8/16/2019 History and Status of ISO 17025

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History and status of ISO 17025:2005

Prior to the issuing of ISO 17025:1999 there was no internationally accepted standard for 

laboratory uality syste!s that could pro"ide a globally accepted basis for accreditation#

$ccreditation was based on national standards# %owe"er& there was a considerable le"el

of unifor!ity between the reuire!ents e'pressed in these "arious standards due to the

e'istence of ISO (uide 25& a docu!ent drawn up by the ISO )ouncil )o!!ittee on)onfor!ity $ssess!ent *)$S)O+ in response to a reuest by the International

,aboratory $ccreditation )ooperation *I,$)+ held in $uc-land& .ew /ealand& in

October 19#

he declared purpose of ISO (uide 25& ta-en fro! its foreword& is to establish the

 principle that third party certification syste!s 3for laboratories4 should& to the e'tent

 possible& be based on internationally agreed standards and procedures# ISO guides are

intended to be used by local standards institutions when preparing their own national

standards# y this !eans& it is hoped to achie"e a high degree of co!patibility between

standards prepared in different countries so as to facilitate bilateral and !ultilateral

agree!ents# *6uotations fro! the foreword to ISO (uide 25& rd 8dition#+

he docu!ent now -nown as ISO 17025 began life as a re"ision of the third edition of ISO (uide 25& but during the re"ision process it was decided to con"ert the guide to a

standard& so pro"iding a truly global basis for accreditation# It was also decided to

introduce as !uch co!patibility as possible between ISO 17025 and the generic uality

!anage!ent syste! standard ISO 9001& which was also under re"ision at the sa!e ti!e#

he obecti"e appears to ha"e been to create a logical connection between ISO 9001 and

ISO 17025 such that the for!er would be seen as a !aster standard with ISO 17025

 being a specific application of that standard to testing and calibration laboratories#

ISO 17025: 1999 was accepted by ISO subscribing countries in late 1999 and ca!e into

effecti"e use during the first uarter of 2000 after its adoption as a national standard by

!ost countries around the world# he new "ersion of ISO 9001& the 2000 edition& was

accepted at a later date#

he e'ercise intended to har!onise ISO 17025 and ISO 9001 was& in the e"ent& regarded

as i!perfect& especially in that ISO 9001 placed great e!phasis on continual

i!pro"e!ent in the uality syste!# $lthough this was included in ISO 17025& its

i!portance as a part of the standard was not strongly e!phasised# %ence a re"ision of 

ISO 17025 was underta-en and this led to ISO 17025:2005 which was adopted as an ISO

standard in late ay of 2005#

here are no funda!ental differences between ISO 17025:1999 and ISO 17025:2005 and

nothing which i!pinges essentially on the technical reuire!ents# he !ain differences

can be su!!ed up as follows:;

< Insistence on a de!onstrated co!!it!ent to continually i!pro"e the uality!anage!ent syste! and identified !echanis!s for achie"ing this#

< (reater e!phasis of the need to co!!unicate with custo!ers and& especially& to

acti"ely solicit feedbac- on ser"ice uality and ensure the resulting infor!ation is

used as the basis of action to i!pro"e the !anage!ent syste!#

< (reater e!phasis of the need to use infor!ation fro! uality control data to

e"aluate the perfor!ance of the uality syste! and to identify opportunities for 

i!pro"e!ent#

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he transitional period between ISO 17025:1999 and ISO 17025:2005 lasted two years&

with the two standards running together# In ay 2007 ISO 17025:1999 beca!e defunct

and e'isting laboratories who had not been assessed against the 2005 "ersion ceased to be accredited#!