Silitronics Achieves ISO 9001 and ISO 13485 Compliance rapidly in 3 Days with Akitra's Next-Generation eQMS and Compliance Automation Platform
Akitra’s Compliance Automation Empowers Silitronics with Consistency and Scalability for Future Certifications.
Silitronics, a leader in microelectronic assembly, is known for delivering high-quality design and assembly solutions tailored to the microelectronics industry. To strengthen its focus on operational excellence and maintain strict quality controls, the company set its sights on achieving ISO 9001 and ISO 13485 certifications, key Quality Management System (QMS) standards critical to industries like manufacturing and medical devices. Recognizing the inefficiencies of their manual compliance processes, Silitronics turned to Akitra, a leading AI-enabled, Next-Generation Compliance Automation platform, to streamline the certification process and ensure continuous adherence to these rigorous QMS standards.
The Challenge
Silitronics encountered several obstacles in maintaining Quality Management System (QMS) compliance for ISO 9001 and ISO 13485 standards using manual processes:
Heavy Paperwork: The traditional approach involved managing a significant amount of paperwork, which was labor-intensive and required meticulous tracking.
Manual Record-Keeping: Record-keeping was a major challenge, especially when the team was shorthanded. Ensuring that all records were properly maintained and organized required constant attention.
Time-Consuming Documentation Reviews: Reviewing documentation to verify correct forms were filled, issued, and followed in operations was time-consuming and repetitive.
Corrective Actions Oversight: Ensuring that corrective actions were implemented effectively required ongoing follow-up and monitoring, further straining available resources.
Lack of Automation: With minimal automation, all processes from filing to corrective action implementation were manual, increasing the workload and chances of error.
What Akitra really helped with was the time and effort we used to spend on audits. Before, we would have to manually review everything, making sure every document was in place, which was time-consuming and stressful. Now, with automation, it’s all organized, updated instantly, and easy to search. Preparing for certifications like ISO 9001 or ISO 13485 is so much quicker.
Frederick Solomon
Director of Quality and MPI, Silitronics
Akitra's Solution
Akitra’s compliance automation platform and Electronic Quality Management Systems (eQMS) platform offered a transformative solution to streamline Silitronics’ QMS compliance processes:
Automated Compliance Processes: Akitra’s platform automated many operational tasks, allowing the system to handle routine activities without constant manual intervention. The Silitronics team only needed to review reports, drastically reducing the need for active management.
Instant Updates and Organization: The platform provided real-time updates, ensuring all compliance-related data was kept organized and easily searchable, improving efficiency and reducing the time spent tracking down information.
Hands-Off Oversight: Automation allows operations to run seamlessly, minimizing the need for follow-up on every step while ensuring accurate, up-to-date reports for review.
Audit-Ready Features: The platform significantly reduced the time needed to prepare for QMS audits, allowing Silitronics to be audit-ready in just a few days.
Tailored Support and Flexibility: Akitra’s platform offered flexible solutions that Silitronics’s team could further customize to align with specific QMS processes using Akitra’s eQMS and Compliance Automation Platform.
The Result
By implementing Akitra’s compliance automation and eQMS platform, Silitronics achieved significant improvements in its QMS compliance efforts:
Enhanced Efficiency: Automated documentation processes streamlined compliance efforts, reducing the manual work required to maintain QMS records and manage corrective actions.
Consistent Documentation: Standardized processes ensured all departments followed uniform quality procedures, improving consistency in record-keeping.
Reduced Manual Workload: Automation eliminated the need for constant manual intervention, allowing the team to focus on quality improvement initiatives instead of administrative tasks.
Prepared for Future Certifications: Silitronics is now better equipped to pursue ongoing certifications, with the scalability of Akitra’s platform supporting future QMS compliance efforts.
With Akitra, managing the dual certification for ISO 9001 and ISO 13485 was seamless. Akitra eQMS and Compliance Automation platform brought clarity to complex processes, allowing us to focus on quality and safety, while the automation handled the heavy lifting.
Terrance Hamel
Director Operations & Supply Chain, Silitronics
