Quality & Compliance

We aim to lead by example and employ the best operational and social business practices, the latest technologies, and skilled workers to deliver our promise of first class quality to customers.

We have a quality management system that is used throughout the organization and this supports our programme of continuous improvement.

In the highly regulated medical sector, we are certified to the highest quality levels globally with certification in:

• ISO 13485:2016
• ISO 15378:2017
• ISO 9001:2015
• MDSAP

We are also committed to chemical compliance and safety, being RoHS compliant and UL approved with traceability systems and testing protocols.

Device Life Cycle

We play an active role across various distinct but concurrent stages of a device’s life cycle;right from leveraging our in-house design (DFM) competencies and material expertise for designing and validating the product to manufacturing and scaling up production using innovative assembly techniques under cleanroom manufacturing conditions.

Quality

At Shaily, we believe in upholding the highest standards of quality. Our Quality Management System is both ISO 13485 and ISO 15378 certified, complying with:

• FDA 21 CFR 820 Quality System Regulation & cGMP
• MDD 93/ 42 EEC Medical Device Directive
• MDSAP

Our QMS employs a risk-based approach for all processes along with a mix of time tested and cutting-edge techniques to ensure adherence to quality standards, while optimizing operational efficiencies. These techniques include:

• Six Sigma
• Continuous Improvement Initiatives
• Process Capability Monitoring, through the use of Statistical Process Control methods
• Root Cause Analysis & CAPA
• DFMEA & PFMEA
• Use of CMM and Custom Fixtures for In-process Quality Control