Accreditation Readiness & Gap Assessment
Understanding where your laboratory currently stands is the first step toward successful accreditation. Our Accreditation Readiness & Gap Assessment provides a structured evaluation of your laboratory’s quality systems, documentation, and operational practices against the requirements of ISO/IEC 17025 and AOAC accreditation standards.
This service is designed to help laboratories identify strengths within their existing quality management system while also uncovering areas that may require improvement prior to pursuing accreditation. Through a comprehensive review of your laboratory’s policies, procedures, records, and technical practices, we evaluate how closely your current operations align with recognized accreditation requirements.
During the assessment, we examine both management system elements and technical activities to determine whether your laboratory has the necessary processes, documentation, and controls in place to demonstrate competence and compliance. This evaluation provides laboratories with an objective understanding of their current level of preparedness and highlights the steps needed to move toward accreditation with confidence.
Following the assessment, your laboratory will receive detailed feedback outlining key findings, areas of compliance, and opportunities for improvement. Our goal is to provide a clear and practical roadmap that allows laboratory leadership and quality personnel to prioritize actions, strengthen quality systems, and prepare effectively for accreditation.
This service is particularly valuable for laboratories that are beginning the accreditation process, expanding their scope of testing, or seeking an independent evaluation of their quality system prior to submitting an application for accreditation.
Typical Price Range
$2,500 – $8,000
Pricing varies depending on laboratory size, testing scope, and the maturity of the existing quality management system.
What This Service Includes
Clients receive a structured evaluation and practical guidance to support accreditation readiness. The assessment typically includes:
Comprehensive Review of Quality Documentation
Evaluation of your laboratory’s quality manual, standard operating procedures, policies, and supporting records to determine alignment with accreditation requirements.
Evaluation of Laboratory Practices and Technical Operations
Assessment of current laboratory practices against GLP principles, ISO/IEC 17025 requirements, and applicable AOAC guidance to determine compliance and identify areas needing improvement.
Identification of Compliance Gaps
Systematic identification of missing documentation, incomplete processes, or operational practices that may lead to nonconformities during an accreditation assessment.
Objective Review of Quality Management System Implementation
Evaluation of how effectively your quality management system is implemented across the laboratory, including training, document control, corrective actions, and internal audit practices.
Written Summary of Key Findings
A detailed report summarizing observations, compliance status, and areas that require attention before pursuing accreditation.
Prioritized Action Plan
Clear, practical recommendations outlining steps your laboratory can take to close gaps, strengthen documentation, and improve system implementation.
Follow-Up Consultation
A dedicated consultation session to review assessment findings, discuss recommended improvements, and answer questions related to accreditation preparation.
Outcomes for Your Laboratory
By the end of the assessment, your laboratory will have:
• A clear understanding of current compliance with ISO/IEC 17025 and AOAC requirements
• A prioritized list of actions needed to achieve accreditation readiness
• Greater confidence when preparing for accreditation body assessments
• A stronger and more structured laboratory quality management system
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