夏木友人帐iso17025中英文对照

2021年1月19日发(作者：舒翁)
iso17025
中英文对照

ISO/IEC 17025:2005
中英文对照版

特别声明
:
若对本版本有疑义，请以英文版本为准。

4
管理要求
Management requirements
4.1
组织
Organization
4.1.1
实验室或其所在的组织应是一个能够承担法律责任的实体。

The laboratory or the organization of which it is part shall be an
entity that can be held legally responsible.
4.1.2
实验室的职责是以符合本标准的要求的方式从事检测和校准，并能满足
客户、法定管

理机构或提供认可的组织的需求。

It is the responsibility of the laboratory to carry out its testing
and calibration activities in
such a way as to meet the requirements of this International
Standard and to satisfy the needs of the customer, the regulatory
authorities or organizations providing recognition. 4.1.3
实验室的管理体
系应覆盖实验室在固定设施内、开其固定设施的场所，或在相关的临

时或移动设施中进行的工作。

The management system shall cover work carried out in the
laboratory’s permanent facilities, at sites away
from its permanent
facilities, or in associated temporary or mobile facilities.
4.1.4
如果实验室所在的组织还从事检测和
(
或
)
校 准以外的活动，为了鉴别潜
在的利益冲

实，应界定该驵织中参与检测和
(< br>或
)
校准或对检测和
(
或
)
校准有影响的关键人员的职责。

If the laboratory is part of an organization performing activities
other than testing and/or calibration, the responsibilities of key
personnel in the organization that have an involvement or influence on
the testing and/or calibration activities of the laboratory shall be
defined in order to identify potential conflicts of interest.
注
1:
如果实验室是某个较大组织的一部分，该组织应使其有利益冲突的部
门，如生产、

商贸营销或财务部门，不对实验室满足本标准的要求产生不良影响。

NOTE 1 Where a laboratory is part of a larger organization, the
organizational arrangements should be such that departments having
conflicting interests, such as production, commercial marketing or
financing do not adversely influence the laboratory's compliance with
the requirements of this International Standard.
注
2:
如果实验室希望作为第三方实验室得到认可，应能证明其公正性。并且
实验室及其
< br>员工能够扺御任何可能影响其技术判断的、不正当的商业、财务和其分方面的
压力。第三方

检测或校准实验室不应参与任何损害其判断独立性和检测或校准诚信度的活
动。

NOTE 2 If the laboratory wishes to be recognized as a third-party
laboratory, it should be able to demonstrate that it is impartial and
that it and its personnel are free from any undue commercial, financial
and other pressures which might influence their technical judgement. The
third-party testing or calibration laboratory should not engage in any
activities that may endanger the trust in its independence of judgement
and integrity in relation to its testing or calibration activities.
4.1.5
实验室应
:
The laboratory shall
a)
有管理人员和技术人员，不考虑他们的其他职责为何，他们应具有所需的
权力和资源来

履行包括实施、保持和改进管理体系的职责，识别对管理体系或检测和
(
或
)
校
准程序的偏离，

以及采取措施预防或减少这种偏离
(
见
5.2);
have managerial and technical personnel who, irrespective of other
responsibilities, have the authority and resources needed to carry out
their duties, including the implementation, maintenance and improvement
of the management system, and to identify the occurrence of departures
from the management system or from the procedures for performing tests
and/or calibrations, and to initiate actions to prevent or minimize such
departures (see also 5.2);
b)
有措施保证管理层和员工不受任何对工作质量有不良影响的、来自内外部
的不正当的商

业、财务和其他方面的压力和影响
;
have arrangements to ensure that its management and personnel are
free from any undue internal and external commercial, financial and
other pressures and influences that m ay adversely affect the quality of
their work;
c)
有保护客户的机密信息和所有权的政策和程序，包括保护电子存储和传输
结果的程序
;
c) have policies and procedures to ensure the protection of its
customers' confidential information and proprietary rights, including
procedures for protecting the electronic storage and transmission of
results;
d)
有政策和程序以避免卷入任何可能会降低其能力、公正性、判断或运作诚
实性的可信程

度的活动
;
have policies and procedures to avoid involvement in any activities
that would diminish confidence in its competence, impartiality,
judgement or operational integrity; e)
确定实验室的组织和管理结构、其在
母体组织中的地位，以及质量管理、技术运作和支

持服务之间的关系
;
define the organization and management structure of the laboratory,
its place in any parent organization, and the relationships between
quality management, technical operations and support services;
f)
规定所有对检测和
(
或
)
校准质量有影响的所有管理、操作和核查人 员的职
责、权力和相互

