ISO 9001:2015 Certification

Coarc Contract Manufacturing: FDA Registration, ISO 9001: 2015 Certified

Coarc Manufacturing applies stringent quality control methodologies to every aspect of production. Our expertise is backed by a strong labor force with qualified personnel, guaranteeing that your product will be of the highest quality, produced on-time and to your exact quality requirements.

Coarc Manufacturing is proud to announce the successful completion of the ISO 9001:2015 certification process and is now an ISO 9001:2015 Certified business. The International Organization of Standardization (ISO) is a worldwide organization that develops many different kinds of standards that customers look for when choosing a supplier for their business needs.  Implementing an ISO 9001:2015 program ensures a good Quality Management System that focuses on enhancing customer satisfaction and continual method and product improvement.  As a result of completing ISO 9001:2015 Certification, Coarc has organized well-defined and documented procedures that improve the consistency of output. These procedures are focused heavily on a robust preventive/corrective action process that effectively drives down defect rates. These procedures not only allow for defects to be recognized and eliminated earlier, but also identify and help eliminate inefficient manufacturing practices.

Both our Mellenville and Hudson, NY facilities feature:

• FDA registration
• ISO 9001:2015 Certification
• Able to support lot traceability
• FAI
• In-process inspection
• Functional certification

 Our Quality Policy

Since our origination in 1965 as a contract manufacturer, Coarc Manufacturing has maintained constant allegiance to the highest quality standards and pursues the qualification certifications required by key clients.

Our quality policy is to be an ethical, customer-oriented workforce continuously improving to meet our customers’ needs in a timely manner. We will work with you to design the optimal level of inspection and quality documentation you require within your budget constraints. We have the ability to provide accurate, consistent measurement to demonstrate the required level of quality control.

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