7 Essential ISO Standards in the Medical Field

7 Essential ISO Standards in the Medical Field

7 Essential ISO Standards in the Medical Field

The medical field is synonymous with instruction and regulation from governing bodies and medical associations. The reason behind this is because the excellence and quality required of this field cannot be put into disregard.

To this end, here are excellent ISO standards that you can use to streamline daily hospital operations, and embrace the best global practices.

Pre-requisite ISO standards for health providers

These include:

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

Let’s explore how some of these standards affect the quality of healthcare.

ISO/IEC 17025:2017- General requirements for the competence of testing and calibration laboratories

This standard is responsible for laboratory testing. Its key mandate is to ensure that laboratory equipment is calibrated correctly and tested. It also standardizes the top-rated testing practice of laboratories in line with global practices.

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

This is the standard that is responsible for medical devices. It ensures that manufacturers of medical equipment adhere to the highest standards by developing quality systems to test the devices at all stages of production. When the requirements of this standard are not applicable to the organization, it is their responsibility to ensure monitoring, maintaining, and controlling of the processes.

ISO 9001:2015- Quality Management Systems – Requirements

The ISO 9001:2015 standard provides requirements for a QMS that enhances the ability of a hospital to deliver quality care. It also enables hospitals to comply with regulatory and statutory requirements of governing authorities.

Benefits of ISO 9001:2015 in hospitals

  • Control and measurement of suppliers
  • Ensure preventive measures are put in place by deploying a customer service survey
  • Internal audits and periodic management reviews to ensure the QMS functions as it is designed
  • Risk management and procedures to curtail unforeseen events
  • Standardized corrective action procedures
  • Continual improvement through productivity enhancement and process optimization.

ISO 14001:2015 – Environmental Management Systems

This environmental Management System (EMS) plays a significant role in the way hospitals relate to the environment. The volume of goods and services that hospitals deal with, and must dispose of, requires a rigorous system to mitigate damages to the environment.

Advantages of using ISO 14001:2015 for hospitals

  • The hospital’s supply chain is managed effectively from keeping track of purchase quantities, consumption, and material to waste management.
  • Effective waste management requires the hospital to have a fully-fledged waste treatment and recycling plant as per the environmental policy. An EMS will ensure that these are run virtually to eliminate environmental pollution.
  • Hospitals consume a lot of energy. Those that follow the EMSs requirement on energy consumption will see energy levels start to decrease, resulting in environmental preservation.

ISO 50001:2018Energy Management Systems – Requirements with guidance for use

This standard complements the environmental management standard by prescribing an effective energy management system. It helps hospitals to reduce operating expenditure by maximizing energy efficiency.

ISO 45001:2018- Occupational Health and Safety Management Systems

The health and safety standard is geared to avoid workplace hazards. It achieves this by keeping the hospital clean, training on health and safety awareness, and corrective actions in case of non-conformities.

ISO/IEC 27001:2013 – Information Security Management Systems

Hospitals deal with a lot of client-sensitive data. An Information Security System will help the hospital maintain the privacy of its records while ensuring that cyber risks are taken care of.


ISO shows its commitment to quality health care by providing and advocating for standards that ensure hospitals can focus on what they do best- save lives.

30 thoughts on “7 Essential ISO Standards in the Medical Field

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