EDQM 实验室联合审计标准指南.docx

EDQM: PA/PH/OMCL (06) 72 (EDIV/04) 2006年7月

Standard “Aide mémoire” for the Mutual Joint Audit of Official Medicines Control Laboratories
药品官方控制实验室联合审计标准指南

I. General
一、概况

This “aide-mémoire” was elaborated on a standard checklist for EN ISO/IEC 17025 and corresponding EA and ILAC guidelines, published by an accreditation body on the internet. Specific OMCL requirements arising from adopted OMCL guidelines were incorporated.
这个指南是为阐述《检测和校准实验室能力的通用要求》和相应的欧洲认证协会及国际实验室认可合作组织准则的一个标准清单，并被一个认证机构发表在互联网上。药品官方检验实验室的具体要求因被采用的药品官方检验实验室准则而注册成立。

This document has been revised and updated in accordance with the second edition of the EN ISO/IEC 17025 of 15th May 2005.
此文件已被修改和更新，符合了2005年5月15日第二版的《检测和校准实验室能力的通用要求》。

The questions in the first column are addressed to the testing laboratories; they are to be answered thoroughly by the laboratory itself before the evaluation takes place, with indication of corresponding reference documents (e.g. Quality Manual, SOP, working instructions etc.) to provide an efficient assessment basis to the auditors. Should any requirement of the standard be non-applicable, this must be indicated by "NA" under the "References" column and duly justified.
第一列的问题是针对测试中的实验室；要求实验室在评估开始前，根据文件和相应的参考指标全部解答，（例如：质量手册，标准操作规程，工作指示等），从而为核数师提供一个有效的评估依据。假如任何一个标准的要求不适用，则必须在参考项下注明“不适用”，并用合理的解释说明。

During the audit, this document provides a practical tool for the auditors to make sure that all elements of the ISO/IEC 17025 standard and OMCL guidelines are covered, but it will not be used as such to prepare the audit report.
在审计过程中，这份文件为审计人员提供了一个实用的工具，以确保所有的《检测和校准实验室能力的通用要求》标准以及药品官方检验实验室准则所涵盖的内容，但文件并不会使用像这样准备的审计报告。

This document may also be used by OMCLs as self-assessment of the implementation status of the Management System, independently of any external assessment.
《检测和校准实验室能力的通用要求》也可使用这份文件，作为管理系统执行情况的自我评估，它独立于任何的外部评估。

II. Definitions and Abbreviations
二、定义和缩略词

Documents, records: documents and records can be stored in paper or electronic (computer) form. Rules must be defined for the availability of, access to and safeguarding of electronic records.
文件，记录：文件和记录可以以纸张或电子（电脑）的形式存储。且必须为电子记录的可用性、访问和维护定义相应的规章制度。

QM = quality manual
QM =质量手册
OMCL = Official Medicines Control Laboratory
OMCL =药品官方检验实验室
MJA = Mutual Joint Audit
MJA =联合审计
OOS = Out of Specification
OOS =超标

NB: in the text « Authority » refers to: competent authority that gives the order to test a medicinal product
NB：官方文件中指：主管机关下令检测药品

EDQM/OMCL NETWORK MJA AUDIT INFORMATION
欧洲药品管理委员会/药品官方检验实验室网络联合审计信息
(to be filled in prior to the MJA or during assessment as an audit record)
（提前填写，并在联合审计或评估期间作为审计记录）

Name of OMCL 药品官方检验实验室名称
MJA Number 联合审计号
Self-assessment 自我评估 ❒ YES 是 ❒ NO 否
Date of self-assessment or MJA 联合审计或自我评估日期
If YES date of submission 自我评估项填“有”的，填提交日期
Name of person responsible 负责人姓名
Signature 签名
If NO date of MJA 自我评估项填“否”的，填联合审计日期
Name of MJA team coordinator 联合审计团队协调员姓名
Name of MJA team members 联合审计团队成员姓名
Name of person issuing this record 此记录发行者姓名

SUMMARY
摘要
(figures in parentheses refer to standard EN ISO/IEC 17025)
（括号中的数字参考《检测和校准实验室能力的通用要求》标准）

1. Organisation 组织机构
1.1 Organisation and management 组织和管理机构(4.1)
2. Management system 管理系统
2.1 Management system 管理系统(4.2)
2.2 Document control 文件监控(4.3)
2.3 Record control 记录监控(4.13)
3. External co-operation (with competent authorities and suppliers)
对外合作（和主管部门及供应商）
3.1 Testing order review 顺序审查检测(4.4)
3.2 Sub-contracting of tests 分包检测(4.5)
3.3 Purchasing services and supplies 采购服务和供应(4.6)
3.4 Service to the authority 服务管理机构 (4.7)
3.5 Complaints 起诉(4.8)
4. Maintenance of the management system管理系统的维护
4.1 Control of nonconforming testing work
控制不合格检测工作(4.9)
4.2 Improvement 改善(4.10)
4.3 Corrective action 纠正措施(4.11)
4.4 Preventive action 预防措施(4.12)
4.5 Internal audits 内部审计(4.14)
4.6 Management reviews 管理审查(4.15)
5. Personnel 人员(5.2)
6. Premises and equipment 物业及设备
6.1 Premises 物业(5.3)
6.2 Equipment 设备(5.5)
6.3 Computer system, control of data 计算机系统，数据控制(5.4)
6.4 Measurement traceability 可追溯性测量(5.6)
6.5 Reference standards 参考标准(5.6/OMCL)
7. Handling of test items 检测项目处理
7.1 Sampling 取样(5.7)
7.2 Handling of test items 检测项目处理(5.8)
8. Test methods 检测方法
8.1 Test methods and procedures, including validation (5.4)
检测方法和程序，包括验证
8.2 Questions relevant for method transfer and screening
有关问题的方法转让和筛选(5.4/OMCL)
8.3 Questions relevant for laboratory-developed methods (5.4)
有关问题的实验室开发方法
8.4 Assuring the quality of test results (5.9/OMCL)
保证检测结果质量
8.5 Technical records (4.13.2)
技术记录
9. Test reports 检测报告
9.1 Reporting the results 报告结果(5.10)
9.2 Tests performed by subcontractors 由分包商进行测试(5.10.6)

1. Organisation组织
Y
N
References/Comments参考/评论
1.1 Organisation and management (4.1)组织和管理

1.1.1
(4.1.1) - Name and address of the OMCL
药品官方检验实验室的名称和地址

-Legal identity of the organisation (entry in the commerce register or public institution)
该组织的合法身份（登记在商业注册处或公共机构）

-Field of activities of the OMCL
药品官方检验实验室现场活动

o Market surveillance testing
市场监督检测
o Official Batch release testing
官方批放行检测
o …
-Name and address of the laboratory
实验室的名称和地址

-Field of activities of the laboratory (general)
实验室现场活动（一般）

Has the OMCL already been accredited?
该药品官方实验室是否已经被认可？

If YES, scope for which accreditation has been granted and by which accreditation body
如果已被认可，获资格认证的范围，且被哪个机构认证

If NO, scope of the applied Management System
如果未被认可，这个应用管理系统的范围

Scope of activities to be audited during the MJA
联合审计期间的活动审计范围

1.1.2
(4.1.4) Is the laboratory part of a parent organisation? If YES what organisation?
这个实验室是否是上级组织的一部分？如果是，是什么组织

1.1.3
(4.1.5e) Is there one or several organisational chart(s) for the whole OMCL showing the position of the testing laboratory, and is such a chart available for the testing laboratory itself?
是否有一个或是数个组织结构图，为药品官方实验室显示该检测实验室的位置，且这种图标是否能供实验室本身使用？

1.1.4
(4.1.4) Are the responsibilities and authorities of the key personnel in the laboratory suitably defined so that conflicts of interest can be avoided?
是否界定了实验室中关键人员的责任和权力，来避免利益冲突？

1.1.5
(4.1.5b )Is it possible to exclude any influence on the results exercised by persons or organisations external to the testing?
是否可以排除由个人或机构进行的外部检测而对结果造成的任何影响？

1.1.6
Is it ensured that the OMCL is not engaged in other activities that may endanger its impartiality, its independence and its integrity?
是否能保证药品官方检验实验室没有从事其他可能危及其公正性，独立性和完整性的活动？

1.1.7
(4.1.5b) Is the technical and financial independence between the laboratory and external customers ensured?
在实验室和外部客户之间是否能确保技术和经济的独立？

1.1.8
(药品官方 How is it ensured that the OMCL performs the检验实验室) testing of products independently from any contract work by order of a pharmaceutical manufacturer or entrepreneur?
如何确保药品官方检验实验室对来自任何药品生产商或企业家的合同要求进行独立的产品测试？

See contracts with other customers, see if the OMCL controls products from the contractor
看看其他客户的合同，药品官方检验实验室是否控制来自承建商的产品
1.1.9
(4.1.5h) Name of the technical manager who has the overall responsibility for the operation of the laboratory.
指派一名对实验室的运作负有全面责任的技术经理。

1.1.10
(4.1.5h) Are the qualifications (training, courses, publications, experience) of the technical manager documented?
技术经理是否有资格对（培训，课程，出版物和经历）进行记录？

1.1.11
(4.1.5h/
4.2.6) Is the area of competence of the technical manager defined?
是否对技术经理的职权范围进行了界定？

1.1.12
(4.1.5j) Has a deputy technical manager been appointed?
是否有副技术经理被任命？

1.1.13
(4.1.5i) Name of the quality manager responsible for the follow up of the prescribed working procedures and of the management system
指派质量经理负责跟进规定的工作程序和管理制度。

1.1.14
(4.1.5i) Are the qualifications (training, courses, publications, experience) of the quality manager documented?
质量经理是否有资格对（培训，课程，出版物和经历）进行记录？

1.1.15
(4.1.5/
4.2.6) Is the area of competence of the quality manager defined?
是否对质量经理的职权范围进行了界定？

1.1.16
(4.1.5j) Has a deputy quality manager been appointed?
是否有副质量经理被任命？

1.1.17
(4.1.5i) Does the quality manager have direct access to the highest level of management for the laboratory?
质量经理是否能直接进入实验室的最高管理层？

1.1.18
(4.1.5k) Is it ensured that 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?
是否能确保工作人员意识到他们活动的相关性和重要性，是否能确保他们有助于管理体系目标的实现？

1.1.19
(4.1.6) Have appropriate communication processes been established within the laboratory?
实验室是否有建立合理的沟通过程？

1.1.20
(4.1.6) Does communication regarding the effectiveness of the management system takes place?
对管理体系的有效性是否进行了沟通？

2. Management System 管理体系
Y 是
N否
References / Comments
参考/评论
2.1 Management system (4.2)

2.1.1
(4.2.1) Has the OMCL established and implemented a management system covering the full range of activities for which an audit is requested?
药品官方检验实验室是否建立并实施了一个覆盖审计要求的全部活动范围的管理体系？

2.1.2
(4.2.1)Is the management system documented to the required
extent?
管理体系是否已记录到所需程度？

2.1.3
(4.2.1)Has the documentation been made available to all staff members concerned?
文件是否已受到工作人员的关注？

2.1.4
(4.2.1)Have the staff members understood the management
system?
工作人员是否了解这个管理体系？

2.1.5
(4.2.2)Are the various steps of the management system, including a quality policy statement, documented in a quality manual (QM)?
管理体系的各个步骤，包括质量政策声明，是否在质量手册中有所记录？

2.1.6
(4.1.3)Does the management system cover all the activities of the OMCL that are performed inside and outside the permanent and mobile facilities for which the audit is requested?
覆盖官方药品检验实验室所有活动的管理体系，是否为审计要求在内外设置了永久性和可移动的设施？

2.1.7
(4.2.2)Has the responsible management defined in writing the quality policies and objectives?
在修订质量政策和目标时，是否对有责任的管理进行了定义？

2.1.8
(4.2.2)Are overall objectives established, and are they reviewed during management review?
是否建立了总体目标，在管理审查时是否进行了复审？

2.1.9
(4.2.2)Does the quality policy statement include at least the
following:
质量政策声明是否至少包括以下内容：

a) the laboratory management’s commitment to good
professional practice and quality of the testing,
1）对实验室管理需承诺有良好的专业实践和质量检测

b) a statement of the management’s intentions with
respect to the standard of service the laboratory will
provide,
2）管理目的的声明，需提供关于服务实验室的标准

c) the purposes of the management system,
3）管理体系的目的

d) a requirement that all personnel concerned with testing
activities within the laboratory familiarise themselves with
the quality documentation and implement the policies and
procedures in their work,
4）要求所有人员在实验室中熟悉有关的测试活动，以及在工作中的质量文件和政策过程的实施

e) the laboratory management’s commitment to
compliance with the international standard ISO/IEC17025
and to continually improve the effectiveness of the
management system?
5）实验室管理要承诺遵守《检测和校准实验室能力的通用要求》的国际标准，并不断完善管理体系的有效性

2.1.10
(4.2.3)Has the top management provided evidence of commitment to the development and implementation of the management system and to continually improve its effectiveness?
最高管理部门是否能承诺发展和实施管理体系并不断完善其有效性？

2.1.11
(4.2.4)Has the top management communicated to the organisation the importance of meeting authority requirements as well as statutory and regulatory requirements?
最高管理部门是否向组织传达了会议权威以及法律法规要求的重要性？

2.1.12
(4.2.5)Does the quality manual include or make reference to all the technical and supporting procedures, requirements and rules, and does it outline the structure of the documentation used in the management system?
质量手册是否包括或参考了所有的技术，配套程序，以及要求和规则？是否概述了在管理系统中使用的文件结构？

2.1.13
(4.2.7)Is it ensured that the integrity of the management system is maintained when changes to the management system are planned and implemented?
当要变更已策划和实施的管理体系时，是否能保证维护后管理体系的稳定性？

2.2 Document control (4.3)文件控制

2.2.1
(4.3.1)Is a procedure established to control all documents (of both internal and external origin) that are necessary for the correct performance of testing operations?
是否建立程序来控制对正确实行检验操作有必要的文件（包括内部和外部来源）

2.2.2
(4.3.2.1)Does the procedure specify who is responsible for the establishment, review, approval for use and maintenance of the management system documents?
是否指定程序来负责管理体系文件的编制，审查，批准使用和维修？

2.2.3
(4.3.2.1)Is there a list, table or equivalent system for identifying all management system documents, with the current revision status and distribution?
在当前的修订状态和分布下，是否有列表、表格、或是类似的系统来识别管理系统文件？

2.2.4
(4.3.2.2) 程序是否能确保：

a) authorised editions of appropriate documents are
available at all locations where operations essential to the
effective functioning of the laboratory are performed,
1）适当文件的授权版本在所有位置都可用，这些位置是实验室有效运作操作说必需的

b) documents are periodically reviewed and where
necessary revised to ensure continuing suitability and
compliance with applicable requirements,
2）文件需定期审查，并在必要时修订以确保持续的适应性，同时要遵守适用要求

c) invalid or obsolete documents are promptly removed
from all points of issue or use, or otherwise assured
against unintended use,
3)及时从发行或使用过程中删除所有无效或过期的文件，否则需确保无误用

d) obsolete documents retained for either legal or knowledge preservation purposes are suitably marked?
4）无论是对于法律还是知识保存目的，过期文件的保留需进行适当记录

2.2.5
(4.3.2.3) Are all management system documents clearly identified?
是否所有管理文件已明确界定？

a) the date of issue and/or approval for use,
1）发行和/或批准使用之日起

b) the page numbers and the total number of pages,
2）页码和总页数

c) the persons authorised for issuing the documents?
3）发行文件的授权人

2.2.7
(4.3.3.1)Are the responsibilities and authorities for the revision and amendment of documents clearly and suitably defined?
对于文件的修订和修正是否能清楚并合适地界定其职责和权限？

2.2.8
(4.3.3.1)Has a procedure been established for the amendment of documents?
对于文件的修订是否已建立程序？

2.2.9
(4.3.3.2) Are the changes made in documents clearly identified?
文件中的更改是否可以清楚辨认？

2.2.10
(4.3.3.2) Is it possible to trace the changes made in documents?
是否可以追踪文件所做的更改？

2.2.11
(4.3.3.3)Is the amendment of documents by hand allowed? If yes, has a procedure been defined for such amendments?
是否允许手工修改文件？如果可以，是否已确定了修改程序？

2.2.12
(4.3.3.4)Is there an established procedure to describe how changes are to be made in documents maintained in computerised systems?
是否建立了程序来描述如何对电脑系统中保存的文件进行变更？

2.3 Record control (4.13)记录控制

2.3.1 Is there a procedure for XX of quality and technical records?:是否有一个质量技术记录的XX程序：

（4.13.1.1) a) identification,1）鉴定

b) collection, 2）收集

c) registration, 3）登记

d) access, 4）获取

e) indexing, 5）索引

f) storage, 6）保存

g) mai