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