1. Management Responsibility
1.1. Management Review (PR-QA026)
2. Calibration Program (PR-QA015)
2.1. Calibration Request (Form 109)
2.2. Calibration History Record (Form 084)
3. Control of Nonconforming Product
3.1. Control of Nonconforming Product (PR-QA005)
3.1.1. QCN Origination (Form 014)
3.1.1.1. QCN Log (QP 131)
3.1.1.2. QC Reject Tag (Form 013)
3.1.1.2.1. ULINE Reject Tag
3.1.2. Material Review Board Procedure (PR-QA041)
3.1.2.1. MRB Review (Form 701)
3.1.2.1.1. Use As Is
3.1.2.1.2. Rework
3.1.2.1.3. Scrap
3.1.2.1.4. Return to Supplier
3.1.2.1.5. Hold For Evaluation
3.1.2.2. Failure Investigation Form (Form 744)
3.1.2.3. MRB Flow Chart (Form 231)
4. Acceptance Activites
4.1. First Article Inspection (PR-QA033)
4.2. Incoming Inspection Procedure (QP105)
4.2.1. Levels Inspection Sheet (QP149)
4.2.2. Incoming Inspection Test (Form 668)
4.3. In Process Inspection
4.3.1. Rejected Components Procedure (PR-PUR001)
4.3.1.1. Reject Tag
4.3.1.1.1. Rejected Components Log
4.3.2. Autoread
4.3.2.1. Final Test (Form 101)
4.3.2.2. Test & Align (MP005) [Printed Results]
4.3.3. QBC Centrifuge
4.3.3.1. Final Test (BLTQS0027)
4.3.4. STAR m/i
4.3.4.1. Base Assembly (Form 573)
4.3.4.2. Tower Assembly (Form 574)
4.3.4.3. Back Panel Assembly (Form 575)
4.3.4.4. Middle Assembly (MP166)
4.3.4.5. Centrifuge Assembly (Form 577)
4.3.4.5.1. Motor/Rotor Assy
4.3.4.6. Top Housing Assembly (Form 578)
4.3.4.7. Final Assembly (Form 579)
4.3.4.8. Test & Align (Form 728)
4.3.5. Paralens
4.3.5.1. Light Source Output (MP010, Form 355)
4.3.6. Tubes
4.3.6.1. Idexx
4.3.6.1.1. Lab Tests
4.3.6.1.2. Inspection (QP183)
4.3.6.2. STAR
4.3.6.3. Capillary
4.3.6.4. Malaria
4.3.6.5. AccuTube
4.3.6.5.1. Lab Tests
4.3.6.5.2. Inspection (QP187)
4.3.6.6. Venous
4.3.7. F.A.S.T.
4.3.7.1. AFB (MP057-080)
4.3.7.2. Malaria (MP054-055)
4.3.8. Drucker Centrifuges
4.3.8.1. Manufacturing Inspection (MP111)
4.3.8.1.1. Manufacturing Order
4.3.8.1.2. Factory Cal Label
4.3.9. BD Centrifuges
4.3.9.1. Compact II
4.3.9.1.1. Crimp Test (Form 619)
4.3.9.1.2. Torque Tool Ver. (Form 624)
4.3.9.1.3. S/N Record (Form 625)
4.3.9.1.4. Inspection Results (Form 607)
4.4. Final Product Inspection
4.4.1. Autoread (QP005)
4.4.1.1. Final QC (Form 035)
4.4.1.2. Final Test (MP005)
4.4.2. QBC Centrifuge (QP007)
4.4.2.1. Final QC (Form 037)
4.4.3. STAR m/i (QP180)
4.4.3.1. Final QC (Form 293)
4.4.3.1.1. Hematology Controls (QP016)
4.4.3.2. Mock Installation (Form 036)
4.4.4. Paralens (QP115)
4.4.4.1. Levels Inspection Sheet (QP149)
4.4.5. Tubes
4.4.5.1. Idexx (MP186)
4.4.5.1.1. Final Inspection (Form 562)
4.4.5.2. STAR
4.4.5.3. Capillary (QP182)
4.4.5.3.1. Levels Inspection Sheet
4.4.6. F.A.S.T.
