Services

Systems Implementation and Conformance Assessment

Implementation and Conformance Assessment for the for the ISO Standards: 

ISO 9001:  Quality management systems - Requirements

ISO 14001: Environmental management systems - Requirements with guidance for use

ISO 13485 with 21 CFR 820: Medical devices - Quality management systems - Requirements for regulatory purposes

ISO/IEC 17025:  General requirements for the competence of testing and calibration laboratories

ISO/IATF 16949:  Quality management systems - Requirements for the application of ISO 9001 for Automotive Production

ISO 50001: Energy management systems - Requirements with guidance for use

Certification Audits

Audits to Register Your System to a Particular Standard:

 

ISO 9001:  Quality management systems - Requirements

ISO 14001: Environmental management systems - Requirements with guidance for use

ISO 13485 with 21 CFR 820: Medical devices - Quality management systems - Requirements for regulatory purposes

ISO/IEC 17025:  General requirements for the competence of testing and calibration laboratories


Federal Regulatory Compliance

Evaluating Your Organization to ensure Compliance with Federal Regulatory such as the Code of Federal Regulations including FDA, OSHA and EPA requirements, Federal Acquisition Regulation, Defense Federal Acquisition Regulation, GSA Acquisition Manual 

Services

Technical Assessment

Evaluation of Processes and Infrastructure to Provide Critical Information such as Capability, Capacity, Efficiency, Calibration and Opportunities for Improvement 

Training

Training courses on ISO Standards, Lean Six Sigma, Internal Auditing, Federal Regulatory Audit / Inspection Preparation