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ISO 13485 : Creating Greater Reach For Medical Device Manufacturers

ISO 13485 is an ISO Standard

Representing the quality requirements that need to be incorporated into the management systems of medical device manufacturers. The main points of ISO 13485 are focused on meeting customer and regulatory requirements, creating and maintaining effective risk management process and other operational procedures involved in the production, creation and distribution of medical devices. Unlike ISO 9001, it does not focus on achieving customer satisfaction and continuous improvement; although most medical sub-tier suppliers are required by medical device manufacturers to be certified in ISO 13485 to be a viable business partner.


Even though ISO 13485 aims to create a management system that helps organizations to comply in customer and regulatory demands, it is not meant to take place the requirements of FDA or other foreign regulators. The biggest advantage of being ISO 13485 certified is to have a management system that can comply to different customer and regulatory requirements in different countries and industries.


Drafting a manual defining the goals and procedures aimed for compliance and quality is the first step. Development of these requirements requires expertise and therefore most companies hire consultants to provide professional assistance, especially in this crucial step. Once the quality management document had been created, implementation of the management system is the next phase. Once an organization is comfortable with the management system, they can seek for a qualified certification body. Certification should be sought to countries wherein an organization aims to sell its products.


Majority of the steps in being ISO 13485 certified is similar to ISO 9001. If an organization already has an existing quality management system in place, it is easier to assimilate ISO 13485. On-going surveillance is required after certification and the assessment’s duration and frequency may vary depending on the company’s size, product complexity and types. This surveillance assessment aims to evaluate fulfillment of management responsibilities, implementation of internal audits and the overall company performance in the industry and in its customer base.


Being ISO 13485 certified, just like being certified to other ISO standards, aim to bring credibility to organizations and help build a framework of management system aligned with different regulatory compliance requirements. This gives a company the flexibility to expand its reach by developing new market base depending on its products and locations.


Considering the benefits of being ISO 13485 certified, aside from cost savings and higher quality output, as well as competitive advantage, professional guidance are highly recommended to achieve certification. ISO consultants are crucial in successfully drafting the quality document which will be the basis of the overall management process. Such task requires a consultant to have expertise not only in ISO standards but also in your industry and market.

 Help with ISO 13485 certification

QSE Consultants from Atlanta, Georgia have been providing professional assistance to companies aiming to successfully be ISO 13485 certified. With more than 20 years of experience, they developed the 10 Step Approach program to help organization secure ISO certifications.  This program is based on proven and tested lean management tools which aims for operational excellence and aligned with most ISO Standards. For more information about QSE consultant services, visit their website or call 770-518-9967 now.

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Quality System Enhancement has been a leader in global certification services for the past 30 years. With more than 800 companies successfully certified, our proprietary 10-Step Approach™ to certification offers an unmatched 100% success rate for our clients.

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