Service Intro

BHILOGS develop and deploy customized robust Quality Management System (QMS) adhering to any of the regulatory standards of your choice with minimal time and cost.

There will be productivity increase and cost savings of more than 60% using our service.

Our Offering

  • Implement QMS based on ISO 9001:2000, ISO 13485:2003, FDA Quality System Regulation Title 21 CFR Part 820, 210, 211 etc.
  • Identify general compliance expectations of the FDA, EU and local authorities for medical device and drug manufacturers.
  • Identify the key points of the Quality System Regulation.
  • Complete an initial “gap analysis” of what’s new/different in a regulated industry
  • Identify the technical and non-technical requirements for organizational readiness for effective QMS implementation
  • Identify a problem in standard interpretation; be able to resolve it to meet compliance
  • Identify factors to consider when planning a QMS implementation: organizational environment, human elements, business objectives, and costs
  • Identify cost saving and business value of registration to a QMS standard for the organization
  • Identify role of important quality and productivity methods such as Six Sigma, Lean, Baldridge, and Balanced Scorecard in a QM
  • Identify tools that can assist and improve QMS implementation
  • Identify metrics to assess implementation success
  • Identify ISO/EU/FDA audit process, including QSIT, QSR “satellites” and Part 11 compliance issues

The service also provides correlation between different standards, applicable clauses and gap analysis. The quality management system service will establish policies and requirements that apply to organizations employees, facilities, products and services involved in the design, manufacture, test, distribution, installation and servicing of products intended for use. The quality management system designed will ensure that products are safe and effective and to prevent nonconformance’s at all product stages from design through servicing.