QUALITY CERTIFICATIONS: ISO 9001 AND ISO 13485
The standards of the ISO 9000 series have been defined by the International Organization for Standardization, the most important worldwide organization for the definition of technical standards and requirements for quality management systems within companies. These are general and flexible rules, applicable to the most varied processes and business sectors. ISO 9001 is the best known and most used standard for quality systems throughout the world: in fact, more than a million companies are now certified according to this standard in 170 different countries. ISO 9001 is a certificate, “a brand”, te possession of which demonstrates that the company’s activities reflect the minimum requirements of the ISO 9001 standard; in this way the end customer can have full confidence that the services and products placed on the market correspond to certain specifications and that all the phases relating to their realization can be traced and verifiable. The adoption of ISO 9001 certification is not mandatory, but its possession is becoming increasingly essential to face all the challenges of the market.
ISO 13485 defines a company-specific quality management system standard that assists both in the design and manufacture of medical devices and related services, including aspects of the ISO 9001 standard and specific requirements for the medical sector. The standard has been harmonized taking into consideration three European directives associated with: medical devices, in vitro diagnostic medical devices, active implantable medical devices. Having a management system certified according to ISO 13485 criteria allows you to demonstrate compliance with the three directives, demonstrates the company’s willingness to pursue continuous improvement and to provide its customers with the proven ability to place safe products on the market. ISO 13485 concerns all device manufacturers who sell their products not only in the European Union, but also in the rest of the world; at the same time, it interests and involves suppliers of special processes, such as sterilization, suppliers of related services, such as transport and installation, but also companies that deal exlusively with their marketing. In Europe, the standard is the reference for quality management systems relating to medical devices, consequently it offers the guarantee of the conformity of the system itself, in the event of an assessment of the requirements for affixing the CE marking by a notified body. Referring to the global market, there are countries such as Canada for example, which require ISO 13485 certification as an indispensable condition for the marketing of medical devices.
ALTAVIA GETS THE CERTIFICATIONS
The certification audit, carried out by an accredited body, verified the compliance of the system with the requirements of the standard and, ascertaining its validity, issued the certificate which will be valid for three years, but which, at least annually, must be reconfirmed with the first and second surveillance audits to verify the effective maintenance of the system itself. When the certificate exipires, a renewal audit will be carried out to extend its validity for a further three years. In May 2022, the certification attests to all parties that the Altavia organization operates in compliance with the requirements estabilished in the reference standard; therefore, it represents an element of guarantee that can be spent towards third parties. Altavia has therefore obtained the ISO 9001 and ISO 13485 quality certifications and complies with all the regulations that meet the requirements of medical devices. These certifications have increased the level of recognition of Altavia which aims at a future in constant and continuous professional and qualitative growth.