G-BOHAN- OD-05 多场所认证管理要求Management Requirements for Multi-site Certification
发布时间 : 2024-01-02

发行日期:2024年1月2日  版本号:2  修订号:4

lssue Date:Jan.2, 2024   Issue Number: 2   Revise No: 4

目录

1 目的Purpose 2

2  范围Applicable scope 2

3 定义Definition 2

4 职责 Responsibility 5

5 应用 Application 6

6 多场所组织认证的资格要求Eligility of a Multi-site Organization for certification 7

7 方法Methodologies 8

8 多场所组织的认证的实施 Certification implementation for multi-site organization 1

 

 

1 目的Purpose

明确多场所的理解、可能的多场所和多场所抽样的原则,对多场所组织的评定、多场所的抽样审核、多场所的审核时间、多场所组织及各多场所在认证证书的表达进行规定,满足ISO/IEC 17021《管理体系认证机构要求》(CNAS-CC01)、IAF-MD 1《基于抽样的多场所认证》CNAS-CC11《多场所组织的管理体系审核与认证》等的要求,一般工业产品认证不适用此管理要求。

It is to define the understanding of multi-site,possible multi-site and the sampling principle and stipulate the assessment of multi-site,sampling audit,audit duration,and how to express each location on the certificate, which meet the requirements of ISO/IEC 17021 “Management System Certification Body Requirements” and IAF-MD1 “IAF Mandatory Document for the Audit and Certification of a Management System Operated by a Multi-Site Organization”.

2 范围Applicable scope

本管理要求适用认证公司各认证领域对多场所组织认证申请的评审受理、认证审核、认证评定及认证证书表达。

It applies to the review and acceptance,certification audit and certification decision and the expression on the certificate.

3  定义Definition

3.1 组织Organization

为实现目标,由职责、权限和相互关系构成自身功能的一个人或一组人。

Person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives.

3.2 常设场所 Permanent Site

客户组织持续进行工作或提供服务的场所(有形或虚拟)。

Site (physical or virtual) where a client organization performs work or from which a service is provided on a continuing basis.

3.3 临时场所 Temporary Site

客户组织为在有限时期内进行特定工作或提供服务而设立的场所(有形或虚拟),该场所不准备作为常设场所。

Site (physical or virtual) where a client organization performs specific work or from which a service is provided for a finite period of time and which is not intended to become a permanent site.

3.4 多场所组织 Multi-site Organization

某单一管理体系覆盖的一个组织,其构成包括经识别的中心职能以及多个场所,中心职能(并不必须是组织的总部)对某些过程、活动进行策划和控制,在多个场所(常设的、临时的或虚拟的)中这些过程、活动得到全部或部分实施。

An organization covered by a single management system comprising an identified central function (not necessarily the headquarters of the organization) at which certain processes/activities are planned and controlled, and a number of sites (permanent, temporary or virtual) at which such processes/activities are fully or partially carried out.

3.5 中心职能 Central Function

对管理体系负责并对管理体系集中控制的职能。

The function that is responsible for and centrally controls the management system (refer to Section 5).

3.6 虚拟场所Virtual Site

   虚拟地点指客户组织完成工作或提供服务所用到的,允许处于不同物理地点的人员执行过程的在线环境。

   Virtual location where a client organization performs work or provides a service using an on-line environment allowing persons from different physical locations to execute processes.

    1:当某过程必须在某一有形环境实现时不能将其考虑为虚拟场所,如:仓储、

物理检测实验、安装或维修有形产品等。

     Note 1: A virtual site cannot be considered as such where the processes must be executed in a physical environment e.g. warehousing, physical testing laboratories, installation or repairs to physical products.

2:这类虚拟场所的一个例子是,一个设计和开发组织的所有员工在远程位置

开展工作,在云环境中工作。

Note 2: An example of such a virtual site is a design & development organization with all employees performing work located remotely, working in a cloud environment.

3:一个虚拟场所(如:一个组织的内部网络)被当作一个独立场所来计算审

核时间。

    Note 3: A virtual site (e.g. an organization’s intranet) is considered a single site for the purpose of calculating of audit time.

4:更进一步信息见 CNAS-CC14(IAF MD4)《计算机辅助审核技术在获得

认可的管理体系认证中的使用》。

    Note 4: For further information, see also IAF MD 4: Use of Computer Assisted Auditing Techniques ("CAAT") for Accredited Certification of Management Systems.

3.7 子范围 Sub-scope

单个场所的范围。

The scope of a single site.

1:单个场所的范围可能与多场所组织的全部范围相同,但也有可能是多场所

组织范围的一小部分。

    Note: The scope of a single site might be the same as the full scope of the multi-site organization but may also be only a small part of the multi-site organization’s scope.

2:本文件中所说的“子范围”针对认证范围而言,而非针对认可范围。

Note: The above definition of “sub-scope” is to be used for the purposes of implementing the requirements of this document (in contrast with the use of the term on page 2 of this document, where reference is made to “sub-scope” in the context of accreditation and not certification).

3.8 最高管理者Top Management

   在最高层指挥和控制组织的一个人或一组人。

   Person or group of people who directs and controls an organization at the highest level.

4  职责 Responsibility

4.1 市场部负责确定申请认证的组织是否为多场所组织,并要求被审核方提交临时/多场所清单;

Marketing department is responsible for ensuring whether the application organization has multi-site and is required to submit all sites list.

4.2 审核部根据被审核方确认的临时/多场所清单,进行审核方案策划并确定审核员时间。将相关信息传递给审核组,审核组负责按多场所组织审核要求实施审核。

Audit department makes audit programme and determine the audit duration according to the temporary/multi-site list confirmed by audited party, and transmits relevant information to audit team. Audit team is responsible for implementing audit in accordance with audit requirements for multi-site organization.

4.3 认证决定人员负责依据多场所组织认证要求评审全部认证审核资料,并做出认证决定。

Decision maker is responsible for making the certification decision depending on reviewing all certification audit documents required by multi-site certification and make the decision.

5  应用 Application

5.1  场所 Site

5.1.1 场所可以包括所有土地,在其上的特定地点实现组织所控制的过程、活动,包括任何相关联或附属的仓库,用以储存原材料、副产品、中间产品、最终产品和废料,以及上述过程、活动涉及的任何固定的或活动的设备或设施。另外,如果法律有要求,场所的定义应以国家或地方的相关注册登记制度的定义为准。

A site could include all land on which processes/activities under the control of an organization at a given location are carried out, including any connected or associated storage of raw materials, by-products, intermediate products, end products and waste material, and any equipment or infrastructure involved in the processes/activities, whether or not fixed. Alternatively, where required by law, definitions laid down in national or local licensing regimes shall apply.

5.1.2 在无法确定地点时(如:服务提供组织可能会有这种情况),认证的覆盖范围

宜考虑组织总部的过程、活动以及服务的交付。适用时,本机构可以决定仅在组织

交付服务的地方进行认证审核。此时,本机构应识别并审核所有与中心职能有关的

接口。

Where it is not practicable to define a location (e.g. for services), the coverage of the certification should take into account the organization’s headquarters processes/activities as well as delivery of its services. Where relevant, BOHAN may decide that the certification audit will be carried out only where the organization delivers its services. In such cases all the interfaces with its central function shall be identified and audited.

5.2 临时场所 Temporary Site

5.2.1 认证机构应通过抽样对组织管理体系覆盖的临时场所进行审核,以获得管理体系运行和有效性的证据。当认证机构和客户组织协商一致时,多场所认证的范围以及认证文件中也可以包括临时场所。当认证文件中显示临时场所时,应注明该场所是临时的。

 Temporary sites that are covered by the organization's management system shall be subject to audit on a sample basis to provide evidence of the operation and effectiveness of the management system. They may, however be included within the scope of a multi-site certification and included on the certification document, subject to agreement between the Certification Body and the client organization. When temporary sites are shown on the certification documents, such sites shall be identified as temporary.

5.3 多场所组织Multi-site Organization 

5.3.1 一个多场所组织可以包含一个以上的法律实体,但该组织的所有场所应与该组织的中心职能具有法律或合同联系,并服从于单一管理体系。该管理体系应由中心职能制定、建立,并服从于中心职能的持续监督和内部审核。这意味着中心职能有权要求任何场所在必要时采取纠正措施。适用时,中心职能与各场所的正式协议宜对此作出规定。

A multi-site organization need not be a unique legal entity, but all sites shall have a legal or contractual link with the central function of the organization and be subject to a single management system, which is laid down, established and subject to continuous surveillance and internal audits by the central function. This means that the central function has rights to require that the sites implement corrective actions when needed in any site. Where applicable this should be set out in the formal agreement between the central function and the sites.

6  多场所组织认证的资格要求Eligility of a Multi-site Organization for certification

6.1 组织应具有单一管理体系。

   The organization shall have a single management system.

