AsureQuality Diagnostics is committed to the development, production and marketing of quality products that maximise benefits to all stakeholders.
We achieve this by ensuring our products, processes and services are consistently fit for their intended purpose.
Through our Quality Systems we foster a culture of business improvement, customer focus, and innovation.
AsureQuality Diagnostics ensures that all employees understand, support and implement the Quality System by clearly communicating our Quality Policy to them and by supporting their active participation in the maintenance of the Quality System.
Quality management is built into all aspects of designing, developing, testing and transferring technology and services to our clients to provide the customer with the highest level of satisfaction. All design, development, testing and transfer of technology shall comply with relevant standards and specifications to ensure that they perform effectively.
Guiding principles and objectives:
- Quality is the responsibility of everyone in the company and all personnel shall have a high level of quality consciousness through training to meet the required standard of workmanship.
- The principals of Good Manufacturing Practice (GMP) are implemented throughout the facility. All staff are appropriately trained in GMP with defined roles of responsibility, that are identified in their job descriptions.
- Adequate resources will be provided to ensure all processes are carried out according to the requirements of GMP.
- The International Organisation for Standards (ISO) ISO13485:2003 and USA FDA 820 – Quality Systems Regulations shall be used as guiding documents for the Quality System. Where required, industry, regulatory and guidance documents shall define our standards and procedures.
- Quality shall be defined and managed through the organisation by effective documents and records.
- All standards for consulting with customers, training of staff and products shall be defined, documented, managed and maintained.
- Quality improvement shall be achieved by focusing on customer requirements and defect prevention.
- The quality system shall be maintained through effective auditing and a timely corrective and preventive action system.
- Changes to suppliers, materials or procedures must not be made without change control procedures and where necessary, the notification of relevant regulatory authorities.