ISO 9001 is suitable for any organization that wants to improve the way it operates and its management, regardless of size or business area. The best return on investment, however, is recorded in the companies that are willing to apply it throughout the organization and not only in offices, departments or divisions. ISO 9001 is also designed to be compatible with other management systems standards and specifications, such as OHSAS 18001 (health and safety) and ISO 14001 (environment). The integrated management allows you to integrate them seamlessly and get a great price / performance ratio thanks to the sharing of numerous principles. ISO 13485 specifies requirements for a quality management system suited for an organization who needs to demonstrate its ability to provide medical devices and related services that meet customer and regulatory requirements in providing medical devices and related services. The ISO 13485 starts with the intention of merging together the previous ISO 13485-13488, supplementing and updating the content of both. The ISO 13485 primary objective is to facilitate harmonized quality management systems medical device regulatory requirements. Therefore it includes some specific requirements for medical devices and excludes some of the ISO 9001 requirements that are not suitable for the purpose of regulation. For this reason, organizations that conform to ISO 13485 can not claim conformity to ISO 9001 unless their quality management system comply with all requirements of ISO 9001.
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