance, nonconformities, observations, and recommended corrective actions.

Corrective Action Guidance and Remediation Planning
Support in developing corrective action strategies that address audit findings, strengthen quality system implementation, and prepare the laboratory for future accreditation assessments.

Outcomes for Your Laboratory

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

• A clear understanding of its current compliance with ISO/IEC 17025 and related quality requirements
• Identification of potential nonconformities before an external accreditation audit
• Practical recommendations for strengthening laboratory processes and documentation
• A structured plan for corrective actions and system improvements
• Greater confidence when preparing for accreditation body assessments