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Oracle Precision Achieves Flawless ISO 13485 Surveillance Audit for Medical Device Accreditation

October 2023

At Oracle Precision, excellence isn't just a goal; it's our commitment to the industries we serve. We are proud to announce a significant milestone in our journey of providing precision subcontract machining services, especially for the medical industry. Oracle Precision has just successfully completed a two day surveillance audit for our ISO 13485 Medical Device accreditation, and we are delighted to share the remarkable news - no Non-Conformities (NCRs) or advisories were raised by our notified body.

ISO 13485: A Mark of Quality in Medical Device Manufacturing

ISO 13485 is an internationally recognised quality management standard for organisations involved in the design, development, production, installation, and servicing of medical devices. Achieving and maintaining this accreditation is a testament to an organisation's commitment to the highest standards of quality, safety, and performance in the medical industry.

Excellence in Precision Subcontract Machining for the Medical Sector

Oracle Precision's services are critical to the medical industry, where precision is not just a requirement but a mandate. Our team's dedication to adhering to the most stringent quality standards has earned us the trust of numerous medical device manufacturers. We provide the highest level of precision and reliability to ensure that medical devices, equipment, and components meet the industry's strictest requirements.

The Surveillance Audit: A Test of Excellence

Our recent ISO 13485 surveillance audit was a rigorous examination of our systems, processes, and commitment to quality. Conducted by our notified body, this audit covered every facet of our operations that relate to medical device manufacturing. The auditors closely scrutinised our documented quality management system to ensure all processes are meticulously controlled and monitored to meet the ISO 13485 standards.

Traceability and Accountability: We demonstrated our ability to track and trace all components used in medical device manufacturing, offering complete transparency and accountability.

Risk Management: Our proactive approach to risk management ensures that potential issues are identified and mitigated before they impact the final product.

Continual Improvement: Oracle Precision's commitment to continuous improvement was recognised, emphasising our pursuit of perfection.

A Remarkable Achievement: No NCRs or Advisories

The outcome of the surveillance audit is a testament to the unwavering dedication of the Oracle Precision team to quality and precision. The fact that no Non-Conformities (NCRs) or advisories were raised by our notified body is a significant accomplishment. It underscores our commitment to delivering medical devices and components that meet the highest standards of quality and safety.

Why Choose Oracle Precision for Your Medical Device Needs

Our ISO 13485 accreditation demonstrates our dedication to providing exceptional services to the medical industry. When you choose Oracle Precision, you're partnering with a company that not only meets but exceeds industry standards. We understand the importance of precision in medical device manufacturing and are committed to delivering products of the highest quality.

With this recent success, Oracle Precision is more prepared than ever to meet the precision machining needs of the medical industry. We remain a reliable partner in creating safe and efficient medical devices.

Contact Us

For more information about our precision subcontract machining services and our recent ISO 13485 accreditation, please visit our website at www.oracleprecision.com or email info@oracle-precision.co.uk Discover how Oracle Precision can elevate your medical device projects to a new level of excellence.

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