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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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