KEY Integrated Service Limited
ISO 13485:2016 Medical Devices Quality Management System (QMS)
Strengthen Quality. Manage Risk. Support Medical Device Compliance.
ISO 13485 is an internationally recognized quality management standard specifically designed for organizations involved in the medical device industry. It provides a structured framework to help organizations consistently meet customer and applicable regulatory requirements throughout the medical device lifecycle.
ISO 13485 is not simply about quality procedures or obtaining a certificate. When implemented properly, it helps an organization establish effective process controls, clear responsibilities, systematic risk-based practices, appropriate documentation and stronger quality management throughout medical device operations.
ISO 13485 is not simply about quality procedures or obtaining a certificate. When implemented properly, it helps an organization establish effective process controls, clear responsibilities, systematic risk-based practices, appropriate documentation and stronger quality management throughout medical device operations.
Importance
Why ISO 13485 Matters to Your Business
Strengthen Quality Management for Medical Devices
Establish a systematic approach to managing quality throughout your medical device activities, helping ensure that processes are consistently controlled and applicable customer and regulatory requirements are addressed.
Establish a systematic approach to managing quality throughout your medical device activities, helping ensure that processes are consistently controlled and applicable customer and regulatory requirements are addressed.
01
Strengthen Product & Process Control
Establish consistent controls over relevant processes such as design and development, purchasing, production, installation and servicing, as applicable to your organization.
02
Support Regulatory Requirements
Establish a structured quality management framework to support applicable regulatory requirements for medical devices and related services.
03
Manage Quality & Product Risks
Integrate appropriate risk-based controls throughout relevant processes to help identify, manage and reduce quality and product-related risks.
04
Improve Traceability & Documentation
Maintain appropriate documentation, records, identification and traceability to demonstrate effective control and support applicable requirements.
05
Build Customer & Market Confidence
Demonstrate your commitment to medical device quality and regulatory compliance, strengthening confidence among customers, regulators and business partners.
Assist you in building your own management system capabilities.
Enable you to take control of your processes.
Choose KEY, choose a partner dedicated to your self-sufficiency and system optimization.
Enable you to take control of your processes.
Choose KEY, choose a partner dedicated to your self-sufficiency and system optimization.
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