Medical Device Directory

Quality Control Systems and Services

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P.O. Box 3411
San Clemente, CA 92674-3411
Phone: click for phone
About Quality Control Systems and Services
  • QCSS under the leadership of Senior Consultant and President Gunter B. Gumpp has been providing quality system services since 1972 and was one of the first consulting companies offering its services on the internet world wide. As of today we have assisted close to 1200 companies to meet respective quality standard requirements for ISO 9001- for commercial products, ISO13485-medical devices, AS 9100-aerospace parts, AS9120-distributor of aerospace components and TS 16949 -automotive products, in form of consulting, training, implementation and certification audit services.

    We also provide QCSS patented Quality and Procedure Manuals and Audit Checklists enabling a company to self-implement and/or improve existing QMS documentation with the best current practices the industry offers. In addition we provide consulting services from start to finish to help you achieve product CE Mark certification that will enable you to offer your product in the EU market. For more information please log on to our web site or call us for a free consultation
Competitors of Quality Control Systems and Services
  • mdi Consultants, Inc.

    mdi Consultants, Inc. is a leader in providing consulting services to the healthcare industry worldwide. We have extensive expertise in helping medical device, pharmaceutical, biotechnology and food companies achieve compliance with U.S., European and Canadian regulations. Read More
  • RCRI

    For more than a decade, RCRI has been turning medical product concepts into successful, revenue-generating businesses for clients worldwide. More than 450 companies – from entrepreneurial start-ups to Fortune 100 market leaders – have experienced the value of RCRI’s expert insights. RCRI... Read More
  • D&K Engineering Inc

    D&K Engineering is a global product realization company specializing in the design, engineering and manufacturing of complex electro-mechanical products and equipment. With integrated R&D, engineering and contract manufacturing capabilities in both San Diego and Singapore, D&K Engineering works... Read More
Products by Quality Control Systems and Services
  • ISO 13485-2003 Medical Device Quality & Procedure Manual (ISBN 1-881006-80-8)

    This all in one Quality and Procedure Manual meets ISO 13485 - 2003 as well as ISO 9001-2008 Standard requirements and is specifically designed for the Medical Devices Engineering and Manufacturing Industries. The Hardcopy Manual contains the following: Policies and Objective addressing each... Read More
  • Internal Audit Checklist and Guide how to Audit (ISBN 1-881006-85-5)

    This is a 24 page Internal Audit Checklist and Guide How to Audit; it addresses each ISO 13485-2003 and ISO 9001-2008 Standard requirement in form of 328 questions including a simple to use Rating System, enabling the user to measure and provide metrics in regard to quality management system... Read More