关系
;
specify the responsibility, authority and interrelationships of all
personnel who manage, perform or verify work affecting the quality of
the tests and/or calibrations; g)
由熟悉各项检测和
(
或
)
校准 的方法、程序、
目的和结果评价的人员对检测和校准人员包

括在培员工进行足够的监督
;
provide adequate supervision of testing and calibration staff,
including trainees, by persons familiar with methods and procedures,
purpose of each test and/or calibration, and with the assessment of the
test or calibration results;
h)
有技术管理层，全面负责技术运作和确保实验室运作质量所需的资源
;
have technical management which has overall responsibility for the
technical operations and the provision of the resources needed to ensure
the required quality of laboratory operations;
i)
指定一名人员作为质量主管
(
不论如何称 谓
)
，不管现有的其他职责，应赋
予其在任何时候

都能保证质量体 系得到实施和遵循的责任和权力。质量主管应有直接渠道接触
决定实验室政

策和资源的最高管理层
;
appoint a member of staff as quality manager (however named) who,
irrespective of other duties and responsibilities, shall have defined
responsibility and authority for
ensuring that the management system related to quality is
implemented and followed at all times; the quality manager shall have
direct access to the highest level of
management at which decisions are made on laboratory policy or
resources; j)
指定关键管人员的代理人
(
见注
)
。

appoint deputies for key managerial personnel (see Note);
k)
确保实验室人员理解他们所从事的活动的相互关系和重要性，以及如何为
管理体系质量

目标的实现做出贡献。

ensure that its personnel are aware of the relevance and importance
of their activities and how they contribute to the achievement of the
objectives of the management system.
注
:
个别人可能有多项职能，对每项职责都指定代理人可能是不现实的。

NOTE Individuals may have more than one function and it may be
impractical to appoint deputies for every function.
4.1.6
最高管理者应确保在实验室内部建立适宜的沟通机制，并就与管理体系
有效性的事宜

进行沟通。

Top management shall ensure that appropriate communication processes
are established within the laboratory and that communication takes place
regarding the effectiveness of the management system.
4.2
管理體系
Management system
4.2.1
實驗室建 立、實施和維持與活動范圍相適應的管理體系
.
應將其政策、
制度、計劃、程

序和指導書制定成文件
,
並達到確保實驗室檢測和
(
或
)< br>校准結果質量所需的程
度
.
體系文件應

傳達至有關人員
,
並被其理解、獲取和執行
.
The laboratory shall establish, implement and maintain a management
system appropriate to the scope of its activities. The laboratory shall
document its policies, systems, programmes, procedures and instructions
to the extent necessary to assure the quality of the test and/or
calibration results. The system’s documentation shall be

communicated to, understood by, available to, and implemented by the
appropriate
personnel.
4.2.2
實驗室管理體系中與質量有關的政策
,
包括質量方針聲明
,
應在質量手冊(
不論如何稱

謂
)
中闡明
.
應制定總體目標並在管理評審時加以評審
.
質量方針聲明應在最高
管理者的授權

下發佈
,
至少包括下列內容
:
The laboratory's management system policies related to quality,
including a quality policy statement, shall be defined in a quality
manual (however named). The overall objectives shall be established, and
shall be reviewed during management review.
The quality policy statement shall be issued under the authority of
top management. It shall include at least the following:
a)
實驗室管理層對良好職業行爲和爲客戶提供檢測和校準服務質量的承諾
;
the laboratory management's commitment to good professional practice
and to the quality of its testing and calibration in servicing its
customers; b)
管理層關於實驗室服務標準的聲明
;
the management’s statement of the laboratory's standard of service;

c)
與質量有關的管理體系的目的
;
the purpose of the management system related to quality;
d)
要求實驗室所有與檢測和校準活動有關的人員熟悉與之相關的質量文件
,
並
在工作中執

行這些政策和程序
;
a requirement that all personnel concerned with testing and
calibration activities within the laboratory familiarize themselves with
the quality documentation and implement the policies and procedures in
their work; and
e)
實驗室管理層對遵循本標準及持續改進管理體系的承諾
.
the laboratory management's commitment to comply with this
International Standard
and to continually improve the effectiveness of the management
system.
注
:
質量方針聲明宜簡明
,
可包括應始終按照規定的方法和客戶的需要來進
行檢測和
(
或
)< br>校準

