Breadcrumbs

Quality Standards

Quality Objective

To provide high quality contract manufacturing and distribution services.

Quality Policy & Deployment

AsureQuality Diagnostics maximises benefits to all stakeholders through the production and distribution of high quality products. We achieve this by ensuring our products, processes and services are consistently fit for their intended purpose, customer focused, innovative and exceed stakeholder expectations. This is accomplished through our highly trained, motivated, and dedicated people.

The deployment of the quality policy is achieved through our guiding principle.

Guiding principle: Quality is the responsibility of everyone at AsureQuality Diagnostics:

  • Effective Leadership
  • Engagement of people
  • Appropriate and relevant training
  • Ensuring adequate resources
  • Predefined roles and responsibilities
  • Predefined processes and standards
  • Evidence and risk based decision making and processes
  • Continuous improvement and corrective and preventive programs
  • Management of change over product, process, quality management system, materials and equipment
  • Documented systems and processes
  • Customer focus and feedback

Accreditiation & Licences

AsureQuality Diagnostics is licenced by the Australian Pesticides and Veterinary Medicines Association (APVMA), the USDA and has accreditation for ISO 9001:2015.

Regulatory Codes & Standards

The AsureQuality Diagnostics QMS is designed such that quality is embedded into the site culture, processes and operation. Our Quality Management System is intended to satisfy and comply with the relevant regulatory and ISO accreditation requirements.

Regulatory Codes
  • United States Department of Agriculture (USDA): Code of Federal Regulations - 9CFR 
  • APVMA Australian Pesticides & Veterinary Medicines Authority (APVMA) - Australian Code of Good Manufacturing Practice for Veterinary Chemical Products
Standards
  • ISO 9001:2015 Quality Management Systems - Requirements
  • ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

 

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