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ISO 9000, 9001, ISO 9001:2008, 13485, 16949, 22000 Training Consulting, 510K, CE & ISO Certification
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 22000, ISO 14000, ISO 16949, GMP, and GLP. We have a strong consulting team in California, and consultants available 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 cost-effective process for securing FDA 510k clearances, and CE certification. 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 that will allow me to do my job effectively...." Donald Lopez, QA Manager of IDT. Read more testimonials..
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ISO Training:
We offer 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 14000 and, AS9100 Rev. C. The training use the exact text of the standards or regulation, and will provide accurate training, free of distortions and misinterpretations other training typically have. 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 saving on similar classes. The pair of ISO 9000 online training and the Auditor course WERE IATCA, RAB-approved ISO 9000:2000 transition training for RAB-certified QMS auditors during the transition period. All the standards excerpts used in the online training are provided online with permission of ANSI AS9100 is provided online with permission of ASE.
Corporate Training:
For corporations and institutions that wish to implement or launch company-wide training for their employees on Quality, Environmental, Regulatory Affairs, or Safety standards and regulations, we offer three types of services:
Volume discounts for purchases of over 100 course licenses 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.
Offering SCORM compliant modules for organizations to set up or include in their internal training portal or intranet cyber-training program.
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Cost-Saving remote ISO consulting support We offer remote consulting programs in order to support companies located in areas and foreign countries, where travel to costs are high, and would make certification too expensive. We will support you by email and skype to drive the implementation of ISO 9001, AS9100, ISO 13485, ISO 14001, ISO 22000, CE Marking, FDA 510k ISO/TS 16949 and GMPs. Take advantage of this opportunity to get your company certificatified at a lower cost, or drive Operational and with training focused on increasing your organization's effectiveness, efficiency and profitability. We have a team of consultants at your service. Contact us 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, 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 - CEO of Advanced Machining Technologies. More success stories......
__________________________________________________________________________________ISO 9004:2009 replaces ISO 9004:2000. It makes substantial changes to its structure and contents of the earlier edition and introduces changes intended to improve consistency with ISO 9001:2008 and other management system standards. An example of an important change in the structure of ISO 9004 is that the "body" of the standard starts with the chapter giving guidance on how to manage an organization aiming for sustained success and not how to build a quality management system.
Although ISO 9004:2009 complements ISO 9001:2008, it can also be used independently. It is not intended for third-party certification, regulatory, or contractual use, nor as a guide to the implementation of ISO 9001:2008. To help users get the best out of the standard, an annex gives a clause-by-clause correspondence between ISO 9001:2008 and ISO 9004:2009.
"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
New MDD for CE Marking
The Medical Device consolidated Directive, MDD 93/42/EEC has become mandatory on March 21, 2010. This means that all medical device manufacturers have to review their compliance to this directive and be in compliance. OTHERWISE they have to stop selling their devices in the European community. This is especially critical for the new classification rules, if a Class I device is now classified as Class II a or b, or from Class II to Class III, a new conformity assessment is required. So it is URGENT to conduct a review of your product to the new MDD requirements and classification rules, or risk having to stop market presence.
The FDA and ISO 22000: The Food and Drug Administration (FDA) is moving towards requesting ISO 22000 as a prerequisite for FDA registration. It is requesting comments
on the use of third-party certification programs for foods and feeds, including pet foods. An increasing number of firms that sell foods to the public, such as retailers and food service providers, are requesting that their suppliers become certified as meeting food safety and quality standards as a condition of doing business. FDA seeks more information on the existence and use of these programs to better understand how they can help to ensure that food products are safe and meet FDA requirements.
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