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Quality Manual Quality Manual Page 4 of 31 EForm-0411-11 Company Profile This Quality Manual applies to the following operations: Moog Medical Devices Group Manufacturing Solutions (Buffalo), Moog Medical Devices Group Life Science Laboratories (Rush) and Moog Medical Devices Group Sterilization (Erie). All three locations were previously IMSXpress ISO 13485 Template Documentation is part of IMSXpress ISO 13485 software. The template documentation covers both ISO 13485:2003 and FDA QSR (21 CFR Part 820) requirements under one quality system, and is thus ideally suited for companies that must comply with both the US FDA and international regulations. Writing a short Quality Manual for ISO9001 implementation allows easy management and can be used to promote your company's Quality Management System. In many cases the Quality Manual will identify none, but the most common exclusion is the requirement of the ISO 9001 standard for "Design The Supplier Quality Agreement defines the expectations for all Helmer Scientific suppliers. The supplier agrees to meet or exceed the requirements and guidelines defined in this document. Throughout this document, the word "shall" or "must" indicates a requirement. The word "should" indicates a recommendation. This manual and all other Litron quality management documentation are proprietary. All unauthorized use is prohibited. This Quality Manual applies to all activities and personnel associated with the processes depicted in the Process Interaction Diagram shown in Section 3 of this manual. Litron applies this quality management 1.2.2 The quality system complies with the international standard ISO 13485:2003. List any other standards with which your quality system complies, for example, ISO 9001, 21 CFR Part 820 (FDA's QSR), other national regulations, etc.. 1.2.3 The manual is divided into eight sections modeled on the sectional organization of the ISO 13485:2003 FDA 21 CFR §820 Title 21 Food and Drugs, Subchapter H Me

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