![]() The certification demonstrates their commitment to building high-quality medical devices. Many companies seek the certification because of the financial benefits to their business. The Benefits of ISO 13485:2016īusinesses that have implemented ISO 13485 cite numerous benefits. For those seeking their first ISO 13485 certification, the following information can serve as a starting place for implementation. The auditing process can appear overwhelming, but it does not have to be. It is important for these organizations to understand the advantages of becoming ISO certified, identify the key differences between the 2003 publication and the 2016 publication and begin the work for first-time certification. If your company was once certified to ISO 13485:2003, and you want to reenter markets that require certification to ISO 13485, you may seek a first-time certification to ISO 13485:2016. Those that haven't have had to pull out of European Union (EU) and Canadian markets. Many organizations that needed to keep an active ISO 13485 certification have already adopted the 2016 standards. The three-year transition period from ISO 13485:2003 to ISO 13485:2016 ended in March 2019. Becoming ISO 13485 certified can increase your client base and reduce barriers to entry of foreign markets, product liabilities and production down-time. It assures a commitment to quality and increases efficiencies within the organization. ISO 13485 provides a great advantage for organizations producing medical devices and related services. ISO 13485 was developed to address these needs. ![]() However, medical device and pharmaceutical companies have specialized requirements that made some of the requirements of ISO 9001 difficult to apply. ISO 13485 derived from ISO 9001, a quality management system certification that's available to businesses in a wide variety of industries. The most recent update to the standard was published in February of 2016, overriding previously published versions from 20.
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