WHAT IS ISO 13485?

ISO 13485:2016 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485 contains requirements essential for organizations operating at any tier in the medical devices and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and, as a result, it includes some particular requirements for manufacture, installation, and servicing such as added requirements on record control, sterilization, and risk management. Organizations can register to ISO 13485 as a standalone certification or in conjunction with an ISO 9001 or other registration. An ISO 13485 certification from us demonstrates your organization's commitment to providing products and related services that consistently meet customer and regulatory requirements applicable to the medical industry.

Key Benefits — Implementing ISO 13485 Really Helps Your Company In The Following Way.

• Provides a robust framework for assuring product consistency
• Creates a competitive advantage
• Engages top management involvement
• Ensures a consistent and effective approach to business
• Reduces risk factors via the use of risk management
• ISO 13485 requirements for manufacturers of medical devices align with regulatory expectations used across many countries
• A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance.
• It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.

Certification to ISO 13485 supports regulatory readiness, but it is not itself CE marking, MDSAP or FDA clearance — those are separate regulatory processes that your organization pursues independently.