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Testimonial
"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.
Testimonial
"Certification Xpert was so easy to work with. We were worried about the impact of culture change by implementing the AS 9100 standard. They 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.
Testimonial
"Mikron Vinyl would like to announce their ISO 9001 certification status. We were recently audited by RWTUV USA on December 13th and successfully passed the audit with only one minor nonconformity. We were very satisfied with the services provided by Certification Xpert and we were particularly pleased with their responsiveness to our issues and their knowledge about keeping a QMS simple and easy to implement...." Doug Allen, QA Manager of Mikron Vinyl.
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Certification Xpert partners with
CALISO Consulting Inc. for ISO certification and can assist you in implementing and achieving the following certifications for your organization:
ISO 9001, ISO 14001, ISO 13485, ISO/TS 16949, and AS9100.
We have helped hundreds of companies located in California and also worldwide in their certification projects to meet one of these international standards and improve their quality or environmental management system.
Certification Guarantee
Provided you follow our recommendations in a timely manner, your certification is guaranteed. We have 100% success rate helping companies achieve their certification cost-effectively and on schedule.
Which standard are you interested in?
Link to CALISO Consulting for your ISO 9001 certification needs.
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Certification Xpert can assist you in achieving US FDA or CE approval for your medical device, or pharmaceutical product
We prepare, review and coordinate with the applicable administration your 510K or CE certification, so that you can secure your approval in a timely manner, and save on your regulatory expenses.
We have expertise in a wide range of products which require compliance to FDA or EU regulations such as MDD and IVD.
Medical Devices
For medical devices classified as Class II or Class III, a 510K clearance for the US, and CE Marking are necessary in order to market your product. The clearance requires compliance to the CFR, Part 820 Quality System Regulations (QSRs), Good Manufacturing Practices (GMP) and the other applicable CFRs for the product type and indications for use for the US, and ISO 13485:2003 as well as the MDD or IVD directives for Europe.
Which approval are you interested in?
All the standards excerpts used in the online training are provided online with permission of ANSI and AS9100 with permission of SAE  Watch an overview video of ISO 13485 Online Training |
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We offer online training classes for ISO 9000, ISO/TS 16949, GMP, ISO 13485, ISO 19011, AS9100, ISO 22000, GMPs, GLP, Six-Sigma, HACCP and ISO 14000 standards.
The course provide complete training on the standard, regulation or best industry practices as well as on how to audit to them. The online training courses that have gained industry recognition, and are approved by the German Registrar TUV-USA. The certificate of training bears the TUV logo and if you are not satisfied with our course trainingonline training classes we will refund 100% of your registration fee within 30-days of registration for a any course you have not completed.
TRAINING AVAILABLE:
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LATEST NEWS
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ISO 9001:2008 was released The new version of ISO 9001 was released and replaces ISO 9001:2000.
ISO 9001:2008 contains no new requirements compared to the 2000 edition. It mainly provides clarifications to the existing requirements of ISO 9001:2000 and introduces changes intended to improve consistency with the environmental management system standard, ISO 14001:2004.
AS9100 was released
AS9100 Revision C incorporates changes to ISO 9001:2008, it expands scope to include land and sea based systems for defense applications. It also ensures alignment with IAQG strategy (on-time, on-quality performance), adopts new requirements based on stakeholder, and needs and improve existing requirements where stakeholders identified need for clarification.
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CUSTOMER TESTIMONIAL
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Certification Xpert quickly and accurately assessed the readiness of siteROCK to pass the final audit by making the intellectual effort to really understand our business processes. This allowed us to focus our efforts on those things that were really needed both to improve our business and to obtain the certification. The detailed plan for implementing their recommendations was followed to the letter and resulted in our obtaining registration without any non-conformances, on time, and under budget. Rarely have I worked with a consultant who so clearly took our business objectives as his own. At this point, I am pleased to say that we are not only an ISO 9001 registered company, we are a better managed company as a result of your contribution.
Dave Lilly
SiteRock CEO
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