Certified Biomedical Auditor (CBA) Exam - Suggestions how to prepare for it

H

hctang

#1
Hello.

This is the first time I send a message at this forum.
Have anyone taken a CBA exam?
I am planning to take the exam in October 2006. I could use any suggestion how to prepare for it.
Thank you.

Hartanti
 
Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#3
Akio is correct in writing there is a lot more pertinent information about certification exams at the ASQ website, which has the added benefit of also being reviewed by ASQ staff who administer such exams.

In short, there are three important things about ALL the ASQ certification exams:
  1. Time management is key - most people who fail the exam fail because they "ran out of time" - not because they didn't know the material. Find as many practice exams as you can and take them according to a timer.
  2. Be sure to practice looking stuff up in the reference books you take with you into an "open book" exam - again, TIME is the issue. Don't bring in more reference material than you can handle. Don't bring any you are not familiar with.
  3. There are no "trick questions" - but many test takers trick themselves by "stretching" the limits of what the question asks. This is a good reason to take practice exams that have good explanations of how the answers are derived.
If English is not your primary language, the test will also be a true test of character.

Moderator's Note: We here at the Cove are not in competition with the ASQ Forums. Often, though, some topics are better covered in one Forum than another. When it comes to info about ASQ certification exams, it will never hurt to use both ASQ and the Cove. Sadly, the ASQ top paid staff members have been withholding resources from the ASQ Forums and they pale in comparison to the Cove in terms of number and frequency of posts on a variety of topics.

Many of the ASQ folk who answer queries in the ASQ Forums are also frequent visitors and posters here in the Cove.

Nice to see you are starting to visit and post here, Akio:bigwave:
 

Govind

Super Moderator
Staff member
Super Moderator
#5
Wes Bucey said:
Anyone else have comments they'd like to add about taking ANY ASQ exams?
Wes,
You have pretty much covered all important points and hence I did not add further.

I will also recommend Hartanti (thread poster) to read the hyperlinked article if he/she is taking the certification exam for the first time. http://www.asq.org/pub/qualityprogress/past/1004/qp1004rooney.pdf
I don’t know specifics of CBA. There are only very few out there with this certification. The one I knew was Akio san. That is why I requested Akio San to add his thoughts. I did not know that he also proctors this exam. Hence this will be difficult for him to go into details. He may come back and add his general thoughts.

Regards,
Govind.
 
A

Akio Miura

#6
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
 
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