Your Company developed and implemented a Quality Management System in order to document the company’s best business practices, better satisfy the requirements and expectations of its customers and improve the overall management of the company.

The Quality Management System of Your Company meets the requirements of the international standard ISO 13485:2016. This system addresses the design, development, production, installation, and servicing of the company’s products.

The manual is divided into eight sections that correlate to the Quality Management System sections of ISO 13485:2016. Each section begins with a policy statement expressing Your Company’s obligation to implement the basic requirements of the referenced Quality Management System section. Each policy statement is followed by specific information pertaining to the procedures that describe the methods used to implement the necessary requirements.

This manual describes the Quality Management System, delineates authorities, inter relationships and responsibilities of the personnel responsible for performing within the system. The manual also provides procedures or references for all activities comprising the Quality Management System to ensure compliance to the necessary requirements of the standard.

This manual is used internally to guide the company’s employees through the various requirements of the ISO standard that must be met and maintained in order to ensure customer satisfaction, continuous improvement and provide the necessary instructions that create an empowered work force.

This manual is used externally to introduce our Quality Management System to our customers and other external organizations or individuals. The manual is used to familiarize them with the controls that have been implemented and to assure them that the integrity of the Quality Management System is maintained and focused on customer satisfaction and continuous improvement.