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ISO 9000, 9001, ISO 9001:2008, 13485, 16949 Training Consulting, 510K, & ISO Certification
Also see our full line of ISO Training Courses & Consulting Services Consulting Services:
We offer a full range of consulting services geared towards helping small and medium-size businesses and organizations achieve competitiveness, certifications and compliance to international standards and regulations. The services include:
1- Company ISO Certifications: We fully assist companies and organizations that want or need to achieve compliance or certification to the following standards, and regulations: ISO Certification, ISO 9001:2008, ISO 9000, ISO 13485 , ISO 14971, AS 9100, HACCP, ISO 14000, Six-Sigma , ISO 16949, TL 9000, GMP, GLP, OHSAS 18000, ISO 27001 and ISO 17799. We have a strong consulting team in California, and in all the other states. For explanations on the various standards and regulations, click on the following link: ISO standards and regulations. 
2- FDA 510k approval and CE Certifications:
We also help medical device manufacturers obtain product certifications such as CE Marking, and FDA 510K approval in a timely manner in order to meet business objectives. We have an efficient and very cost-effective process for securing FDA 510k clearances, and CE certifications. 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 510 (k) sections) , internal expert review of your submission to minimize additional questions from the FDA, and communicating with the FDA on your behalf. If necessary, we parallel process the company certifications (ISO 13485) or compliance (FDA 21 CFR 820) to achieve regulatory and quality compliances in an integrated approach.
"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 certification and we acknowledge all the extra hardwork and "labor of love" you have provided. I have personally gained a lot of knowledge from you and this entire project that will allow me to do my job effectively and efficiently...." Donald Lopez, QA Manager of IDT. Read more testimonials.
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Training:
We offer class and online courses for ISO 9001:2008, ISO 9000, ISO/TS 16949, FDA cGMP, FDA GLPs, ISO 13485, ISO 19011, HACCP, Six-Sigma, Sarbanes-Oxley (SOX) and ISO 14000. The courses use the exact text of the standards or regulation, and will provide accurate training, free of distortions and misinterpretations other courses typically have. They can be taken from the convenience of your office or your home, at your own pace, with no time limit on completion, and with 60% cost saving on similar classes. The pair of ISO 9000 online courses and the Auditor course WERE IATCA, RAB-approved ISO 9000:2000 transition training for RAB-certified QMS auditors during the transition period, which ended December 15, 2003. All excerpts of the standards used in the online courses are reprinted with permission of ANSI.
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California only: The State will fund your training for implementation of ISO 9001, AS9100, ISO 13485, ISO 14971, TL 9000, OHSAS 18001, Six Sigma, GMPs, ISO/TS 16949, ISO 14000, ISO 27001 and ISO 17799. Take advantage of this opportunity to get your company's certification, or drive Operational and process improvement with training focused on increasing your organization's effectiveness, efficiency and profitability. See our workshops also. We have a team of consultants and trainers that covers all 50 states, with a traditionally strong presence and offices in Northern California, the Silicon Valley, the Bay Area and Southern California. Contact us before the budget is exhausted!!! at 1-800-306-1366 or E-mail.
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ISO Certification:
We will assist you in obtaining ISO certification to ISO 9001, AS9100, ISO 13485, ISO/TS 16949, TL 9000, GMP, ISO 14000 or GO GREEN, OHSAS 18001, and HACCP, in the most effective and beneficial way. We work with the most reputable registrars and notified bodies to ensure your certification has the proper national and international recognition. Checkout our success stories, and Current projects......
"CALISO was so easy to work with. We were worried about the impact of culture change by implementing the AS 9100 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 - owner of Advanced Machining Technologies. More success stories......
CALISO has 100% success rate in helping customers reach their Time To Market and iso certification objectives. We are headquartered in California and have offices and/or consultants in the 50 States, and Mexico. Contact us if you have any questions or need a quotation on a particular consulting or training service. Tel: 1-800-306-1366. |
