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ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
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 that are safe for their intended purpose.
ISO 13485 is suitable for organizations of all types and sizes, be they private, not-for-profit or governmenl. The quality management for medical devices standard lasts for three years and is subject to mandatory audits to ensure that you are compliant. At the end of the three years, you will be required to complete a reassessment audit in order to receive the standard for an additional three years.
QACS is an accredited certification body which provides International Organization for Standardization (ISO) management system certification and inspection services to organizations globally.
QACS is accredited by QASL Independent accreditation to audit and certify organizations to ISO 13485.
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