This standard establishes the requirements that must be met by clinical laboratories to demonstrate that they are able to perform reliable results
This standard describes the requirements that must be met for a laboratory to operate under a quality management system
CSA’s Medical Division offers consultancy services for Clinical Laboratories. Our main target is to offer advice for the implementation of ISO standards. For the last 15 years we have been working on the implementation of ISO 9001 and ISO 15189 in Clinical Laboratories and Patological Anatomy Services, and ISO 13485.
“Hacer del trabajo la mayor motivación.”
Quality Manager & Quality Systems Consultant
Bussiness Management Graduate – MBA
“Si no conozco una cosa, la investigaré.”
Quality Systems Consultant
PhD in Chemistry
– Admission – Teaching Committe – Daily Hospital – Sterilization Centers – First Attention Equipment
– Pathological Anatomy Services – Hematology Service – Radiation Oncology Service – Nuclear Medicine Service – Physics Service – Electromedicine
– Biochemistry Laboratory – Microbiology Laboratory – Toxicology Laboratory – Pharmacological Laboratory – Immunological Laboratory – Pharmacy
ICSA uses Internal Audits as a tool for review the requirements of the Quality System detailed in the ISO standard.
UNE-EN ISO standard establishes the requirements that must be met by clinical laboratories to demonstrate that they are able to perform reliable results.
The main target of the UNE-EN ISO 15189 standard is improving healthcare by tracking activities, finding problems and developing appropiate solutions to prevent them.
UNE-EN ISO 9001 standard can be applied to all enterprise types. In recent years there has been further implementation in the health sector.
The main target of this standard is to describe the enterprise’s processes and take actions to improve them.
UNE-EN ISO 13485 standard is aimed to design, develop, manufacture, instal and offer medical products and to design and develop related services. System requirements of the quality management system specified in this standard must complement the technical product requirements.
Medical Products Manufacturers
The purpose of the Quality Standard of the Consejería de Salud (Ministry of Health) of the Junta de Andalucía (Andalusian government) is ensuring a quality standard in the healthcare provided to the citizen.
Nutrition and Diet Services