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1 QM-1 SUPPLEMENT QUALITY MANAGEMENT SYSTEMS MANUAL Revision 6 Page: 1 of 6

2 APPROVED BY: TITLE DATE Electronic Signature on file Quality Director 10/3/15 D. Picciotti Page: 2 of 6

3 DOCUMENT REVISION HISTORY Paragraph Revisions: or Rev: Date: Section: Initial Release 0 12/14/09 Table 1, Section 7, Product Realization. Removed IP 7.1.2, Production Job Planning requirements 1 7/10/10 covered in IP and IP Replaced IP with CQP /13/10 Table 1 Replaced IP with CQP /18/10 Table 1 Replaced CQP with IP Replaced CQP with IP /7/13 Table 1 Replaced IP with IP /18/ Deleted reference to Quality Manager 6 10/3/15 Page: 3 of 6

4 1. PURPOSE 1.1 The purpose of this document is to provide supplemental information to QM-1, Quality Management Systems Manual. 1.2 This Supplement depicts by section, the second tier procedures that address how the Quality Manual requirements are met. 2. SCOPE 2.1 This document requires only the approval of the Quality Management Representative. 2.2 In the event that a second tier procedure changes, this document is revised to reflect those changes Newly developed procedures may also be added. Training for such procedures is described below. 2.3 Training of applicable personnel is performed in the following manner: 3 REFERENCES If the title of the procedure is changed, but the content remains relatively the same, notifications are sent to managers and department heads If the substance of the procedure is changed in a more significant, managers and department heads will receive classroom structured training or notifications that outline those changes. 3.1 Table 1 lists, by section, the Quality Management Systems Manual section and second tier procedures applicable to each section. Page: 4 of 6

5 QM Section TABLE 1 1 INTRODUCTION Not applicable 1.2 Scope 3 TERMS AND DEFINITIONS Not applicable 4 QUALITY MANAGEMENT SYSTEM 4.1 General Requirements 4.2 Documentation Requirements 5 MANAGEMENT RESPONSIBILITY 5.1 Management Commitment 5.2 Customer Focus 6 RESOURCE MANAGEMENT 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment 7 PRODUCT REALIZATION 7.1 Planning of Product Realization 7.2 Customer-Related Processes 7.3 Design (Not Applicable) 7.4 Purchasing 7.5 Production Provision 7.6 Control of Monitoring and Measuring Devices Applicable Procedures IP 4.2.1, Document Control IP 4.2.2, Quality Related Records IP 4.3.1, Software QA Controls IP 5.6.1, Management Reviews IP 7.2.1, Customer-Related Process Administration IP 6.2.1, Training and Qualification Records IP Personnel Competence IP 6.3.1, Maintenance Procedures IP 7.1.1, Product Development IP 7.1.3, Configuration Management IP 7.2.1, Customer-Related Process Administration IP 7.4.1, Purchase Order Administration IP 7.4.2, Verification of Purchased Materials IP 7.4.3, Supplier Selection & Evaluation IP 7.5.1, Traveler Requirements IP 7.5.2, Process Validations IP 7.5.3, Identification & Traceability of Products IP 7.5.4, Handling Customer Property Page: 5 of 6

6 IP 7.5.5, Preservation of Product IP 7.6.1, Control & Calibration of Measurement and Test Equipment QM Section 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General 8.2 Monitoring and Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement TABLE 1 (Continued) Applicable Procedures IP 7.2.1, Customer-Related Process Administration IP 8.2.2, Internal Audit Program IP 8.2.4, Monitoring & Measurement of Product IP 8.2.5, Product Certification IP 8.3.1, Control of Nonconforming Product IP 8.3.2, Program for Compliance with 10CFR21 IP 8.4.1, Analysis of Data IP 8.5.1, Corrective Action IP 8.5.2, Preventive Action Page: 6 of 6