ISO 13485 Certification

What is ISO 13485 Certification?

ISO 13485 is a global standard dedicated to the quality management system (QMS) specifically designed for the design and manufacturing of medical devices. Stemming from the ISO 9001 quality management system, this standard assists medical device organizations in fulfilling regulatory requirements for the production of safe and effective medical devices. ISO 13485 certification serves as validation, affirming that a company has adopted a QMS that conforms to the ISO 13485 standard.

Why Obtain ISO 13485 Certification?

The certification of ISO 13485 is essential for businesses, offering a framework for an effective quality management system. Based on the Plan-Do-Check-Act model, it assists organizations in consistently enhancing their quality management systems. This certification covers all phases of medical device design and production, from the initial concept to the final delivery.

ISO 13485 certification communicates to customers, regulators, and stakeholders that an organization is committed to quality and safety. Moreover, it can elevate business prospects, as many stakeholders prefer engaging with suppliers possessing an ISO 13485 certificate.

Benefits of ISO 13485 Certification

» Facilitates the optimization of your quality management processes, resulting in enhanced product quality and decreased costs.
» Mitigates the risk of product recalls and other expensive issues linked to subpar quality.
» Acts as a valuable marketing asset, showcasing to customers that your products adhere to the highest standards of quality and safety.
» Contributes to gaining a competitive advantage in the marketplace.
» Affirms your dedication to quality and customer satisfaction.
» Simplifies the process of securing regulatory approval for your products in various markets.
» Offers a structured framework for the ongoing improvement of your quality management system.
» Contributes to gaining a competitive advantage in the marketplace.

What Organizations Are Eligible to Apply?

Organizations engaged in the design, manufacturing, or distribution of medical devices are eligible to seek the ISO 13485 certificate. This includes suppliers of materials, components, and sub-assemblies utilized in the production of medical devices.

Our team is composed of certified ISO 27001 experts with substantial experience in establishing, implementing, operating, monitoring, reviewing, maintaining, and enhancing Information Security Management Systems (ISMS). For further details, kindly reach out to us via email.

ISO 13485 Certification Process

» Fill out the application form to initiate a quote request from Ocean Standard Certification.
» Execute a contract and remit the registration fee.
» A lead auditor from Ocean Standard Certification will be designated to your project. They will create an ISO 13485 audit checklist and formulate a customized audit plan tailored to your specific needs.
» The lead auditor will conduct an on-site assessment of your quality management system to evaluate compliance with the standard's requirements.
» Ocean Standard Certification will provide a comprehensive report detailing the audit findings.
» If your organization is found to be in compliance with the standard, Ocean Standard Certification will issue an ISO 13485 certificate.