ISO 13485 certification

Comparison with other courses

CALISO Online Training courses

Other courses

Cost

50-60% cheaper than other courses AND there is no training material or travel cost. Travel costs for sending employees to training courses and seminars, often represent 20% of training budgets....

Charge a premium because they have less registrants and much narrower reach in a class environment than the CALISO online training, which has trainees from as far as South Africa, Malaysia, Iceland and Japan.

Content

The courses use the exact excerpts of the standards or regulations with no distortions and innacuracies because of paraphrasing or trainer's "own" interpretation.

Because of time and cost constraints regular class courses use material that very often paraphrases the standard and use the trainer's own experience and interpretation. This results in a lot of inaccuracies and distortions.

Learning experience

With no time limits on the training or on taking the quizzes you can really absorb the information and provide more accurate answers on quizzes.

Time constraints very often make for incomplete learning experiences. People learn at a various speeds and rates; time constraints prevent effective learning. Very often in a class-training environment without a continuous evaluation mechanism such as in the CALISO courses only a fraction of the attendees benefit from the training.

Convenience

You don't need to travel to go attend a seminar or class out-of-town. You can take it from your office, your home or any other location, at your own pace and take as much training as you want until you complete the course.

On most class courses you have to go off-site for at least one day if not five days for lead auditor courses where you also stay in a hotel. They also very often get canceled because of a lack of attendance, thus delaying your training plans and schedules. On-site courses will also have you spend at least a day locked in a conference room.

Approvals

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, GLP, GMP, ISO 16949 and other ISO standards and FDA regulations.

NOTE: TAKING A CERTIFIED RABQSA or IRCA COURSE DOES 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 20 audit days, with at least 4 complete audits as member of an audit team witnessed by a certified Auditor, you can then 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.

Recognition

Very large and reputable organizations such as Philips Medical, CISCO, Intel, FDA, the Military, Dell, Sears, Baxter and Raytheon are using our online training programs to train more employees effectively and save on cost.

Only a handful of training costly course providers has good recognition. A lot of training courses come very short in providing recognized training achievement that can advance your career or benefit your organization. See the IRCA Auditor certification or the RABQSA Auditor certification schemes

Benefits for implementation

Very exact knowledge of the standards results in streamlined and beneficial implementation. The more employees are trained effectively on the standard or regulation the better the implementation.

Very often lack in preciseness as to standard requirements and lead to over or under implementation.

Benefits for internal audits

Training relating directly to the standard requirements result in value -added audits.

Except for a few good courses from costly training provider, they often yield to subjective and disruptive non-beneficial audit results.

Benefits for external audits

Better communication with external auditors by referencing requirements of the standards or regulations, not subjective interpretations. This is often the key to succesfully passing your external audits.

Except for a few good courses from costly training providers, the trainees are unable to communicate clearly with registrar and customer auditors on compliance to specific requirements.