As of December 12, 2006 High Point Precision is compliant to ISO 13485:2003,
adding to our already certified ISO 9001:2000. Compliance means we abide
by the standards for the medical device directive. We will be certified the first
half of 2007 when we complete the audit process. Here is a
brief introduction from that manual.
High Point Precision Products, Inc. has 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 High Point Precision Products, Inc. complies
with the requirements of the international standards ISO 9001:2000 &
ISO 13485:2003. This system addresses the comprehension, planning
and production of the company's products.
The manual is divided into eight sections that correlate to the Quality
Management System sections of ISO 13485:2003 and expands on the sections
of the ISO 9001:2000. Each section begins with a policy statement
expressing High Point Precision Products, Inc.'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.
High Point Precision Products, Inc. manufactures and supplies
precision metal parts to our customer's specification. The company serves
medical/dental, aerospace, nuclear, automotive, fiber optic and military
customers. Medical and dental parts, which are turned and milled, are used for
tooling or as parts in implantable parts. The products comply with medical
standards for an implantable medical device. Sterilization is the
responsibility of the medical and dental customers but the company utilizes
procedures to prevent or remove cleaning or manufacturing contaminates.
At High Point Precision Products, Inc. we focus on utilizing our facility and personnel
to maximum efficiency. Our processes are reviewed on a regular basis to allow
us to provide a product of the highest quality and dependability. It is our
belief that our customers will benefit from these efforts and we will gain their
confidence and their continued business.
At High Point Precision Products, Inc., we procure our products through reliable and conscientious suppliers that
have proven themselves with years of excellent results. Our products are made
to our customer's exacting specifications with repeatable quality. We are a
well-managed company that accepts only the finest work from our staff and
suppliers.
The primary mission of High Point Precision Products, Inc., as it relates to its customers,
is to offer flawless products, responsive services and quick delivery. We
strive to provide service in a professional manner so that our customers will
come back again and again. The result of accomplishing our mission to our
customers will be increased customer satisfaction and increased market share.
An essential requirement of the continuing maintenance and development of the
Company's objectives is the implementation and compliance to a quality system
that conforms to ISO 13485:2003 and ISO 9001:2000 standing.
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