Comparison Betweeniso 15189 2003andiso 15189

Comparison between ISO 15189:2003 and ISO 15189:2007

The first version of ISO 15189 Medical laboratories Particular requirements for quality and competence was released in
2003. It was subsequently issued as Australian Standard AS 4633 Medical laboratories Particular requirements for quality
and competence on 1 December 2004, as prepared by Standards Australia Committee HE-029 Clinical Laboratory Testing
and In Vitro Diagnostic Test Systems.
In 2005, a revised version of ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
was released. ISO 15189 is based on this document and changes were therefore necessary to bring the 2003 version of ISO
15189 into line with the 2005 version of ISO/IEC 17025. Fortunately, the authors of ISO 15189 were aware of some of the
changes being mooted for the revision of the 1999 version of ISO/IEC 17025 and incorporated these into the first version of
ISO 15189.
The changes between the 2003 and 2007 versions of ISO 15189 are listed in the Table below. The 2007 version was
published by Standards Australia in August 2009 as AS ISO 15189:2009.
Section / Clause
Introduction
ISO 15189:2003
Fourth para: last sentence altered from
For it is surely preferable that a laboratory
seeking accreditation select an accrediting
body which operates
ISO 15189:2007
To: If a laboratory seeks accreditation, it
should select an accrediting body which
operates..
Para 5 details the concurrent revision of

ISO/IEC 17025 and ISO 9001
Para 5 omitted
Para 6 pre-empts the release of a second

edition of this document and references the
replacement of ISO/IEC Guide 58 by ISO/IEC
17011
Para 6 omitted
Be Absolutely Assured
Section / Clause
Introduction
ISO 15189:2003
ISO 15189:2007
NEW PARA 5 specifies that conformity with this
Standard does not imply that the laboratorys
quality management system operates to all the
requirements of ISO 9001. This Standard is not
for use for the purposes of certification.
NEW PARA 6 advises that the correlation
between the clauses and subclauses of the
second edition of ISO 15189 and those of ISO
9001:2000 and ISO/IEC 17025 are detailed in
Annex A.
2 Normative References
Altered from:
ISO/IEC Guide 2
ISO 31
ISO/IEC Guide 43-1
ISO 9000
ISO 9001:2000
ISO/IEC 17025:1999
International vocabulary of basic and general
terms in metrology
To:
ISO 31
ISO 9000:2005
ISO 9001:2000
ISO/IEC Guide 43-1
ISO/IEC 17025:2005
3 Terms and definitions
Altered from For the purposes of this

document, the terms and definitions given in
ISO 9000, ISO/IEC Guide 2, VIM and the
following apply
To: For the purposes of this document, the

following terms and definitions apply
3.1
No definition of accreditation
NEW Definition included as 3.1
Definitions 3.1 3.12
Now numbered as 3.2 3.13
Page 2 of 4
Section / Clause
3.14
4 Management
requirements
4.1
ISO 15189:2003
ISO 15189:2007
No definition of quality management system NEW Definition included as 3.14
Definitions 3.13 3.17
Now numbered as 3.15 3.19
Heading is Management requirements
Heading is Management requirement
No subclause 4.1.6
NEW Subclause 4.1.6

Laboratory management shall ensure that appropriate
communication processes are established within the
laboratory and that communication takes place regarding
the effectiveness of the quality management system.
4.4.4
Clients (e.g. clinicians, health care

bodies
Customers (e.g. clinicians, health care

bodies
4.6.3
Second sentence altered from This system

should include the recording of lot
numbers.
To : This system shall include the recording of lot

numbers
4.8
Reference altered from: (see 4.13.3)
To: [see 4.13.3 i)]
4.9.2
Reference altered from: (see 4.11)
To: (see 4.10)
4.11.2
Second sentence
NOTE
Second half of first sentence moved to:
Becomes NOTE 1
Becomes NOTE 2
First half of first sentence
4.14.1
5 Technical requirements
5.1.3
NOTE includes Here as first word
Page 3 of 4
Section / Clause
Annex A
ISO 15189:2003
Stated to be (normative)
Correlation with ISO 9001:2000 and ISO/IEC
17025:1999
Annex A
Table A1 Correlation between ISO 9001:2000

and ISO 15189:2003
ISO 15189:2007
Stated to be (Informative)
Correlation with ISO 9001:2000 and ISO/IEC
17025:2005
Introduction wording differs
Table A1 Correlation between ISO
9001:2000 and ISO 15189:2007
Table A2 - Correlation between ISO/IEC

17025:1999 and ISO 15189:2003
Table A2 - Correlation between ISO/IEC

17025:2005 and ISO 15189:2007
First para, reference at end altered from For an

example, see [17].
NB the actual reference is the same
To: For an example, see [19] in the

Bibliography.
[1] ISO Guide 30 Terms and definitions used in

connection with reference materials
Deleted, replaced by International vocabulary

of basic and general terms in metrology
References [28] and [29] reordered to
References [10] and [11]
Annex C
C1
Bibliography
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