6.2 组织应识别其中心职能。中心职能是组织的一部分并且不应被分包给外部的组织。

  The organization shall identify its central function.The central function is part of the organization and shall not be subcontracted to an external organization. 

6.3 中心职能应获得组织的授权以规定、建立并保持该单一管理体系。

   The central function shall have organizational authority to define, establish and maintain the single management system.

6.4 组织的单一管理体系应服从集中的管理评审。

The organization’s single management system shall be subject to a centralized management review.

6.5 所有场所应服从组织的内部审核程序。

    All sites shall be subject to the organization’s internal audit programme.

6.6 中心职能应有责任确保来自于所有场所的数据得到收集和分析,并且应能够证明其权威和能力,以便在需要时(包括但不限于下述情况)发起组织的变更。

    The central function shall be responsible for ensuring that data is collected and analyzed from all sites and shall be able to demonstrate its authority and ability to initiate organizational change as required in regard, but not limited, to:

体系文件和体系变更;

     system documentation and system changes; 

管理评审;

   management review;

投诉;

   complaints;

纠正措施的评价; 

   evaluation of corrective actions;

内部审核的策划和对结果的评价;

    internal audit planning and evaluation of the results;

与适用标准有关的法律法规要求。 

    statutory and regulatory requirements pertaining to the applicable standard(s).

注:中心职能是实施控制并得到组织最高管理者授权的,是对所有场所产生影响

的。并没有要求中心职能仅处于某个单一场所。

   Note:The central function is where operational control and authority from the top management of the organization is exerted over every site. There is no requirement for the central function to be located in a single site.

7 方法Methodologies

7.1 应用场所抽样对多场所组织审核的方法 

Methodology for Auditing of a Multi-site Organization Using Site Sampling

7.1.1 条件Conditions

7.1.1.1 当每个场所均运行非常相似的过程、活动时,允许对这组场所抽样。

     Sampling of a set of sites is permitted where the sites are each performing very similar processes/activities.

7.1.1.2 并非所有满足“多场所组织”定义的组织都具备抽样的资格。

    Not all organizations fulfilling the definition of “multi-site organization”will be eligible for sampling.

7.1.1.3 并非所有的管理体系标准都适合于多场所认证。例如,当标准要求对差异性的当地因素审核时,对多场所的抽样是不适宜的。在一些方案中也会适用特定规则,如包括航空业(AS 9100系列)或汽车业(IATF 16949),这些方案的要求应被优先考虑。

     Not all management systems standards are suitable for consideration for multi-site certification. For example, multi-site sampling would be unsuitable where the audit of variable local factors is a requirement of the standard. Specific rules also apply for some schemes, for example those including aerospace (AS 9100 series) or automotive (IATF 16949) and the requirements of such schemes shall take precedence.

7.1.1.4 为了通过审核获得对管理体系有效性的充分信任,以下情况(包括但不限于下述情况)不适宜进行场所抽样 

    In order to obtain sufficient trust in the effectiveness of the management system through the audit, it is not appropriate to conduct site sampling in the following situations,but not limited:

范围类别或过程、活动相关的风险或复杂程度很高或很复杂;

       The risk or complexity associated with the scope category or process or activity is high or complex. 

l  2)具备多场所审核资格的场所规模;

       Size of sites eligible for multi-site audit;

l  3)为处理不同的过程、活动或不同的合同与法规系统,在当地运行管理体系的差异 

Variations in the local implementation of the management system to address different processes/activities or different contractual or regulatory systems.

在组织管理体系之下运行的临时场所,即便这些临时场所未列入认证文件。

Temporary locations operating under the organizational management system, even if these temporary locations are not included in the certification documents.

7.1.2 抽样Sampling

7.1.2.1 样本中应有一部分根据7.1.2.4因素选取,一部分随机抽取;并且其结果应选到在有代表性的不同场所,确保认证范围内覆盖的所有过程将被审核到。

    The sample shall be partly selective based on the factors set out 7.1.2.4 and partly random, and shall result in a representative range of different sites being selected, ensuring all processes covered by the scope of certification will be audited.

7.1.2.2 至少25% 的样本应随机抽取。

    At least 25% of the sample shall be selected at random.

7.1.2.3 考虑到下述规定,其余部分的选择应使得证书有效期内所选场所之间的差异尽可能大。

    Taking into account the provisions mentioned below, the remainder shall be selected so that the differences among the sites selected over the period of validity of the certificate is as large as possible.

