I am preparing for CBA exam and wanted to know where can I get the standards mentioned in BOK (eg.13485) for cheaper price. For any of you who have taken this exam please let me know whether I should invest so much money on these standards.

Wendy

Can anyone help out Wendy?

For some reason my previous A search can save money (http://elsmar.com/Forums/blog.php?b=84) suggestion does not offer 13485 but Malaysian Standards (http://www.msonline.gov.my/msonline/registrationAction.do?actionname=Default) offer 13485 for
70.00 MYR = 19.2218 USD
Malaysia Ringgits United States Dollars

You need to register first.
When I looked for ISO9001 they had not yet published it.
Please check the various restrictions

I am preparing for CBA exam and wanted to know where can I get the standards mentioned in BOK (eg.13485) for cheaper price. For any of you who have taken this exam please let me know whether I should invest so much money on these standards.

Wendy

For those who (like me, before I looked it up) don't know what "CBA" is, it's Certified Biomedical Auditor (http://www.asq.org/certification/biomedical-auditor/index.html).

I am preparing for CBA exam and wanted to know where can I get the standards mentioned in BOK (eg.13485) for cheaper price. For any of you who have taken this exam please let me know whether I should invest so much money on these standards.

Wendy

I haven't taken the CBA exam but am considering doing so in the future. I have purchased "The Biomedical Quality Auditor Handbook" from ASQ and would recommend it. ISO 14969 (the guide for 13485) contains 13485 so in effect you could get two for one. A lot of the other BOK documents (GHTF stuff for instance) can be accessed for free on the internet.

I am preparing for CBA exam and wanted to know where can I get the standards mentioned in BOK (eg.13485) for cheaper price. For any of you who have taken this exam please let me know whether I should invest so much money on these standards.

Wendy

Are you currently working for a company that does 13485-type work? If so, and they don't have a copy of the standard, maybe you can talk them into getting it.

Thanks all for your helpful answers

Thanks but I donot need any help as I have bought my standards.

Dear Ms. Wendy

Please find hereunder the list of study materials for CBA, I have listed by chapter wise, Hope that it will be more useful for your material collection.

Chapter- I Auditing Fundamentals

1. Russell, J.P. The Quality Audit Handbook: Principles, Implementation, and Use. Milwaukee: Quality Press. 2005.
2. The ASQ Auditing Handbook, Third Edition. Milwaukee: Quality Press. 2005.
3. Kausek, Joe The Management System Auditor's Handbook, ASQ, 2006.
4. The Quality Audit Handbook: Principles, Implementation, and Use. Milwaukee: Quality Press. 2005.
5. Juran, J.M., A.B. Godfrey. Juran's Quality Handbook, Fifth ed. New York: McGraw-Hill Publishing Co., 2000.
6. ISO 19011:2002 (Guidelines for quality and/or environmental management systems auditing)
7. Russell, J.P. & Regel, T. After the Quality Audit: Closing the Loop on the Audit Process, Second Edition
8. Anderson & Wortman; CQA Primer, Quality Council of Indiana, 1997
9. Russell, J.P. The Internal Auditing Pocket Guide, ASQ, 2007

Chapter- II Auditing & Inspection Processes

1. Guide to Inspections of Quality Systems (QSIT). FDA. 1999
2. Hitchcock, Russell, & West. ASQ's Foundations in Quality: Certified Quality Auditor. ASQ. 2004.
3. Blank, R. The Basics of Quality Auditing. Productivity Press. 1999
4. Russell, J.P. The ASQ Auditing Handbook. Third Ed. Milwaukee: Quality Press. 2006.
5. Cianfrani, C.A., Tsiakals, J.J. & West, J.E. ISO 9001:2000 Explained. Second Ed. Milwaukee: Quality Press. 2001.
6. Blank, R. The Basics of Quality Auditing. Productivity Press. 1999
7. NIST. Malcolm Baldrige National Quality Award Examiner Training Manual. 2007.
8. Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements (GHTF.SG4.(99)28). GHTF. 1999.
9. Ketola, J. & Roberts, K. ISO 9000:2000 In a Nutshell. Paton Press. 2001.
10. US compliance programs for medical devices (FDA CPG 7382.845)
11. GHTF SG4 (99)28, GHTF SG4 (99)14, GHTF SG4 (00)3