的要求
.
當檢測和
(
或
)
校 準實驗室是某個較大組織的一部分時
,
某些質量方針要
素可以列以其

他文件之中
.
NOTE The quality policy statement should be concise and may include
the requirement that tests and/or calibrations shall always be carried
out in accordance with stated methods and customers' requirements. When
the test and/or calibration laboratory is part of a larger organization,
some quality policy elements may be in other documents.
4.2.3
最高管理者應提供建立和實施管理體系以及持續改進其有效性承諾的證
據
.
Top management shall provide evidence of commitment to the
development and implementation of the management system and to
continually improving its effectiveness.
4.2.4
最高管理者應將滿足客戶要求和法定要求的重要性傳達到組織
.
Top management shall communicate to the organization the importance
of meeting customer requirements as well as statutory and regulatory
requirements. 4.2.5
質量手冊應包括或指明含 技術程序在內的支持性程序
,
並概
述質量體系中所用文件的

架構
.
The quality manual shall include or make reference to the supporting
procedures including technical procedures. It shall outline the
structure of the documentation used in the management system.
4.2.6
質量手冊中應界定技術管理層和質量主管的作用和責任包括確保遵循本
標準的責任
.
The roles and responsibilities of technical management and the
quality manager, including their responsibility for ensuring compliance
with this International Standard, shall be defined in the quality manual.
4.2.7
當策劃和 實施管理體系的變更時
,
最高管理者應確保維持管理體系的完
整性
.
Top management shall ensure that the integrity of the management
system is maintained when changes to the management system are planned
and implemented.
4.3 4.3
文件控制
Document control
4.3.1
總則
General 實驗室應建立和維持程序來控制構成其質量體系的所有文件
(
內部制定或來自
外部 的
),
諸如

規章、標準、其他規範化文件、檢測和
(
或< br>)
校準方法
,
以及圖紙、軟件、規
範、指導書和手冊
.
The laboratory shall establish and maintain procedures to control
all documents that
form part of its management system (internally generated or from
external sources), such as regulations, standards, other normative
documents, test and/or calibration methods, as well as drawings,
software, specifications, instructions and manuals.
注
1:
本文中的“文
件”可以是方針聲明、程序、規範、校準表格、圖表、教科書、張貼品、備

忘錄、軟件、圖紙、計劃等
.
這些文件可能承載在各種載體上
,
進化論是硬拷
貝或是電子媒

體
,
並且可以是數字的、模擬的、攝影的或書面的形式
.
NOTE 1 In this context “document” could be policy statements,
procedures, specifications, calibration tables, charts, text books,
posters, notices, memoranda, software,
drawings, plans, etc. These may be on various media, whether hard
copy or electronic, and they may be digital, analog, photographic or
written.
注
2:
有關檢測和校準數據的控制在
5.4.7
條中規定
.
記錄的控制在
4.13
條中
規定
.
NOTE 2 The control of data related to testing and calibration is
covered in 5.4.7. The control of records is covered in 4.13.
4.3.2
文件的批准和發布
Document approval and issue
4.3.2.1
凡作爲質量體系組成部分發給實 驗室人員的所有文件
,
在發佈之前應
由授權人員審

查並批准使用< br>.
應建立識別質量體系中文件當前的修訂狀態和分發的控制清單
或等同的文件

控制程序並易於查閱
,
以防止使用無效和
(
或
)
作 廢的文件
.
All documents issued to personnel in the laboratory as part of the
management system shall be reviewed and approved for use by authorized
personnel prior to issue. A master list or an equivalent document
control procedure identifying the current
revision status and distribution of documents in the management
system shall be established and shall be readily available to preclude
the use of invalid and/or obsolete documents.
4.3.2.2
所用程序應確保
:
The procedure(s) adopted shall ensure that:
a)
在對實驗室有效運作起重要作用的所有作業 場所
,
都能得到相應文件的授權
版本
;
authorized editions of appropriate documents are available at all
locations where operations essential to the effective functioning of the
laboratory are performed; b)
定期審查文件
,
必要時進行修訂
,< br>以保證持續適用
和滿足使用的要求
;
documents are periodically reviewed and, where necessary, revised to
ensure continuing suitability and compliance with applicable
requirements;
c)
及時地從所有使用和發佈處撤除無效或作廢的文件
,
或用其他方法確保 防止
誤用
;
invalid or obsolete documents are promptly removed from all points
of issue or use,
or otherwise assured against unintended use;
d)
出於法律或知識保存目的的而保留的和廢文件
,
應有適當的標記
.
obsolete documents retained for either legal or knowledge
preservation purposes are suitably marked.
4.3.2.3
實驗室制定的管理體系文件應有唯一 性標識
.
該標識應包括發佈日期
和
(
或
)
修訂標< br>
識、頁碼、總頁數或表示文件結束的標記和發佈機構
.
Management system documents generated by the laboratory shall be
uniquely identified. Such identification shall include the date of issue
and/or revision identification,
page numbering, the total number of pages or a mark to signify the
end of the document, and the issuing authority(ies).
4.3.3
文件變更
Document changes
4.3.3.1
除非另有特別指定
,
文件的變更應由原審查責任人進行審查和批准
.
被指定的人員