4.4.6.1. AFB (QP055-069)
4.4.6.1.1. Final QC (Form 293, Levels)
4.4.6.2. Malaria (QP170-177)
4.4.6.2.1. Final QC (Form 293, Levels)
4.4.7. Drucker Centrifuges
4.4.7.1. Final QC (QP021)
4.4.7.1.1. Manufacturing Order
4.4.7.1.2. Final Inspection Procedure (MP111)
4.4.8. BD Centriifuges
4.4.8.1. Compact II
4.4.8.1.1. Final QC (QP193)
5. Corrective & Preventive Action
5.1. Corrective/Preventive Action Procedure (PR-QA007)
5.1.1. Corrective Action Request (Form 019)
5.1.2. Preventive Action Request (Form 020)
5.1.3. CAPA Log (Issued Documents\Logs)
5.1.4. Failure Investigation (QP002)
5.1.4.1. Failure Investigation Checklist (Form 021)
5.1.4.2. Failure Investigation Form (Form 744)
6. Production and Process Controls
6.1. Production Processes (MP's, Build Spec's)
6.1.1. Material Handling (PR-IC001)
6.1.1.1. Drucker Material Log
6.1.1.2. Epicor Pick List
6.1.1.3. Request for Material (Form 147)
6.1.2. Autoread
6.1.2.1. Final Assembly (Wi-027)
6.1.3. QBC Centrifuge
6.1.3.1. Final Assembly (MP272)
6.1.3.1.1. Lid Assembly (MP273)
6.1.4. Paralens
6.1.5. Tubes
6.1.6. F.A.S.T.
6.1.7. Drucker Centrifuges
6.1.8. BD Centrifuges
6.1.9. STAR m/i
6.1.9.1. Base Assembly (MP128))
6.1.9.2. Tower Assembly (MP126)
6.1.9.3. Back Panel Assembly (MP124)
6.1.9.4. Middle Assembly (MP166)
6.1.9.5. Centrifuge Assembly (MP127 and Form 577)
6.1.9.5.1. Motor/Rotor Assy
6.1.9.6. Top Housing Assembly (MP131)
6.1.9.7. Final Assembly (MP129)
6.1.9.8. Test & Align (MP204)
6.2. Inspection, Measuring and Test Equipment
6.2.1. COGZ
6.3. Process Validation
6.3.1. VQ's
6.4. Environmental Controls
7. Purchasing Controls
7.1. Evaluation of Suppliers
7.1.1. Supplier Qualification (PR-PUR002)
7.1.1.1. Supplier Approval (Form 181)
7.1.1.2. Drucker Suppler Survey (Form 182)
7.1.1.3. QBC Supplier Survey (Form 183)
7.1.2. Supplier Performance (PR-PUR005)
7.1.2.1. Supplier Report (PUR001)
7.1.2.1.1. Supplier Acceptance (Form 228)
7.1.2.1.2. Supplier Probation (Form 229)
7.1.2.1.3. Supplier Unacceptable (Form 230)
7.2. Purchasing Data
7.2.1. Purchase Order by Requisition (PR-PUR003)
7.2.1.1. Purchase Requisition (Form 146)
7.2.2. Purchase Order by MRP (PR-PUR004)
7.2.2.1. Purchase Order Form (Epicor)
7.2.2.2. Drawings, Specifications
8. Document Controls
8.1. Document Approval, Changes and Distribution
8.1.1. Document Review and Approval (PR-QA001)
8.1.1.1. Change Request (Form 018)
8.1.1.2. Document Control Numbering (QP001)
8.1.1.3. Document Review Log (QP004)
8.1.1.4. Manual Update (QP025)
8.1.1.5. Document Completion Record (Form 003)
8.2. Change Request Procedure (PR-QA037)
8.2.1. Request for Change (Form 018)
8.2.2. QBC Project Procedure (PR-ENG004)
