Services
What We do
Internal and Supplier Audits
ISO & Quality System Audits
We provide independent quality system audits to help organizations evaluate their quality systems, identify risks, and strengthen compliance. Our audits can be aligned with ISO 9001, ISO 13485, customer requirements, and your organization’s established procedures.
We also support gap assessments, mock audits, and corrective-action follow-up. Our practical approach helps identify issues before they become larger problems and improves readiness for customer, certification, and regulatory audits
Supplier Audits & Assessments
We evaluate suppliers to help identify quality risks, verify compliance with requirements, and improve supplier performance. Assessments can include quality system reviews, process audits, corrective-action follow-up, and supplier development support
Inspection Readiness
Inspection Preparation & Support
We help organizations prepare for customer, regulatory, and certification inspections by reviewing documentation, processes, records, and overall quality-system readiness. Our approach identifies potential gaps before the inspection and helps ensure your team is organized, prepared, and confident.
Mock Audits & Corrective Action
We conduct mock audits and readiness assessments to identify weaknesses before they become inspection findings. When gaps are identified, we can assist with corrective actions, documentation improvements, and follow-up activities to strengthen ongoing compliance and inspection readiness.
Interim Quality Leadership
Temporary Quality Leadership
We provide experienced interim quality leadership when organizations need temporary support during staffing transitions, growth, special projects, or periods of increased operational demand. We can help oversee day-to-day quality activities, maintain compliance, support your team, and keep critical quality initiatives moving forward.
Flexible, On-Demand Support
Our interim support can be tailored to your organization’s needs and timeline—from short-term project leadership to ongoing fractional quality management. This provides experienced quality leadership without the cost or long-term commitment of adding a full-time position
Document Control and Training
Document Control
We help organizations establish and maintain effective document control systems for procedures, work instructions, forms, records, and other controlled documents. Our support includes document development, review and revision processes, approval workflows, version control, and record management to help ensure information remains accurate, current, and accessible.
Training
We provide practical quality training tailored to your organization’s needs. Topics can include quality system requirements, internal auditing, inspection methods, CAPA, document control, and applicable industry standards. Training can be provided on-site or virtually and customized for different roles within your organization.
Let’s Talk About Your Quality Needs
Request A Quote
Tell us about your quality needs, project, or current challenge. We’ll discuss your requirements and determine how Fractional Quality Consultants can provide practical, flexible support for your organization.