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.
Gowanda fully supports the initiatives set forth by the EICC (Electronics Industry Citizenship Coalition) and the GeSi (Global e-Sustainability Initiative) pertaining to “Conflict Minerals”. We encourage all our suppliers to take the appropriate steps to continuously monitor both direct and indirect supply chain functions to avoid the procurement or use of “Conflict Minerals”.
Gowanda now requires a completed EICC/GeSi Conflict Mineral Reporting template from each of our suppliers. This template will undergo a review process every year, from August 1st to the 15th. This review will ensure we are sustaining our commitment to the Dodd-Frank Act, and our commitment to being responsible global citizens.
For more information regarding Conflict Minerals, see the following links:
Protecting, nurturing and improving our natural environment is something we take seriously. To this end, we:
- Work aggressively to reduce our waste stream by all means possible, including finding recycling methods for all unused materials where possible.
- Work aggressively to replace ozone-depleting chemicals, other environmentally-harmful products and potentially human-harmful chemicals from our processes and operations.
- Diligently monitor our processes and operations to verify that we are in full compliance with the spirit, intent and letter of all laws dealing with the protection of the environment.
Gowanda has established a Quality Policy that has been approved by the top levels of management. It is posted throughout our facility and is available to interested parties upon request. It states:
Gowanda has made a commitment to continuously improve our QMS to supply superior quality products and services to our customers that will meet or exceed their requirements, both real and perceived, recognizing that every employee must share in the responsibility of producing a quality product.
Gowanda’s Quality Manual is designed to address key requirements, not ALL requirements for our QMS. It meets the basic quality manual requirements for all standards indicated in the scope.
Quality Requirements For Suppliers
A document entitled Supplier Quality Requirements for Purchased Materials or Services provides information about the terms and conditions relating to the quality of materials and services supplied to Gowanda that are used in the final component or production of product.
In keeping with the needs of specific applications, reliability testing (HRIP Life Test) has been done for many, but not all, of Gowanda’s products. You can access the available information here. For additional assistance please contact Gowanda.
Gowanda offers RoHS-compliant and lead-free alternatives. We are committed to supplying superior quality products and meeting ever-changing global environmental regulations, and we offer RoHS 3 compliant products that meet the requirements as defined in the EU Directive 2015/863. Details of specific RoHS products, solder finishes, marking and packaging methods can be found on our website.
Gowanda’s Definition of a “Lead Free Component”
Gowanda defines a lead free component as one that is produced with a true 100% lead free solder alloy on both the internal joint connections and external lead finishes of the component.
Note: Gowanda does not claim the exemption outlined in paragraph 7 of the Annex table allowing a solder alloy of 85% lead or greater to be used in its lead free products. Please refer to the EU Directive for further information.
Gowanda’s Definition of a RoHS Compliant Component
Gowanda defines a RoHS component the same as its lead free component. A lead free component can be considered as being RoHS compliant by meeting the 0.1% of the homogeneous material of the device requirement and, in addition, is also compatible with 260°C soldering processes, verified through internal product testing. Upon request, we offer a RoHS compliant component using high temperature solder on the internal joint connections and a lead free finish on the external lead terminals. Contact us for details.
RoHS and Lead Free Marking
RoHS and lead free products will typically be identified using an “LF” (lead free) suffix following the part number tolerance. For example, 10M472KLF. All bulk, reel and outer container labels will be identified in accordance with JESD97 marking standard for lead free products as shown.
Lead Free Solder Type
Gowanda currently utilizes SnCu solder as its lead free solder.
In most cases, when ordering RoHS and lead free products, the LF suffix will be assigned to the part number and identified on the purchase order as described in the marking example above. Since there are some exceptions to using the LF suffix, please contact Gowanda for assistance prior to placing your order.
Current Catalog Parts
Gowanda’s current standard catalog product will remain unchanged and will continue to be available upon request.
RoHS and lead free products are currently available upon request. Contact Gowanda’s sales department at email@example.com or ask customer service for details at (USA) 716-532-2234.
Gowanda offers several soldering profiles for your reference: