Certification of medical institutions for compliance with the requirements of DSTU ISO 9001
In accordance with the requirements of the Order of the Ministry of Health of Ukraine dated December 20, 2013 No. 1116 on changing the criteria for state accreditation of healthcare institutions, in order to obtain the highest category in a medical institution, a quality management system must be implemented and certified according to the DSTU ISO 9001: 2009 standard.
Thus, it becomes impossible for a medical institution to obtain a higher category without an ISO 9001 certificate.
The development, implementation and certification of a Quality Management System can be carried out in two ways:
- The first is long and laborious.
- Develop and implement the system yourself.
A process that takes from 3 months to a year. This process consists of the following stages:
- development of documents on the Quality Management System in accordance with the requirements of ISO 9001 / DSTU ISO 9001 standards (6 mandatory standards, general Quality Manual, additional standards depending on the specifics of the services provided);
- implementation of documents in work practice;
- internal audit, adjustment of actions based on the results of the internal audit;
- preparation of a package of documents for the certification body that has the right to conduct certification of services in the field of healthcare and medical care;
The following stages require the mandatory participation of an independent third party (certification body):
- support for external audits of the certification body, implementation of corrective actions, registration and obtaining a certificate.
The last 2 stages (system audit at the certification body and obtaining a certificate) are paid.
The second is quick and easy: entrust the development to professionals.
Наша компанія підготує необхідний комплект документів для отримання сертифіката:
- log forms
- set of mandatory standards for a medical facility
- quality manual
- additional standards (if necessary)
Will carry out all stages of preparation of your system for certification, including diagnostic, internal and external audit.
The cost includes training of personnel involved in the work of the System.
The terms of development and certification of the system will be from one to two months.
Thus, you will receive not only the document necessary to confirm the Higher Category of your medical institution, but also an effective tool for managing the quality of services provided and a team that professionally owns this tool.
We offer:
- Initial audit
- Development and implementation of ISO 9001 system
- ISO 9001 certificate. We issue a certificate based on the goals you have.