Quality Manual
Issuance and maintenance of the Quality Manual is the responsibility of the Head of Quality and will be reviewed and updated, as appropriate, to ensure that it reflects the current status of our quality manual.
Revision status is illustrated on each page of the manual via revision date and level. Monitoring the accuracy of the revision status is the responsibility of the Head of Quality. The approval of all revisions is the responsibility of the Head of Quality.
Master Copy of the Quality Manual is retained electronically. A controlled hardcopy (with signature) resides with the head of quality for registrar purposes.
Distribution - The Quality System is available electronically.
Authorization of the Quality Manual is the responsibility of the Head of Quality.
Table of Contents
| Title | Contents | Type | Issue Date | Revision |
| Introduction | Signature Page, Exclusions, Facilities | Level 1 | 9/6/24 | F |
| 4 Context of the Organization | Organization & Context; Interested Parties; QMS Scope; QMS & Processes | Level 1 | 9/6/24 | F |
| 5 Leadership | Leadership & Commitment; Customer Focus; Quality Policy; Roles, Responsibilities, & Authorities, Organizational Chart Reference | Level 1 | 12/29/21 | D |
| 6 Planning | Actions to Address Risks & Opportunities; Quality Objectives and Planning to Achieve Them; Planning of Changes | Level 1 | 11/24/23 | A |
| 7 Support | Resources, Training, Monitoring & Measuring; Competence; Awareness; Communication; Documented Information | Level 1 | 11/22/19 | A |
| 8 Operation | Operational Planning & Controls; Requirements for Products & Services; Control of External Provision of Goods & Services; Production & Service Provision; Release of Products & Services; Control of Nonconforming Outputs | Level 1 | 11/2/18 | A |
| 9 Performance Evaluation | Monitoring, Measurement, Analysis and Evaluation; Internal Audit; Management Review; | Level 1 | 11/2/18 | A |
| 10 Improvement | General; Nonconformity & Corrective Action; Continual Improvement; | Level 1 | 7/20/18 | Original |
| Miscellaneous | List of QMPs, Interaction of Processes Diagram | Level 1 | 8/30/18 | A |
| QMP 6.3 Planning of Changes | Purpose, Scope, Responsibility, Definitions, Application, Emergency Change, Pre-Startup Review, Facility Communication/Training | Level 2 | 8/31/18 | A |
| QMP 7.5 Documented Information | Purpose, Scope, Responsibility, Application, Control | Level 2 | 11/1/18 | B |
| QMP 8.1 Award Review | Purpose, Scope, Non-Fab & Fab Awards, Flowcharts, Applicable Documents and Records | Level 2 | 7/20/18 | Original |
| QMP 8.4 New Supplier Evaluation & Approval | Scope, Responsibilities, Checklist | Level 2 | 7/9/18 | Original |
| QMP 8.7 Control of Nonconforming Outputs | Purpose, Scope, Responsibility, Application | Level 2 | 11/1/18 | B |
| QMP 9.2 Internal Audit | Purpose, Scope, Documentation, Responsibility, Application | Level 2 | 7/20/18 | Original |
| QMP 10.2 Nonconformity & Corrective Action | Purpose, Scope, Documentation, Application | Level 2 | 4/25/19 | C |
| COP (Customer Oriented Processes) | ||||
| COP #1 Sales, Quotation, Contract Review | Diagram | Level 2 | 11/2/18 | A |
| COP #2 Production | Diagram | Level 2 | 11/2/18 | A |
| COP #3 Design & Development (Excluded) | N/A | N/A | N/A | N/A |
| MOP (Management Oriented Processes) | ||||
| MOP #1 Management Review | Diagram | Level 2 | 4/25/19 | A |
| SOP (Support Oriented Processes) | ||||
| SOP #1 Training | Diagram | Level 2 | 7/20/18 | Original |
| SOP #2 Purchasing | Diagram | Level 2 | 7/20/18 | Original |
| SOP #3 Control of Monitoring & Measuring Resources | Diagram | Level 2 | 11/22/19 | A |