檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力認(rèn)可準(zhǔn)則(ISO-IEC-17025-2017)講解

Accreditation

CriteriafortheCompetencyof

TestingandCalibration

Laboratories

檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力認(rèn)可準(zhǔn)則（ISO/IEC

17025:2017）北京列伯實(shí)驗(yàn)室認(rèn)可技術(shù)交流中心二零一八年四月一日CNAS-CL011ISO/IEC

17025修訂進(jìn)展

012015年6月工作小組草案（WorkDraft；WD）2015年8月委員會(huì)草案1（CommitteeDraft1；CD1）22016年2月委員會(huì)草案2（Committee

Draft2；CD2）2016年12月國(guó)際標(biāo)準(zhǔn)草案（DraftInternationalStandard；DIS）2017-8-14（投票期至2017-10-9）最終國(guó)際標(biāo)準(zhǔn)版草案(

Final

Draft

International

Standard；FDIS)ISO

P

成員，99%，

IEC

P成員，100%2017年11月國(guó)際標(biāo)準(zhǔn)版(International

Standard；IS)0203040506ISO/IEC

17025修訂

01020304主要原則與ISO

9001:2015在管理要求上相協(xié)調(diào)采用新版術(shù)語(yǔ)標(biāo)準(zhǔn)，如VIMLIMS廣泛使用，如電子采集

數(shù)據(jù)和電子報(bào)告引入風(fēng)險(xiǎn)管理要求053簡(jiǎn)化主體內(nèi)容，刪除不必要的注和解釋ISO/IEC

17025:2005ISO/IEC

17025：2017Scope1

范圍Normative

references2

引用標(biāo)準(zhǔn)Terms

and

definitions3

術(shù)語(yǔ)和定義Management

requirements4

管理要求Technical

requirements5

技術(shù)要求Annex

A

(informative)

Nominal

cross-references

to

ISO9001:2000附錄

ISO/IEC17025

與

ISO9001:2000

的條款對(duì)照Annex

B

(informative)

Guidelines

for

establishingapplications

for

specific

fieldsBibliography參考文獻(xiàn)Scope1

范圍Normative

references2規(guī)范性引用文件Terms

and

definitions3

術(shù)語(yǔ)和定義General

requirements4

通用要求Structural

requirements5

結(jié)構(gòu)要求Resource

requirements6

資源要求Processrequirements7

過(guò)程要求Management

requirements8

管理體系要求Annex

A

(

informative)

Metrological

traceability附錄A

（資料性）計(jì)量溯源性Annex

B

(informative)

Management

system

in

alaboratory附錄B（資料性）實(shí)驗(yàn)室管理體系Bibliography參考文獻(xiàn)Mandatory

requirements4IntroductionThis

document

has

been

developed

with

the

objective

of

promoting

confidence

in

the

operation

of

laboratories.

This

document

contains

requirements

for

laboratories

to

enable

them

to

demonstrate

they

operate

competently,

and

are

ableto

generate

valid

results.

Laboratories

that

conform

to

this

document

will

also

operate

generally

in

accordance

with

the

principles

of

ISO

9001.制定本準(zhǔn)則的目的是增強(qiáng)對(duì)實(shí)驗(yàn)室運(yùn)作的信任。本準(zhǔn)則包含了實(shí)驗(yàn)室能夠證明其運(yùn)作能力，并且能夠產(chǎn)生出有效結(jié)果的要求。符合本準(zhǔn)則的實(shí)驗(yàn)室通常也是基本依據(jù)ISO9001的原則來(lái)運(yùn)作的。5效應(yīng)的基礎(chǔ)。實(shí)驗(yàn)室有責(zé)任確定要應(yīng)對(duì)哪些風(fēng)險(xiǎn)和機(jī)遇。風(fēng)險(xiǎn)管理8.5應(yīng)對(duì)風(fēng)險(xiǎn)和機(jī)遇的措施（方式A）8.5

Actions

to

address

risks

and

opportunities

(Option

A)IntroductionThis

document

requires

the

laboratory

to

plan

and

implement

actions

to

addressrisks

and

opportunities.

Addressing

both

risks

and

opportunities

establishes

abasis

for

increasing

the

effectiveness

of

the

management

system,

achievingimproved

results

and

preventing

negative

effects.

The

laboratory

is

responsible

for

deciding

whichrisks

and

opportunities

need

tobeaddressed.本準(zhǔn)則要求實(shí)驗(yàn)室計(jì)劃并采取措施應(yīng)對(duì)風(fēng)險(xiǎn)和機(jī)遇。同時(shí)應(yīng)對(duì)風(fēng)險(xiǎn)和機(jī)遇是提升管理體系有效性、取得改進(jìn)效果、以及預(yù)防負(fù)面6前

言7本準(zhǔn)則等同采用

ISO/IEC

17025:2017“檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力的通用要求”。

本準(zhǔn)則包含了檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室為證明其按管理體系運(yùn)行、具有技術(shù)能力并能

提供正確的技術(shù)結(jié)果所必須滿足的所有要求。同時(shí)，本準(zhǔn)則已包含了ISO

9001

中與

實(shí)驗(yàn)室管理體系所覆蓋的檢測(cè)和校準(zhǔn)服務(wù)有關(guān)的所有要求，因此，符合本準(zhǔn)則的檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室，也是基本依據(jù)ISO

