Hibernicor is a quality driven organization which has aligned its people, process, and technology throughout the medical device manufacturing lifecycle.

Quality statement:

Our company is committed to maintain and continuously improve product quality, reliability to deliver safe and effective products by complying with all applicable requirements and regulations. We will strive for excellence by maintaining an effective quality management system for the products, services, supplier and customer relationships.

Quality Management System

Hibernicor has established an electronic Quality Management System which is a set of business processes implemented to help the organization deliver products which consistently achieve customer satisfaction. This is an effective system for managing quality which translates Hibernicor’s purpose and goals into policies and resources which allows adoption of structured guidance in the form of standardized procedures.

Supply Chain

Because Hibernicor is a medical device manufacturer of finished products designed for human use, it critical that we partner with suppliers who can help meet our goals.  We recognize that our suppliers are integral of the quality process and have central role in providing innovative high quality & low cost medical products.  It is important that our global suppliers are able to maintain standardized controls in the work environment to ensure product safety.  These include documenting and validating processes during product design, development, and manufacturing, as well as verification of the effectiveness of corrective and preventative actions.

Such standards include:

ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
FDA 21 CFR Part 820 Quality System Regulation – Medical Device Good Manufacturing Practices
ISO 9001 Quality management systems – Requirements
MIL-STD United States Military Standards
NIST National Institute for Standards and Technology
DIN Deutsches Institut für Normung e.V. (German Institute for Standardization)

Hibernicor maintains a reference library of regulatory standards and specialized guidance documents which is available to qualified suppliers. A supplier quality manual is available:

Hibernicor Supplier Quality Manual