Audit and QMS

Illustration of audit documents, charts, and graphs with checkmarks and a magnifying glass, symbolizing review and analysis.

Internal audits often get rushed because your team is focused on daily operations. When audits are done under time pressure or by those too close to the process, they can miss key issues. The result: bias, blind spots, and audits that feel like a formality instead of a powerful improvement tool.

At the same time, many Quality Management Systems (QMS) are treated as paperwork exercises: built to pass audits rather than to actually improve performance. A weak or overly complex QMS can create confusion, add cost, and fail to deliver real value.

At QualDatics, we bring a fresh, objective perspective. Our audits uncover risks and improvement opportunities, while our QMS services focus on making your system simple, practical, and aligned with business results. We help ensure your quality system adds value to your business, not just checklists for compliance.

Some of the audit and QMS services we provide include:

  • Internal audits for ISO, API Q1 and Q2, GMP, GFSI, BRCGS and more

  • ISO 9001, 14001, 45001, and IATF audit preparation

  • Customer audit readiness and mock audit walkthroughs

  • Regulatory audit preparation and documentation review

  • Gap assessments to identify risks and improvement areas

  • Evaluation of KPIs and controls for effectiveness

  • Certification consulting: is it the right path for your business

  • Risk Analysis, FMEA, HACCP, and Recall management

  • SOP development: simple, effective, and easy-to-use procedures

  • Specifications: setting the right specifications and aligning them with customers and production

  • Process capability studies: ensuring your processes consistently meet requirements

  • Measurement system analysis: gage R&R to evaluate measurement variation and identify improvement opportunities

  • Design of Experiments (DOE): structured approach to optimize processes and reduce variability

  • Process simplification: streamlining complex systems into clear, practical workflows

Schedule your free QMS consultation. We will assess your current system, highlight areas of risk, and share practical steps to strengthen your compliance and performance.