Scala was recommended for certification for the Globally recognised standard ISO 13485 (2016) Quality Management Practice for Medical Devices by a BSI auditor.
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The company's initiative saw us reach specific criteria for a quality management system (QMS) that meets the highest customer and regulatory requirements.
The certification states that Scala Surgical is certified in the “Manufacture and distribution of non-sterile reusable surgical instruments and associated products".
What is an ISO 13485 Quality Management System?
ISO 13485 is a stand-alone Quality Management System (QMS), derived from the internationally recognised and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices are safe for their intended purpose.
What are the benefits of being certified to ISO 13485?
ISO 13485 certification helps improve overall performance, eliminate uncertainty, and widen market opportunities. With this certification, we can:
- Communicate a commitment to quality to both customers and regulators
- Constantly review and improve processes across our organisation
- Increase efficiency, cut costs and monitor supply chain performance
- Demonstrate that we produce safer and more effective medical devices
- Meet regulatory requirements and customer expectations