Quality Consulting

Our services

  • QMS Certification Support and Preparation

  • Laboratory Testing Improvement

  • Quality Control / Quality Assurance Program Development

    • Reduction in the Cost of Poor Quality (CoPQ)

Our Methodology

QMS Certification Support and Preparation

  • Gap assessment of QMS against ISO standard or policy

    • Define the scope, objectives, and resources required for the gap assessment audit.

    • Assess the existing documentation to ensure it aligns with ISO requirements.

    • Assess actual practices and compare them to documented procedures and ISO requirements.

    • Document findings and identify the root causes of non-compliance or inefficiencies.

    • Create an action plan to address the identified gaps and improve the QMS.

    • Address identified gaps and ensure compliance with ISO requirements.

    • Ensure continuous improvement and ongoing compliance with ISO requirements.

    • Engage top management and ensure long-term commitment to ISO compliance.

    • Finalize preparations for the ISO certification audit.

Cost of Poor Quality - Improvement

  • Conduct a COPQ assessment

  • Engage leadership and build a culture of quality.

  • Focus on high-impact areas contributing to COPQ.

  • Improve process reliability and reduce defects.

  • Ensure incoming materials meet quality standards.

  • Engage employees in quality improvement efforts.

  • Design for manufacturability and reliability.

  • Increase precision and consistency in manufacturing.

  • Reduce external failures and warranty claims.

  • Ensure lasting results and ongoing quality improvement.

  • Quantify the impact of quality improvements and celebrate success.

QMS Certification Support and Preparation

  • We help you achieve ISO compliance!

    • ISO 13485:2016

    • ISO 17025:2017

  • Internal Auditing and Gap Assessments

  • Authoring Quality Manual and Procedures

  • Audit Finding Responses, including investigations, root cause analysis, and corrective and preventive actions

Quality Control / Quality Assurance Program Development

We help you establish programs to reduce your cost of poor quality (COPQ) to increase your bottom line:

  • Prevention cost

  • Appraisal cost

  • Internal error cost

  • External error cost

  • Customer-incurred cost

  • Customer-dissatisfaction cost

  • Loss-of-reputation cost

Laboratory Testing Improvement

We help you improve your testing precision and accuracy by implementing:

  • Statistical Process Control

  • Proficiency Testing, and evaluation programs

  • Methodology and Matrix uncertainties

Questions before getting started? Get in touch.