Why Frameshift Quality Consulting?

Are quality processes confusing, time-consuming and costly to manage?

Frameshift Quality Consulting simplifies compliance for medical genomics laboratories, enabling you to focus on what matters most; delivering safe, high-quality test results and operational excellence.  

Our Expertise Includes:

  • Simplifying complex regulatory requirements such as ISO 15189 and NPAAC guidelines
  • Developing tailored, patient-focused quality management systems
  • Supporting laboratories to continually improve and stay audit-ready  

What We Do

Gap Analysis

A systematic method to identify gaps against regulatory requirements including ISO 15189 and NPAAC standards. Utilising skills and experience as a lead external auditor, the analysis will provide clear, actionable findings, which will define steps required to meet or maintain accreditation goals.

Quality Management Systems Development

We design and implement quality systems to meet regulatory requirements. Processes, systems and training can include:

    • Internal Auditing
    • Electronic Quality Management System set-up
    • Training and Competency Management
    • Documentation Development (policies, procedures, forms, templates)
    • Document Control Systems
    • Quality Policy and Objective Setting
    • Management Reviews
    • Non-conformance and Risk Analysis
    • Preparing for external audit
    • + More

Saving you significant amounts of time and resource, we establish effective, compliant quality systems in months rather than years.

Maintenance & Bespoke Services 

We offer a full range of quality management services tailored to meet your specific needs. We understand that it can be difficult to maintain all of the required quality management activities, or that you may need help in a specific area.

Who We Work

Our clients include genomics laboratories, research institutions, community and healthcare providers. We work closely with senior management and personnel across all levels to ensure compliance with frameworks such as ISO 15189, NPAAC, ISO 13485, GLP, CLIA, CAP, ISO 9001, the NDIS Quality Standards and the Aged Care Standards.