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In the medical device industry, quality and safety are paramount. Various international standards exist to ensure that products are consistently manufactured, controlled, and validated. Among the most relevant are ISO 13485, ISO 9001, and ISO 11137. While they all promote quality and consistency, each serves a different purpose.
ISO 9001: General Quality Management
ISO 9001 is a broad, internationally recognized standard for quality management systems (QMS) applicable to all industries. It emphasizes customer satisfaction, continual improvement, and risk-based thinking. Key features include:
- Process-based approach to quality
- Customer focus
- Continuous improvement (Plan-Do-Check-Act cycle)
- Internal audits and management review
ISO 9001 provides the foundational QMS principles but does not include specific requirements for regulated sectors like medical devices.
ISO 13485: Quality Management for Medical Devices
ISO 13485 builds upon ISO 9001 but is specifically tailored to the medical device industry. It includes additional requirements to meet regulatory and customer demands for safe and effective devices. Key differences include:
- Focus on risk management throughout the product lifecycle
- Stricter documentation and traceability requirements
- More comprehensive controls for design, validation, and process changes
- Emphasis on meeting regulatory requirements (e.g., FDA, EU MDR)
While ISO 9001 promotes improvement, ISO 13485 is more compliance-oriented, prioritizing safety and effectiveness, and very aimed at medical device products.
ISO 11137: Sterilization by Radiation
ISO 11137 a technical standard that addresses sterilization of healthcare products using radiation, including gamma, electron beam (E-beam), and X-ray. It is not a quality system standard like ISO 9001 or 13485, but a product and process validation standard. It has four parts:
- Part 1: Requirements for development, validation, and routine control
- Part 2: Establishing the sterilization dose
- Part 3: Guidance on dosimetric aspects
- Part 4: Guidance on process control (in addition to dosimetry)
We have previously written a short overview of ISO 11137.
ISO 11137 ensures that products labeled “sterile” have a sterility assurance level (SAL) of 10⁻⁶ (or other targets when specified) and that radiation sterilization is validated and consistently controlled.
ISO 11137: Sterilization by Radiation
In summary, ISO 9001 provides the baseline for quality, ISO 13485 customizes it for medical device safety and compliance, and ISO 11137 governs how radiation sterilization is validated and monitored. All three are often used together to support safe and effective medical device manufacturing.
At NextBeam, we work closely with med device manufacturers to navigate these standards and build sterilization strategies that hold up under audit and scale with your business. Whether you’re refining an existing process or exploring E-beam sterilization for the first time, we’re here to help.
Have questions about applying these standards to your product? Contact us or book a 1:1 call with a sterilization expert.
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