Quality Management Systems

  • Input from QMS stakeholders is crucial during QMS design in order to maximize QMS-effectiveness and stakeholder “buy-in”.
  • QMS operators need user-friendly turnkeys to unlock and efficiently run the system.
  • Truly effective QMS processes are based on gold-standard practices that functionally address the letter and intent of QMS regulations and standards. It’s not enough to just read the regulations and copy them into procedures.
  • Procedures should be written to simultaneously meet FDA and ISO 13485 requirements.
  • Interdependent subsystems must be seamlessly integrated (like Risk Management and Corrective Action) to assure systemic continuity.
  • QMS processes need to be strategically installed in the right order to reduce everyone’s frustration and to avoid wasted time.

These are some of the core principles that ComplianceAcuity uses when we assist you with your FDA or ISO 13485 QMS. Click on a link below to review the QMS solutions about which ComplianceAcuity is most passionate:

Corrective & Preventive Action (CAPA)

Complaint Handling

Design Controls / Product Development

Risk Management

GMP Training

Internal/Mock Audits

Management Responsibility

Production and Process Control

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