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 to acquire mission critical training for their businesses or careers. The 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.

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.

"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 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, Six-Sigma, Sarbanes-Oxley (SOX), 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 Training:

For corporations and institutions 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 three 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 for free for any course. The system provides a tracking and reporting system for registrations and course progress.
• Setting up a SCORM based Learning Management System (LMS) that can host our courses or any of the the internal corporate training material

Download international standards

Self-Implementation for ISO 9001, ISO 14001, ISO 13485, & AS9100:

CALISO offers a consulting and training programs in order to support certifications for companies that are under a budget crunch. We will support you to drive the implementation of you Quality Management System (QMS), and/or Safety and Environmental Management System through a program using a combination of on-site training, a targeted documentation implementation kit and phone support so the you can achieve your certification for: ISO 9001, AS9100, ISO 13485, ISO 14001, ISO and ISO 16949 (also called TS 16949). Take advantage of this opportunity to get implement an ISO Quality Assurance program and/or and environmental management system and get your company certified at a lower cost. You can drive operational improvements with training focused on increasing your organization's effectiveness and profitability at great cost savings. We have a team of consultants at your service. Contact us at 1-800-306-1366 or E-mail.

ISO Certification:

"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...

"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

One third of disputes trade cases brought before the World Trade Organization (WTO) involve standards! Most of them claiming that the certification requirements are in reality technical trade barriers. This may actually get worse with the publication of the newest release of ISO 26000, the social responsibility standard, which may become a very steep obstacle to companies operating in countries with minimal labor and environmental protection laws or practices. ISO 26000 provides a solid framework to balancing economic, environmental and social sustainability. But organisations operating within an environment that does not promote or regulate these aspects, may choose to push-back through trade disputes rather than adopt this standard, or lobby with their governments not to accept this standard. Only 60 countries have adopted the standard so far. Anxiety is high and Google searches on ISO 26000, which is already available in 22 languages, are sky-rocketing

The Food Safety Modernization Act:

The Food & Drug Administration has released the Food Safety Modernization Act. ISO 22000, which as well as the food GMP are now required by large food distributors and importers from their suppliers. ISO 22000 certification, which includes HACCP and cGMP compliance, by a third party or Registrar has become a must for domestic and foreign food manufacturers and processors . In other words the new FDA law explicitly places primary responsibility for food safety for prevention on food producers and processors. The new importer accountability provisions require importers to implement a foreign supplier verification program. It requires importers to verify safety of foreign foods. They will thus need to provide adequate assurance that imported foods have been produced under appropriate risk-based preventive controls that provide the same level of public health protection as those required of the domestic food industry. The FDA can also now require an accredited third-party certification as a prerequisite for the importation of high-risk foods into the U.S. when they believe it necessary to protect the health of our consumers.

Interesting News and reports
-The FDA set up a Voluntary Report Submission Pilot Program . It allows medical device manufacturers to submit their ISO 13485 audit reports, issued by notified bodies to the FDA. The FDA had then the ability to get information on the level of compliance of a manufacturer's QMS. The FDA then uses these reports to prioritize their audits.
- CALISO has just released a new online training course ISO/TS 16949 Lead Auditor
- CALISO can offer free ISO certification in collaboration NSAI of Ireland
- ISO 50001 is a success!!!
- More Stringent FDA Review
- Additional ISO 9001 documentation.