When selecting a System on Module (SOM) provider, ISO 13485 certification offers significant advantages that extend well beyond its medical device origins. While ISO 9001 is common in the SOM industry and provides a general framework for quality management, ISO 13485 adds crucial layers of control and validation specifically developed for medical device manufacturing – layers that benefit any project requiring high reliability, not just medical. Where ISO 9001 focuses broadly on customer satisfaction and continuous improvement, ISO 13485 implements more rigorous requirements for risk management, documentation, and process control throughout the entire product lifecycle.
Systematic Risk Management: Preventing Issues Before They Occur
ISO 13485 places a strong emphasis on risk management throughout the product lifecycle. In medical device manufacturing, these enhanced requirements ensure thorough validation of component changes. For example, when modifying a SOM’s firmware, each change undergoes comprehensive risk analysis and validation before implementation, preventing potential safety issues.
This same systematic approach brings value to other applications as well. For example, when SOMs operate in harsh environments, the risk management framework ensures thorough validation of thermal performance, EMC compliance, and long-term reliability – critical factors for preventing costly system failures. This evidence-based approach to risk management helps manufacturers identify and mitigate potential issues during the development phase, before they impact production.
Enhanced Documentation Control: Building Trust Through Traceability
ISO 13485 mandates detailed documented procedures throughout the entire product lifecycle – from initial design through manufacturing and long-term support. For medical devices, this means complete traceability of components and changes. Every modification, from component sourcing to firmware updates, must be documented and validated, enabling rapid response to any quality issues. This comprehensive documentation and traceability system enables manufacturers to rapidly identify, isolate, and address any quality concerns by providing instant access to the complete history of components, processes, and distribution channels involved. If manufacturers discover defects or faults, complete traceability allows them to perform targeted recalls efficiently and confidently, minimizing impact while ensuring comprehensive resolution.
Such detailed documentation is invaluable for complex systems across other industries as well. When troubleshooting performance issues, engineers can quickly trace the root cause through comprehensive records of component history, environmental testing, and system modifications. This level of traceability significantly reduces debugging time and supports long-term maintenance.
Supplier Control: Ensuring Component Quality and Reliability
ISO 13485 implements strict requirements for supplier management. This includes thorough evaluation and continuous monitoring of suppliers, ensuring only high-quality, trusted sources are used. The standard mandates detailed criteria for supplier selection, covering aspects like product specifications, quality system effectiveness, and production capacity. Organizations must maintain records of acceptable suppliers and regularly reassess their performance. This approach, crucial in medical device production, delivers exceptional reliability across all applications by ensuring consistent component quality throughout the supply chain. When component quality is assured from the source, manufacturers can prevent issues before they impact production, reducing long-term risks significantly.
Variscite has both ISO 9001 and 13485 certification
Beyond Medical: ISO 13485 Benefits Every Industry
Choosing an ISO 13485 certified SOM provider brings distinct advantages beyond ISO 9001 requirements. As one of the few SOM manufacturers holding this certification, Variscite demonstrates its commitment to exceptional quality through:
- Comprehensive testing procedures that validate performance across operating conditions
- Complete traceability for efficient troubleshooting and maintenance
- Systematic quality controls that prevent issues before they impact production
- Evidence-based decision making through continuous data collection and analysis
This certification represents more than regulatory compliance or quality assurance – it provides a framework for excellence. Building upon the solid foundation of ISO 9001, ISO 13485 adds layers of control and validation that benefit any high-reliability application. For engineering teams developing embedded systems, working with Variscite ensures their projects benefit from medical-grade precision and systematic risk management. This comprehensive approach gives embedded projects a competitive advantage through validated quality, faster troubleshooting, and reduced long-term risks.
Explore Variscite’s range of international certifications and standards, including ISO 13485, ISO 9001, ISO 14001, and other quality and environmental standards, and contact to discuss the required standards for your embedded system design.