應獲得進行審查和批准所依據的有關背景資料
.
Changes to documents shall be reviewed and approved by the same
function that performed the original review unless specifically
designated otherwise. The designated personnel shall have access to
pertinent background information upon which to base their review and
approval.
4.3.3.2
若可行
,
更改的或新的內容應在文件或適當的附件中標明
.
Where practicable, the altered or new text shall be identified in
the document or the appropriate attachments.
4.3.3.3
如果實驗室的文件 控制度允許在文件再版之前對文件進行手寫修改
,
則應確定修改

的程序和權 限
.
修改之處應有清晰的標注、簽名縮寫並注明日期
.
修訂的文件應
儘快地正式發

佈
.
If the laboratory's document control system allows for the amendment
of documents
by hand pending the re-issue of the documents, the procedures and
authorities for
such amendments shall be defined. Amendments shall be clearly marked,
initialled
and dated. A revised document shall be formally re-issued as soon as
practicable.
4.3.3.4
應制定程序來描述如何更改和控制保存在計算機系統中的文件
.
Procedures shall be established to describe how changes in documents
maintained
in computerized systems are made and controlled.
4.4
要求、標書和合同的評審
Review of requests, tenders and contracts
4.4.1
實驗室應建立和維持評審客戶 要求、標書和合同的程序
.
這些爲簽訂檢
測和
(
或
)
校準合

同而進行評審的政策和程序應確保
:
The laboratory shall establish and maintain procedures for the
review of requests, tenders and contracts. The policies and procedures
for these reviews leading to a contract for testing and/or calibration
shall ensure that:
a)
對包括所用方法在內的要求應予適當規定
,
形成文件
,
並易於理解< br>(
見
5.4.2);
the requirements, including the methods to be used, are adequately
defined, documented and understood (see 5.4.2);
b)
實驗室有能力和資源滿足這些要求
;
the laboratory has the capability and resources to meet the
requirements;
c)
選擇適當的、能滿足客戶 要求的檢測和
(
或
)
校準方法
(
見
5.4.2);
the appropriate test and/or calibration method is selected and is
capable of meeting
the customers' requirements (see 5.4.2).
客戶要求或標書與 合同之間的任何差異
,
應在工作開始之前得到解決
.
每項合同
應得到 實驗

室和客戶雙方的接受
.
Any differences between the request or tender and the contract shall
be resolved before any work commences. Each contract shall be acceptable
both to the laboratory and the customer.
注
1:
對要求、 標書和合同的評審需以可行和有效的方式進行
,
並考慮財務、法
律和時間安排

等方面的影響
.
對內部客戶的要求、標書和合同的審查可用簡化方式進行
.
NOTE 1 The request, tender and contract review should be conducted
in a practical and efficient manner, and the effect of financial, legal
and time schedule aspects
should be taken into account. For internal customers, reviews of
requests, tenders
and contracts can be performed in a simplified way.
注
2:
對實驗室能力的評審
,
應證實實驗室具備了必要的物力、人力和信息資源
,< br>且實驗室人

員對所從事的檢測和
(
或
)
校準具有必 要的技能和專業技術
.
該評審也可包括以
前參加的實驗

室間比對或 能力驗證的結果和
(
或
)
爲確定測量不確定度、檢出限、置信限等而
使用的已知值

樣品或物品所做的試驗性檢測或校準計劃的結果
.
NOTE 2 The review of capability should establish that the laboratory
possesses the
necessary physical, personnel and information resources, and that
the laboratory's personnel have the skills and expertise necessary for
the performance of the tests and/or calibrations in question. The review
may also encompass results of earlier participation in interlaboratory
comparisons or proficiency testing and/or the running of trial test or
calibration programmes using samples or items of known value in order to
determine uncertainties of measurement, limits of detection, confidence
limits, etc.
注
3:
合同可以是爲 客房提供檢測和
(
或
)
校準服務的任何書面的或口頭的協議
.
NOTE 3 A contract may be any written or oral agreement to provide a
customer with testing and/or calibration services.
4.4.2
應保存包括任 何重大變化在內的評審記錄
.
在執行合同期間
,
就客戶的要
求或工作 結果

