CALISO offers the best and most popular web-based courses for ISO standards and FDA regulations. Fortune 500, small businesses, AND individuals use them for their businesses or careers. CALISO has delivered tens of thousands online courses that have many unique advantages:
"The Registrar has just
recommended IDT for ISO/TS 16949 certification. Thank you very much for all your help and support. You have
been instrumental in this auditor certification and we acknowledge all the extra hard work and "labor of love" you
have provided. I have personally gained a lot of knowledge from you that will allow me to do my job
Donald Lopez, QA Manager of IDT.
CALISO offers class and online training for ISO 9001 auditor, ISO/TS 16949, FDA cGMP, FDA GLPs, ISO 13485, ISO 19011, ISO 22000 HACCP, ISO 14001 and, AS9100 Rev. C. The training uses excerpts of the exact text of the standards or regulation, and will provide accurate training, free of distortions and misinterpretations other training (such as auditor or standard instructor-lead classes) typically have. We have Auditor training, and Lead Auditor training courses. They can be taken from the convenience of your office or your home, at your own pace, with a 3-year limit on completion, and with 60% cost savings on similar classes or courses. All the standards or regualtion excerpts used in the online training are provided online (view only) with permission of ANSI, courtesy of the US FDA, the FAO, and AS9100 with permission of SAE International.
For organizations that wish to implement or launch company-wide standard or auditor training for their employees on Quality Assurance, Environmental Management, Regulatory Affairs, or Safety standards and regulations, we offer 2 types of services:
We fully assist companies and organizations that want to achieve compliance or certification to the following standards, and regulations: ISO Certification, ISO 9001, ISO 14001, ISO 13485, AS9100, Codex Alimentarius, Food Code, HACCP, ISO 22000, ISO/TS 16949, GMP, and GLP. For explanations on the various standards and regulations, click on the following link: ISO standards and regulations.
We assist medical device manufacturers obtain product certifications such as CE Marking, and FDA 510 K approval. CALISO's cost-effective consulting process ensures certifications and approvals are obtained in a timely manner in order to meet business objectives. For FDA 510k Premarket Notification Submissions: We will prepare your Traditional, Abbreviated or Special 510k submission for FDA approval. Our services include: developing an effective regulatory strategy for submission, product specific background research, documentation preparation (all required 510k sections), internal expert review of your submission to minimize additional FDA questions, and communicating with the FDA on your behalf. If necessary, we parallel process the company certifications or compliance (FDA 21CFR820) to achieve regulatory and quality compliances in an integrated approach.
CALISO assists you in
your certification and employee standard or ISO 9001 lead auditor training in the most cost-effective and
beneficial way. We work with the most reputable registrars to ensure your certification
has the proper recognition. Checkout our certification success stories, and projects.
"CALISO was so easy to work with. We were worried about the impact of culture change by implementing the AS9100 standard. CALISO made the standard work for us, they are very experienced with different methods to implementing the standard and their responsiveness is unmatched."
Frank Dutra - CEO of Advanced Machining Technologies.
More success stories...
Interesting News and
-The Draft International standard is released for 9001. The DIS on quality management systems, ISO's most famous standards is, as of July 10, 2014, ready for public comment as it hits another milestone. The final standard is expected a year later with a 3-year transition period. Watch the ISO 9001 DIS revision video from ISO.
-ISO 45001, which sets requirements for occupational health and safety management systems, has now reached Committee Draft stage.
-CALISO has a new consulting and training partnership in Mauritus BBCL Consulting.
-First draft of ISO 14001 revision for environmental management systems is released; Watch the ISO 14001 changes highlight video.
-First draft of ISO's standard for sustainable communities reaches CD stage; ISO 37101 sets requirements, guidance and supporting techniques and tools for sustainable development in communities, has now reached Committee Draft stage.
-Companies and organizations are integrating an energy management system to reduce consumption. Now, however, they can take this exercise a step further with the new ISO 50002:2014, the International Standard on energy audit, which will help them make informed decisions about how they use their energy.
-Additional Training documentation.
|ISO 9001 Overview||$159.95|
|ISO 9001 Auditor||$229.95|
|ISO 9001 Lead Auditor||$355.95|
|ISO 9001 Kit||$529.95|
|ISO 9001 Business Strategy||$219.95|
|ISO 14001:2004 Auditor||$229.95|
|ISO 14001 Lead Auditor||$319.95|
|ISO 13485:2003 Auditor||$279.95|
|ISO 13485 Lead Auditor||$389.95|
|ISO/TS 16949:2009 Auditor||$239.95|
|ISO/TS 16949 Lead Auditor||$369.95|
|AS9100 Rev. c||$329.95|
|FDA GMP: Medical Devices||$189.95|
|FDA GMP: Pharmaceuticals||$229.95|
|FDA GMP: Human Food||$229.95|
|OHSAS 18001 Kit||$159.95|