Internal, Supplier, and Third-Party Laboratory Audits
Independent Audit Programs Designed to Strengthen Oversight and Compliance
Laboratory audits are essential tools to ensure compliance, data integrity, and operational excellence. Depending on who conducts the audit and its purpose, audits fall into three main categories: internal audits, supplier audits, and third-party audits.
Schedule a consultation
Internal Laboratory Audits
SME Lab Auditing and Consulting provides structured internal laboratory audits to help organizations evaluate the effectiveness of their quality systems and technical operations. Our internal audits are aligned with FDA regulatory expectations and ISO/IEC 17025 requirements, assessing compliance with procedures, data integrity, personnel competency, and laboratory practices. By identifying gaps, risks, and opportunities for improvement, our audits strengthen inspection readiness, support continuous improvement, and enable laboratories to maintain sustainable compliance with confidence.
Supplier Audits
SME Lab Auditing and Consulting conducts comprehensive supplier audits to ensure that external vendors providing critical products and services meet regulatory, quality, and technical requirements. Our supplier audits evaluate quality management systems, compliance with FDA regulations and ISO/IEC 17025 principles, data integrity, and risk controls across the supply chain. By independently assessing and qualifying suppliers, we help laboratories reduce compliance risk, ensure reliable results, and maintain confidence in the integrity of outsourced activities and materials.
Third-Party (External) Laboratory Audits
SME Lab Auditing and Consulting provides independent third-party laboratory audits to objectively evaluate compliance, technical competence, and overall readiness for regulatory inspections and accreditation assessments. Our audits are aligned with FDA regulations and ISO/IEC 17025 requirements and are designed to identify gaps, assess risk, and strengthen data integrity and quality systems. Whether supporting accreditation audits, FDA inspections, or client and sponsor expectations, our third-party audits deliver clear, actionable findings that help laboratories demonstrate credibility, maintain compliance, and operate with confidence.