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Ward Engineering Earns ISO 13485:2003 Certification
The ISO 13485 standard is an internationally recognized Medical Device Quality Management System (QMS) standard developed by the International Organization for Standardization (ISO). To be certified to the standard, companies must implement a Medical Device QMS ensuring steps have been taken to identify, manage and minimize the risks involved with the design and manufacturing of medical devices. Certification to ISO 13485:2003 reinforces to customers through an independent third-party that Ward Engineering operates their Medical Device QMS in accordance with the standard. "It is our goal to provide the high degree of personal customer service, ethical business practices and quality symbolic of Ward Engineering since it was founded in 1991," stated Tom Ward, the company's President. "Our quality system adheres to the regulations of the FDA, and this certification demonstrates our commitment to designing and manufacturing safe and effective world-class medical devices for our Clients and meeting and exceeding their expectations." "For a research and development company that has been in business and evolving for the last 17 years; fine-tuning creative processes into a quality management system was an incredible undertaking," stated Rebeccah Quam, Ward's Quality Manager. "Ward employees have been operating on documented procedures since the inception of the Company; now those procedures have been formalized and are auditable by BSI, a recognized leader in the quality systems registrar industry. It's taken significant diligence from our employees to document and learn systems that cover all the bases of the ISO 13485 standard and we are very proud of this certification." About Ward Engineering Ward Engineering, Inc. is a research and development engineering and manufacturing firm, founded in 1991, and located in the Tech Corridor of Columbus, Ohio. Ward has focused energies towards medical devices while maintaining activities in other technical fields. Ward's expertise in design control and innovative problem solving has been instrumental in creating disposables, surgical tools, therapy delivery devices, and implants. Engineering services include medical or other system design, concept development, critical testing, verification, validation, documentation and turn-key manufacturing. Ward facilities include the major design and engineering software packages, a range of test equipment, a fully complemented precision CNC facility, as well as a clean room for assembly. Visit the Ward Engineering website at: www.wardengineering.com Contacts: Tom Ward, President, (614) 228-8008 ext. 200 | ||
published date: 10-18-2007 |
COLUMBUS, OH – August 31, 2007 — Ward Engineering, Inc., a medical device design, development, and manufacturing company, today announced that it has achieved ISO 13485:2003 certification from BSI Management Systems.