![]() ![]() “This Estonian standard EVS-EN ISO 13485:2016/A11:2021 consists of the English text of the European standard EN ISO 13485:2016/A11:2021. ![]() Here’s a copy of the text from the beginning of the Standard: This version is also referred to as A11:2021. The only difference between the EN ISO version and the International ISO version is that the EN ISO version includes harmonization Annex ZA for compliance with the EU MDR and Annex ZB for compliance with the EU IVDR. If you purchase a copy, we recommend selecting the option for a multi-user license so the standard can be used by more than one person in your company and printed. If you are looking for the best place to purchase a copy of the ISO 13485:2016 standard, we recommend the Estonian Centre for Standardisation and Accreditation. Yes, you need to maintain a copy of the ISO 13485 standard as a “document of external origin.” This is needed for reference when you are making updates to procedures in your quality system. Do you have to purchase a copy of ISO 13485? If your company wants to design, manufacture, or distribute medical devices you should consider becoming ISO 13485 certified. ISO 13485:2016 is the most recent version of the standard, and it has become the blueprint for medical device company quality systems globally. ISO 13485 is an international standard for quality management systems that is specific to the medical device industry. ![]()
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