What is it?
SIGUCERT is a registered trademark of the Italian Society of Human Genetics (SIGU) and represents a certification model for a Quality Management System for Medical Genetics Structures , which include medical genetics laboratories, genetic biobanks and medical genetics clinical structures .SIGUCERT Certification therefore represents a guarantee for users that the Medical Genetics Laboratory (Molecular Genetics and Cytogenetics) operates at the highest level of quality , having implemented methods for systematic quality assessment and activated effective tools for monitoring the quality of the services provided.
Key points
- Analysis of the operational context, stakeholders, and patient/user needs , according to the “risk-based thinking” approach.
- Definition of quality policies and objectives, clearly defined roles and responsibilities , organized documentation.
- Constant monitoring through genetics-specific indicators (laboratories, activity totals, internal and external quality controls) that allow for the systematic evaluation of the services provided.
- Verification through initial audits, surveillance audits, and periodic renewals : the SIGUCERT model combines peer verification (by SIGU) with an independent third party - such as CSQA - to ensure impartiality and technical competence.
Advantages
Certified facilities can demonstrate:- Reliability and transparency : the facility demonstrates that it works according to recognized standards in the genetics sector, tangibly verified.
- Specialization of the quality path: this is not just a generic QMS, but one designed for genetics facilities, with dedicated requirements and targeted indicators.
- Continuous improvement : thanks to the use of indicators and periodic reviews of the Standards, the structure can evolve systematically.
- Reputation enhancement : being able to declare SIGUCERT certification strengthens your image with patients, partners, clients, and institutions.
- Integration with other systems : The SIGUCERT standard is designed to be compatible and integrable with ISO 9001, ISO 15189 (medical laboratories) and other management systems.