9001

的原則運(yùn)作的。實(shí)驗(yàn)室質(zhì)量管理體系符合ISO

9001

的要求，并不證明實(shí)驗(yàn)室具有出具技術(shù)上有

效數(shù)據(jù)和結(jié)果的能力；實(shí)驗(yàn)室質(zhì)量管理體系符合本準(zhǔn)則，也不意味其運(yùn)作符合ISO9001

的所有要求。前言Introduction附錄B（資料性附錄）管理體系方式與ISO9001:2015的關(guān)系B.3方式B（見(jiàn)8.1.3）允許實(shí)驗(yàn)室按照ISO

9001的要求建立和維持管理體系，并能支持和證明持續(xù)符合第4條款至第7條款的要求。因此實(shí)驗(yàn)室實(shí)施第8條款的方式B，也是按照ISO9001運(yùn)作的。實(shí)驗(yàn)室管理體系符合ISO

9001的要求，并不證明實(shí)驗(yàn)室具有出具技術(shù)上有效的數(shù)據(jù)和結(jié)果的能力。此時(shí)，實(shí)驗(yàn)室還應(yīng)符合第4條款至第7條款。8前言Introduction中國(guó)合格評(píng)定國(guó)家認(rèn)可委員會(huì)（英文縮寫(xiě)：CNAS）使用本準(zhǔn)則作為對(duì)檢測(cè)和校

準(zhǔn)實(shí)驗(yàn)室能力進(jìn)行認(rèn)可的基礎(chǔ)。為支持特定領(lǐng)域的認(rèn)可活動(dòng)，CNAS還根據(jù)不同領(lǐng)域

的專業(yè)特點(diǎn)，制定一系列的特定領(lǐng)域應(yīng)用說(shuō)明，對(duì)本準(zhǔn)則的通用要求進(jìn)行必要的補(bǔ)

充說(shuō)明和解釋，但并不增加或減少本準(zhǔn)則的要求。申請(qǐng)CNAS認(rèn)可的實(shí)驗(yàn)室應(yīng)同時(shí)滿足本準(zhǔn)則以及相應(yīng)領(lǐng)域的應(yīng)用說(shuō)明。本準(zhǔn)則的附錄是信息性的，不是要求，旨在幫助理解和實(shí)施本準(zhǔn)則。9? 本準(zhǔn)則規(guī)定了實(shí)驗(yàn)室能力公正性以及持續(xù)運(yùn)作的通用要求。This

document

specifies

the

general

requirements

for

the

competence,

impartiality

andconsistent

operation

of

laboratories1 范

圍S c o p e101范圍Scope? 本準(zhǔn)則適用于所有從事實(shí)驗(yàn)室活動(dòng)的組織，不論其人員數(shù)量多少。This

document

is

applicable

to

all

organizations

performing

laboratory

activities,

regardlessof

the

number

of

personnel.11?1范圍Scope實(shí)驗(yàn)室的客戶、法定管理機(jī)構(gòu)、采用同行評(píng)審的組織和制度、認(rèn)可機(jī)構(gòu)及其他機(jī)構(gòu)使用本準(zhǔn)則來(lái)確認(rèn)或承認(rèn)實(shí)驗(yàn)室能力。Laboratory

customers,regulatory

authorities,

organizations

and

schemes

using

peer-assessment,

accreditation

bodies,and

others

use

this

document

in

confirming

or

recognizing

the

competence

of

laboratories.121范圍ScopeCNAS-CL01：2006

檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力認(rèn)可準(zhǔn)則刪除e1.3

本標(biāo)準(zhǔn)中的注是對(duì)正文的說(shuō)明、舉例和指導(dǎo)。它們既不包含要求，也不構(gòu)成本準(zhǔn)則的主體部分1.5本標(biāo)準(zhǔn)不包含實(shí)驗(yàn)室運(yùn)作中應(yīng)符合的法規(guī)和安全要求1.6

如果檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室遵守本準(zhǔn)則的要求，其針對(duì)檢測(cè)和校準(zhǔn)所運(yùn)作的質(zhì)量管理體系也就滿足了ISO

9001

的原則。附錄提供了ISO/IEC

17025:2005

和ISO

9001

標(biāo)準(zhǔn)的對(duì)照。本準(zhǔn)則包含了ISO

9001中未包含的技術(shù)能力要求。注

1：為確保這些要求應(yīng)用的一致性，或許有必要對(duì)本準(zhǔn)則的某些要求進(jìn)行說(shuō)明或解釋。注

2：如果實(shí)驗(yàn)室希望其部分或全部檢測(cè)和校準(zhǔn)活動(dòng)獲得認(rèn)可，應(yīng)當(dāng)選擇一個(gè)依據(jù)ISO/IEC17011運(yùn)作的認(rèn)可機(jī)構(gòu)。132規(guī)范性引用文件Normativereferences? 本準(zhǔn)則引用了下列文件，這些文件的部分或全部?jī)?nèi)容構(gòu)成了本準(zhǔn)則的要求。對(duì)注明日期的引用文件，只采用引用的版本；對(duì)沒(méi)有注明日期的引

用文件，采用最新的版本（包括任何的修訂）。ISO/IEC指南99

國(guó)際計(jì)量學(xué)詞匯—基本和通用概念及相關(guān)術(shù)語(yǔ)1）

ISO/IEC

17000合格評(píng)定—詞匯和通用原則The

following

documents

are

referred

to

in

the

text

insuch

a

way

that

some

or

all

of

their

contentconstitutes

requirements

of

this

document.

