G M Butcher The first two are good. Do not overlook the advantages of self-study. In that regard, Juran - Quality Control Handbook, Snedecor/Cochran - Statistical Methods, Natrella (NBS #91)- Experimental Statistics, the work in statistics by W. A. Taylor, and the most excellent article by J. J. Filliben "Testing Basic Assumptions in the Measurement Process". The AIAG has published an excellent series of guides for auto use but they can be applied elsewhere too.
PM me for any audit questions

Julie Omohundro I don't see RAPS as the best resource for the specific topics you have listed. It sounds like you are primarily interested in compliance as it applies to a manufacturing quality standard, which could be a regulation (e.g., the QSR), but could also a non-regulatory standard (ISO 13495). RAPS is a better fit for someone more broadly interested in the regulation of pharmaceutical and/or medical devices.

SQA has its Quality College. If you are really serious about auditing, then I'd definitely go for certification specifically as an auditor. RAPs doesn't offer this, but ASQ does. I think SQA may have more of a slant toward regulated industry than ASQ, and takes a broader look at quality, while ASQ may be a better choice for a specific topic such as auditing.

Naveen Agarwal, Ph.D. ASQ certifications are pretty good but will require a significant amount of preparation. I have CQE and CMQ and I think the Body of Knowledge required for these certifications is pretty good. You will need to stay active in the field to accumulate credits for recertification, which is required every 3 years.

I have also taken certification courses from BSI on ISO 13485, which were pretty good. I am now doing ISO 9001 with BSI in February.

I think there are a lot of certifications - they tend to be expensive and require a lot of work. Highly recommend prioritizing your focus and align directly with your career goals.

Let me know if you have any questions or want to talk more. Best wishes.

John English, HCCP This may be a duplicate - if your focus on audit and quality includes Information Systems, I would suggest you consider ISACA. (Think CISA, CRISC et al.)
You may find them here:
http://m.isaca.org/CERTIFICATION/Pages/default.aspx

John English, HCCP If your focus where more around Information Systems audit and quality, I would suggest ISACA. (Think CISA et al.) You may find them at :
http://m.isaca.org/CERTIFICATION/Pages/default.aspx

I suggest that you check out the ASQ CBA.
The body of knowledge is excellent.

Based on your statement I would suggest ASQ Certified Quality Auditor and then ASQ Certified Six Sigma Green Belt.

If your device contains software then the Certified Professional for Medial Software (CPMS) is a great plus even if you want to audit the software development only.It covers all aspects of the software development (QMS, Plans, testing, validation, regulatory).

Have you checked out BSI or IRCA for auditing skills training?

LSS black belt is worth considering as you will learn statistics, process control. It does not require recertification but you can apply it at your current position in a learn by doing manner. Recommend taking at an accredited university. Other suggestions made by commentors are spot on. Good Luck.

Hi Matt Not sure what you were looking for but SQA also has accreditation in GCP and GLP auditing. They also have on-line and face-to-face courses on GCP, GLP and Pharmacovigilance.

Matt Jensen I just learned about BSI recently. Sounds like they're worth checking into. Thanks.