Training courses for ISO 9000, ISO 9001, ISO 13485, ISO 14001, AS9100, ISO
16949, ISO 22000, GMP, GLP
Training and Consulting for ISO 9001, ISO 14001, ISO 13485, AS9100,
HACCP, GMP and other standards:
CALISO offers a full
range of training and consulting services geared towards helping businesses and
organizations achieve certifications and compliance to international standards and regulations in
quality assurance, environmental compliance, and product safety. Our strength lies in our
ability to understand all the various business models and industries, without adopting a cookie cutter
approach other consulting firms use. We adapt the standards or regulation to the company's business needs,
and bring operational improvements by implementing industry best practices. Our ability to provide very
pertinent classed training, as well as the most successful online training sold worldwide
through the web, give us additional reach and ability to provide very cost-effective 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 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.
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 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..
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 use the exact text of the standards or
regulation, and will provide accurate training, free of distortions and misinterpretations other training
typically have. It 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. All the standards excerpts used in the
online training are provided online (view only) with permission of ANSI, and AS9100 with permission of
SAE
International.
Corporate ISO
9001 Training and Management Systems:
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.
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. 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 will assist you in
obtaining ISO certification to ISO 9001, AS9100, ISO 13485, ISO 16949, GMP, ISO 14000, 14001
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 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......
ISO 9004:2009 replaced ISO
9004:2000. It made 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 an
ISO quality assurance quality management system. Although ISO 9004:2009 complements ISO 9001:2008, it can
also be used independently. 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
The Medical Device consolidated Directive, MDD 93/42/EEC has become mandatory.
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 & Drug Administration 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.
Interesting News and
reports
-New CMTC partnership
-ISO 50001 is a success!!!
-CALISO in the news in SAE
Update
-More Stringent FDA Review
-AS9100 Revision C is released
-ISO 14971 is being audited for risk management of
medical devices.
-DaimlerChrysler Mandates ISO/TS 16949 to its suppliers.
-Additional ISO 9001
documentation.
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