Biomedical Auditor - References

References

These references support the topic areas in the CBA Body of Knowledge. They are used to write and review the questions in the test question pool. To determine which references you need, review the CBA Body of Knowledge. Determine which topic areas you need to study further. Then review this reference list to identify those that support your needs.

Note: ASQ Certification Board does not endorse any one particular reference source.

• ANSI/ISO/ASQ Q9001-2000, Quality Management Systems: Requirements
   
• Arter, Dennis R., Quality Audits for Improved Performance, 3rd ed., Milwaukee, WI: ASQ Quality Press, 2003
   
• ASQ Biomedical Division, The Biomedical Quality Auditor Handbook, Milwaukee, WI: ASQ Quality Press, 2003
   
• ASQ Code of Ethics
   
• Brassard, Michael, and Diane Ritter, The Memory Jogger II, Goal/QPC, 1994
   
• ANSI/ISO/ASQ QE19011S-2004, Guidelines for quality and/or environmental management systems auditing – U.S. version with supplemental guidance added
   
• EED 93/42/EEC, Council Directive 93/42/EEC, Medical Devices Directive (14 June 1993)
   
• EN 550:1994, Sterilization of medical devices—Validation and routine control of ethylene oxide sterilization
   
• EN 552:1994, Sterilization of medical devices—Validation and routine control of sterilization by irradiation
   
• EN 556:1995, Sterilization of medical devices—Requirements for terminally sterilized medical devices
   
• EN 868-1:1997, General requirements and test methods, packaging materials and systems for medical devices which are to be sterilized
   
• EN-ISO 10993-1:2003, Biological evaluation of medical devices—Part 1; Evaluation and Testing
   
• ISO 14971:2007, Medical devices—Application of risk management to medical devices
   

For the most current FDA Regulations

• FDA - 10-Jan-94, Guideline for the Manufacture of In Vitro Diagnostic Products
   
• FDA - 11-May-2005, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
   
  
• FDA - 9-Sep-99, Off-The-Shelf Software Use in Medical Devices
   
• FDA - 11-Jan-02, General Principles of Software Validation Final
   
• FDA - Blue Book #G95-1, Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices
  FDA - Code of Federal Regulations (CFR) Title 21
• Part 7, Enforcement Policy
• Part 11, Electronic Records; Electronic Signatures
• Part 201 Subpart A, Labeling(sections 201.1-201.25)
• Part 801 Subpart A, Labeling(sections 801.1-801.16)
• Part 803, Medical Device Reporting
• Part 806, Medical Devices: Reports of Corrections and Removals
• Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
• Part 820, Quality System Regulation (QSR)
• Part 821, Medical Device Tracking Requirement
   
• FDA - CPG 7382.845 (7Feb2001), Inspection of Medical Device manufacturers—Final Guidance for Industry and FDA
   
• FDA - Food Drug, and Cosmetic (FD&C) Act, Sections 301-4; 501-2; 513; 518; 704
     
• FDA - QSIT; 8/99, Guide to Inspection of Quality System
   
• GHTF - SG2-N21R8, Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative
   
• GHTF - SG3-N99-10, Process Validation Guidance
   
• GHTF - SG4 (99) 14, Audit Language Requirements
   
• GHTF - SG4 (99) 28, Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers—Part 1: General Requirements
   
• GHTF - SG4(00) 3, Training Requirements for Auditors
   
• Gryna, Frank M., Richard Chua, Joseph Defeo, Juran’s Quality Planning and Analysis for Enterprise Quality, 5th ed., New York: McGraw-Hill Co, 2007
   
• ISO 11134:1994, Sterilization of healthcare products—Requirements for validation and routine control
   
• ISO 11607:2003, Packaging of terminally sterilized medical devices
   
• ISO 13485:2003, Quality Systems—Medical devices—Quality management systems - Requirements for regulatory purposes
   
• ISO 17025:1999, General Requirements for the competence of testing and calibration laboratories
   
• ISO/TR 13409:2002, Sterilization of health care products – Radiation sterilization --Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
   
• ISO/TR 14969:2004, Medical Devices – Quality Management systems – Guidance on the application of ISO 13485:2003
   
• Ishikawa, Kaoru, Guide to Quality Control, White Plains, NY: Quality Resources, 1986. ISBN 9283310365
   
• Juran, Joseph .M., Juran’s Quality Handbook, 5th ed., Milwaukee, WI: ASQ Quality Press, 1999
   
• Mills, Charles A., The Quality Audit: A Management Evaluation Tool, McGraw-Hill Professional, 1988. ISBN 0070424284
   
• MEDDEV - 2.12-1 Rev 4, Guidelines on a medical devices vigilance system (April 2001).
   
• Parsowith, B. Scott, Fundamentals of Quality Auditing, Milwaukee, WI: ASQ Quality Press, 1995
   
• Russell, J.P., ed., ASQ Quality Audit Division, The ASQ  Auditing Handbook, 3rd ed., Milwaukee, WI: ASQ Quality Press, 2005
   
• Sayle, Allan J., Management Audits, 3rd ed., Brighton, Michigan: Allan Sayle Associates, 1997. ISBN 0951173901
   
• Tague, Nancy R., The Quality Toolbox, 2nd ed., Milwaukee, WI: ASQ Quality Press, 2004
   
• US - USP/NF, United States Pharmacopoeia and National Formulary (current edition)
   
• Wilson, Paul F., Larry D. Dell, and Gaylord F. Anderson, Root Cause Analysis: A Tool for Total Quality Management, Milwaukee, WI: ASQ Quality Press, 1993

All EN standards can be obtained from http://www.global.ihs.com

All FDA Regulations can be obtained from www.fda.gov

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