與客戶進行討論的有關記錄
,
也應予保存
.
Records of reviews, including any significant changes, shall be
maintained. Records
shall also be maintained of pertinent discussions with a customer
relating to the customer's requirements or the results of the work
during the period of execution of
the contract.
注
:
對例行的和其他簡單任務的評審
,
由實 驗室中負責合同工作的人員注明日期
並加以標識

(
如簽名縮寫
)< br>即寫
.
對於重復性的例行工作
,
如果客戶要求不變
,
僅需在初期調
查階段
,
或在與

客戶的總協議下對持續進行的例行工 作合同批准時進行評審
.
對於新的、複雜
的或先進的檢

測和
(
或
)
校準任務
,
則需保存較全面的記錄
.
NOTE For review of routine and other simple tasks, the date and the
identification
(e.g. the initials) of the person in the laboratory responsible for
carrying out the contracted work are considered adequate. For repetitive
routine tasks, the review need be made only at the initial enquiry stage
or on granting of the contract for on-going routine work performed under
a general agreement with the customer, provided
that the customer's requirements remain unchanged. For new, complex
or advanced testing and/or calibration tasks, a more comprehensive
record should be maintained.
4.4.3
評審的內容應包括被實驗室分包出去的所有工作
.
The review shall also cover any work that is subcontracted by the
laboratory. 4.4.4
對合同的任何偏離均應通知客戶
.
The customer shall be informed of any deviation from the contract.
4.4.5
工作開始後如果 需要修改合同
,
應重復進行同樣的合同評審過程
,
並將所有修
改內容 通

知所有受到影響的人員
.
If a contract needs to be amended after work has commenced, the same
contract review process shall be repeated and any amendments shall be
communicated to all affected personnel.
4.5
檢測和校準的分包
Subcontracting of tests and calibrations
4.5.1
當實驗室由於未預料的原因
(
如工作量、需要更多專業技術或暫 不具備
能力
)
或持續性

的原因
(
如通過長期分包 、代理或特殊協議
)
需將工作分包時
,
應分包給合格的
分包方
,
例如能

夠遵照本標準要求進行工作的分包方
.
When a laboratory subcontracts work, whether because of unforeseen
reasons (e.g.
workload, need for further expertise or temporary incapacity) or on
a continuing basis (e.g. through permanent subcontracting, agency or
franchising arrangements), this work shall be placed with a competent
subcontractor. A competent subcontractor is one that, for example,
complies with this International Standard for the work in question.
4.5.2
實驗室應將分包安排以書面形 式通知客戶
,
適當時應得到客戶的准許
,
最
好是書面的同

意
.
The laboratory shall advise the customer of the arrangement in
writing and, when appropriate, gain the approval of the customer,
preferably in writing. 4.5.3
實驗室 應就其分包方的工作對客戶負責
,
由客戶或
法定管理機構指定的分包方除外
.
The laboratory is responsible to the customer for the
subcontractor’s work, except in the case where the customer or a
regulatory authority specifies which subcontractor is to be used.
4.5.4
實驗室應保存檢測和
(
或
)
校 準中使用的所有分包方的註冊資料
,
並保存
其工作符合本

標準的證明記錄
.
The laboratory shall maintain a register of all subcontractors that
it uses for tests and/or calibrations and a record of the evidence of
compliance with this International
Standard for the work in question.
4.6
服務和供應品的採購
Purchasing services and supplies
4.6.1
實驗室應有選擇和購買對檢測 和
(
或
)
校準質量有影響的服務和供應商品
的政策和程序
.
還應有與檢測和校準有關的試劑和消耗材料的購買、驗收和存儲的程序
.
The laboratory shall have a policy and procedure(s) for the
selection and purchasing of services and supplies it uses that affect
the quality of the tests and/or calibrations. Procedures shall exist for
the purchase, reception and storage of reagents and laboratory
consumable materials relevant for the tests and calibrations. 4.6.2
實驗
室應確保所購買的、影響檢測和
(
或
)
校 準質量的供應品、試劑和消耗材料
,
只有在

經檢查或證實符合有關檢測和< br>(
或
)
校準方法中規定標準規範或要求之後才投入
使用
.所使用

的服務和供應品應符合規定的要求
.
應保存採取的符合性檢查活動的記錄
.
The laboratory shall ensure that purchased supplies and reagents and
consumable materials that affect the quality of tests and/or
calibrations are not used until they have been inspected or otherwise
verified as complying with standard specifications
or requirements defined in the methods for the tests and/or
calibrations concerned.
These services and supplies used shall comply with specified
requirements. Records of actions taken to check compliance shall be
maintained.
4.6.3
影響實驗室輸出質量的物品採購文件中
,
應包含描述所購服務和 供應品
的資料
.
這些採