Industrial Radiation Sources - High Technology Sources Ltd

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QA Information System & Regulations Quality Management System (ISO9001:2000) Eckert & Ziegler Isotope Products (formerly known as IPL: Isotope Products Laboratories) established in 1967 is a manufacturing company specializing in the production of various types of radiation sources. Its products cover the development, manufacturing, testing, calibration, and sale of radioactive sources for medical, industrial, analytical, and environmental applications. The Quality Management System used at Eckert & Ziegler Isotope Products enables management and employees to comply with its Quality Policy and to realize its objectives. The Quality Management System provides for an organized systematic approach to activities affecting quality, including verification. It assures that each activity has been satisfactorily performed, and demonstrates that the desired level of quality has been achieved in order to achieve customer satisfaction. The Quality Management System governs activities conducted at the following Eckert & Ziegler Isotope Products locations: 1800 North Keystone St., Burbank, California 91504 1811 Keystone St., Burbank, California 91504 2319 Empire St., Burbank, California 91504 24937 Avenue Tibbitts, Valencia, California 91355 Eckert & Ziegler Isotope Products’ goal is to assure that products are manufactured, tested, and calibrated to contractual requirements including performance, function, and delivery, and to realize Quality Management System objectives. 62
Eckert & Ziegler Isotope Products complies with the following Regulations and Standards. • ISO 9001:2000, Quality Management Systems Requirements • ISO 9001:1994, Quality Systems - Model for Quality Assurance in Design, Development, Production, Installation and Servicing • ISO 13485:1996, Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9001 • ISO 13485:2003, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes • CMDR: Canadian Medical Device Regulations, sections 1 to 78 • ISO 14971:2000, Medical Devices – Application of Risk Management to Medical Devices • Food and Drug Administration (FDA), 21 CFR 820, Quality System Regulation • 93/42/EEC, Medical Device Directive • ISO/TR 10013:2001 Guidelines for quality management system documentation • ISO 9000:2000(E), Quality Management Systems – Fundamentals and Vocabulary • 10 CFR 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants • ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories • ISO 2919:1999, Radiation Protection – Sealed Radioactive Sources – General Requirements and Classification • ISO 9978:1992, Radiation Protection – Sealed Radiation Sources – Leakage Test Methods • Nuclear Regulatory Commission, 10 CFR Parts 1-50 • Title 17, State of California Code of Regulations, Division 1, Chapter 5, Subchapter 4 (Radiation) • NIST / NEI, National Institute of Standards and Technology / Nuclear Energy Institute • Department of Transportation (DOT), 49 CFR Parts 100-185 • IAEA, International Atomic Energy Agency; Regulations for the Safe Transport of Radioactive Material (IAEA TS-R-1) • IATA Dangerous Goods Regulations; International Air Transport Association • ICAO, Internation Civil Aviation Organisation • ISO 14971:2007 63
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Industrial Radiation Sources Produc
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Product Finder Available Radionucli
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Am-241 Standard Capsule Designs Am-
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Am-241 / Be Standard Capsule Design
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Page 32 and 33: Cs-137 Standard Capsule Designs Am-
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Page 44 and 45: Fe-55 Standard Capsule Designs Am-2
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Page 48 and 49: Kr-85 Standard Capsule Designs Am-2
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Page 52 and 53: Mössbauer Sources Mössbauer Effec
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Page 67 and 68: Quality Assurance Eckert & Ziegler
Page 69 and 70: A Note on Special Form The safety c
Page 71 and 72: Capsule Data Capsule Radionuclide M
Page 73 and 74: Capsule Data Capsule Radionuclide M
Page 75 and 76: SEALED SOURCE USAGE / TEST & CLASS
Page 78 and 79: Inquiry Form Form and Instructions
Page 80: Eckert & Ziegler Isotope Products 2
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Industrial Radiation Sources - High Technology Sources Ltd

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