ISO Certifications in the Medical Field – The Must-have Standards

ISO Certifications in the Medical Field – The Must-have Standards

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ISO Certifications in the Medical Field -

Written by: Aurion ISO Consultants

The Healthcare Industry is driven by a set of standard instructions and regulations from the medical associations and governing bodies.

Achieving quality excellence, optimizing process flows, and effectively managing daily operations is the aim of every hospital management.

To streamline the daily hospital operations, and embrace the global best practices, ISO Certification is the right choice.

ISO Standards – Must-Have Certifications for Healthcare Providers

Following ISO Standards are must-haves for a Medical or Healthcare Providers

  • ISO 9001:2015 Quality Management System Certification
  • ISO 14001:2015 Environmental Management Standard
  • ISO 50001:2018 Energy Management Standard
  • ISO 45001:2018 Health and Safety Standard
  • ISO 27001:2013 IT Security Management Standard
  • ISO 13485:2016 Medical Devices Certification
  • ISO 17025:2017 Laboratory Testing Standard

The ISO 9001:2015 Standard provides specific requirements for a quality management system that will enhance the ability to deliver care that will meet the requirements of the patient.

Importance of ISO 9001:2015 Certification in the Medical Field

Also, ISO 9001 Certification enables the hospital to comply with the statutory and regulatory guidelines for the governing authorities.

Benefits ISO 9001:2015 certification will bring to the hospitals

  • Periodic Management Reviews & internal Audits
  • Measurements and control of suppliers
  • Conduct frequent customer feedback survey and ensure preventive measure are taken
  • Standardized and formal corrective action procedures
  • Risk management and assessment to avoid unprecedented events.
  • Continual improvement through process optimizations and productivity enhancements

ISO 14001:2015 Environmental Standard in Hospitals

To reduce the environmental impacts in the hospital sector, ISO 14001:2015 standards play a significant role.

From the number of goods and services purchased to the consumables used, there will be a vital environmental impact.

To reduce and mitigate the risk of environmental impact and transform the hospital operations into a greener and environmentally friendly, ISO 14001 environmental management system comes handy.

The EMS System will ensure the hospital functions in full swing but by keeping a check on the levels of environmental effects at all stages.

Benefits to the hospitals from ISO 14001:2015 Standards

Effective Supply Chain Management – Keeping a track of the purchase quantities, materials, consumption patterns, waste treatment, etc.

Eliminating Waste and Reducing the Impact

Hospitals have huge amounts of food, food containers, plastic drink containers, medical supplies, etc., The daily waste generated will be enormous in a large hospital. Hence, correct recycling is very important. There has to be a full-fledged waste treatment plant and a recycling unit that adheres to environmental policies.

ISO 14001 Standard and the implementation of the environmental management system will help in monitoring the waste treatment and recycling and reduce instances of reducing the environmental pollution in any means.

Lowering Energy Consumption

The EMS System ensures the overall level of energy consumption is kept low. The power consumption is very high for a hospital. ISO 14001 helps in optimizing power usage. As an ISO 14001 compliant hospital, adhering to the ISO standards and follow power-saving practices will result in great cost savings as well as environmental protection.

Compliance to the Environmental Laws

There are a couple of environmental laws a hospital has to comply with. The regulations are spanned from using the right gas in the air-conditioning units to emissions from the site, there are checks to be done.

Also, fire and safety, the process of water usage and treatment, waste management, cleaning, and maintenance, all have to give importance to environmental protection.

ISO 14001:2015 implementation and practising will result in huge cost savings and reduction of waste materials and water. The supply chain will be more effective and help in lowering the environmental impact as a whole.

Empowering the hospital staff and employees on the need for environmental protection is essential to achieve long term sustainability.

ISO 50001:2018 Energy Management Standard

ISO 50001 Standard complements the environmental standard by offering a specialized system for energy management.

It helps hospitals, medical device manufacturers, etc., to reduce their operating expenses and improve overall energy efficiency.

ISO 45001 Health and Safety Standard is a vital standard for healthcare. It helps in avoiding workplace hazards and accidents.

Keeping the hospital clean, enhance hospital staff engagement, provide awareness training on health & safety, take corrective actions to ensure non-occurrence of incidents, etc., are few areas of focus for ISO 45001 Standard.

ISO 27001:2017 IT Security Standard Certification

As medical devices are getting connected and technologically advanced there is a high risk of data breach and healthcare information loss.

Hence incorporating best cybersecurity practices is the need of the hour. Minimizing the risk of stolen data and system hacks has become a key focus for the healthcare sector as a whole.

ISO 27001 is based on internationally recognized best practices in cybersecurity and is not restricted to any single healthcare platform or medical software. It also helps in mitigating the risk of data loss and enhances cybersecurity measures.

ISO Certification for Medical Devices & Laboratory Testing

Product conformity is a crucial part of the design and manufacturing of medical devices. ISO 13485:2016 Standard helps medical devices manufacturers in designing quality systems to test their devices at all stages of production, and in the design phase.

Similarly, the ISO 17025:2017 laboratory testing standard helps in calibrating and testing laboratory equipment.

 It will ensure the laboratory follows top-rated testing practices in line with global practices. It also reduces re-testing and saves the customer’s cost. It helps in improving the brand value of the testing laboratory too.

With these certifications and testings in place, ISO always keeps an updated version of ISO 14971:2019 standard in place to minimize risks (see Risk Management – ISO 14971:2019 infographic).

About the Author

John Wick is an ISO Consultant working with Aurion ISO Consultants in Dubai. John likes to write on ISO Training, ISO Consulting, latest changes in ISO Standards, industry-wise benefits from getting ISO Certified. Reach out for expert consultation on any ISO related queries.

About Aurion

Aurion ISO Consultants, Dubai offers world-class ISO Services such as Training, Consulting, Certification, Implementation, and Audits in Dubai, UAE and Worldwide.

Aurion ISO Consultants is an Award-Winning Consultant firm in Dubai, UAE and one of the fastest-growing ISO Service provider in the UAE and GCC region. We have assisted 1800 clients across several countries globally.

We provide you with a Single-Window Solution with ISO Consulting, ISO Training, and ISO Implementation and ISO Audit Services. With our ISO Certification, you can transform your business into quality first one.

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