8.2.2.1. QBC Project Requirement Checklist (Form 509)
8.2.2.2. QBC Final Review and Approval (Form 510)
8.2.3. Drucker Project Procedure (PR-ENG005)
8.2.3.1. Drucker Project Requirement Checklist (Form 003)
8.2.3.2. Drucker Final Review and Approval (Form 004)
8.2.3.3. New OEM Requirements (Form 299)
9. Records
9.1. Product Complaint Procedure (PR-QA006)
9.1.1. Complaint Log (QP 146)
9.1.2. Return Material Procedure (PR-QA009)
9.1.3. Product Complaint Record (Form 015)
9.1.4. Product Complaint Evaluation (Form 016)
9.1.5. Medical Device Reporting (PR-QA008)
9.2. Device Master Record Procedure (PR-QA003))
9.2.1. Device Master Record (Form 009)
9.2.2. Device Master Checklist (Form 010)
9.3. Device History Record Procedure (PR-QA040)
9.3.1. Job Traveler
9.3.2. Manufacturing Order
9.3.3. QC Documents
10. Regulating Bodies
10.1. ISO
10.1.1. ISO 13485:2003 Medical Devices
10.1.2. ISO 14971:2007 Risk Management
10.1.3. ISO 9001:2008 QMS
10.2. FDA
10.2.1. FDA CFR 21 Part 820
10.3. Health Canada
10.3.1. Canadian Medical Device Regulations (SOR/98-282)
10.4. EU
10.4.1. EU IVD Directive 98/79/EC
11. Design Controls
11.1. Design Control Procedure (PR-ENG001)
11.1.1. Design and Development Planning
11.1.2. Design Input
11.1.2.1. Design Input Checklist (Form 006)
11.1.3. Design Output
11.1.4. Design Review
11.1.5. Design Veriification
11.1.6. Design Validation
11.1.7. Design Transfer
11.1.7.1. Final Review and Approval (Form 0007)
11.1.8. Design Changes
11.1.9. Design History
11.1.9.1. Engineering Design Control File (EP-005)
12. Quality System Requirements
12.1. Quality Audit
12.1.1. Internal Audit (PR-QA011)
12.1.1.1. Audit Corrective Action (PR-QA039)
12.1.1.1.1. ACAR Log
12.1.1.1.2. Audit Corrective Action Form (Form 639)
12.2. Personnel
12.2.1. New Employee Orientation Procedure (PR-HR001)
12.2.1.1. Job Description (Jnnn)
12.2.1.2. Master Training Log (Form 141)
12.2.2. Training
12.2.2.1. Procedure Training (PR-QA023)
12.2.2.2. Work Instruction Training (PR-QA024)
13. Customer Returns
13.1. Service Procedure (PR-MP001)
13.1.1. Service Report Form (Form 034)
13.1.2. Intranet Based Service Log
13.1.3. Decon Form (Form 055)
13.1.4. Service Contract Forms (Form 107 & 053)
13.2. Return Material Procedure (PR-QA009)
13.2.1. RMA Log Entry Procedure (QP145)
13.2.1.1. Return Material Report (RMR) -- (Form 090)
13.2.2. QBC: Epicor Data Entry
13.2.3. Drucker: ACCESS Data Entry
13.3. Complaint (PR-QA006)
13.3.1. Complaint Log Entry Procedure (QP146)
13.3.1.1. Product Complaint Record (Form 015)
13.3.1.2. Product Complaint Evaluation (Form 016)
13.3.2. "Incident" Only (PR-QA008)
13.3.2.1. EU Incident Report (Form 314)
13.3.2.2. EU Final Incident Report (Form 315)