7.1.2.4 场所选取应考虑,但不限于以下方面:

     The site selection shall consider, among others, the following aspects:

l   1)场所内部审核、管理评审或以前认证审核的结果;

     results of internal site audits and management reviews or previous certification audits;

l   2)投诉记录以及纠正和预防措施的其他相关方面;

     records of complaints and other relevant aspects of corrective and preventive action; 

l   3)各场所在规模上的显著差异;

     significant variations in the size of the sites;

l   4)在倒班安排和工作程序上的差异;

     variations in shift patterns and work procedures; 

l   5)管理体系以及在场所实施过程的复杂程度;

     complexity of the management system and processes conducted at the sites;

l   6)上次认证审核后的变化;

     modifications since the last certification audit; 

l   7)管理体系的成熟度和组织的理解程度;

      maturity of the management system and knowledge of the organization;

l   8)对于环境管理体系,考虑环境问题和环境因素及其关联影响的程度;

    environmental issues and extent of aspects and associated impacts for environmental management systems;

l   9)对于职业健康安全管理体系,考虑活动和过程的性质相关的职业健康安全风险程度;For the occupational health and safety management system, consider the degree of occupational health and safety risks related to the nature of activities and processes;

10)文化、语言和法律法规方面的差异;

     differences in culture, language and regulatory requirements; 

l  11)地理位置的分散程度;

     geographical dispersion;

l  12)场所是常设的、临时的或虚拟的。

      whether the sites are permanent, temporary or virtual.

7.1.2.5 并不是必须在审核过程一开始就完成抽样。也可能在完成对中心职能的审核时完成抽样。不论哪种情况,应将样本中所包括的场所通知中心职能。这可能是在相对较短时间内通知,但应给出充分的时间用于审核准备。

     This selection does not have to be done at the start of the audit process. It can also be done once the audit of the central function has been completed. In any case, the central function shall be informed of the sites to be included in the sample. This can be on relatively short notice, but shall allow adequate time for preparation for the audit.

7.1.3 抽样数量 Size of Sample

7.1.3.1 审核组应对每个多场所组织每次应用抽样形成记录,证明其操作符合本文件要求。

    The Audit Team shall have records on each application of sampling for each multi-site organization, justifying it is operating in accordance with this document.

7.1.3.2 每次审核最少访问的场所数量是

The minimum number of sites to be visited per audit is:

l 初次认证审核:样本的数量应为场所数量的平方根(y=√X ),计算结果向上取整为最接近的整数,其中y 为将抽取场所的数量、x 为场所总数。

   Initial audit: the size of the sample shall be the square root of the number of sites: (y=√x), rounded up to the next whole number, where y = number of sites to be sampled and x = total number of sites.

l 监督审核:每年的抽样数量应为场所数量的平方根乘以0.6 即(y=0.6√x ),计算结果向上取整为最接近的整数。

    Surveillance audit: the size of the annual sample shall be the square root of the number of sites with 0.6 as a coefficient (y=0.6 √x), rounded up to the next whole number. 

l  再认证审核:样本的数量应与初次审核相同。然而,如果证明管理体系在认证周期中是有效的,样本的数量可以减少至乘以系数0.8 即(y=0.8√x),计算结果向上取整为最接近的整数。

    Re-certification audit: the size of the sample shall be the same as for an initial audit. Nevertheless, where the management system has proved to be effective over the certification cycle, the size of the sample could be reduced to, y=0.8 √x, rounded up to the next whole number.  

7.1.3.3 在初次认证审核、每次再认证审核以及作为监督的一部分在每个日历年至少一次的审核中,都应对中心职能审核。

      The central function shall be audited during the initial certification and every recertification audit and at least once a calendar year as part of surveillance.

 7.1.3.4 当本机构对拟认证或获证管理体系涵盖的过程、活动进行风险分析,发现

涉及下列因素的特殊情况时,应增加抽样的数量或频率。

      The size or frequency of the sample shall be increased where the BOHAN’s risk analysis of the process/activity covered by the management system subject to certification indicates special circumstances in respect of factors such as:

l  1)场所的规模和员工的数量;

    the size of the sites and number of employees;

l  2)过程、活动以及管理体系复杂程度和风险水平;

    the complexity or risk level of the process/activity and of the management system;

l  3)工作方式的差异(如:倒班);

    variations in working practices (e.g. shift working);

l  4)所从事过程、活动的差异;

    variations in process/activities undertaken;

l  5)投诉记录,以及纠正措施和预防措施的其他相关方面;

     records of complaints and other relevant aspects of corrective and preventive action;

l  6)与跨国经营有关的任何方面;

     any multinational aspects; and

l  7)内部审核和管理评审的结果。

    results of internal audits and management review.