Fordated

references,

only

the

edition

cited

applies.For

undated

references,

the

latest

edition

of

the

referenced

document

(including

any

amendments)applies.ISO/IEC

Guide

99,International

vocabulary

of

metrology

—Basic

andgeneral

concepts

andassociated

terms

(VIM)ISO/IEC

17000,

Conformity

assessment

—

Vocabulary

andgeneral

principles1）也稱為JCGM

200(Joint

Committee

for

Guides

in

Metrology)14? ISO/IEC指南99和ISO/IEC17000中界定的以及下述術(shù)語(yǔ)和定義適用于本準(zhǔn)則。For

thepurposes

of

this

document,

the

terms

and

definitions

given

in

ISO/IEC

Guide

99

and

ISO/IEC17000

and

the

following

apply.? ISO和IEC維護(hù)的用于標(biāo)準(zhǔn)化的術(shù)語(yǔ)數(shù)據(jù)庫(kù)地址如下：ISO

and

IEC

maintain

terminological

databases

for

use

in

standardization

at

the

following

addresses:--

ISO在線瀏覽平臺(tái):

/obp--

ISO

Online

browsing

platform:

available

at

https://

www

.iso.org/obp--

IEC電子開(kāi)放平臺(tái):

/--

IEC

Electropedia:

available

at

http://

www

.electropedia

.org/3術(shù)語(yǔ)和定義Termsanddefinitions153.1impartialitypresence

of

objectivity公正性

客觀性的存在。Note

1to

entry:

Objectivity

means

that

conflicts

ofinterest

do

not

exist,

or

are

resolved

so

as

notto

adversely

influence

subsequent

activities

of

the

laboratory

(3.6).注1：客觀性意味著不存在或已解決利益沖突，不會(huì)對(duì)實(shí)驗(yàn)室（3.6）的活動(dòng)產(chǎn)生不利影響。Note

2

to

entry:

Other

terms

that

are

useful

in

conveying

the

element

of

impartiality

include“independence”,

“freedom

from

conflict

of

interests”,

“freedom

from

bias”,

“l(fā)ack

of

prejudice”,“neutrality”,

“fairness”,

“open-mindedness”,

“even-handedness”,

“detachment”,

“balance”.注2：其他可用于表示公正性的要素的術(shù)語(yǔ)包括：無(wú)利益沖突、沒(méi)有成見(jiàn)、沒(méi)有偏見(jiàn)、中立、公平、思想開(kāi)明、不偏不倚、不受他人影響、平衡。[SOURCE:

ISO/IEC

17021-1:2015,

3.2,

modified

—

Thewords“the

certification

body”havebeen

replaced

by

“the

laboratory”

in

Note

1

to

entry.][源自:ISO/IEC17021-1:2015,3.2，修改—在注1中以“實(shí)驗(yàn)室”代替“認(rèn)證機(jī)構(gòu)”]3術(shù)語(yǔ)和定義Terms

and

definitions163.2Complaint投訴expression

of

dissatisfaction

by

any

person

or

organization

to

a

laboratory

(3.6),relating

to

theactivities

or

results

of

that

laboratory,

where

a

response

is

expected任何人員或組織向?qū)嶒?yàn)室（3.6）就其活動(dòng)或結(jié)果表達(dá)不滿意，并期望得到回

復(fù)的行為。[SOURCE:

ISO/IEC

17000:2004,

6.5,

modified

—

Thewords

“other

than

appeal”

have

beendeleted,

and

the

words

“a

conformity

assessment

body

oraccreditation

body,

relating

to

theactivities

of

that

body”

have

been

replaced

by“a

laboratory,

relating

to

the

activities

or

resultsof

that

laboratory”.][源自:ISO17000:2004,6.5修改—?jiǎng)h除了“除申訴外”，以“實(shí)驗(yàn)室就其活動(dòng)或結(jié)果”代替“合格評(píng)定機(jī)構(gòu)或認(rèn)可機(jī)構(gòu)就其活動(dòng)”]3術(shù)語(yǔ)和定義Terms

and

definitions173術(shù)語(yǔ)和定義Terms

and

definitions3.3interlaboratory

comparison實(shí)驗(yàn)室間比對(duì)organization,

performance

and

evaluation

ofmeasurements

or

tests

on

the

same

orsimilar

items

bytwoormore

laboratories

inaccordance

withpredetermined

conditions按照預(yù)先規(guī)定的條件，由兩個(gè)或多個(gè)實(shí)驗(yàn)室對(duì)相同或類(lèi)似的物品進(jìn)行測(cè)量或檢測(cè)的組織、實(shí)施和評(píng)價(jià)。[SOURCE:

ISO/IEC

17043:2010,

3.4][源自:ISO/IEC17043:2010,3.4]183術(shù)語(yǔ)和定義Terms

and

definitionsintralaboratory

comparison實(shí)驗(yàn)室內(nèi)比對(duì)organization,

performance

and

evaluation

ofmeasurements

or

tests

on

the

same

orsimilar

items,

within

the

same

laboratory

(3.6),

in

accordance

with

predeterminedconditions按照預(yù)先規(guī)定的條件，在同一實(shí)驗(yàn)室（3.6）內(nèi)部對(duì)相同或類(lèi)似的物品進(jìn)行測(cè)量或檢測(cè)的組織、實(shí)施和評(píng)價(jià)。proficiency

testing能力驗(yàn)證evaluation

of

participant

performance

against

pre-established

criteria

bymeans

ofinterlaboratory

comparisons

(3.3)利用實(shí)驗(yàn)室間比對(duì)，按照預(yù)先制定的準(zhǔn)則評(píng)價(jià)參加者的能力。

[SOURCE:

