Healthcare

Why Certification is Essential in Healthcare

Patient safety and security are central to a healthcare organisation’s reputation. ISO certification can support efforts to streamline operations, enhance health and safety practices, and strengthen data protection measures.

ISO 9001 helps organisations improve quality and efficiency through consistent, repeatable processes that support overall operational excellence. ISO 13485 is the international standard for quality management systems specific to medical devices.

Additional benefits can be achieved by integrating these certifications with others, such as ISO 27001 (information security) and ISO 45001 (Occupational Health and Safety), for example.

This page is the hub for healthcare organisations seeking ISO certifications. Find essential guidance on certifications to help your business improve quality and patient safety.

Which ISO Standards Apply to the Healthcare Industry?

A number of ISO standards can apply to organisations that operate within the healthcare industry.

ISO 9001

ISO 9001 can help organisations to achieve operational excellence by implementing a Quality Management System (QMS) to optimise processes.

In the healthcare industry, this standard provides a consistent and controlled approach to processes, enhancing the quality of services and streamlining daily operations.

Discover how ISO 9001 can support your organisation.

ISO 13485

ISO 13485 focuses on Quality Management Systems specifically for medical devices, helping businesses to meet customer and regulatory requirements.

This standard is significant for healthcare organisations involved in the design, manufacturing and servicing of medical devices, as it helps to support the consistent delivery of safe and effective medical technologies.

Achieving certification to ISO 13485 can also support your business in complying with regulations for medical device manufacturing.

Discover how ISO 13485 can support your business.

ISO 14001

ISO 14001 provides guidance and actions for Environmental Management Systems (EMS). It helps healthcare businesses to minimise their environmental impact, supports long-term sustainability and aligns compliance with environmental regulations.

This standard helps healthcare organisations identify and manage environmental aspects, reduce waste, and improve resource efficiency, enhancing their environmental performance and reputation.

Discover how ISO 14001 can support your healthcare business.

ISO 27001

ISO 27001 is essential for managing information security in healthcare, where protecting sensitive patient data is crucial.

This standard helps healthcare organisations strengthen their information security, consider relevant legal and regulatory requirements and prioritise the confidentiality and integrity of patient information.

Discover how ISO 27001 can support your healthcare business.

ISO 45001

ISO 45001 provides requirements for Occupational Health and Safety Management Systems (OHSMS). It is vital for healthcare settings to maintain a safe environment for both staff and patients.

This standard helps healthcare organisations identify and manage workplace risks, reducing injuries and enhancing safety performance.

Discover how ISO 45001 can help your healthcare business.

To discover more about ISO certification, find out about our full range of standards.

The Benefits of ISO Standards

The benefits that ISO standards can provide to healthcare organisations are wide. They include the following:

• Enhanced patient safety: Implementing a Quality Management System through ISO 9001 is the best way to help your business enhance patient safety and provide patient-centred care. ISO 13485 also supports patient safety by helping medical device manufacturers consistently meet safety and regulatory requirements.
• Data security and customer confidence: ISO 27001 certification demonstrates that your healthcare organisation has implemented recognised controls to manage information security risks and protect customers’ sensitive personally identifiable information (PII). It offers set requirements to help organisations implement systems and policies that prioritise the security of the data they hold, minimising the risk of data breaches and damage to reputation.
• Competitive advantage: ISO 9001 sets out requirements to help your healthcare organisation improve consistency and service reliability. It is recognised internationally as the world’s most widely adopted Quality Management System.
• Workplace safety: ISO 45001 improves workplace safety by identifying and managing health and safety risks, reducing injuries and enhancing the overall safety performance of healthcare facilities.
• Regulatory compliance: ISO 13485 supports compliance with regulatory requirements for medical devices, which is vital for maintaining product quality and safety in healthcare.
• Market access: ISO 9001 supports entry to new national and international markets due to its global reputation and popularity.

Certification in the Real World

How can ISO certification benefit businesses? Read the following examples to find out.

Example 1: A National Healthcare Network

• The challenge: A national healthcare network wants to enhance operational efficiency and patient safety. They would like to manage processes across multiple hospitals and clinics while improving data security.
• Why certification: They implement ISO 9001 to help standardise procedures and ISO 27001 to help protect patient data. As a result, the network is supported in improving patient care and reducing treatment errors. Stakeholder trust can also increase due to decreased data breaches.
  

Example 2: Medical Device Manufacturer

• The challenge: A medical device manufacturer aims to improve product quality and expand into international markets. To do so, it must meet stringent regulatory standards.
• Why certification: The manufacturer adopts ISO 13485 for quality assurance, ISO 9001 for operational efficiency, and ISO 45001 for occupational health and safety management. This helps the business achieve increased product reliability, reduced workplace incidents, and an improved reputation, facilitating global market access.