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6 min read

What is the difference between ISO 13485 and 14971?

Both the ISO 13485 and ISO 14971 are important standards in the medical device industry. The ISO 13485 focuses on quality management, whereas ISO 14971 underpins risk management. In this blog, we will examine both these standards, including an overview and key elements of each, their purposes and the benefits of implementing both for the running of your organisation.
Topics: ISO 13485:2016 , ISO 14971:2019

medical practitioner looking at a screen with a patient lying down.


Overview of ISO 13485

What is ISO 13485? It is a Standard that establishes comprehensive guidelines for implementing a quality management system. It is specifically tailored for organisations that are involved in the design, production, and distribution of medical devices.


This Standard emphasises the necessity for these organisations to demonstrate their capability to consistently deliver products and services that meet and even exceed customer expectations. Additionally, it mandates compliance with relevant regulatory requirements, ensuring that all medical devices produced are safe, effective, and reliable. By adhering to these Standards, organisations can enhance their operational processes, improve customer satisfaction, and maintain trust in their products within the healthcare industry.


Key Elements of ISO 13485

The key elements of ISO 13485 include:


Quality Management System (QMS)
—This framework is designed to ensure that organisations consistently meet customer needs through implementing high Standards when making their products. This leads to improved manufacturing practices and processes. Once the devices are created, they produce better results, both for the patients (optimum effectiveness) and those operating the devices (better ease of use and fewer device malfunctions).


Document Requirements
—Clear documentation is essential for maintaining compliance with Standards. This includes everything from procedural manuals to detailed records of quality checks. All these serve to uphold the integrity of the QMS.


Regulatory Compliance
—The medical device industry must adhere to local and international regulations. This Standard emphasises the importance of understanding and integrating these regulations into product development and quality assurance processes.


Overall, this Standard's primary focus is to ensure consistent product quality through meeting the stringent requirements set out by governing bodies in the medical field. This increases the safety and effectiveness of medical devices available on the market.

 


ISO 13485 Complaint Section

The ISO 13485 complaint section outlines systematic procedures that ensure complaints are promptly and thoroughly addressed and managed. This is crucial for the medical device industry, where product reliability and safety are of utmost importance. By adhering to the ISO 13485 complaint section, companies can respond to customer concerns efficiently while gathering valuable insights that can contribute to ongoing improvements in product design. This proactive approach promotes customer trust and satisfaction as well as maintaining regulatory compliance. This strengthens the organisation’s reputation for delivering high-quality medical devices in a competitive marketplace.


dentistry equipment being sterlised

 

Overview of ISO 14971

What is ISO 14971? It is a universally accepted Standard developed to help organisations establish a comprehensive framework for risk management throughout the design, development, production and post-production processes of making medical devices.


This Standard plays a vital role in guiding organisations to systematically identify, and manage risks that may arise while devising and producing products. By adhering to
ISO 14971 risk management guidelines, organisations can implement effective controls that mitigate potential hazards while promoting safety and efficacy that values the well-being of patients and users.


Key Elements of ISO 14971 Risk Management

The ISO 14971 Standard consists of three key elements:

  1.   The risk assessment process involves systematically identifying and analysing risks to understand their potential impact on the organisation.
  2.   The risk control phase outlines strategies and measures for effectively mitigating the identified risks.
  3. Risk evaluation then allows organisations to determine the overall effectiveness of their risk management strategies and make necessary adjustments.

These enable organisations to maintain a proactive approach to risk, putting in place systematic procedures that protect people and assets while confidently navigating uncertainties.


What is the Purpose of ISO 13485 and ISO 14971?

In medical device production, Standards play a crucial role in ensuring product safety and efficacy.


ISO 13485 focuses on establishing a robust quality management system that is compliant with regulations and high-quality production. It promotes continual improvement to meet customer and regulatory expectations.


ISO 14971 is dedicated to risk assessment and control, helping guide organisations in identifying potential hazards throughout the device lifecycle. It helps implement measures to mitigate these risks.


close-up of medical device checking sugar level in blood


Benefits of Implementing Both ISO 13485 and ISO 14971

By implementing both these Standards, companies that produce medical devices help not only improve their products and stay on the cutting edge but also protect users and patients. They also safeguard themselves and their employees regarding reputation (and therefore marketability) and any potential litigation. Using both ISO 13485 and ISO 14971 Standards helps companies create a more robust approach to quality and risk management in the arena of medical devices. Overall, this leads to an ongoing improvement in the Standards provided by the healthcare industry.


Who Should Use ISO 13485 and ISO 14971?

The ISO 13485 and ISO 14971 Standards should be used by any organisation involved in the lifecycle of medical devices, from development to delivery. They are essential for regulatory compliance and maintaining customer trust.


These include:

Designers—the Standards provide an underlying framework for the design and testing phase of product development.


Manufacturers
—the Standards ensure product quality and safety during the manufacturing phase.


Suppliers
—the Standards outline the necessary benchmarks to which suppliers align their processes with, ensuring their components meet strict safety and performance criteria.


Service providers
—the Standards are a key reference for service providers who can in turn provide high-quality maintenance and support for the devices.


Each will greatly benefit from adhering to these established, global Standards, avoiding potentially costly missteps.


Summary of Key Takeaways

ISO 13485 is necessary for quality management, establishing a framework for consistent excellence in products and services. In parallel, ISO 14971 is necessary for risk management as it provides guidelines for identifying and mitigating hazards. By understanding and implementing both Standards, companies can develop high-quality, safe medical devices that meet regulatory and industry expectations, fostering trust in the healthcare sector.

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