ASQ - The Global Voice of Quality
Biomedical Auditor Certification CBA
References - Biomedical Auditor Certification - CBA
All reference materials listed below cover the parts of the Body of Knowledge. ASQ Certification Board does not endorse any one particular reference source.
Quality management systems - Requirements . ANSI/AAMI/IEC 62304: 2006: Medical device software, software life cycle processes.
62304: 2006 Medical device software, software life cycle processes Arter, Dennis R.
Milwaukee, WI: ASQ Quality Press, 2003. Quality Audits for Improved Performance. 3rd ed.
ASQ Code of Ethics ASTM D4169 - 09, Standard Practice for Performance Testing of Shipping Containers and Systems.
ASTM F1980 - 07(2011), Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Guidelines for quality and/or environmental management systems auditing, E-Standard. ANSI/ISO/ASQ 19011-2:2011: Guidelines for auditing management systems.
Australian Regulatory Guidelines for Medical Devices (ARGMD)
https://www.tga.gov.au/sites/default/files/devices-argmd-01.pdf Brassard, Michael, and Diane Ritter.
. Goal/QPC, 2010. ISBN 978-1-57681-113-9 The Memory Jogger 2. 2nd ed Canadian Medical Devices Conformity Assessment System (CMDCAS)
Quality: http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/cmdcas_scecim_syst_pol-eng.php EED 93/42/EEC, Council Directive 93/42/EEC, Medical Devices Directive (14 June 1993) amended by Directive 2007/47/EC.
EU Directive 2012/19/EU on waste electrical and electronic equipment (WEEE)
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32012L0019&from=EN 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, Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices.
FDA - 11-Jan-02, General Principles of Software Validation Final, Guidance for Industry and FDA Staff .
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 11: 201 Subpart A; 801 Subpart A; 803; 806; 807; 820; 821.
FDA - CPG 7382.845 (7 Feb 2001), Inspection of Medical Device manufacturers-Final Guidance for Industry and FDA.
FDA - Food Drug, and Cosmetic (FD&C) Act, Sections 201, 301-4; 501-2; 510, 513, 518,704.
FDA - QSIT: 8/99, Guide to Inspection of Quality Systems.
GHTF/SG2/N54R8: 2006, Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices.
GHTF/SG3/N99-10: 2004, Process Validation Guidance.
GHTF/SG4, Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements, Parts 1-5.
GHTF/SG4(00) 3, Training Requirements for Auditors.
Gryna, Frank M., Richard Chua, and Joseph Defeo.
New York: McGraw-Hill Co, 2007. Juran's Quality Planning and Analysis for Enterprise Quality. 5th ed. IEC 80001-1: 2010 Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities.
IEC/TR 80002-1:2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software.
IEC 60601-1: 2005, Medical electrical equipment - Part 1:General requirements for basic safety and essential performance.
ISO 11135-1: 2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
ISO 11138-1: 2006, Sterilization of health care products - Biological indicators - Part 1: General requirements.
ISO 11737-1: 2006, Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products.
ISO 11607-1: 2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 14644-1: 1999, Part 1: Classification of air cleanliness, cleanrooms, and associated controlled environments.
Medical devices - Quality management systems - Requirements for regulatory purposes. ISO 17665-1: 2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
ISO 14937: 2009, Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.
ISO 14971: 2007, Medical devices -Application of risk management to medical devices.
ISO 17025: 2005,
General requirements for the competence of testing and calibration laboratories. ISO 14969: 2004, Medical Devices - Quality Management systems - Guidance on the application of ISO 13485:2003
ISO/IEC 62366: 2008 Medical devices - Application of usability engineering to medical devices
Guide to Quality Control. White Plains, NY: Quality Resources, 1986. ISBN 9283310365 Juran, Joseph M.
. Milwaukee, WI: ASQ Quality Press, 2010. Juran's Quality Handbook. 6th ed Japanese Pharmaceutical Affairs Law (JPAL) MHLW Ministerial Ordinance No 169, 2004
https://www.emergogroup.com/sites/default/files/japan-regulations-12march2015/Japan%20Regulations/Japan-MHLW-Ord-169-QMS-compliance.pdf. Mills, Charles A.
The Quality Audit: A Management Evaluation Tool. McGraw-Hill Professional, 1988. ISBN 0070424284 MEDDEV - 2.12-1 Rev 6, Guidelines on a medical devices vigilance system (December 2009).
Parsowith, B. Scott.
. Milwaukee, WI: ASQ Quality Press, 1995. Fundamentals of Quality Auditing Pérez, José Rodríguez.
. Milwaukee, WI: ASQ Quality Press, 2011. CAPA for the FDA-Regulated Industry REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals:
http://echa.europa.eu/guidance-documents/guidance-on-reach RoHs - Restriction of the use of certain hazardous materials in electrical and electronic equipment directive 2011/65/EU:
EU Directive for Restriction of the use of certain hazardous materials in electrical equipment Sayle, Allan J.
Management Audits. 3rd ed. Brighton, Michigan: Allan Sayle Associates, 1997. ISBN 0951173901 Tague, Nancy R.
. Milwaukee, WI: ASQ Quality Press, 2004. The Quality Toolbox. 2nd ed Wilson, Paul F., Larry D. Dell, and Gaylord F. Anderson.
. Milwaukee, WI: ASQ Quality Press, 1993. Root Cause Analysis: A Tool for Total Quality Management
Note: For the latest version of the above referenced standards, regulations, and guidance visit:
ISO standards @
www.iso.org FDA regulations @ www.fda.gov
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