ISO/IEC

17043:2010,

3.7,

modified

—Notes

to

entry

have

been

deleted.][源自:ISO/IEC17043:2010,3.7—修改:刪除了注]193術(shù)語(yǔ)和定義Terms

and

definitions3.6Laboratory實(shí)驗(yàn)室bodythat

performs

one

or

more

of

the

following

activities:testingcalibrationsampling,

associated

with

subsequent

testing

or

calibration從事下列一個(gè)或多個(gè)活動(dòng)的機(jī)構(gòu)——檢測(cè)——校準(zhǔn)——與后續(xù)檢測(cè)或校準(zhǔn)相關(guān)的抽樣Note

1

to

entry:

In

the

context

of

this

document,

“l(fā)aboratory

activities”

refer

to

the

threeabove-mentioned

activities.注1：在本準(zhǔn)則中，“實(shí)驗(yàn)室活動(dòng)”指上述三種活動(dòng)。3.7decision

rule判定規(guī)則rule

that

describes

howmeasurement

uncertainty

is

accounted

for

whenstatingconformity

with

a

specified

requirement當(dāng)聲明與規(guī)定要求的符合性時(shí)，描述如何考慮測(cè)量不確定度的規(guī)則。203術(shù)語(yǔ)和定義Terms

and

definitions3.8

Verification驗(yàn)證provision

of

objective

evidence

that

agiven

item

fulfils

specified

requirements提供客觀證據(jù)，證明給定項(xiàng)目滿足規(guī)定要求。EXAMPLE

1

Confirmation

that

a

given

reference

material

as

claimed

is

homogeneous

forthe

quantity

value

and

measurement

procedure

concerned,

down

to

a

measurement

portionhaving

a

mass

of

10mg.例1：證實(shí)在測(cè)量取樣量小至10mg時(shí)，對(duì)于相關(guān)量值和測(cè)量程序而言，給定

標(biāo)準(zhǔn)物質(zhì)的均勻性與其聲稱的一致。EXAMPLE 2 Confirmation that performance properties or legal requirements of ameasuring

system

are

achieved.例2：證實(shí)已達(dá)到測(cè)量系統(tǒng)的性能或法定要求。EXAMPLE

3

Confirmation

that

atarget

measurement

uncertainty

can

bemet.例3：證實(shí)可滿足目標(biāo)測(cè)量不確定度。21Note

1

to

entry:

When

applicable,

measurement

uncertainty

should

be

taken

into

consideration.注1：適用時(shí)，宜考慮測(cè)量不確定度。Note2toentry:

Theitem

may

be,for

example,

aprocess,

measurement

procedure,

material,

compound,or

measuring

system.注2：項(xiàng)目可以是，例如一個(gè)過(guò)程、測(cè)量程序、物質(zhì)、化合物或測(cè)量系統(tǒng)。Note

3

to

entry:

The

specified

requirements

may

be,for

example,

that

a

manufacturer’s

specificationsare

met.注3：規(guī)定要求可以是如滿足生產(chǎn)商的規(guī)定。Note

4

to

entry:

Verification

in

legal

metrology,

as

defined

in

VIML,

and

in

conformity

assessment

ingeneral,

pertains

to

the

examination

and

marking

and/or

issuing

of

a

verification

certificate

for

ameasuring

system.注4：在VIML中定義的法制計(jì)量中的驗(yàn)證，以及通常在合格評(píng)定中的驗(yàn)證，是指對(duì)測(cè)量系統(tǒng)的檢查并加標(biāo)記和/或出具驗(yàn)證證書(shū)。（譯者注：在我國(guó)的法制計(jì)量領(lǐng)域，“verification”翻譯為“檢定”）3術(shù)語(yǔ)和定義Terms

and

definitions223術(shù)語(yǔ)和定義Terms

and

definitionsNote

5

to

entry:

Verification

should

not

be

confused

withcalibration.

Not

every

verification

is

avalidation

(3.9).注5：驗(yàn)證不宜與校準(zhǔn)混淆。不是每個(gè)驗(yàn)證都是確認(rèn)。Note

6

to

entry:

In

chemistry,

verification

of

the

identity

of

the

entity

involved,

or

of

activity,requires

a

description

of

the

structure

or

properties

of

that

entity

or

activity.注6：在化學(xué)中，驗(yàn)證實(shí)體特性或活性時(shí)，需要描述該實(shí)體或活性的結(jié)構(gòu)或特性。[SOURCE:

ISO/IEC

Guide

99:2007,2.44][源自:ISO/IEC指南99:2007，2.44]233術(shù)語(yǔ)和定義Terms

and

definitions3.9

Validation確認(rèn)verification

(3.8),

where

the

specified

requirements

are

adequate

for

an

intended

use對(duì)規(guī)定要求滿足預(yù)期用途的驗(yàn)證（3.8）。EXAMPLE

A

measurement

procedure,

ordinarily

usedfor

the

measurement

of

massconcentration

of

nitrogen

in

water,

may

be

validated

also

for

measurement

of

massconcentration

of

nitrogen

inhuman

serum.示例：一個(gè)通常用于測(cè)量水中氮的質(zhì)量濃度的測(cè)量程序，也可被確認(rèn)為可用于測(cè)量人體血清中氮的質(zhì)量濃度。[SOURCE:

ISO/IEC

Guide

99:2007,2.45][源自:ISO/IEC指南99:2007，2.45]244通用要求Generalrequirements公正性Impartiality25保密性Confidentiality4.1

公正性Impartiality? 4.1.1實(shí)驗(yàn)室應(yīng)公正地實(shí)施實(shí)驗(yàn)室活動(dòng)，并從組織結(jié)構(gòu)和管理上保證公正性。Laboratory

activities

shall

be

undertaken

impartially

and

structured

and

managedso

as

to

safeguard

impartiality.? 4.1.2

實(shí)驗(yàn)室管理層應(yīng)做出公正性承諾。The

laboratory

management

shall

becommitted

to

impartiality.不僅管理層做公正性承諾，全體員工都有公正性承諾，設(shè)計(jì)公正性承諾表格規(guī)定一年一簽，新進(jìn)員工必簽如果實(shí)驗(yàn)室為非獨(dú)立實(shí)驗(yàn)室則雙公正性聲明4

通用要求26? 4.1.3

實(shí)驗(yàn)室應(yīng)對(duì)實(shí)驗(yàn)室活動(dòng)的公正性負(fù)責(zé)，不允許商業(yè)、財(cái)務(wù)或其他方面的壓力損害公正性。The

laboratory

shall

be

responsible

for

the

impartialityof

its

laboratory

activities

and

shall

notallowcommercial,

financial

or

other

pressures

tocompromise

impartiality4通用要求General

requirements4.1

公正性Imp

arti

a

l

i

t

y27? 4.1.4實(shí)驗(yàn)室應(yīng)持續(xù)識(shí)別影響公正性的風(fēng)險(xiǎn)。這些風(fēng)險(xiǎn)應(yīng)包括其活動(dòng)、實(shí)驗(yàn)室的各種關(guān)系，或者實(shí)驗(yàn)室人員的關(guān)系而引發(fā)的風(fēng)險(xiǎn)。然而，這些關(guān)系并非一定會(huì)對(duì)實(shí)驗(yàn)室的公正性產(chǎn)生風(fēng)險(xiǎn)。The

laboratory

shall

identify

risks

to

its

impartiality

on

an

on-going

basis.

This

shall

includethose

risks

that

arise

from

its

activities,

or

from

its

relationships,

or

from

the

relationships

ofits

personnel.

However,

such

relationships

do

not

necessarily

present

a

laboratory

with

a

riskto

impartiality.注：危及實(shí)驗(yàn)室公正性的關(guān)系可能基于所有權(quán)、控制權(quán)、管理、人員、共享資源、財(cái)務(wù)、合同、市場(chǎng)營(yíng)銷(xiāo)（包括品牌）、支付銷(xiāo)售傭金或其它引薦新客戶的獎(jiǎng)酬等。[NEW]NOTE

A

relationship

that

threatens

the

impartiality

of

the

laboratory

can

be

based

onownership,

governance,

management,

personnel,

shared

resources,

finances,

contracts,marketing

(including

branding),

and

payment

of

a

sales

commission

or

other

inducement

forthe

referral

of

newcustomers,

etc.4通用要求General

requirements284.1

公正性Imp

arti

a

l

i

t

y? 4.1.5如果識(shí)別出公正性風(fēng)險(xiǎn)，實(shí)驗(yàn)室應(yīng)能夠證明如何消除或最大程度減小這種風(fēng)險(xiǎn)If

a

risk

to

impartiality

is

identified,

the

laboratory

shall

be

able

to

demonstrate

how

iteliminates

or

minimizes

such

risk.4通用要求General

requirements294.1

公正性Imp

arti

a

l

i

t

y4通用要求General

requirements4.1

公正性Imp

arti

a

l

i

t

yVSISO/IEC

17025:2017ISO/IEC

17025:2005涉及公正性條款2個(gè)涉及公正性條款5個(gè)，新增4個(gè)擴(kuò)大了公正性范圍，由第三方實(shí)驗(yàn)室擴(kuò)展到全部實(shí)驗(yàn)室4.1.4注24.1.5

d30由政策和程序避免降低公正性，轉(zhuǎn)向從組織結(jié)構(gòu)和管理保證公正性CNAS-CL01：2006

檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力認(rèn)可準(zhǔn)則

4.1.4

如果實(shí)驗(yàn)室所在的組織還從事檢測(cè)和/或校準(zhǔn)以外的活動(dòng)，為識(shí)別潛在利益沖突，應(yīng)規(guī)定該組織中涉及檢測(cè)和/或校準(zhǔn)、或?qū)z測(cè)和/或校準(zhǔn)有影響的關(guān)鍵人員的職責(zé)。注

1：如果實(shí)驗(yàn)室是某個(gè)較大組織的一部分，該組織應(yīng)當(dāng)使其有利益沖突的部分，如生產(chǎn)、商業(yè)營(yíng)銷(xiāo)或財(cái)務(wù)部門(mén)，不對(duì)實(shí)驗(yàn)室滿足本準(zhǔn)則的要求產(chǎn)生不良影響。注