7.1.3.5 如果组织的分支机构分为不同等级(如:总部办公室/中心办公室,全国性办公室,地区办公室,地方分支),上述的初次认证审核抽样模式适用于每个等级的场所。

When the organization has a hierarchical system of branches (e.g.head (central) office, national offices, regional offices, local branches), the sampling model for initial audit as defined above applies to each level.

示例Example:

1 个总部办公室:每个审核周期(初次审核、监督审核或再认证审核)都访问;

1 head office: visited at each audit cycle (initial or surveillance or recertification)

4 个全国性办公室:样本数量=2,至少 1 个为随机抽样;

4 national offices: sample = 2: minimum 1 at random

27 个地区办公室:样本数量=6,至少 2 个为随机抽样;

27 regional offices: sample = 6: minimum 2 at random

1700 个地方分支:样本数量=42,至少 11 个为随机抽样。

1700 local branches: sample = 42: minimum 11 at random

地区办公室的样本中宜至少覆盖到每个全国办公室控制的地区办公室。地方分支的样本中宜至少覆盖到每个地区办公室控制的地区分支。这样可能导致每个等级的场所抽样数量超过按照第7.1.3.2 条计算的最小抽样数量。

The sample of regional offices should include at least one regional office controlled by each national office. The sample of local branches should include at least one local branch controlled by each regional office. This may result in the sample size at each level exceeding the minimum sample size calculated in accordance with paragraph 7.1.3.2.

7.1.3.6 抽样过程应作为审核方案管理的一部分。在任何时候(即:在策划监督审核之前、或组织的任何场所变更其结构时、或将在认证边界之内增加新的场所时),审核部应预先评审审核方案中的抽样安排,以便在为保持认证对样本审核之前能确定抽样数量调整的需求。

    The sampling process shall be part of the management of the audit programme. At any time (i.e. before planning the surveillance audit, or when any organization site changes its structure, or in case of acquisition of new site(s) which will be added into the certification boundary), the Audit Department shall review the sampling foreseen in the audit programme in order to establish the need to adjust the sample size prior to auditing the sample with a view to maintaining certification.

7.1.4 增加场所 Additional Sites

     如果对已认证的多场所组织增加新场所或增加一组新的场所,认证机构应确定在证书中增加这些新场所前所需实施的必要活动。这应包括考虑是否对新场所审核。在新场所纳入证书后,需要确定后续监督或再认证审核的抽样数量。

    On the application of inclusion of new sites or a new group of sites to join an already certified multi-site organization, the Certification Body shall determine the required activities to be performed before including the new site(s) in the certificate. This shall include consideration of whether or not to audit the new site(s). After inclusion of the new site(s) in the certificate, the sample size for future surveillance or recertification audits shall be determined.

7.2 对不适用7.1条场所抽样的多场所组织审核的方法

   Methodology for Auditing of Multi-site Organizations Where Site Sampling Using Section 6.1 is not Appropriate

7.2.1 审核方案的构成应包括对所有场所的初次认证审核和再认证审核。在监督审核中,应在每个日历年覆盖30%的场所(向上取整至整数)。每次审核都包括中心职能。第二次监督审核选取的场所通常不同于第一次监督审核所选取的场所。

    The audit programme shall consist of an initial audit and recertification audit of all sites. In surveillance audits, 30% of sites, rounded up to the whole number, shall be covered in a calendar year. Each audit will include the central function. The sites selected for the second surveillance audit will normally be different from the sites selected for the first surveillance audit.

7.2.2 审核方案的设计应确保在认证范围覆盖的所有过程在每个周期内被审核到。

    The audit programme shall be designed to ensure that all processes covered by the certification scope are audited over each cycle.

7.2.3 增加场所 Additional Sites

如果对已认证的多场所组织增加一个新场所,除了在审核方案中策划监督之外,该场所应在被增加到证书中之前被审核到。在新场所纳入证书后,为确定后续监督或再认证审核的审核时间应将其与以前的场所累计。

On the application of a new site to join an already certified multi-site organization, the site shall be audited before being included in the certificate, in addition to the planned surveillance in the audit programme. After inclusion of the new site in the certificate, it shall be cumulated with the previous ones for determining the audit time for future surveillance or recertification audits.

7.3 对场所构成中部分可抽样部分不可以抽样的多场所组织审核的方法 

   Methodology for Auditing Multi-site Organizations that Include a Combination of Sites that can be Sampled and Other Sites that Cannot be Sampled

应按照第7.1条对可抽样的场所并按照第7.2条对组织中剩余不适用抽样的场所建立审核方案。

The audit programme shall be established using Section 7.1 for those sites that can be sampled and Section 7.2 for the remaining part of the organization where Section 7.1 is not appropriate.

