As iso 15189 2009 medical laboratories - particular requirements for quality and competence
1. AS ISO 15189—2009
ISO 15189:2007
AS ISO 15189—2009
Australian Standard®
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Medical laboratories—Particular
requirements for quality and competence
2. This Australian Standard® was prepared by Committee HE-029, Clinical Laboratory Testing
and In Vitro Diagnostic Test Systems. It was approved on behalf of the Council of Standards
Australia on 21 July 2009.
This Standard was published on 11 August 2009.
The following are represented on Committee HE-029:
• Australasian Association of Clinical Biochemists
• Australian Association of Pathology Practices
• Australian Institute of Medical Scientists
• Australian Society for Microbiology
• Consumers Federation of Australia
• Human Genetics Society of Australasia
• Medical Technology Association of Australia
• National Association of Testing Authorities Australia
• National Coalition of Public Pathology
• National Pathology Accreditation Advisory Council
•
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Royal College of Pathologists of Australasia
• Therapeutic Goods Administration
Additional Interests:
• Ausbiotech
This Standard was issued in draft form for comment as DR AS ISO 15189.
Standards Australia wishes to acknowledge the participation of the expert individuals that
contributed to the development of this Standard through their representation on the
Committee and through the public comment period.
Keeping Standards up-to-date
Australian Standards® are living documents that reflect progress in science, technology and
systems. To maintain their currency, all Standards are periodically reviewed, and new editions
are published. Between editions, amendments may be issued.
Standards may also be withdrawn. It is important that readers assure themselves they are
using a current Standard, which should include any amendments that may have been
published since the Standard was published.
Detailed information about Australian Standards, drafts, amendments and new projects can
be found by visiting www.standards.org.au
Standards Australia welcomes suggestions for improvements, and encourages readers to
notify us immediately of any apparent inaccuracies or ambiguities. Contact us via email at
mail@standards.org.au, or write to Standards Australia, GPO Box 476, Sydney, NSW 2001.
4. ii ii
PREFACE
This Standard was prepared by the Standards Australia Committee HE-029, Clinical Laboratory
Testing and In Vitro Diagnostic Test Systems to supersede AS 4633—2004.
This Standard is identical to, and has been reproduced from ISO 15189:2007, Medical
laboratories—Particular requirements for quality and competence.
The objective of this Standard is to provide requirements for quality and competence that are
particular for medical/clinical laboratories.
As this Standard is reproduced from an International Standard, the following modifications
apply:
(a) Its number does not appear on each page of the text, and its identity is shown only on the
cover and title page.
(b) In this reproduced text, ‘this International Standard’ should be read as ‘this Australian
Standard’.
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The reference to International Standards should be replaced by references to the following
Australian or Australian/New Zealand Standards:
Reference to International Standard or other Australian Standard/New Zealand Standard
publication
ISO AS
31 Quantities and units (all parts) 2900 Quantities and units (all parts)
AS/NZS ISO
9000 Quality management systems— 9000 Quality management systems—
Fundamentals and vocabulary Fundamentals and vocabulary
9001 Quality management systems— 9001 Quality management systems—
Requirements Requirements
ISO/IEC AS/NZS ISO
17025 General requirements for the 17025 General requirements for the
competence of testing and competence of testing and
calibration laboratories calibration laboratories
Guide 43-1 Proficiency testing by HB 18.43.1 Guidelines for third-party
interlaboratory comparisons certification and accreditation
Part 1: Development and Guide 43: Proficiency testing by
operation of proficiency testing interlaboratory comparisons—
schemes Part 1: Development and
operation of proficiency testing
schemes
International vocabulary of basic and general —
terms in metrology (VIM). BIPM, CLSI, IEC,
IFCC, ISO, IuPAC, IUPAP, OIML
The term ‘informative’ has been used in this Standard to define the application of the annex to
which it applies. An ‘informative’ annex is for information or guidance only.
8. This is a free preview. Purchase the entire publication at the link below:
AS ISO 15189-2009 Medical laboratories -
Particular requirements for quality and
competence
This is a free 7 page sample. Access the full version online.
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