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Certifications
AS 9100 – ISO 13485 – ISO 9001 – ITAR – Future Certifications
In support of the markets that Gowanda Electronics serves, the company has pursued and achieved the following Quality Management System (QMS) certifications:
AS 9100
This standard goes above and beyond traditional ISO 9001 requirements and specifies nearly 100 additional requirements relating to quality, safety and reliability, in order to provide a quality management system that addresses the specific needs of the aerospace industry. The AS 9100 offers a common standard for the global marketplace and is expected to become a necessity for doing business within the aerospace and aviation markets.
- AS 9100 Certification (PDF)
- AS 9100 Quality Manual - Rev. J (PDF)
Some benefits of AS 9100 certification:
- Well documented processes & procedures
- Quality levels are consistently measured and improved
- Defect rates should decrease
- Early defect detection
- Improved operator efficiencies
- Improved customer satisfaction
- More top down management involvement
- Utilizes risk management practices, FMEA's, Control Plans, Gage R & R's
- Traceability of test equipment used for product acceptance
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ISO 13485
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 Electronics 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 Electronics as a leader in this field.
Some benefits of ISO 13485 certification:
- Improved documentation of processes & procedures
- International recognition with FDA regulations
- Traceability of test equipment used for product acceptance
- Improved processes, product & service quality
- Improved process efficiencies
- Affirms commitment to the medical industry
- Utilizes risk management practices, FMEA's, Control Plans, Gage R & R's
- Early defect detection
- Improved customer satisfaction
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ISO 9001
The ISO 9001 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.
The Benefits of ISO 9001:
- Establishes processes and systems to enable improvement within the company
- Demonstrates to customers and potential customers that you are proactive and take quality seriously
- Satisfies the requirement by some customers to have suppliers ISO 9001 certified, in order to do business with them
ITAR
Gowanda Electronics Corp. is ITAR (International Traffic in Arms Regulations) Registered. A registration has been issued to Gowanda Electronics Corp. by the US State Department Directorate of Defense Trade Controls (DDTC) Compliance Registration Division (CRD). Gowanda Electronics Corp. has created and implemented an Export Compliance Program in support of the registration.
Future Certifications
Gowanda will continue to work towards other certifications in keeping with market needs. The information on this page will be updated as developments occur.
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