2：如果實(shí)驗(yàn)室希望作為第三方實(shí)驗(yàn)室得到承認(rèn)，實(shí)驗(yàn)室應(yīng)能證明其公正性，并能證明實(shí)驗(yàn)室及其員工不受任何可能影響其技術(shù)判斷的、不正當(dāng)?shù)纳虡I(yè)、財(cái)務(wù)或其他方面的壓力。第三方檢測(cè)或校準(zhǔn)實(shí)驗(yàn)室不應(yīng)當(dāng)參與任何可能損害其判斷獨(dú)立性和檢測(cè)或校準(zhǔn)誠(chéng)信度的活動(dòng)。4.1.5實(shí)驗(yàn)室應(yīng)：d)有政策和程序以避免卷入任何會(huì)降低其在能力、公正性、判斷力或運(yùn)作誠(chéng)實(shí)性方面的可信度的活動(dòng)；4通用要求General

requirements4.1

公正性Imp

arti

a

l

i

t

y314.2

保密性Confidentiality? 4.2.1實(shí)驗(yàn)室應(yīng)通過(guò)做出具有法律效力的承諾，對(duì)在實(shí)驗(yàn)室活動(dòng)中獲得或產(chǎn)生的信息承擔(dān)管理責(zé)任。實(shí)驗(yàn)室應(yīng)將其準(zhǔn)備公開(kāi)的信息事先通知客戶。除客戶公開(kāi)的信息，或?qū)嶒?yàn)室與客戶有約定（例如：為回應(yīng)投訴的目的），其他所有信息都被視為專屬信息，應(yīng)予保密。The

laboratory

shall

be

responsible,

through

legally

enforceable

commitments,

for

themanagement

of

all

information

obtained

or

created

during

the

performance

of

laboratoryactivities.

The

laboratory

shall

inform

the

customer

in

advance,

of

the

information

it

intendsto

place

in

the

public

domain.

Except

for

information

that

the

customer

makes

publiclyavailable,

or

when

agreed

between

the

laboratory

and

the

customer

(e.g.

for

the

purpose

ofresponding

to

complaints),

all

other

information

is

considered

proprietary

information

andshall

beregarded

as

confidential.4

通用要求32? 4.2.2實(shí)驗(yàn)室依據(jù)法律要求或合同授權(quán)透露保密信息時(shí)，除法律禁止外，所提供的信息應(yīng)通知到相關(guān)客戶或個(gè)人。When

the

laboratory

is

required

by

law

or

authorized

by

contractual

arrangements

to

releaseconfidential

information,

the

customer

or

individual

concerned

shall,

unless

prohibited

bylaw,be

notified

of

the

information

provided.? 4.2.3從客戶以外渠道（如投訴人、監(jiān)管機(jī)構(gòu)）獲取有關(guān)客戶的信息，應(yīng)在客戶和實(shí)驗(yàn)室間保密。除非信息的提供方同意，實(shí)驗(yàn)室應(yīng)對(duì)信息的提供方（來(lái)源）保密，且不應(yīng)告知客戶。Information

about

the

customer

obtained

from

sources

other

than

the

customer

(e.g.complainant,

regulators)

shall

be

confidential

between

the

customer

and

the

laboratory.

Theprovider

(source)

of

this

information

shall

be

confidential

to

the

laboratory

and

shall

not

beshared

with

the

customer,

unless

agreed

bythe

source.334通用要求General

requirements4.2

保密性Confidentiality?4.2.4人員，包括委員會(huì)委員、合同方、外部機(jī)構(gòu)人員或代表實(shí)驗(yàn)室的個(gè)人，應(yīng)對(duì)在實(shí)施實(shí)驗(yàn)室活動(dòng)過(guò)程中所獲得或產(chǎn)生的所有信息保密，法律要求除外。Personnel,

including

any

committee

members,

contractors,

personnel

of

external

bodies,

orindividuals

acting

on

the

laboratory's

behalf,

shall

keep

confidential

all

information

obtainedor

created

during

the

performance

of

laboratory

activities,

except

as

required

bylaw.4通用要求General

requirements344.2

保密性Confidentiality4通用要求General

requirementsVSISO/IEC

17025:2005涉及保密性條款1個(gè)涉及保密性條款4個(gè)，新增3個(gè)要求更高，由政策和程序要求，轉(zhuǎn)向做出具有法律效力的承諾4.2

保密性Confidentiality4.1.5c）保護(hù)保密ISO/IEC

17025:2017354通用要求General

requirements4.2

保密性ConfidentialityCNAS-CL01：2006

檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力認(rèn)可準(zhǔn)則4.1.5實(shí)驗(yàn)室應(yīng)：c)有保護(hù)客戶的機(jī)密信息和所有權(quán)的政策和程序，包括保護(hù)電子存儲(chǔ)和傳輸結(jié)果的程序；365結(jié)構(gòu)要求Structuralrequirements? 5.1實(shí)驗(yàn)室應(yīng)為法律實(shí)體，或法律實(shí)體中被明確界定的一部分，該實(shí)體對(duì)實(shí)驗(yàn)室活動(dòng)承擔(dān)法律責(zé)任。The

laboratory

shall

be

a

legal

entity,

or

a

defined

part

of

a

legal

entity,

that

is

legallyresponsible

for

its

laboratory

activities.注：在本準(zhǔn)則中，政府實(shí)驗(yàn)室基于其政府地位被視為法律實(shí)體。NOTE

Forthe

purposes

of

this

document,

a

governmental

laboratory

is

deemed

to

be

a

legalentity

onthe

basis

of

its

governmental

status.375結(jié)構(gòu)要求Structural

requirements? 5.2實(shí)驗(yàn)室應(yīng)確定對(duì)實(shí)驗(yàn)室全權(quán)負(fù)責(zé)的管理層。Thelaboratory

shall

identify

management

that

has

overall

responsibility

for

the

laboratory.385結(jié)構(gòu)要求Structural

requirements? 5.3實(shí)驗(yàn)室應(yīng)規(guī)定符合本準(zhǔn)則的實(shí)驗(yàn)室活動(dòng)范圍并制定成文件。實(shí)驗(yàn)室僅應(yīng)聲明符合本準(zhǔn)則的實(shí)驗(yàn)室活動(dòng)范圍，不應(yīng)包括持續(xù)從外部獲得的實(shí)驗(yàn)室活動(dòng)。The

laboratory

shall

define

and

document

the

range

of

laboratory

activities

for

which

itconforms

with

this

document.

The

laboratory

shall

only

claim

conformity

with

this

documentfor

this

range

of

laboratory

activities,

which

excludes

externally

provided

laboratoryactivities

onan

ongoingbasis.分包subcontract395結(jié)構(gòu)要求Structural

requirements? 5.4實(shí)驗(yàn)室應(yīng)以滿足本準(zhǔn)則、實(shí)驗(yàn)室客戶、法定管理機(jī)構(gòu)和提供承認(rèn)的組織要求的方式開(kāi)展實(shí)驗(yàn)室活動(dòng)，這包括實(shí)驗(yàn)室在固定設(shè)施、固定設(shè)施以外的地點(diǎn)，在臨時(shí)或移動(dòng)設(shè)施、客戶的設(shè)施中實(shí)施的實(shí)驗(yàn)室活動(dòng)。Laboratory

activities

shall

be

carried

out

in

such

a

way

as

to

meet

the

requirements

of

thisdocument,

thelaboratory’scustomers,

regulatory

authorities

and

organizations

providingrecognition.

This

shall

include

laboratory

activities

performed

in

all

its

permanent

facilities,at

sites

away

from

its

permanent

facilities,

in

associated

temporary

or

mobile

facilities

or

at

acustomer's

facility.405結(jié)構(gòu)要求Structural

requirements? 5.5實(shí)驗(yàn)室應(yīng)：The

laboratory

shall:a)確定實(shí)驗(yàn)室的組織和管理結(jié)構(gòu)、其在母體組織中的位置，以及管理、技術(shù)運(yùn)作和支持服務(wù)間的關(guān)系；define

the

organization

and

management

structure

of

the

laboratory,

its

place

in

any

parentorganization,

and

the

relationships

between

management,

technical

operations

and

supportservices;41b)規(guī)定對(duì)實(shí)驗(yàn)室活動(dòng)結(jié)果有影響的所有管理、操作或驗(yàn)證人員的職責(zé)、權(quán)力和相互關(guān)系;specify

the

responsibility,

authority

and

interrelationship

of

all

personnel

who

manage,

perform

orverify

workaffecting

the

results

of

laboratory

activities;5結(jié)構(gòu)要求Structural

requirementsc)將程序形成文件的程度以確保實(shí)驗(yàn)室活動(dòng)實(shí)施的一致性和結(jié)果有效性為原則。document

its

procedures

to

the

extent

necessary

to

ensure

the

consistent

application

of

itslaboratory

activities

and

the

validity

of

the

results.42? 5.6實(shí)驗(yàn)室人員應(yīng)具有履行職責(zé)所需的權(quán)利和資源（不論其他職責(zé)），這些職責(zé)包括：The

laboratory

shall

have

personnel

who,

irrespective

of

other

responsibilities,

have

theauthority

and

resources

needed

to

carry

out

their

duties,

including:a)實(shí)施、保持和改進(jìn)管理體系；implementation,

maintenance

and

improvement

of

the

management

system;b)識(shí)別與管理體系或?qū)嶒?yàn)室活動(dòng)程序的偏離；identification

of

deviations

from

the

management

system

or

from

the

procedures

forperforming

laboratory

activities;c)采取措施以預(yù)防或最大程度減少這類(lèi)偏離;initiation

of

actions

to

prevent

or

minimize

such

deviations;5結(jié)構(gòu)要求Structural

requirements435結(jié)構(gòu)要求Structural

requirementsd)向?qū)嶒?yàn)室管理層報(bào)告管理體系運(yùn)行狀況和改進(jìn)需求；reporting

to

laboratory

management

on

the

performance

of

the

management

system

andany

need

for

improvement;e)確保實(shí)驗(yàn)室活動(dòng)的有效性。ensuring

the

effectiveness

of

laboratory

activities.44? 5.7

實(shí)驗(yàn)室管理層應(yīng)確保：Laboratory

management

shall

ensure

that

：a）針對(duì)管理體系有效性、滿足客戶和其他要求的重要性進(jìn)行溝通。a）

communication

takes

place

regarding

the

effectiveness

of

the

management

system

and

theimportance

of

meeting

customers'

and

other

requirements;5結(jié)構(gòu)要求Structural

requirementsb）當(dāng)策劃和實(shí)施管理體系的變更時(shí)，保持管理體系的完整性；b）

the

integrity

of

the

management

system

is

maintained

when

changes

to

the

managementsystem

are

planned

and

implemented.45VSISO/IEC

17025:2005涉及組織的條款6個(gè)涉及結(jié)構(gòu)要求條款7個(gè)，新增2個(gè)不再使用“最高管理者”的說(shuō)法，用“實(shí)驗(yàn)室管理層”來(lái)代替5結(jié)構(gòu)要求Structural

requirements4.1.5

a）刪除“管理人員和技術(shù)人員”4.1.5

h）4.1.5

i）刪除技術(shù)管理者要求刪除質(zhì)量主管要求4.1.5j）刪除指定關(guān)鍵管理人員的代理人ISO/IEC

17025:2017465結(jié)構(gòu)要求Structural

requirementsCNAS-CL01：2006

檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力認(rèn)可準(zhǔn)則4.1.5實(shí)驗(yàn)室應(yīng)：a)