8  多场所组织的认证的实施 Certification implementation for multi-site organization

8.1 申请与申请评审 Application and Application Review

市场部/审核部/合同评审人员在合同评审时应充分识别有关申请组织的必要信息,以:

Marketing department/audit department/contract reviewer shall obtain necessary information concerning the applicant organization to:

1)确认贯穿组织部署了单一管理体系;

confirm that a single management system is deployed across the organization;

2)确定管理体系运行范围及寻求认证的范围,以及适用时的子范围;

 determine the scope of the management system being operated and the requested scope of certification and, if applicable, sub-scopes;

3)理解每个场所的法律与合同安排;

understand the legal and contractual arrangements for each site;

理解“在哪里发生了什么”,即:确定每个场所提供的过程、活动,并识别中心职能;

     understand“what happens where”i.e. processes/activities provided at each site and identify the central function;

确定向所有场所提供的过程、活动(如:采购)的集中化程度;

 determine the degree of centralization of process/activities which are delivered to all

sites (e.g. purchasing);

确定在不同场所之间的接口;

 determine interfaces between the different sites;

确定哪些场所适用抽样(即,哪些场所提供非常相似的过程、活动),以及哪些场所不具备抽样资格;

 determine which sites may be applicable for sampling (i.e. where very similar

 processes/activities are provided) and those that are not eligible;

纳入考虑的其他相关因素(见CNAS-CC14、CNAS-CC105、CNAS-CC106、 GB/T 27204/ISO/IEC TS 17023);

take into consideration other relevant factors (see also IAF MD 4, IAF MD 5, IAF MD11:

IAF Mandatory Document for Application of ISO/IEC 17021 for Audits of Integrated Management Systems (IMS), ISO/IEC TS 17023);

确定组织的审核时间;

 determine the audit time for the organization;

确定审核组的能力要求;

 determine the audit team(s)’competence required; and

11)识别管理体系覆盖的过程、活动的复杂程度和规模范围(如:一个或多个)。

identify the complexity and scale of the processes/activities (e.g. one or many) covered by the management system.

8.2 审核方案Audit Programme

8.2.1 除了 CNAS-CC01:2015 第 9.1.3 条的要求外,审核方案还应至少包括或引用

下述内容:

     In addition to the requirement in ISO/IEC 17021-1:2015 clause 9.1.3, the audit programme shall at least include or refer to the following:

l  1)每个场所的过程、活动;

      processes/activities provided on each site;

l  2)识别哪些场所可以被抽样、哪些场所不能;

    identification of those sites which are liable to be sampled, and which are not; and

l  3)识别哪些场所被抽样覆盖、哪些场所未被抽样覆盖。

     identification of sites which are covered by sampling, and which are not.

8.2.2 当确定审核方案时,由于被审核组织的特定结构,本机构应为额外活动给予充分的时间,这些活动的时间不计入审核时间,例如:用于路途、审核组成员之间联系、审核后会议等。

     When determining the audit programme, BOHAN shall allow sufficient additional time for activities which are not part of the calculated audit time, such as travelling, communicating among audit team members, post-audit meetings,etc. due to the specific configuration of the organization to be audited.

注:假如拟审核过程的属性适用于远程审核(见CNAS-CC01 及 CNAS-CC14),

可使用远程审核技术。

    Note: Remote auditing techniques may be used, provided that the processes to be audited are of such a nature that remote auditing is appropriate (see ISO/IEC 17021-1 and IAF MD 4)

8.2.3 在任何时候使用多于一名成员构成审核组时,审核部有责任与审核组长协同识别出对每个场所及每一部分审核所需的技术能力,并为审核的每一部分分派适当的审核组成员。

    Where audit teams consisting of more than one member are used at any point, it shall be the responsibility of the Audit Department, in conjunction with the team leader, to identify the technical competence required for each part of the audit and for each site and to allocate appropriate team members for each part of the audit.

