ICSA’s methodologies as consultant for laboratories and pathologic anatomy services

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.


Rosana Martínez, responsable de calidad y consultor de sistemas de calidad

ROSANA MARTÍNEZ

“Hacer del trabajo la mayor motivación.”

Quality Manager & Quality Systems Consultant

Bussiness Management Graduate – MBA

rosana.martinez@icsa.es

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OLGA PARDO

“Si no conozco una cosa, la investigaré.”

Quality Systems Consultant

PhD in Chemistry

olga.pardo@icsa.es

Contact

Olga Pardo, consultor de sistemas de calidad

Our consultants have years of experience in clinical laboratories consultancy, ISO standards implementations and Internal Audits in the following areas:

– 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 consultant of laboratories and hospitals of Aragón’s Health Service

Internal Audits

ICSA uses Internal Audits as a tool for review the requirements of the Quality System detailed in the ISO standard.

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Areas

Biochemistry
Anatomic Pathology
Toxicology
Microbiology
Pharmacology

ISO 15189

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.

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Areas

Biochemistry
Anatomic Pathology
Toxicology
Microbiology
Pharmacology

ISO 9001

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.

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Areas

Biochemistry
Anatomic Pathology
Toxicology
Microbiology
Pharmacology

ISO 13485

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.

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Aimed to

Medical Products Manufacturers
Sterilization Centers
Electromedicine Services

ACSA Certification

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.

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Aimed to

Hospital Laboratories
Hemodialysis Services
Pharmacy Services
Nutrition and Diet Services

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