Chapter- III Biomedical Quality Management System Requirements

1. The Biomedical Quality Auditor Handbook by Bruce Haggar
2. MDD 93/42,
3. FD&C Act, sections 301-304, 501-502,704,518 & 513
4. Robitaille, D. The Corrective Action Handbook. Paton Press. 2001
5. 21 CFR 801, subpart A
6. 21 CFR 807
7. 21 CFR 11
8. FDA guideline for the manufacture of in vitro diagnostic (IVD) products (Jan 10, 1994)
9. 21 CFR 820
10. ISO 9001:2008, ISO 9002, ISO 13485:2003
11. GHTF.SG3.N99-8
12. MEDDEV. 2.7.1, April 2003(EVALUATION OF CLINICAL DATA: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES)
13. 21 CFR 820.90
14. MEDDEV 2.12-1 Rev 5, April 2007 (GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM)
15. 21 CFR 820.40, 820.180-820.186
16. 21 CFR 820.50, 820.80, 820.60 & 820.65
17. 21 CFR 820.140-820.170
18. 21 CFR 820.70, 820.75, 820.72, GHTF.SG3.N99-10
19. 21 CFR 820.120, 21 CFR 820.130
20. 21 CFR 820.250(b)
21. 21 CFR 820.250(a)

Chapter- IV Technical Biomedical Knowledge

1. ISO 14971:2007
2. ISO 17665-1:2006
3. ISO 11135-1:2007
4. ISO 11137-1:2006, ISO 11137-2:2006, ISO 11137-3:2006
5. ISO 11737-1:2006, ISO 11737-2:1998, ISO 11737-3:2004
6. ISO 11138-1:2006, ISO 11138-2:2006, ISO 11138-3:2006, ISO 11138-4:2006, ISO 11138-5:2006
7. ISO 11607-1:2006, ISO 11607-2:2006
8. ISO 10993:2003, FDA Blue Book memorandum #G95-1, U.S. Pharmacopoeia (USP) Classes V & VI.
9. ISO 14644-1:1999, ISO 14644-2:2000, ISO 14644-3:2005, ISO 14644-4:2001, ISO 14644-5:2004, ISO 14644-6:2007, ISO 14644-7:2004(Revises ISO/DIS 14644-7), ISO 14644-8:2006, ISO 14644-8:2006
10. FDA Software Guidance for FDA Reviewers and Industry, (May 29, 1998),
11. IEC 62304:2006
12. General Principles of Software Validation, 21 CFR Part 11
13. ISPE Good Automated Manufacturing Practice (GAMP4)
14. ISO/IEC 17025:2005

Chapter- V Quality Tools and Techniques:

1. DataMyte Business DataMyte Handbook, 6th ed. Milwaukee: Allen-Bradley Company, 1995.
2. Juran, J.M., A.B. Godfrey. Juran's Quality Handbook, Fifth ed. New York: McGraw-Hill Publishing Co., 2000. P660
3. Montgomery, D.C. Introduction to Statistical Quality Control, 5 sub ed. Hoboken: Wiley, 2004. P1138
4. Feld, W. M. Lean Manufacturing: Tools, Techniques, and How to Use Them, Boca Raton: CRC Press, 2001
5. Goal QPC, The Black Belt Memory Jogger, 2001.
6. Brassard, M., and Ritter, D. The Memory Jogger II, Goal/QPC, 1994.
7. Woods, J., J.W. Cortada. McGraw-Hill Encyclopedia of Quality Terms and Concepts
8. Berger, R.W., D.W. Benbow, A.K. Elshennawy & H.F. Walker. Certified Quality Engineer Handbook, 2nd ed. Milwaukee: ASQ Quality Press, 2006. H1291
9. Ishikawa, K. Guide to Quality Control, Tokyo: Asian Productivity Organization, 1982.
10. DataMyte Business DataMyte Handbook, 6th ed. Milwaukee: Allen-Bradley Company, 1995.
11. Campanella, J. Principles of Quality Costs: Principles, Implementation, and Use, 3rd ed. Milwaukee: ASQ Quality Press, 1999.
12. Gitlow, H., S. Gitlow, A. Oppenheim, R. Oppenheim. Tools and Methods for Improvement of Quality, Boca Raton: CRC Press, 1989.
13. Montgomery, D.C. Introduction to Statistical Quality Control, 5 sub ed. Hoboken: Wiley, 2004
14. Gitlow, H., S. Gitlow, A. Oppenheim, R. Oppenheim. Tools and Methods for Improvement of Quality, Boca Raton: CRC Press, 1989.
15. Feld, W. M. Lean Manufacturing: Tools, Techniques, and How to Use Them, Boca Raton: CRC Press, 2001.

Regards & Good Luck
S. Subramaniam, INDIA
:)

Thank you so much it will be very useful to others who aretaking this exam too. Very informative!

Hi Wendy

I have taken CBA in Oct'08 and got through (fortunately) and in my view the Chapter IV - Technical Biomedical Knowledge was relatively tougher, since it is too exhaustive. Practically buying all those ISO/EN standards are imaginative and it is prudent to look for some local libraries where you can refer those standards or may be you can borrow from someone for reading.

But there were lot of questions asked from these standards and getting prepared is wise.

:bigwave:hello wendy,
I bought the standar about medical device in the AAMI. Previously is necessary the membership to the AAMI (Association for the Advancement of Medical Instrumentation) the cost is between 35 to 100 dollars, but the cost of the all standar is at half price for members.:read:

:thanx: