What Is the ISO 13485 Standard?

The International Organization for Standardization (ISO) sets worldwide standards for many manufacturing and design industries. The ISO standards require that manufacturers have specific processes and procedures in place to ensure that their products are being manufactured in a reliable manner. Companies who meet the standard can receive ISO certification. One such standard is ISO 13485, which provides standards for quality management systems for manufacturing medical devices. An ISO consulting can help you determine what changes you need to implement to meet this stringent standard. Let’s look at some of the features of this ISO standard.

  • ISO 13485 requires that companies have a comprehensive quality management system in place for the design and manufacture of medical devices. They must be able to ensure highly consistent results in the manufacturing process.
  • ISO 9001 is often used in conjunction with ISO 13485. 9001 requires that a business demonstrate continual improvement to maintain the certification. 13485 only requires that the company effectively implement and maintain the quality management process.
  • It’s an important certification to have for manufacturing and selling medical devices in Europe. It has been harmonized with the European Medical Devices Directive 93/42/EEC. Maintaining ISO 13485 will make it easier for a company to achieve the necessary permits to sell their devices throughout Europe.

ISO 13485 is the worldwide standard for quality management systems for manufacturing medical devices. Like Europe, numerous countries have aligned their standards with this ISO standard. If your business is considering manufacturing any medical devices, then you need to give serious consideration to meeting this standard. There are many ISO firms that offer ISO 13485 consulting. These companies can help you navigate the specific requirements within the standard and help you design a highlyeffective system that will allow you to meet the requirements and receive ISO 13485 certification. They can also work with you to receive other certifications, such as ISO 9001. These certifications will help your business stand out from the competition and will show that you take quality control seriously.

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