Analysis of Quality Normative Requirements: Contributions to the Alignment and Standardization of Standards Applied in Health Laboratories

Abstract

The implementation of Quality Management Standards (QMS) in health laboratories is essential to ensuring the traceability, reliability, and reproducibility of results, thus supporting compliance and continuous improvement. This study identifies and compares the requirements adopted in four widely used four standards for health laboratoriesto evaluate their equivalence and contribute to the harmonization of normative terminology. A comparative analysis of the requirements and their applications in health laboratories was conducted. Subsequently, interrelationships and equivalence among the standards were assessed, followed by an evaluation of the terminology used and the grouping of requirements across the four normative documents. The results revealed a substantial overlap among the standards, particularly regarding quality management, risk management, personnel competence, documentation control, and continuous improvement. However, differences in terminology, structure, and scope were identified, which may hinder the uniform interpretation and implementation of quality systems. The harmonization of terms and equivalent requirements could facilitate compliance, integration of management systems, and accreditation processes. The findings demonstrate that standardizing normative terminology contributes to greater alignment among quality standards, improving their understanding, dissemination, and application in health laboratories while supporting more efficient and reliable quality management practices.