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References - Medical Device Auditor Certification - CMDA

 

References

All reference materials listed below cover the parts of the Body of Knowledge. ASQ Certification Board does not endorse any one particular reference source.


    Publicly available:

  • ASQ Code of Ethics Link
  • FDA – Code of Federal Regulations (CFR) Title 21 Part: 4; 7; 11; 58; 201 Subpart A; 801 Subpart A; 803; 806; 807; 820; 821; 830. Link
  • FDA – 27-Sep-19, Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices. Link
  • FDA – 11-Jan-02, General Principles of Software Validation Final, Guidance for Industry and FDA Staff. Link
  • FDA – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Link
  • FDA – Guidance Document for Applying Human Factors and Usability Engineering to Medical Devices Link
  • GHTF/SG3/N99-10: 2004, Quality Management Systems – Process Validation Guidance Link
  • Health Canada- SOR/98-282 Medical Devices Regulations Link
  • 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 Link

  • Standards

  • IEC 62304: 2006: Medical device software, software life cycle processes.
  • IEC 62366-1: 2015 Medical devices – Application of usability engineering to medical devices
  • ISO 13485:2016, Medical devices -- Quality management systems -- Requirements for regulatory purposes
  • ISO 9001:2015, Quality management systems – Requirements
  • ISO/IEC 17025: 2017, General requirements for the competence of testing and calibration laboratories.
  • 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 11607-1: 2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
  • ISO 10993-1: 2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
  • ISO 14644-1: 2015, Cleanrooms, and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
  • ISO 14644-2: 2015, Cleanrooms, and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
  • 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: 2019, Medical devices -Application of risk management to medical devices.
  • ISO 15223-1: 2016, Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

  • Books

  • Arter, Dennis R. Quality Audits for Improved Performance. 3rd ed. Milwaukee, WI: ASQ Quality Press, 2003.
  • Brassard, Michael, and Diane Ritter. The Memory Jogger 2. 2nd ed. Goal/QPC, 2010. ISBN 978-1-57681-113-9
  • Coleman, Lance B. Sr., The ASQ Certified Quality Auditor Handbook 5th ed., Milwaukee, WI: ASQExcellence, 2020.
  • De Feo, Joseph A., Juran’s Quality Handbook. 7th ed. New York: McGraw-Hill Publishing Co. 2017.
  • Griffith, Gary K., The Quality Technician’s Handbook, 6th ed., New Jersey: Pearson Education, 2013.
  • Gryna, Frank M., Richard C.H. Chua, and Joseph A. Defeo, Juran’s Quality Planning and Analysis for Enterprise Quality, 5th ed., New York: McGraw-Hill, 2007.
  • Laman, Scott., The ASQ Certifed Medical Device Auditor Handbook. 4th ed. Milwaukee, WI: ASQExcellence, 2021.
  • Parsowith, Scott B., Fundamentals of Quality Auditing. Milwaukee, WI: ASQC Quality Press, 1995.
  • Tague, Nancy R. The Quality Toolbox. 2nd ed. Milwaukee, WI: ASQ Quality Press, 2004.

 

Note: For the latest version of the above referenced standards, regulations, and guidance visit:
ISO standards @ www.iso.org
FDA regulations @ www.fda.gov

ASQ books are available from ASQ Quality Press.

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