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ISO 13485  Industry-specific standard for medical devices

Medical Devices – Quality Management Systems – Requirements for regulatory purposes

The ISO 13485 standard is for manufacturers of medical devices or medical device components. Due to the vital nature of products manufactured for medical use, product conformity of medical devices is paramount. The global acceptance of ISO 13485:2016 helps safeguard product conformity as manufacturing supply chains have expanded nationally and internationally.

The processes for design and manufacturing of medical devices is the subject of this standard. It references the ISO 9001:2008 standard with extensive additions pertaining to more stringent controls applicable to such sensitive products. In many countries, statutory and regulatory requirements are based on the ISO 9001 and ISO 13485 standards. An example is the U.S. revised Quality System Regulation (FDA 21 CFR 820) which in large part incorporates these two ISO international standards. Also, ISO 13485:2016 certification is commonly an initial step for medical device manufacturers seeking compliance with the requirements of the Medical Device Directive (MDD) and the CE marking process in the European Union (EU).

Small businesses may gain a number of benefits from an ISO 13485:2016 certification:

Foundation for establishing compliance with FDA, MDD or CE requirements

Ensure QMS practices that produce consistently safe and effective medical devices

Helps you manage risk effectively

Provides for the opportunity to improve QMS processes and efficiencies

Creates opportunities to gain new business within medical device industries

Essential controls to ensure product conformity and regulatory compliance

The new ISO 13485 emphasizes risk management and risk-based decision making for processes outside the realm of product realization. The focus is on safety and performance of medical devices and compliance with regulatory requirements.

The ISO 13485 is a stand-alone standard. It is similar in scope and intent to ISO 9001.

Consulting Support for ISO 13485

Core Business Solutions has qualified ISO 13485 consultants ready to help you achieve certification. Support for the ISO 13485 standard is available through our Full-Service Consulting Program. Our ISO 13485 clients include:

Small businesses currently ISO 9001 certified seeking to add a second certification to meet medical device industry requirements.

Small businesses with no certification seeking ISO 13485 qualification.

For more information about our consulting support for the ISO 13485 medical device standard, please call our consulting office at 866-354-0300, or email info@thecoresolution.com.

Related standard

See ISO 9001:2015 for general quality management system certification

See Integrated Management Systems