Any titles may be semi-customized and ordered below.
STANDARD OPERATING PROCEDURES TABLE OF CONTENTS
0100-SERIES: GENERAL PROVISIONS
...101 Definitions: US FDA's 21 CFR Part 820 -- Q S Regulation
0200-SERIES: QUALITY SYSTEM REQUIREMENTS
...201 Quality Policy
...202 Company Organization [available as a custom written SOP only]
...203 Internal Quality System Audit Program
...204 Outside Regulatory Audit Policy / Procedures
...205 Personnel & Training
...206 Quality Agreements
0300-SERIES: DESIGN CONTROLS
...301 Project Management, New Product Development, Design Control, and the DHF
...302 Verification and Validations (V & V) Protocols
...303 Lab Notebooks
...304 Product Hazard / Risk Analysis (ISO 14971)
...305 Software V&V - Risk Based
...306 Use / Human Factors Engineering (IEC 62366-1)
0400-SERIES: DOCUMENT CONTROLS
...401 Standard Operating Procedure (SOP) System
...402 Deviations & Change Orders (CO/ECO's)
0500-SERIES: PURCHASING CONTROLS
...501 Vendor Audit Program
...502 Supplier / Component Controls (and Continuing Guarantee)
0600-SERIES: IDENTIFICATION AND TRACEABILITY
...601 Lot and/or Serial Numbering System
...602 Line Clearance and Start-up Instructions
0700-SERIES: PRODUCTION AND PROCESS CONTROLS
...701 Component Assembly [available as a custom written SOP only]
...702 Final Assembly [available as a custom written SOP only]
...703 Calibration and 'NCI' Programs
...704 Tooling/Fixturing and Equipment Traceability/Control
...705 Facilities and Environmental Controls
...706 Personnel Cleanliness
...707 Equipment Maintenance Program
0800-SERIES: ACCEPTANCE ACTIVITIES
...801 Material/Component Receiving and Inspection
...802 In-process Inspection
...803 Final Inspection and Product Release
0900-SERIES: NONCONFORMING PRODUCT
...901 Non-Conforming Materials / Components
...902 Dispositioning
...903 Rework / Reprocessing Procedure
...904 Product Recall Procedures
1000-SERIES: CORRECTIVE AND PREVENTATIVE ACTION
..1001 Data Trending
..1002 Corrective and Preventative Action (CAPA)
..1003 Complaints / MDR Reporting
..1004 Failure Investigation and Root Cause Analysis
1100-SERIES: LABELING AND PACKAGING CONTROL
..1101 Labeling System
1200-SERIES: HANDLING, STORAGE, DISTRIBUTION AND INSTALLATIONt
..1201 Handling, Storage and Distribution Systems
..1202 Product Installation [available as a custom writen SOP only]
1300-SERIES: RECORDS
..1301 Device Master Record (DMR)
..1302 Device History Record (DHR)
..1303 Complaint/MDR Systems
1400-SERIES: SERVICING
..1401 Returned Goods Authorization (RGA) System
..1402 Servicing [available as a custom written SOP only]
1500-SERIES: STATISTICAL TECHNIQUES
..1501 Six-sigma Principles
..1502 Sampling Statistics
..1503 Control Charts -- X-bar and R