8.3 审核时间计算Calculation of Audit Time

8.3.1 符合资格准则的组织,可以由可抽样场所构成、不可抽样场所构成,或由这两种情况组合构成。无论组织由何种方式构成,必须有充足的审核时间来实施有效的审核。

除非特定认证方案另有规定,单个被抽样场所审核时间的减少量不应超过 50%。

例如,CNAS-CC105 允许审核时间减少量最大为 30%,另外 20%是由于单一管

理体系所运行中心职能以及任何可能的集中化过程(如:采购)而考虑允许缩减的最

大值。

对每个被选定场所(无论场所是按7.1 抽样的、或不能抽样按 7.2 确定的、或按

7.3 混合方法确定的),包括适用时含中心职能要素的,应使用现有的准则文件(如:

应用 CNAS-CC105对QMS 和EMS,应用 CNAS-CC106 对一体化管理体系)以及

必要时适用的专项方案要求来计算每个场所的审核时间。

    An organization that satisfies the eligibility criteria may consist of sites that can be sampled, sites that cannot be sampled or a combination of both. The audit time must be sufficient to undertake an effective audit irrespective of the makeup of the organization.

Unless precluded by specific schemes, the reduction of audit time per sampled site shall not be greater than 50%.

For example, 30% is the maximum reduction in audit time allowed by IAF MD 5 while 20% is to be considered the maximum reduction allowed for the single management system processes performed by the central function and any potential centralised processes (e.g. purchasing).

The audit time per selected site (whether it comes from sampling as in 7.1, from non-

sampling as in 7.2 or from mixed methodology as in 7.3), including elements of the central function if applicable, shall be calculated for each site using the applicable IAF documents (e.g. IAF MD 5 for quality and environmental management systems, IAF MD 11 for integrated management systems) and, where necessary, any applicable sector scheme requirements for the calculation of man-days.

8.4 审核计划

8.4.1 除了CNAS-CC01:2015 第 9.2.3 条的要求外,审核组长在准备审核计划时还应至少考虑下述内容:

    In addition to the requirement in ISO/IEC 17021-1:2015 clause 9.2.3, the Audit team leader shall at least consider the following when preparing the audit plan:

l 1)认证范围以及每个场所的子范围;

   certification scope and sub-scopes for each site;

l 2)在考虑多个管理体系标准的情况下,对每个场所的管理体系标准;

   management system standard for each site, if multiple management system standards are being considered;

l 3)拟审核的过程、活动;

     processes/activities to be audited;

l 4)每个场所的审核时间;

    audit time for each site; and

l 5)分派审核组。

   allocated audit team.

8.5 初次认证审核:第一阶段Initial Audit: Stage 1 

通过第一阶段审核,审核组应完善信息以:

During Stage 1, the audit team shall complete the information to:

l  1)确认审核方案;

    confirm the audit programme;

l  2)策划第二段审核,考虑对每个场所拟审核的过程、活动;

    plan Stage 2, taking into account the processes/activities to be audited in each site; and

l  3)确认承担第二阶段审核的审核组具备必要的能力。

     confirm that the Stage 2 audit team has the required competence.

8.6 初次认证审核:第二阶段Initial Audit: Stage 2 

初次认证审核的输出中,审核组应将在每个场所审核了哪些过程形成文件。这些信息将用于修正审核方案以及后续监督审核的审核计划。

 At the outcome of the initial audit, the audit team shall document which processes were audited on each site visited. This information will be used to amend the audit programme and audit plans for subsequent surveillance audits.

8.7 不符合与认证Nonconformities and Certification 

8.7.1 在任何独立场所发现不符合(如 CNAS-CC01 中规定),无论是由内部审核发现或经由本机构审核的审核发现,应开展调查以确定其他场所是否可能受到影响。因此,本机构审核组应要求组织对不符合评审,以确定这些不符合是否指出了适用于其他场所的 总体上的系统不足。如果发现确实如此,应同时对中心职能及受到影响的独立场所实施纠正措施并验证。如果发现并非如此,组织应能够向认证机构证明其限定后续纠正措施范围的正当理由。

    When nonconformities, as defined in ISO/IEC 17021-1, are found at any individual site, either through the organization’s internal auditing or from auditing by BOHAN, investigation shall take place to determine whether the other sites may be affected. Therefore, the Audit team shall require the organization to review the nonconformities to determine whether or not they indicate an overall system deficiency applicable to other sites. If they are found to do so, corrective action shall be performed and verified both at the central function and at the individual affected sites. If they are found not to do so, the organization shall be able to demonstrate to the Certification Body the justification for limiting its follow-up corrective action.

8.7.2 本机构应要求提供这些措施的证据并增加其抽样频率和/或抽样数量,直到确信恢复了控制。

     BOHAN shall require evidence of these actions and increase its sampling frequency and/or the size of sample until it is satisfied that control is re-established.

