Consultant Listing
ISOguru, Inc.
- Website: http://www.isoguru.com
- Standards: ISO 9001, ISO/TS 16949, AS 9100, TL 9000, ISO 13485, ISO 27001, OHSAS 18001, CMMI, ISO 14001, BS OHSAS 18001, ISO 27001, ISO 20000, ISO 22000, ISO 17025
- Location: California, USA
- Email Address: vinod@isoguru.com
About the founder and ISOguru
Vinod Kumar, founder President of ISOguru Incorporated, is a BSME (Mechanical Engineer) and an MBA with more than 30 years of experience in the field of quality and environmental management systems. He was President/General Manager of Aerospex Corporation till 1992 after which he has been in the consulting/auditing/gap analysis and training business as a co-founder of Quality 2000 Incorporated, and has helped several companies to achieve ISO 9001, QS 9000, ISO/TS 16949, AS 9100, ISO 13485, ISO 14001 and other international certifications. Vinod Kumar has also been on the panel of experts in international forums on quality system standards. Many of his clients have had not even a single minor nonconformance in their certification audits. This is the level of expertise he brings to you in this field.
Vinod Kumar is not only a RABQSA (Registrar Accreditation Board and Quality Society of Australia) Certified Quality System Lead Auditor (QS-LA), RABQSA ‘Skill Examiner’;, RABQSA Environmental Management Systems Lead Auditor (EMS-LA) and IPC (International Personnel Certification Association, formerly known as IATCA – International Auditor and Training Certification Association) Lead Auditor, he has also attained the distinction of being recognized as a “Responsible Person and Verifying Auditor” by the IPC/IATCA Executive Panel. Vinod Kumar has also served on the 2005, 2006 and 2007 Board of Examiners for the Malcolm Baldrige National Quality Award.
We provide consulting, training, implementation /compliance and auditing /gap-analysis service in the United States and Mexico for ISO 9001, ISO/TS 16949, AS 9100, TL 9000, ISO 13485, ISO 27001, OHSAS 18001, CMMI, ISO 14001, BS OHSAS 18001, ISO 27001, ISO 20000, ISO 22000, ISO 17025, and BS 25999. We can also help with procedures and manual preparation. We also provide consulting and training services for the Malcolm Baldrige National Quality Award program.
Besides individual training seminars and per man-day and per man-hour consulting services, we also have guaranteed success plans. Under the guaranteed success plans, our ISO gurus have had 100% success rate so far. We have accelerated programs to achieve certification within 5-8 months. We also have special programs for integrated management systems or upgrades to ISO 9001, ISO/TS 16949, AS 9100, TL 9000, ISO 13485, ISO 27001, OHSAS 18001, CMMI, ISO 14001, BS OHSAS 18001, ISO 27001, ISO 20000, ISO 22000, ISO 17025, and BS 25999. certified companies.
Our consulting partners/associates are a full service regulatory consulting company specializing in Medical Device and Diagnostic industries and provide services for compliance (QSRs & GMPs), submissions (FDA and CE Marking) and clinical trials (protocols, IDE, IRB, set up, monitor, statistics, report).
Medical Device and Diagnostics
Our consulting partners/associates are a full service regulatory consulting company specializing in Medical Device and Diagnostic industries and provide services for compliance (QSRs & GMPs), submissions (FDA and CE Marking) and clinical trials (protocols, IDE, IRB, set up, monitor, statistics, report).
For FDA registration, complete service is available for filling and obtaining approval to legally market your device in the United States. This service may include all FDA registrations (PMA’s, 510(K)’s, etc.). For clinical trials, services may include help with preparing protocols, locating investigators, obtaining study approvals with IRBs and if necessary the FDA, investigator training and study monitoring. At the end of the study, help can also be provided with statistical summaries and final report preparation for either FDA submission or marketing use.
Please contact us for details of fees on services for MDD industry.
ISOguru, Inc.
San Diego, California
(Your guide in a world of change)
http://www.isoguru.com
ISO Terms Explained
To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.