ISO 15189 Medical laboratories — Requirements
ISO 15189 scope
This International standard set sup requirements for the Quality and competence of medical laboratories. The standard is intended to medical laboratories, which create and develop their own Quality management system for assessment of their competence and for use by the accreditation bodies (for Bulgaria EA BAS).
ISO 15189 is based on ISO/IEC 17025 and ISO 9001 and although it is not intended to be used for certification purposes, compliance with its requirements means that the medical laboratory meets both the requirements for technical competence and the requirements of the management system that are necessary for the issuance of technically valid results.
The services provided by medical laboratories are essential for the patient and medical staff care. The services provided by the medical laboratories actively participate in the diagnosis and treatment of the patient, as well as in the prevention (prophylaxis) of the disease. They are an important part of the care provided to patients, because they "measure health."
Medical services may include:
- arrangements for research requests;
- patient preparation and patient identification;
- taking samples;
- transport, storage, processing and verification of clinical samples;
- reporting and interpretation of results;
- consultations to ensure the safety of staff and compliance with medical ethics and morals in laboratory work.
ISO 15189 Medical laboratories — Requirements
Implementation of management standards
CONSEJO EOOD is a consulting company formed by a team of consultants with over 15 years of experience in management systems in the field of international standards. The focus of the company is the provision of consulting services in the development and implementation of management systems that meet the requirements of international standards for quality, the environment, safe working conditions, information security, good production practices based on international standards: ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001, IFS Food, HACCP and others.
The CONSEHO team has participated in the realization of projects in all branches of the economy. The projects implemented by the CONSEHO team are over 1000, in the fields of production and design, construction, trade, information and communication technologies, transport and forwarding, hotel and restaurant industry, special production, energy, design, food industry, services, etc. The company has established a strict procedure for monitoring the compliance with the agreed requirements with the clients, both the terms of the contracts and the quality of service performance. The established working style of the company consists of developing real management systems together with our customers, on the basis of conducting multiple trainings and providing full assistance in the implementation process. Through its approach to work, CONSECO ensures and guarantees trouble-free certification of the built systems in extremely short terms.
