ISO 13485 certification

FREQUENTLY ASKED QUESTIONS ABOUT COURSE ACCREDITATIONS:

I WANT TO CONDUCT INTERNAL AND SUPPLIER AUDITS, DO I NEED TO BE TAKE AN IRCA OR RABQSA CERTIFIED COURSE AND EXAM?

RABQSA or IRCA certification of the courses do not make you a certified auditor.  They enable you should you want to work for a registrar to apply for an "associate auditor" certification.   After completing a 20 audit days, with at least 4 complete audits as member of an audit team witnessed by a certified Auditor, you can apply for an auditor accreditation.
The courses are expensive and the accreditation process is extremely costly and lengthy.  The accreditaion has also to be maintained with a certain number of audits per year, and a substantial yearly application fee.
CALISO developed its own accreditation scheme to train internal auditor and supplier auditor at a lower cost in 1999.  The goal was to meet a growing demand for auditor training by companies and individuals that do not intend to work for registrars.  Since then, we have become the largest training provider in the US with over 20,000 certificates issued and a training certification recognized by all registrars as evidence of training for internal auditors and supplier auditors for ISO 9001, ISO 13485, ISO 14001, and ISO 16949.
The 4-5 day certified courses are not the recommended route if you do not intend to work for a notified body or registrar.  But, please do not hesitate to call should you need additional information on the training certification schemes, we would be more than happy to answer any questions you may have.

WHAT ARE THE REQUIREMENTS FOR ISO/TS 16949 INTERNAL AUDITOR QUALIFICATION? I'VE HEARD THAT AUDITORS MUST BE QUALIFIED BY AN AIAG, IRCA OR RABQSA MEMBER ORGANIZATION. IS THIS TRUE?
Please read this Quality Digest Article.

I WORK IN THE SEAFOOD INDUSTRY, DO I NEED TO TAKE AN FDA CERTIFIED EXAM?

No, the regulation is 21CFR123 is very clear on that. "At a minimum, the following functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who is otherwise qualified through job experience to perform these functions. Job experience will qualify an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum.
(a) Developing a HACCP plan, which could include adapting a model or generic-type HACCP plan, that is appropriate for a specific processor, in order to meet the requirements of 123.6(b);
(b) Reassessing and modifying the HACCP plan in accordance with the corrective action procedures specified in 123.7(c)(5), the HACCP plan in accordance with the verification activities specified in 123.8(a)(1), and the hazard analysis in accordance with the verification activities specified in 123.8(c); and
(c) Performing the record review required by 123.8(a)(3); The trained individual need not be an employee of the processor."

I WORK IN THE MEAT AND POULTRY INDUSTRY, DO I NEED TO TAKE A USDA CERTIFIED EXAM?

No the regulation 9CFR417 is very clear on recommending the degree of training for the HACCP Plan Manage: "(a) Only an individual who has met the requirements of paragraph (b) of this section, but who need not be an employee of the establishment, shall be permitted to perform the following functions:
(1) Development of the HACCP plan, in accordance with Sec. 417.2(b) of this part, which could include adapting a generic model that is appropriate for the specific product; and
(2) Reassessment and modification of the HACCP plan, in accordance with Sec. 417.3 of this part.
(b) The individual performing the functions listed in paragraph (a) of this section shall have successfully completed a course of instruction in the application of the seven HACCP principles to meat or poultry product processing, including a segment on the development of a HACCP plan for a specific product and on record review."


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