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Quality Control Systems and Services

Standards, Manuals & Quality Management Systems

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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

Company Details

Address
P.O. Box 3411
San Clemente, CA 92674-3411

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Products & 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...

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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...

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Categories

Business Services > Consulting and Training Services
Regulatory & Quality Control > ISO 13485 Consultants
Med Device Med Rect 4.30.26
Med Device