8.7.3 在作出决定的过程中,如果任一场所出现严重不符合,在得到满意的纠正措施之前应拒绝对整个多场所组织所列的场所进行认证。

     At the time of the decision-making process, if any site has a major nonconformity, certification shall be denied to the whole multi-site organization of listed sites pending satisfactory corrective action.

8.7.4 在认证过程中,认证机构不应允许组织为克服由于某个场所存在不符合造成的问题,而从认证范围中删除存在问题的场所。

    It shall not be admissible that, to overcome the obstacle raised by the existence of a nonconformity at a single site, the organization seeks to exclude from the scope the "problematic" site during the certification process.

8.8 认证文件 Certification Documents

8.8.1 认证文件应反映认证范围以及多场所认证所覆盖的场所、法律实体(适用时)。

     The certification document shall reflect the scope of certification and the sites and /legal entities (where applicable) covered by the multi-site certification.

8.8.2 认证文件应包含所有场所的名称和地址,反映出组织与认证文件相关。范围或认证文件引用的其他信息应清晰表明经认证的活动由清单中所列场所实施。然而,如果某一场所的活动仅是包含于组织范围内的一部分,认证文件应包括该场所的子范围。当在认证文件上展示临时场所时,应注明这些场所为临时场所。

     Certification documents shall contain the name and address of all the sites, reflecting the organization to which the certification documents relate. The scope or other reference on these documents shall make it clear that the certified activities are performed by the sites on the list. However, if a site’s activities only include a subset of the organization’s scope, the certification document shall include the site’s sub-scope. When temporary sites are shown on the certification documents, such sites shall be identified as temporary.

8.8.3 如果向一个场所颁发认证文件,其中应包括:

   Where certification documents for one site are issued, they shall include:

l 1)管理体系针对被认证的整个组织;

    that it is the management system of the whole organization which is certified;

l 2)该认证所覆盖对特定场所、法律实体的活动;

   the activities performed for that specific site / legal entity which are covered by this certification;

3)与主证书之间的可追溯性,如:编号/代码;

 traceability with the main certificate, e.g. a code; and

l  4)声明:本证书的有效性取决于主证书有效。

    a statement saying “the validity of this certificate depends on the validity of the main certificate”.

在任何情况下,都不得以该场所、该法律实体的名义颁发认证文件,或误导该场所、该法律实体被认证(被认证的是客户组织),也不应包括该场所、该法律实体的过程、活动符合规范文件的声明。

 Under no circumstances, can this certification document be issued to the name of the site/legal entity or suggest that this site/legal entity is certified (the one certified is the client organization), nor shall it include a declaration of conformity of the site processes/activities to the normative document.

8.8.4 一旦任何场所不能满足保持认证的必要规定,认证文件将被整体撤销。

     The certification documentation will be withdrawn in its entirety if any of the sites does not fulfil the necessary provisions for the maintenance of the certification.

8.9 监督审核Surveillance Audits 

8.9.1 对可以抽样多场所组织的监督审核应与 7.1 条一致。每个场所审核时间计算应与上述8.3 条一致。

     Surveillance of multi-site organizations that can be sampled shall be audited in accordance with Section 7.1. The audit time per site shall be calculated in accordance with Clause 8.3 above.

8.9.2 对不能按照 7.1 条抽样的多场所组织,监督基于对 30%场所的审核外加对中心职能的审核。认证周期中第二次监督选取的场所通常应不包括第一次监督所选取的场所。每个场所审核时间的计算应与上述 8.3 条一致。

    Surveillance of multi-site organizations that cannot be sampled in accordance with Section 7.1 is based on auditing 30% of the sites plus the central function. The sites selected for the second surveillance of a certification cycle shall normally not include any sites sampled as part of the first surveillance audit. The audit time per site shall be calculated in accordance with Clause 8.3 above.

8.10 再认证审核Recertification Audits 

8.10.1 对可以抽样多场所组织的再认证审核应与 7.1 条一致。每个场所审核时间计算应与上述 8.3 条一致。

    Recertification of multi-site organizations that can be sampled shall be audited in accordance with Section 7.1. The audit time per site shall be calculated in accordance with Clause 8.3 above.

8.10.2 对不能抽样的多场所组织,再认证应按照初次认证审核,即对所有场所外加中心职能审核。对每个场所以及中心职能的审核时间计算应与上述 8.3 条一致。

     Recertification of multi-site organizations that cannot be sampled shall be audited as per initial audit, i.e. all sites audited plus the central function. The audit time per site and central function shall be calculated in accordance with Clause 7.3 above.

 

 

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