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How To Get ISO Certification For Hospitals

ISO 9001:2015 Certification

In these days, every hospital needs to be identified by the type of services provided by them through demonstrating their way of working handling the patients accept their system of handling the patient’s treatment is one of the best at the national-international level. So that the patients the guardian has trust in the hospital and their doctors and understand that the hospital its doctors, employees are at a world-class level and the management system of the hospital is being certified by the third party.

Best Way to Get ISO Certification for Hospital with the Certification Body

Each and every Hospital is thinking how to get ISO certification for their Hospital in India how to get a new identity in the field of medical services

Every owner of Hospital has the several common questions prior to going to ISO certification Hospital are – ISO 9001 certification requirements, ISO 9001 certification process, ISO 9001 certification cost, ISO 9001 certification procedure, how to get ISO 9001 certification, iso 9001 certification bodies in India, time needed to get ISO 9001 certified and document required to get ISO 9001 certification for Hospital, ISO 9001 implementation requirements for Hospital etc.

Now the answer to common questions to the Hospital those who want to know how to get ISO Certification for Hospital.

Then identify the process involve in performing the type of Hospital (Multi-Specialty Hospital), identify the process required to run a multispecialty hospital Such as legal compliances, admission process, doctors consultation, MLC cases procedure, causality ward, general ward, OT, special ward etc.. arrange the in fracture for the pathological lab, other testing requirements as per medical council of India guidelines, Monitor the performance of each process etc. The hospital should be registered to the state level medical council for providing medical services.

The hospital should be registered with the state pollution control board, Consent is mandatory as hazardous wastage such as biomedical waste is generated from them.

Then identify the type of Biomedical wastages generated in the hospital, make an agreement with the biomedical waste collection agency who is approved by the state pollution control, follow the guidelines provided by the waste collection, preserve the cotton wastage, used syringes, plastic wastages as instructed.

Then verify whether all the permanent visiting doctors are registered with the state-level medical council. The nurse’s sister should be registered to the nurse-midwifery council at the state level. In the case of the maternity hospital, the hospital should be registered under the abortion act the doctor should be registered for the same. In case the hospital has its own sonography machine, a license to operate should be obtained from the state-level govt.

Work environment – The OT & ambulance should be fumigated after every surgery as per guidelines provided by the medical council of India, wards should be fumigated every week.

MLC cases should be intimated immediately to the nearest police station at earliest & the record has to be maintained as per the rules of the state government.

After developing each process – implement the ISO 9001 requirements as stated in standard from clause 4 to 8. Develop the Quality Manual of Hospital in line with ISO 9001:2008 requirements considering the statutory & regulatory requirements wrt product/service. Establish the Quality policy and objective for the hospital considering the type of medical services provided, statutory & regulatory requirements. Set the role and responsibility of each person within the Hospital. Provide the awareness training to each person ISO 9001 requirements, statutory & regulatory requirements, work environment, Quality policy & objective, process, procedure, criteria etc.

Conduct the Internal Audit and Management review meeting on the implemented QMS Management System. ISO 9001 certification process – After the implementation of ISO 9001 and conducting Internal Audit, should be covered all the departments & the process of the hospital, Internal audit should be done by a trained auditor & MRM -Should cover all the accepts such admission process, MLC cases, death cases, patients complaints, method & the quantity of biomedical wastage disposal, resources need for further expansion, Apply to ISO Certification Body for ISO 9001 certification of Hospital. The certification body will visit your Hospital and conduct the Audit. After the Audit, the Audit team leader will prepare the Audit report and submit to the Certification body for review and certification decision. Based on the certification decision the ISO 9001 certificate of your Hospital shall be issued.

ISO certification cost to Hospital in general practice the cost of certification shall be derived considering, Number of employee (Full time/ Part-time/ Subcontracted), Number of Sites or Brach of Hospital , Beds is covered under the certification, number of working shift etc. The ISO certification cost is not fixed, it varies from organization to organization and certification body to certification body.


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