ISO 9001 is the world’s most widely recognized Quality Management System (QMS). It belongs to the ISO 9000 family of quality management system standards (along with ISO 9004), and helps organizations to meet the expectations and needs of their customers, amongst other benefits.
An ISO 9001 quality management system allows companies to continually monitor and manage quality across all operations, and outlines ways to achieve, as well as benchmark, consistent performance and service. Internationally, it is the quality system of choice!
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. ISO9001 is focused on continual improvement whereas, ISO13485 is more focused on risk management and the effectiveness of procedures, standards, etc..
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
Certification under the JCP establishes the eligibility of a U.S. contractor to obtain technical data governed, in the U.S., by DoD Directive 5230.25. A certification is required by U.S. contractors that wish to obtain access to unclassified technical data disclosing militarily critical technology with military or space application that is under the control of, or in the possession of the U.S. Department of Defense (DoD). Contractors must submit a DD Form 2345 to the Joint Certification Office, along with a copy of the company’s State License, Incorporation Certificate, Sales Tax Identification Form or other documentation which verifies the legitimacy of the company. The Defense Logistics Information Services (DLIS) in Battle Creek, MI is the only authorized source of these Certification Numbers.
The U.S. Government requires all manufacturers, exporters, and brokers of defense articles, defense services, or related technical data to be ITAR (International Traffic in Arms Regulations) compliant.
For a company involved in the manufacture, sale or distribution of goods or services covered under the United States Munitions List (USML), or a component supplier to goods covered under the USML, the stipulation or requirement of being “ITAR certified (compliant)” means that the company must be registered with the State Department’s DDTC (Directorate of Defense Trade Controls) and must understand and abide by the ITAR as it applies to their USML linked goods or services.
All import and export laws of the United States is performed by Homeland Security Investigations Special Agents (formerly U.S. Customs) within Immigration and Customs Enforcement, an agency of the Department of Homeland Security. Additionally, Customs and Border Protection Officers, also under the Department of Homeland Security, inspect imports and exports at U.S. Border Crossings and International Airports and enforce import and export regulations.