I got the consent of ASQ Certification Dept. to advising you how to prepare for the CBA exam here.
The CBA exam is for the certification of those who are professional in management system auditing and GMP for medical device, or good candidates auditor in that field.
You have to first fully review the Body of Knowledge (BOK) of the CBA. It can be downloaded from
http://www.asq.org/certification/biomedical-auditor/bok.html
You have to be acquainted with almost all topics in the BOK.
As this is an open book exam, you can bring some books into the exam site. I recommend you to study and bring the following books and materials:
Books
1. ASQ Auditing Handbook, Third Edition (Quality Press of ASQ. Edited by JP Russell)
http://qualitypress.asq.org/perl/catalog.cgi?item=H1263
2. The Biomedical Quality Auditor Handbook
(Quality Press of ASQ. Edited by ASQ Biomedical Division)
http://qualitypress.asq.org/perl/catalog.cgi?item=H1171
Standards (indispensable for many questions)
1. ISO 13485 and many ISO Standards for medical devices referred to in the BOK
2. All CFRs of the FDA for medical devices referred to in the BOK. You can download any of them free from the FDA website.
For the tips on the exam date, you can download from:
http://www.asq.org/certification/faq/14.html
This is short but very easy-to-understand and useful. Maybe the best data on exam taking tips.
If you have any further question, please post it at:
http://www.asq.org/discussionBoards/...spa?forumID=52
Akio Miura