Statement of Scope
Barwon Health - Clinical Engineering, located at University Hospital, Geelong is responsible for the management of a wide range of medical devices and technologies. Clinical Engineering service many external sites across the Barwon and South West Victorian Region. Clinical Engineering department manages the medical devices and medical systems throughout their life cycle. This includes evaluation, corrective maintenance, preventive maintenance, technical support, and disposal of medical equipment.The scope of our quality management system covers life cycle management of medical equipment.
The department is not responsible for design, development and manufacturing of medical equipment. Clinical Engineering is responsible for only the management of medical equipment once they are purchased. All the medical equipment are designed and developed by their respective manufacturers and the department is only a stakeholder in purchasing such medical equipment. End users (customers) are the key stakeholder in purchasing new medical equipment to suit their clinical and operational requirements. Clinical Engineering is responsible to provide inputs in terms of serviceability and regulatory requirements. When these medical equipment are purchased, the installation and commissioning of medical equipment is carried out in accordance with Australian standards AS/NZS 3551. Hence, the design development clause (8.3) in the ISO 9001:2015 standard is considered a scope exclusion for quality management system in the department.
The consistency of the service delivery is assured by adherence to relevant Australian standards, manufacturer’s recommendations and defined controlled processes in accordance with ISO 9001:2015. Continuous improvement is applied towards service delivery to enhance customer satisfaction and process efficiency.
This scope for quality management system has been developed considering expectations of the interested parties and issues that are valid to the current context of the business. After careful consideration, all the other clauses of ISO 9001:2015 standard are considered relevant and applied accordingly. The department’s quality management system is applied to the full extent in rendering services to ensure customer satisfaction and compliance with regulatory standards of managing medical equipment.
This statement of scope is revised at least every 3 years to check its validity against changing business environment and requirements.