IS/ISO 15189: 2007

Indian Standard

MEDICAL LABORATORIES PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE

( First Revision )

ICS 03.120.10; 11.100

August 2010 Price Group 12

B U R E A U O F I N D I A N S T A N D A R D S MANAK BHAVAN, 9 B A H A D U R S H A H ZAFAR M A R G

NEW DELHI 110002

Hospital Planning Sectional Committee, MHD 14

NATIONAL FOREWORD

This Indian Standard (First Revision) which is identical with ISO 15189 : 2007 'Medical laboratories Particular requirements for quality and competence' issued by the International Standards Organization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Planning Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 2005 with a view to align it with ISO 15189 : 2003. This revision of the standard has been brought out with a view to align its requirements with ISO 15189 : 2007. In this revised version few additional clauses under scope, terms and definition, management requirement, etc, have been incorporated.

Medical laboratory services are essential to patient care and, therefore, have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Such services include arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.

Whenever allowed by the national regulations, it is desirable that medical laboratory services include the examination of patients in consultation cases, and that those services actively participate in the prevention of disease in addition to diagnosis and patient management. Each laboratory ought also to provide suitable educational and scientific opportunities for professional staff working with it.

While this standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines could also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this standard as the basis for their activities, if a laboratory seeks accreditation, it should select an acccediting body which operates to appropriate Indian Standard and which takes into account the particular requirements of medical . laboratories.

Demonstrated conformity to this standard does not imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001. This standard is not intended to be used for the purposes of certification.

The correlation between the clauses and sub clauses of IS/ISO 15189 : 2007 and those of ISO 9001 : 2000 and ISO/IEC 17025 : 2005 detailed in Annex 'A' of this standard.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words 'International Standard' appear referring to this standard, they should be read as 'Indian Standard'.

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.

In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards, which are to be substituted in their respective places, are listed below, along with their degree of equivalence, for the editions indicated:

International Standard

ISO 31 (All Parts) Quantities and units

ISO 9000:2005 Quality management s y s t e m s F u n d a m e n t a l s and vocabulary

ISO 9001 : 2000 Quality management systems Requirements

ISO/ IEC 17025 : 2 0 0 5 G e n e r a l requirements for the competence of testing and calibration laboratories

Corresponding Indian Standard

IS 1890 (All Parts) Quantities and units

IS/ISO 9000:2005 Quality management s y s t e m s F u n d a m e n t a l s a n d vocabulary

IS/ISO 9001:2000 Quality management systems Requirements'

IS / ISO/ IEC 17025 : 2005 Gene ra l requirements for the competence of testing and calibration laboratories

Degree of Equivalence

Identical

do

do

do

The technical committee has reviewed the provisions of the following International Standard referred in this adopted standard and has decided that it is acceptable for use in conjunction with this standard:

International Standard Title

ISO/IEC Guide 43-1 Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes

For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2 : 1 9 6 0 'Rules for rounding off numerical values (revised)'. The number of significant places retained in the rounded off value should be the same as that of the specified value in this standard.

IS/ISO 15189 : 2007

Indian Standard

MEDICAL LABORATORIES PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE

(First Revision )

1 Scope

1.1 This International Standard specifies requirements for quality and competence particular to medical laboratories.

1.2 This International Standard is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 31 (all parts), Quantities and units

ISO 9000:2005, Quality management systems Fundamentals and vocabulary

ISO 9001:2000, Quality management systems Requirements

ISO/IEC Guide 43-1, Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes

ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

3.1 accreditation procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks

3.2 accuracy of measurement

closeness of the agreement between the result of a measurement and a true value of the measurand

[VIM: 1993, definition 3.5]

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