Page  1 Medical Designs Implements ISO 9000 Quality Management Systems P: F: W: E:

Page  2 Quality Assurance and Management Systems Medical Designs Innovation is a privately owned company specialising in the design, manufacturing and installation of operating theatre equipment, intensive care units, critical care and other patient treatment areas. Their office is located at: PO Box 5615 Brendale, DC, QLD 4500 PH:

Page  3 Quality Assurance and Management Systems Introduction to Management Systems The ISO 9000 series of International Standards emphasise the importance of audits as a management tool for monitoring and verifying the effective implementation of an organisation's quality policy. Audits are also an essential part of conformity assessment activities such as external certification/registration and of supply chain evaluation and surveillance.

Page  4 Management System Requirements The organisation shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organisation shall a) determine the processes needed for the quality management system and their application throughout the organisation, b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure where applicable, and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes.

Page  5 Outcomes A management system should have : An effective audit program Scheduled audits on the basis of risk and importance of processes Effective audit checklists Review and follow up corrective actions Management Review Meeting Your can join our free webinar for-small-business-registration

Page  6 Independent Inspections /FWR Group Pty Ltd Independent Inspections Pty Ltd Mr. Peter Greenham Qualifications: -Diploma of Civil Engineering -Associate Diploma of Laboratory Operations -Diploma of Quality Management -Diploma of Business -Lead Environmental Auditor -Diploma of workplace training and Assessment -NATA Asessor Your Auditors and Trainers P: F: Team Mr. Sydney Lue M: Mr. Peter Greenham M: