Implementation of ISO/IEC 17025 in forensic genetics laboratories in Brazil.

In Brazil, while there are legal regulations establishing technical requirements to promote quality management systems in forensic genetics laboratories based on ISO standards, accreditation is not yet mandatory. In this study, we assess the compliance of Brazilian forensic genetics laboratories with ISO/IEC 17025 and try to identify the challenges these labs face in meeting those standards. A survey was responded by the 28 laboratories of the Integrated Network of Genetic Profile Databases (RIBPG) in order to gauge compliance with eight critical criteria: personnel management, equipment management, equipment calibration, method validation, proficiency testing, internal auditing, risk management, and critical review. The results indicate that laboratories reported greater compliance with ISO/IEC 17025 clauses already mandated and audited under the current national quality standard (Resolution 12 of the CG-RIBPG), such as pessoal competence (64 %) and equipment management (57 %). However, the results also revealed challenges in meeting some ISO requirements, especially those related to procurement of external services such as calibration (29 %) and proficiency testing through accredited providers (14 %). This article highlights the need for strategic public policy projects to support forensic laboratory accreditation, including capacity-building, specialized training, and monitoring of implementation. External motivators for accreditation and strategies tailored to the specific needs of the laboratories are also necessary.