ISO Certification for Healthcare Industry | ISO 9001, 14001, 45001, 13485

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    The healthcare industry involves all the institutions that ensure the health and safety of people. It includes drug manufacturers, hospitals, pharmacies, medical devices industries, and so on. The quality of products and services and efficiency of processes are extremely important in this industry. For this purpose, the International Organization for Standardization (ISO) publishes a certain set of ISO Certification for Healthcare Industry that can help the organizations belonging to the healthcare sector in demonstrating their credibility in the market.

    Which ISO Standards are best Healthcare Industry?

    The following ISO Certification for hospitals / healthcare industry are applicable to the organizations belonging to the healthcare sector.

    ISO 9001 Standard

    With the implementation of a quality management system in an organization through ISO 9001 standard, the organization can conduct periodic management reviews and internal audits to check for any lapse in the system and apply corrective measures to ensure an effective QMS. The focus on risk management and continual improvement helps in meeting the changing market demands.

    ISO 14001 Standard

    ISO 14001 helps in the implementation of the Environmental management system in the organizations that results in reducing the environmental impacts of this sector. With EMS, the healthcare organization can ensure reduction of wastages and compliance to all the environmental laws. This helps them in gaining a reputation in the market for being environmentally responsible.

    ISO 45001 Standard

    In order to ensure the occupational safety of healthcare workers, ISO 45001 certification becomes very important. It helps in avoiding healthcare hazards by identifying the risks on time and performing prevention measures.

    ISO 27001 Standard

    The organizations belonging to the healthcare sector are custodian of personal information about their patients or customers. The onus of protecting the customer’s privacy lies with them. Therefore, by the implementation of ISO 27001 standard for Information Security Management System, these organizations can ensure that the data is protected against any breach or loss.

    ISO 13485 Standard

    This standard helps in the implementation of quality management systems for medical devices. Any medical device, either external or implantable, should be safe for use as it directly affects the life of the patient. This standard ensures that the medical devices are of premium quality and completely safe for use.

    ISO 50001 Standard

    The healthcare companies can reduce their operational expenses and improve their overall efficiency by effective implementation of ISO 50001 for energy management systems.

    Benefits of ISO Certifications for healthcare industries

    ISO Certification process for Healthcare Industry

    • Application & contract 
    • Audit team Assignment 
    • Document view 
    • Certification Audit Independent review 
    • Notification of Certification
    • Surveillance audit
    • Re-Assessment

    The certification process goes further. click here to view the next steps to ISO certification Process

    ISO certifications have huge significance across a varied range of industries. They not only help in improving the processes within the organization, but also ensure a smooth flow of services throughout the supply chain. Know more about Sis Certifications: Click here


    What are the ISO requirements for healthcare industries

    The most commonly required ISO Certification healthcare industry that are applicable for all kinds of healthcare sector are as listed below:

    How do we become ISO Certified for the healthcare industries?

    Achieving ISO Certification is no big deal in today’s upgraded systems. The basic steps to become ISO Certificate for healthcare industries are as follows:
    • Firstly, you need to prepare all the relevant information about your company in a systematized way (It is always best and safe to hire a legal consultant.)
    • Secondly, you need to document all the relevant information about your business.
    • Thirdly, you have to implement all the documented information in your organization.
    •  Fourthly, get ready for the internal audits which are performed first during the certification process and then periodically after.
    •   Lastly, if the certifying body approves your management system then you will be awarded the required ISO standard.

    How long is an ISO certificate valid for?

    An ISO Certificate is valid for 3 years. And during this time period of 3 years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.

    How can I apply for ISO Certification for the healthcare industry?

    • Firstly, select the type of ISO certification you want for your healthcare industries.
    • Secondly, selecting a recognized and credible ISO certification body (ISO Registrar)
    • Thirdly, make an application in the prescribed form which should include liability issues, confidentiality, and access rights.
    • Fourthly, the ISO certification body will review all the documents related to various policies and procedures being followed in the organization. If there are any existing gaps, the applicant has to prepare an action plan to eliminate these gaps.
    • Then, the ISO registrar will conduct a physical onsite inspection to audit the changes made in the organization.
    • As soon as the certifying body approves your management system, you will be awarded the required ISO standard. 

    How much does it cost for ISO certification?

    Basically, when you approach a certifying body for ISO Certification and they approve your management systems and all your processes, they will then quote an amount for the certificate. Moreover, the cost for achieving ISO certification depends mostly on your organization, such as the no. of employees in your organization, No. of branches your organization has, and many more.

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