Certifications

The International Organization for Standardization (ISO) use numerous certification bodies to audit organizations.  After successfully passing the audit, a company is then issued ISO 9001 compliance certificates. Although commonly referred to as "ISO 9000” certification. The current standard to which an organization's quality management system can be certified is ISO 9001:2015

An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products, services, and processes.  The certificate is limited by a certain scope for each manufacturing facility For example, (production of injection molded parts, or machined parts or stamped parts).  Each certificate will list/describe what core competencies to which the certificate refers.

An ISO 9001 certificate is regularly renewed so it is not a once-and-for-all award but must be renewed at regular intervals recommended by the certification body, usually once every two to three years. There are no grades of competence within ISO 9001: It is a pass or fail certificate either a company is certified and receives the certificate or they fail the audit and they do not receive the certificate. 

Nadcap is company-level accreditation based on specific processes used by aerospace suppliers such as chemical processing, coatings, conventional machining, heat treating, nondestructive testing and welding among others.  It is an industry-managed approach to conformity assessment of 'special processes required in the Aerospace and Defense industry. 

The aerospace industry has unique requirements for quality management, which is why many companies that deliver products and services within the aviation, space and defense spheres work to earn AS9100 certification. This standard sets quality management system requirements with the challenges of the aerospace industry in mind.

An ISO system focused on medical devices/components and assemblies. ISO 13485:2016 specifies the 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 and applicable regulatory requirements. 

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size.  Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

IATF was developed by the International Automotive Task Force.  IATF 16949 certification is often an industry requirement for manufacturers wanting to supply parts/assemblies into the automotive industry.  It builds upon ISO 9001and aligns automotive quality management systems throughout the world. It defines the quality system requirements for the design, development, manufacturing, installation and servicing of automotive-related products.

(ITAR) is a set of government regulations related to defense exports and re-exports of specific commodities, defense services, and technical data. A company is subject to ITAR if they ship or transmit items or technical data that has been designed, developed, adapted, or modified for military use under the United States Munitions List (USML). ITAR registration is how the U.S. Government tracks the shipment and activities of companies involved with defense-related products, services, and data. All manufacturers, exporters as well as brokers of defense articles pertaining to defense services as defined on the United States Munitions List are required to register.