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AS9100D with ISO 9001:2015
AS9100D Aerospace Management Systems is a widely adopted and standardized quality management system for the aerospace industry. AS9100D encompasses ISO 9001, with additional requirements for quality and safety relevant to aerospace and defines the quality management systems standard for the industry. The ISO 9001:2015 standard contains requirements affecting virtually all aspects of any company. Because ISO 9001 is designed for any company of any size and in any industry, the requirements are rather broad but incorporate the following elements: quality management system, management responsibility, resource management, product realization and measurement/analysis/improvement.
This standard is an international standard recognized throughout the world for establishing a business management system specific to the medical device industry. This ISO certification is applicable to organizations that are involved in the manufacture of medical devices, and to companies like Gowanda that manufacture components for such devices. In addition to typical ISO documentation control and record-keeping requirements, ISO 13485 also includes risk management elements and greater emphasis on root cause analysis, with long term reliability as the overall goal.
Gowanda is the first inductor manufacturer to attain ISO 13485, establishing Gowanda as a leader in this field.
Gowanda-GEC,LLC is ITAR (International Traffic in Arms Regulations) Registered. A registration has been issued to the company by the US State Department Directorate of Defense Trade Controls (DDTC) Compliance Registration Division (CRD). Gowanda-GEC, LLC has created and implemented an Export Compliance Program in support of the registration.