At Able, our customers can trust that we will treat their parts with care. As part of being an ISO 9001 and ISO 13485 registered company, and a supplier to medical device and aerospace customers across the country, Able Electropolishing has completed the validation of its electropolishing and passivation processes in accordance with “Quality Management Systems – Process Validation Guidance” authored by SG3 and endorsed by The Global Harmonization Task Force. Able chose this document as a foundation for its process validation because of the representation of individuals in medical device regulatory agencies.
The guidance obtained from this document was used to assist Able in continuing to improve our quality management systems and to address the requirements of our manufacturing customers in all industries, but specifically in the medical device industry, which we consider to have the tightest controls and regulations surrounding process validation.
Electropolishing and Passivation Standards
Able adheres to international standards of excellence, ensuring that we consistently provide a variety of high-quality metal finishing services.
We meet standards set by:
- ASTM (The American Society for Testing and Materials)
- ASME (Formerly The American Society of Mechanical Engineers)
- SAE (Formerly The Society of Automotive Engineers)
- ISO 9001 (The International Organization for Standardization)
- ISO 13485 (The International Organization for Standardization)
By meeting or exceeding the various standards set by these organizations, we can provide services like electropolishing, passivation and more while giving our clients a sense of true security in our quality. When you work with Able Electropolishing, you can enjoy the peace of mind that we are meeting high standards, whether you’re sending us one part or thousands.
These standards allow us to provide finishing services for critical parts in industries like pharmaceutical, medical device, aerospace, automotive, appliance and more.
For more information about these standards and our own practices for electropolishing and more, please contact our sales department at firstname.lastname@example.org or call us at 866-465-8427.