ISO 9000 certification ISO 9000 certification ISO 9000 certification ISO 9000 certification

Training courses for ISO 9000, ISO 9001, ISO 13485, ISO 14001, AS9100, ISO 16949, ISO 22000, GMP, GLP

Training for ISO 9001, ISO 14001, ISO 13485, AS9100, TS 16949 HACCP, GMP, GLP, ISO 16949 & ISO 22000:

CALISO Corporation offers the most successful and cost-effective web-based courses in the field of ISO standards and FDA regulations. Fortune 500 companies, small businesses, AND individuals use them worldwide their businesses or careers. CALISO educational courses are specialized in quality assurance, environmental compliance, and product safety. CALISO's strength lies in its ability to understand all the various business models and industries, and deliver web-based training at a fraction of the cost as to what other trainers charge. Companies can therefore train more employees, which make the certification or compliance efforts a lot easier. CALISO has provided tens of thousands of its online courses that have the particularity of being very precise compared to other courses, which are based on interpretations or paraphrasing of the standards and regulations.

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1- Company ISO Certifications:

We fully assist companies and organizations that want to achieve compliance or certification to the following standards, and regulations: ISO Certification, ISO 9001, ISO 9000, 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.
ISO 9001 proposal

2- FDA 510k approval and CE Certifications:

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 (ISO 13485) or compliance (FDA 21CFR820) to achieve regulatory and quality compliances in an integrated approach.

510k proposal

"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 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 effectively...."

Donald Lopez, QA Manager of IDT.

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Training and education for ISO 9001, ISO 14001, ISO 13485, AS9100, GMP, GLP & other standards:

CALISO offers class and online training for ISO 9001:2008, ISO 9000, 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 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.

Corporate ISO Training:

For organizations that wish to implement or launch company-wide training for their employees on ISO 9001, Quality Assurance, Environmental Management, Regulatory Affairs, or Safety standards and regulations, we offer 2 types of services:

  • Volume discounts for purchases of over 10 course licenses online, or for 50 licenses or more at a time based on an RFP.
  • Setting up a webpage that the client can host on their website where employees can register take any course. The system provides a tracking and reporting system for registrations and course progress.

ISO Certification:

CALISO assists you in obtaining certification to ISO 9001, AS9100, ISO 13485, ISO 16949, GMP, ISO 14000, 14001 , 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 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.
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Interesting News and reports

Strategic decisions before the release of ISO 9001:2015

For companies that are already certified:

  • "Marginally involved" Top Management in the current ISO 9001 compliant management system, needs to increase its focus and start progressively building auditable records as objective evidence of its involvement.
  • Quality objectives need to be progressively fine-tuned to be more business oriented, and with greater emphasis on producing desired outputs and providing confidence in the organization's products.
  • At upcoming management reviews, time needs to be spent at identifying risks and opportunities and planning actions to address these business and quality risks and opportunities identified. This activity will replace preventive actions when the new standard is finally released. So it would be smart to merge this risk analysis activity with Preventive Action reviews in the Management Review agenda from now on. Again, we are talking about identifying and addressing risks, which can affect conformity of goods and services and customer satisfaction.
  • For companies that dropped their certification or are not currently certified:
  • First advice, is that you should seriously consider achieving certification to ISO 9001:2008 registration by December 2014. The current version is an easier standard to be certified to. You will then have 3 years to transition to ISO 9001:2015.
  • For companies, which for economic or organizational reasons cannot get certified by December 2014, the Draft International Standard should be released before August 2014. It should be purchased so as to start progressively implementing some of the "heavy" requirements of ISO 9001:2015 such as risk analysis and the business focus of the management system. It will make a future registration effort less difficult.

  • - Additional ISO 9001 documentation.

    ISO 9001 standard
    ISO 9001 online training
    ISO 9001 Overview $159.95
    ISO 9001:2008 $229.95
    ISO 9001 Auditor $229.95
    ISO 9001 Lead Auditor $355.95
    ISO 9001 Kit $529.95
    ISO 9001 Business Strategy $219.95
    ISO 19011:2011 $169.95
    ISO 14001:2004 $229.95
    ISO 14001:2004 Auditor $229.95
    ISO 14001 Lead Auditor $319.95
    ISO 13485:2003 $269.95
    ISO 13485:2003 Auditor $279.95
    ISO 13485 Lead Auditor $389.95
    ISO/TS 16949:2009 $229.95
    ISO/TS 16949:2009 Auditor $239.95
    ISO/TS 16949 Lead Auditor $369.95
    ISO 22000:2005 $289.95
    AS9100 Rev. c $329.95
    FDA GMP: Medical Devices $189.95
    FDA GMP: Pharmaceuticals $229.95
    FDA GMP: Human Food $229.95
    FDA GLP $185.95
    USDA/FDA HACCP $159.95
    SEAFOOD HACCP $159.95
    FDA HACCP $159.95
    Six-Sigma Course $159.95
    Sarbanes-Oxley (SOX) $269.95
    OHSAS 18001 Kit $159.95
    ISO 9001 registration

    Download international standards INTERNATIONAL STANDARD

    ISO 9001 online training

    15% Discount on any course when you register 10 or more employees from your organization.

    "Thank you very much for this course and service. It beats going to a live class which is much less convenient and far more expensive......." -Charles Poirier - QA Manager - Knurr Inc.


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    ISO 9000 regulation

    ISO certification success stories

    CALISO has 100% success rate in helping customers reach their iso certification objectives. We have experts in high-tech industries, medical devices and low-tech industries and services. Contact us if you have any questions or need a quotation on a particular consulting or training service. Tel: 1-800-306-1366.

    "We wanted to take a quick minute to say a big THANK YOU for all you have done for us. You came in as an outside consultant and within a short time have become part of the team! We appreciate all the extra care you have provided. Our wish is to repay your hard work by continuing and growing the ISO 14001 compliant EMS you have put in place."

    Steph, Bobbie, and all the guys!! From MERIT PARTNERS

    Contact us by email or call us, should you need clarifications or help for 510K and new MDD and CE Mark implications for your medical device(s) at 1-800-306-1366.

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