有管理人員和技術(shù)人員，不論他們的其他責(zé)任，他們應(yīng)具有所需的權(quán)力和資源來(lái)履行包括實(shí)施、保持和改進(jìn)管理體系的職責(zé)，識(shí)別對(duì)管理體系或檢測(cè)和/或校準(zhǔn)程序的偏離，以及采取預(yù)防或減少這些偏離的措施（見(jiàn)5.2）；h)有技術(shù)管理者，全面負(fù)責(zé)技術(shù)運(yùn)作和提供確保實(shí)驗(yàn)室運(yùn)作質(zhì)量所需的資源；i) 指定一名員工作為質(zhì)量主管（不論如何稱謂），不論其他職責(zé)，應(yīng)賦予其在任何時(shí)候都能確保與質(zhì)量有關(guān)的管理體系得到實(shí)施和遵循的責(zé)任和權(quán)力。質(zhì)量主管應(yīng)有直接渠道接觸決定實(shí)驗(yàn)室政策或資源的最高管理者；j)指定關(guān)鍵管理人員的代理人（見(jiàn)注）；476資源要求Resource

requirements6.46.56.66.16.26.348總則General人員Personnel設(shè)施和環(huán)境條件

Facilities

andenvironmental

conditions設(shè)備Equipment計(jì)量溯源性Metrological

traceability外部提供的產(chǎn)品和服務(wù)Externally

providedproducts

and

services6

資源要求? 實(shí)驗(yàn)室應(yīng)獲得管理和實(shí)施實(shí)驗(yàn)室活動(dòng)所需的人員、設(shè)施、設(shè)備、系統(tǒng)及支持服務(wù)。The

laboratory

shall

have

available

the

personnel,

facilities,

equipment,

systems

and

supportservices

necessary

to

manage

and

perform

its

laboratory

activities.6.1

總則General49VSISO/IEC

17025:2005未明確提出“資源要求”的概念明確提出“資源要求”概念6資源要求Resource

requirements6.1

總則G

e

n

e

r

al

整合“資源要求”的范圍——管理和實(shí)驗(yàn)室活動(dòng)首提“系統(tǒng)和支持服務(wù)”ISO/IEC

17025:2017506

資源要求? 6.2.1

所有可能影響實(shí)驗(yàn)室活動(dòng)的人員，無(wú)論是內(nèi)部人員還是外部人員，應(yīng)行為公正、有能力、并按照實(shí)驗(yàn)室管理體系要求工作。All

personnel

of

the

laboratory,

either

internal

or

external,

that

could

influence

the

laboratoryactivities

shall

act

impartially,

be

competent

and

work

in

accordance

with

the

laboratory'smanagement

system.6.2

人員Personnel51? 6.2.2實(shí)驗(yàn)室應(yīng)將影響實(shí)驗(yàn)室活動(dòng)結(jié)果的各職能的能力要求制定成文件，包括對(duì)教育、資格、培訓(xùn)、技術(shù)知識(shí)、技能和經(jīng)驗(yàn)的要求。The

laboratory

shall

document

the

competence

requirements

for

each

function

influencingthe

results

of

laboratory

activities,

including

requirements

for

education,

qualification,training,

technical

knowledge,

skills

and

experience.6資源要求Resource

requirements6.2

人員P

e

r

s

o

n

n

el

52? 6.2.3實(shí)驗(yàn)室應(yīng)確保人員具備其負(fù)責(zé)的實(shí)驗(yàn)室活動(dòng)的能力，以及評(píng)價(jià)偏離的重要程度的能力。The

laboratory

shall

ensure

that

the

personnel

have

the

competence

to

perform

laboratoryactivities

for

which

they

are

responsible

and

to

evaluate

thesignificance

of

deviations.6資源要求Resource

requirements6.2

人員P

e

r

s

o

n

n

el

53? 6.2.4實(shí)驗(yàn)室管理層應(yīng)與實(shí)驗(yàn)室人員就其職責(zé)、責(zé)任和權(quán)限進(jìn)行溝通。The management of the laboratory shall communicate to personnel their duties,responsibilities

and

authorities.? 未使用“工作描述”一詞? 取消了對(duì)工作描述的注釋（5.2.4注）6資源要求Resource

requirements6.2

人員P

e

r

s

o

n

n

el

54? 6.2.5實(shí)驗(yàn)室應(yīng)有以下活動(dòng)的程序并保留相關(guān)記錄：Thelaboratory

shall

have

procedure(s)

and

retain

records

for:a)確定能力要求determining

the

competence

requirementsb)人員選擇selection

of

personnelc)人員培訓(xùn)training

of

personnel6資源要求Resource

requirements6.2

人員P

e

r

s

o

n

n

el

55d)人員監(jiān)督supervision

of

personnel6