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
AltaVia has gained direct experience in adopting, managing, and auditing quality systems for the medical sector. We previously obtained and maintained ISO 13485 certification for the production and marketing of the RamWeb medical device software version 4.0.0, implementing processes, controls, and traceability compliant with the relevant standards and regulations.
The company currently operates with an ISO 9001-certified quality system.
What this means for our clients
- The skills, procedures, and documentation developed for ISO 13485 remain in place within the company.
- We can quickly reactivate an ISO 13485-compliant system should a project require it, supporting the client through certification.
- We continue to operate with an ISO 9001-certified quality system and with risk management, validation, and traceability methodologies derived from our experience in the medical field.
