Leonard Steinborn

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The United States Military Specification, Quality Program Requirements (MIL-Q-9858A)

Leonard Steinborn, Leonard Steinborn, 2004 .

International Organization for Standardization ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories

Leonard Steinborn, Leonard Steinborn, 2004 .

International Organization for Standardization ISO 13485 Quality Systems — Medical Devices — Particular Requirements for the Application of ISO 9001

Leonard Steinborn, 2004 .

The United States Code of Federal Regulations 21 CFR, Section 820, Quality System Regulation (QSR), Current Good Manufacturing Practices (CGMP) Requirements for Medical Devices

Leonard Steinborn, Leonard Steinborn, 2004 .

International Organization for Standardization ISO 13488 Quality Systems — Medical Devices — Particular Requirements for the Application of ISO 9002

Leonard Steinborn, 2004 .

The United States Code of Federal Regulations 21 CFR, Section 821.25 for Medical Device Tracking

Leonard Steinborn, 2004 .

The European Community (EC) Guide to Good Manufacturing Practices for Medicinal Products, including Annexes 1 and 15

Leonard Steinborn, 2004 .

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 1 - With Checklists and Software Package)

Leonard Steinborn, Leonard Steinborn, 2003 .

International Organization for Standardization ISO 9001:1994 Quality Systems — Model for Quality Assurance in Design, Development, Production, Installation and Servicing

Leonard Steinborn, Leonard Steinborn, 2004 .

The United States Code of Federal Regulations 21 CFR, Section 806.10 for Corrections and Removals

Leonard Steinborn, 2004 .

The United States Military Standard–790F, Standard Practice for Established Reliability and High Reliability Qualified Products List (QPL) Systems for Electrical, Electronic and Fiber Optic Parts Specifications

Leonard Steinborn, 2004 .

International Organization for Standardization ISO 9000-3, Guidelines for the Application of ISO 9001:1994 to the Development, Supply, Installation and Maintenance of Computer Software

Leonard Steinborn, 2004 .

The United States Food and Drug Administration and ICH Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

Leonard Steinborn, 2004 .

International Organization for Standardization ISO 19011 Guidelines for Quality and/or Environmental Management Systems Auditing

Leonard Steinborn, Leonard Steinborn, 2004 .

The United States Code of Federal Regulations 21 CFR, Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals

Leonard Steinborn, Leonard Steinborn, 2004 .

The United States Code of Federal Regulations 21 CFR, Part 11, Electronic Records/Electronic Signatures

Leonard Steinborn, 2004 .