What is ISO 13485?
ISO 13485:2016 is recognized throughout the world as a quality management system standard designed specifically for medical device manufacturers. Based on the same basic principles and clause structure as ISO 9001:2015, ISO 13485:2016 is a crucial first step in ensuring manufacturing and design processes consistently produce quality products that meet regulatory requirements.
ISO 13485:2016 is used to assist in the synchronization of quality management systems and medical device regulatory requirements in organizations involved in one or more stages of the life-cycle of a medical device.
Who should seek ISO 13485 Certification?
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Companies who manufacture private label medical devices and hope to eventually place them in the EU market
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Organizations that design and assemble medical devices
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Medical component manufacturers
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Manufacturers that want to prepare for future IVD regulatory obligations to enter the EU
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Companies who store and/or distribute medical products
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Companies who install and/or service medical devices
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Companies that design, develop, or provision associated services (e.g. technical support)
Explore the Benefits of ISO 13485 Certification
With ISO 13485:2016 certification, manufacturers are provided with a process-based model and approach to developing and improving the effectiveness of a quality management system. ISO 13485:2016 certification also assists in meeting customer and global regulatory requirements by:
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Maintaining global recognition as the best quality practices from companies within the medical device industry
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Enabling companies to work within various countries and organizations, meeting necessary regulations and obligations
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Helping to create an organized framework in which companies can maintain and evaluate their processes and customer response
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Providing a framework to ensure maintenance and improvement of the effectiveness of those processes with applicable requirements
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Enabling improved performance, such as increased sales, increased timeliness in getting products to the global marketplace, reduced costs, fewer errors, less waste, better use of time and resources and a lower product failure rate
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Demonstrating compliance with European Union Directives through establishment and independent assessment of the quality management system
