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From the From the National Serology Reference Laboratory, National Serology Reference Laboratory, Australia Australia 41 Victoria Parade, Fitzroy, Vic Australia 3065 41 Victoria Parade, Fitzroy, Vic Australia 3065 WHO Collaborating Centre on HIV/AIDS since 1985 WHO Collaborating Centre on HIV/AIDS since 1985 Roderick Chappel, Sandy Walker and Roderick Chappel, Sandy Walker and Roderick Chappel, Sandy Walker and Roderick Chappel, Sandy Walker and Elizabeth M. Dax Elizabeth M. Dax Elizabeth M. Dax Elizabeth M. Dax www.nrl.gov.au www.nrl.gov.au www.nrl.gov.au www.nrl.gov.au Aims of the QMS Section Aims of the QMS Section To clarify the requirements of a Quality To clarify the requirements of a Quality To clarify the requirements of a Quality To clarify the requirements of a Quality Management System (QMS) Management System (QMS) Management System (QMS) Management System (QMS) Objectives of the QMS Section (1) Objectives of the QMS Section (1) Define aims, costs and benefits of a QMS Define aims, costs and benefits of a QMS Define aims, costs and benefits of a QMS Define aims, costs and benefits of a QMS Share NRL’s experience in preparing for Share NRL’s experience in preparing for Share NRL’s experience in preparing for Share NRL’s experience in preparing for and implementing a QMS and implementing a QMS and implementing a QMS and implementing a QMS Define requirements of ISO/IEC 17025 and Define requirements of ISO/IEC 17025 and Define requirements of ISO/IEC 17025 and Define requirements of ISO/IEC 17025 and the overlap with ISO 9001 the overlap with ISO 9001 the overlap with ISO 9001 the overlap with ISO 9001 Objectives of the QMS Section (2) Objectives of the QMS Section (2) To train in the more ‘difficult’ elements of ISO/IEC 17025 To train in the more ‘difficult’ elements of ISO/IEC 17025 To train in the more ‘difficult’ elements of ISO/IEC 17025 To train in the more ‘difficult’ elements of ISO/IEC 17025 and ISO 9001, including and ISO 9001, including and ISO 9001, including and ISO 9001, including Requirements of a documented quality system Requirements of a documented quality system Requirements of a documented quality system Requirements of a documented quality system Document control Document control Document control Document control Internal audits Internal audits Internal audits Internal audits Corrective action Corrective action Corrective action Corrective action Equipment Equipment Equipment Equipment Management review Management review Management review Management review Aims in Achieving Quality Aims in Achieving Quality To ensure that outputs and outcomes are To ensure that outputs and outcomes are To ensure that outputs and outcomes are To ensure that outputs and outcomes are consistent consistent consistent consistent reproducible reproducible reproducible reproducible traceable traceable traceable traceable efficacious efficacious efficacious efficacious To ensure no harm To ensure no harm To ensure no harm To ensure no harm
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