The ISO (International Organization for Standardization) standards are the cornerstone of quality and safety—and this is especially true in the medical device sector. Primary ISO standards, such as ISO 13485, are supplemented with a wide range of specific ISO standards, such as ISO 15223, which covers medical device labeling, and ISO 14155, which concerns human medical trials.
These globally recognized benchmarks are essential for manufacturers and organizations, providing a clear and comprehensive roadmap for producing medical devices that meet and exceed international expectations for performance, safety, and regulatory conformity.
By rigorously applying these standards, manufacturers are able to manage their systems and processes consistently with the goal of providing products which consistently meet the highest quality, safety, and efficiency benchmarks, playing a pivotal role in advancing global healthcare standards.
Learn more about the International Organization for Standardization in our guide.
Key ISO Standards for Medical Devices
Numerous ISO standards are associated with medical device safety, effectiveness, and quality. These standards cover a wide range of specifications—from the design and production of medical devices to their testing and regulatory compliance.
The key standard for medical devices is ISO 13485 Medical Devices Quality Management Systems (requirements for regulatory purposes). This is the overarching framework for a series of other medical standards.
ISO 13485 is an internationally recognized standard that defines the requirements for a Quality Management System (QMS) specific to the medical device industry. The standard emphasizes the importance of management responsibility, resource management, product realization, risk management, and regulatory compliance. Applicable to organizations of all sizes in the medical device sector, ISO 13485 is a critical tool for demonstrating a commitment to quality and safety in this highly regulated industry.
Other medical ISO standards play a role in risk assessments, operations, production, and usage of medical devices. These often work as frameworks alongside ISO 13485, expanding your organization’s management systems and widening regulatory compliance.
Some of the key standards besides ISO 13485 include:
- ISO 14971—Provides a detailed process for managing risks associated with medical devices. It helps manufacturers to identify hazards, estimate and evaluate risks, and implement necessary control measures.
- ISO 11137—This standard series gives guidelines for sterilizing health care products, specifically providing details for sterilization by radiation.
- ISO 10993—A group of standards that provides guidelines for the biological evaluation of medical devices. It helps determine the potential biological risks arising from the materials used in the manufacture of a medical device.
- ISO 15223—Provides requirements for medical device labeling and includes symbols that can be used on medical device labels.
- ISO 17664—Provides guidelines for processing instructions for reusable medical devices.
- ISO 14155—Specifies good practices for conducting clinical trials involving human subjects for medical devices.
- ISO 62304—Outlines the lifecycle requirements for medical device software, including software development, validation, and post-market surveillance.
- ISO 62366—Relates to the application of usability engineering to medical devices, helping to ensure the device is designed to be user-friendly and minimize use-related safety issues.
- IEC 60601—A series of technical standards for the safety and effectiveness of medical electrical equipment developed by the International Electrotechnical Commission (IEC).
What Is ISO 13485?
ISO 13485 is an international standard specifying requirements for a QMS where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices, as well as the design, development, and provision of related services.
The primary requirements of ISO 13485 are:
- Quality management system (Section 4)—The organization must establish, document, implement, maintain, and continually improve a QMS in accordance with the requirements of ISO 13485.
- Management responsibility (Section 5)—Senior management must provide evidence of its commitment to developing and implementing the QMS and improving its effectiveness.
- Resource management (Section 6)—The organization must identify and provide the resources needed to implement and maintain the QMS, ensuring that personnel are competent based on their education, training, skills, and experience.
- Product realization (Section 7)—The organization must plan and develop the processes needed for product realization. This includes requirements for product development, purchasing, creating, and maintaining product documentation, and monitoring and measuring equipment control.
- Measurement, analysis, and improvement (Section 8)—The organization must establish a plan to monitor, measure, analyze, and improve products and processes to demonstrate product conformity, ensure QMS conformity and maintain the effectiveness of the QMS.
- Risk management—ISO 13485 requires that the organization apply a risk management system for all stages of product realization, clinical data evaluation, and production processes.
- Regulatory requirements—The organization must establish documented procedures to ensure regulatory requirements are met for the medical devices.
- Documentation and control of records—The organization must manage all relevant documentation, including procedures, records, a quality manual, and policy, and must control and retain records to provide evidence of conformity to requirements and the effective operation of the QMS.
Overall, the requirements of ISO 13485 are designed to ensure a high level of quality for medical devices and to promote best practices for any activities that could impact the ability to meet customer and regulatory requirements.
Learn more about the benefits of ISO 13485 in our guide.
Who Should Use ISO 13485?
ISO 13485 is designed for organizations in any stage of the medical device lifecycle.
The size of the organization doesn’t matter. Whether a small start-up or a multinational corporation, any organization that wants to improve its quality management processes and ensure regulatory compliance in the medical device industry can employ ISO 13485.
Medical Device Manufacturers
These are companies that design, produce, and distribute medical devices. The standard applies to all aspects of manufacturing, including design, production, storage, and distribution.
Contract Manufacturers
Firms that produce devices or components according to another company’s specifications can use ISO 13485 to ensure they meet their clients’ quality requirements.
Suppliers of Medical Device Manufacturers
Companies that supply raw materials, components, or services to medical device manufacturers can use ISO 13485 to demonstrate their commitment to quality and customer satisfaction.
Service Providers
These include companies that provide services related to medical devices, such as maintenance, servicing, refurbishment, or calibration services.
Distributors and Retailers
Even companies that don’t directly manufacture medical devices but play a role in their distribution or sales could benefit from ISO 13485.
Regulatory Bodies
Regulatory bodies or certification organizations may also use ISO 13485 as a basis for their certification schemes.
Design Services
Firms that provide design services for medical devices can use ISO 13485 to ensure they are designing safe and effective devices.
Why Use ISO Standards for Medical Devices?
ISO standards for medical devices, such as ISO 13485, are globally recognized and widely applied across the medical device industry. Using these standards benefits manufacturers, healthcare providers, regulators, and ultimately, patients.
Here’s why ISO standards for medical devices are important.
- Safety and quality—ISO standards establish procedures and guidelines with the goal to ensure medical devices are safe and of high quality, minimizing risks to patients and medical professionals.
- Regulatory compliance—Many countries require compliance with ISO standards for medical devices. Following these standards aids manufacturers in meeting legal and regulatory requirements, both domestically and internationally.
- Global market access—ISO standards are globally recognized. Compliance can facilitate entry into international markets and increase business opportunities.
- Consistency—ISO standards provide a consistent set of expectations. This means that if a device is manufactured in Asia, Europe, or the U.S., its quality and safety are assured to a certain level if it complies with ISO standards
- Efficiency and cost savings—By following ISO standards, manufacturers can improve processes, increase efficiency, and reduce waste and errors. This can lead to significant cost savings over time.
- Customer confidence—Compliance with ISO standards shows a commitment to quality, safety, and efficiency, which can build trust and confidence among customers and users.
- Continuous improvement—ISO standards like ISO 13485 promote a culture of continuous improvement, encouraging manufacturers to constantly improve their products, services, and processes.
Using ISO standards for medical devices is about more than just compliance. It is a strategic tool that provides the framework to reduce risks, drive performance, with the goal of ensuring safe, effective, and high-quality medical device manufacture.
Start Your Journey to ISO 13485 Certification
Our team of expert auditors at Orion Registrar can help assess if your QMS meets ISO 13485 specifications, including identifying gaps and helping you prepare for an audit. Find out more about ISO 13485 and how it can illustrate your commitment to producing safe and efficient medical equipment.
