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DOCUMENTATION

IMPLEMENTATION
REQUIREMENTS OF ISO/IEC 17025: 2005
CONCLUSION/COMMEN
TS
c have policies & procedures to ensure the
protection of its custoers! con"dential
inforation and proprietar# ri$hts% includin$
procedures for protectin$ the electronic stora$e
and transission of results&
d have policies & procedures to avoid involveent
in an# activities that 'ould diinish con"dence
in its copetence% ipartialit#% (ud$ent or
operational inte$rit#&
e de"ne the or$anisation and ana$eent
structure of the la)orator#% its place in an#
parent or$anisation and the relationships
)et'een *ualit# ana$eent% technical
operations and support services&
f specif# the responsi)ilit#% authorit# and
interrelationships of all personnel 'ho ana$e%
perfor or verif# 'or+ a,ectin$ the *ualit# or
the tests and/or cali)rations&
$ provide ade*uate supervision of testin$ and
cali)ration sta,% includin$ trainees% )# persons
failiar 'ith ethods and procedures% purpose
of each test and/or cali)ration% and 'ith the
assessent of the test or cali)ration results&
h have technical ana$eent 'hich has overall
responsi)ilit# for the technical operations and
the provision of the resources needed to ensure
the re*uired *ualit# of la)orator# operations&
i appoint a e)er of sta, as *ualit# ana$er
-ho'ever naed. 'ho% irrespective of other
duties and responsi)ilities% shall have de"ned
responsi)ilit# and authorit# for ensurin$ that the
ana$eent s#ste related to *ualit# is
ipleented and follo'ed at all ties& the
*ualit# ana$er shall have direct access to the
hi$hest level of ana$eent at 'hich decisions
are ade on la)orator# polic# or resources&
( appoint deputies for +e# ana$erial personnel/
+ ensure that its personnel are a'are of the
relevance and iportance of their activities and
ho' the# contri)ute to the achieveent of the
o)(ectives of the ana$eent s#ste
0/1/
2
Top ana$eent shall ensure that appropriate
counication processes are esta)lished 'ithin
the la)orator# and that counication ta+es place
re$ardin$ the e,ectiveness of the ana$eent
s#ste/
DOCUMENTATION
IMPLEMENTATION
REQUIREMENTS OF ISO/IEC 17025: 2005
CONCLUSION/COMMEN
TS
4 MANAGEMENT REQUIREMENTS
4.1 ORGANISATION
0/1/1 The la)orator# or the or$anisation of 'hich it is
part shall )e an entit# that can )e held le$all#
responsi)le/
0/1/3 It is the responsi)ilit# of the la)orator# to carr# out
its testin$ and cali)ration activities in such a 'a#
as to eet the re*uireents of this International
Standard and to satisf# the needs of the custoer%
the re$ulator# authorities or or$anisations
providin$ reco$nition/
0/1/4 The ana$eent s#ste shall cover 'or+ carried
out in the la)orator#!s peranent facilities% at sites
a'a# fro its peranent facilities% or in associated
teporar# or o)ile facilities/
0/1/0 If the la)orator# is part of an or$anisation
perforin$ activities other than testin$ and/or
cali)ration% the responsi)ilities of +e# personnel in
the or$anisation that have an involveent or
in5uence on the testin$ and/or cali)ration activities
of the la)orator# shall )e de"ned in order to
identif# potential con5icts of interest/
0/1/6 The laboratory shall
a have managerial and technical personnel who, irrespective
of other responsibilities, have the athority and resorces
needed to carry ot their dties, inclding the
implementation, maintenance and improvement of the
management system, and to identify the occrrence of
departres from the !ality system or from the procedres
for performing tests and"or calibrations, and to initiate
actions to prevent or minimise sch departres #see also
$%&'(
) have arran$eents to ensure that its
ana$eent and personnel are free fro an#
undue internal and e7ternal coercial%
"nancial and other pressures and in5uences
that a# adversel# a,ect the *ualit# of their
'or+&
DOCUMENTATION
IMPLEMENTATION
REQUIREMENTS OF ISO/IEC 17025: 2005
CONCLUSION/COMMENT
S
4.2 QUALITY SYSTEM
0/3/1 The la)orator# shall esta)lish% ipleent and
aintain a ana$eent s#ste appropriate to the
scope of its activities/ The la)orator# shall
docuent its policies% s#stes% procedures and
instructions to the e7tent necessar# to assure the
*ualit# of the test and/or cali)ration results/ The
s#ste!s docuentation shall )e counicated to%
understood )#% availa)le to% and ipleented )#
the appropriate personnel/
0/3/3 The la)orator#!s ana$eent s#ste policies
related to *ualit#% includin$ a *ualit# polic#
stateent% shall )e de"ned in a *ualit# anual
-ho'ever naed./ The overall o)(ectives shall )e
esta)lished% and revie'ed durin$ ana$eent
revie'/ The *ualit# polic# stateent shall )e issued
under the authorit# of top ana$eent/ It shall
include at least the follo'in$8
a the la)orator# ana$eent!s coitent to
$ood professional practice and to the *ualit# of
its testin$ and cali)ration in servicin$ its
custoers&
) the ana$eent!s stateent of the la)orator#!s
standard of service&
c the purpose of the ana$eent s#ste related
to *ualit#&
d a re*uireent that all personnel concerned 'ith
testin$ and cali)ration activities 'ithin the
la)orator# failiarise theselves 'ith the
*ualit# docuentation and ipleent the
policies and procedures in their 'or+& and
e the la)orator# ana$eent!s coitent to
copl# 'ith this International standard and to
continuall# iprove the e,ectiveness of the
ana$eent/
)%&%* Top ana$eent shall provide evidence of
coitent to the developent and
ipleentation of the ana$eent s#ste and
continuall# iprovin$ its e,ectiveness/
0/3/0 Top ana$eent shall counicate to the
or$anisation the iportance of eetin$ custoer
as 'ell as statutor# and re$ulator# re*uireents
0/3/6 The *ualit# anual shall include or a+e reference
to the supportin$ procedures includin$ technical
procedures/ It shall outline the structure of the
docuentation used in the ana$eent s#ste/
0/3/2 The roles and responsi)ilities of technical
ana$eent and the *ualit# an$er% includin$
their responsi)ilit# for ensurin$ copliance 'ith
this International standard% shall )e de"ned in the
*ualit# anual/
0/3/9 Top ana$eent shall ensure that the inte$rit# of
the ana$eent s#ste is aintained 'hen
chan$es to the ana$eent s#ste are planned
and ipleented/