ISO Certification for Healthcare Industry

Home Healthcare Industry

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 standards 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 standards are applicable to the organizations belonging to the healthcare sector.

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 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.

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.

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

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.

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.

Benefits of ISO Certifications in healthcare industries


What are the ISO requirements for healthcare industries

The most commonly required ISO standards that are applicable for all kinds of healthcare industries are as listed below:

  • ISO 9001 Standard: Quality Management System.
  • ISO 14001 Standard: Environmental Management System.
  • ISO 45001 Standard: Occupational Health and Safety Management System.
  • ISO 50001 Standard: Energy Management System.
  • ISO 27001 Standard:  Information Security Management System
  • ISO 13485 Standard: Quality Management Systems for Medical Devices

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.

Looking for ISO Certification or Training Services?

Join one of the India’s leading ISO certification bodies for a straightforward and cost-effective route to ISO accreditation.


Apply Now