{"id":1749,"date":"2021-02-11T10:28:43","date_gmt":"2021-02-11T10:28:43","guid":{"rendered":"http:\/\/medicallab.coreco.es\/?p=1533"},"modified":"2026-07-01T15:54:39","modified_gmt":"2026-07-01T15:54:39","slug":"manufacturing-of-medical-refrigerators-in-accordance-with-iso-13485","status":"publish","type":"post","link":"https:\/\/medicallab.coreco.es\/en\/fabricacion-de-refrigeradores-medicos-segun-la-norma-iso-13485\/","title":{"rendered":"Manufacturing of medical refrigerators in accordance with ISO 13485"},"content":{"rendered":"

In this post, we\u2019ll take a closer look at the most important aspects of manufacturing medical refrigerators in accordance with the ISO 13485 standard and the quality process requirements this entails for the manufacturer<\/p>\n\n\n\n

The Importance of the ISO 13485 Standard<\/h2>\n\n\n\n

In the case of medical-grade refrigerators\u2014perhaps more so than with any other product\u2014quality directly affects the effectiveness of the device and the safety of patients, users, and possibly others. <\/p>\n\n\n\n

For this reason, many national regulations require manufacturers and suppliers of medical refrigerators to demonstrate that they have a quality management system that has been independently audited and certified.<\/p>\n\n\n\n

Medical devices manufactured or offered by companies that do not have a certified quality management system often face greater difficulties in gaining approval in major markets. <\/p>\n\n\n\n

Expiration of the regulation<\/h4>\n\n\n\n

Companies that already hold a certificate under the EN ISO 13485 standard were required to transition their certification to the new standard by May 31, 2019. All certificates issued under the old standard will now remain valid for a period of three years until the European Commission publishes the expiration date of the superseded standard. <\/p>\n\n\n\n

After this publication, the expiration date will become the validity date. Manufacturers with certificates that still have a longer validity period should prepare in advance and ensure that their certificate is converted to the new EN ISO 13485:2016 standard before the expiration date of the old standard.<\/p>\n\n\n\n

What is the ISO 13485 standard?<\/h2>\n\n\n\n

The EN ISO 13485 standard, \u00abMedical Devices: Quality Management Systems\u2014Requirements for Regulatory Purposes,\u00bb addresses the Requirements that manufacturers and suppliers of medical devices must meet <\/a>in the development, implementation, and maintenance of management systems for the medical device industry. <\/p>\n\n\n\n

Originally developed in the 1990s, the standard sets forth requirements for quality management systems that meet customer requirements as well as regulatory requirements in the European Union (EU), Canada, and other major markets around the world.<\/p>\n\n\n\n

The EN ISO 13485 standard has a scope and purpose similar to those of the ISO 9001 standard, but it contains additional requirements specific to medical devices\u2014including medical refrigerators\u2014and revises some of the requirements of the ISO 9001 standard. <\/p>\n\n\n\n

Therefore, in most markets, certification under ISO 9001 is not an adequate substitute for certification under the requirements of EN ISO 13485.<\/p>\n\n\n\n

Harmonized Versions of ISO 13485 (EN ISO 13485)<\/h4>\n\n\n\n