The biotechnology development headquarter held the workshop of production quality management and analysis of risk and ISO 13485 systems for active knowledge-based companies in the area of biotechnology.

According to the public relations and information center of the Vice-Presidency for science and technology affairs, the production quality management and analysis of risk and ISO 13485 systems was held in the presence of 12 representatives of active knowledge-based companies.

The main goal of this workshop was familiarization of the present companies with presentable services by standard production and quality management of final product’ companies and evaluation of risk-taking of products to enter the market. 

The ISO 13485 medical equipment management standard has been designed to help the organizations in design, development, install and establishment of products and services in the area of medical equipment. This standard contains requirements that must be adhered by organizations in the design, development and provision of relevant services.

In fact, this standard complements the requirements of ISO 9001 standard. The audit process in these two standards are similar and all general documents of quality management system are evaluated during the audit process.  

With regard to the importance of quality management systems and specialization of standards in various industries, especially medical industries which are related to the health of human beings, these standards are of paramount importance. For instance, risks of diseases caused by consumption of a product can be avoided by using this standard. Moreover, all items of good manufacturing process, that are applicable in these industries, are taken into account.