ISO 13485:2016 Standard - QMS for Medical Industry


ISO 13485:2016 Standard - QMS for Medical Industry


ISO 13485 2016 is an international Quality Management Standard issued by ISO(International Organization for Standardization). It is commonly used by the medical industry which focuses on the manufacturing of medical devices and equipment.

In 1996, ISO 13485 was first released as a quality control standard based on ISO 9001 for medical device companies. Then It was reported in two versions: ISO 13485 for original equipment manufacturers (OEMs) and ISO 13488 for contract manufacturers (suppliers). And after that, the documents combined into one quality level in 2003. And finally, it was released in 2016 as ISO 13485:2016 Standard for the medical industry. The ISO 13485:2016 is the latest version of this standard.

ISO 13485 2016 standard is used in order to show consumers and clients that your business takes quality very seriously.

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Benefits of using ISO 13485 Standard -


  • It allows an organization to fulfill legal, regulatory, contractual, and marketing requirements.

  • It Improves medical product quality, reduces costs, and track supply chain performance.

  • This Quality Management System Standard helps to reduce the expense of non-conforming products, thus improving customer satisfaction. It can result in a strong relationship with clients. Since medical devices have a significant effect on people's lives, thus, there should be no mistakes.

Quality Management System Standard ISO 9001 is designed to check the quality of all sorts of industry, it can be food, fabric, snacks, etc., but the standard ISO 13485 is specifically designed to check the quality of medical equipment and medical device manufacturing.

About ISO


ISO is a non-governmental organization that is the world's largest standards organization used to strengthen business standards, ISO management system standards are categorized by different sectors and industries. This can be based on the quality, safety, and protection, health management, environment and energy, IT, medical industry.

Who are we?


We are an ISO certification provider online in India, at an affordable price. Receiving an ISO 13485:2016 certificate on your own will generally be very difficult. But with our help, if you are trying to get through the sources, we will help you get your ISO 13485 registration without any trouble. Our ISO Registrar will assist you in obtaining this certification if you comply with a set of regulations.


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