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How To Get ISO Certification For Hospitals

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ISO 9001:2015 Certification

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

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

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

Every owner of a Hospital has several common questions prior to going to ISO certification for Hospitals 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, the 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 is those who want to know how to get ISO Certification for Hospital.

Then identify the process involved in performing the type of Hospital (Multi-Specialty Hospital), and 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 with 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 waste such as biomedical waste is generated from them.

Then identify the type of Biomedical waste generated in the hospital, make an agreement with the biomedical waste collection agency to be approved by the state pollution control, follow the guidelines provided by the waste collection, and preserve the cotton wastage, used syringes, and plastic wastage 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 with 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, and wards should be fumigated every week.

MLC cases should be intimated immediately to the nearest police station at the 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 the standard form clauses 4 to 8. Develop the Quality Manual of the Hospital in line with ISO 9001:2008 requirements considering the statutory & regulatory requirements wrt products/services. Establish the Quality Policy and objective for the hospital considering the type of medical services provided, and statutory & regulatory requirements. Set the role and responsibility of each person within the Hospital. Provide awareness training to each person for 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 an 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 accepted admission processes, 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 it 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 employees (Full time/ Part-time/ Subcontracted), the Number of Sites or Brach of hospitals, Beds covered under the certification, the number of working shifts, etc. The ISO certification cost is not fixed, it varies from organization to organization and certification body to certification body.


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