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Issue Number:1    Revise No.:2   Implementation Date:Jun. 15, 2020

审核活动工作人日管理程序               

Audit Duration Management Procedure

1  目的 Purpose

为了进一步规范认证审核活动,加强审核工作的管理,根据IAF强制性文件“IAF MD5:2019《确定 QMS \EMS\OHSMS 审核时间》”的要求,编制本作业指导书。

Establishing this working instruction is to further regulate certification audit activity and enhance the audit management based on the IAF MD5: 2019 “Determination of Audit Time of Quality, Environmental, and Occupational Health & Safety Management Systems” .

2  适用范围 Applicable scope

适用于公司质量/环境/职业健康安全管理体系领域认证审核活动工作人日的管理要求。

It applies to the management requirement of audit duration for the certification of quality/environment/occupational health & safety management system.

3  职责 Responsibility

3.1 审核部项目管理人员负责依据本管理要求对认证审核活动工作人日进行策划;

Audit programme management personnel of audit department are responsible for planning on the audit duration according to this management requirement.

3.2审核组长依据审核策划的人日数要求编制审核计划。

Lead auditor makes the audit plan in accordance with the requirement of the planned duration.

4  工作程序 Procedures

4.1 管理体系初审审核时间确定原则

Determination principles on the initial audit duration of management system

4.1.1 初审审核时间及现场审核时间的选择取决于诸多因素,应着重考虑的情况有:

Determination of initial audit duration and on-site duration depends on many factors, it shall consider following factors:

相关管理体系标准的要求

The requirement of related management system standard;

受审核方经营活动类型;

Type of audited party’s operating activity;

b) 生产方式(单一、复杂、品种、类型);

Production ways (simple, complicated, item, type);

c) 管理体系的成熟度;Maturity of management system;

d) 管理体系的整合程度;Level of integration for management system;

e)是否存在多现场以及多现场的抽样量;

Whether the organization has multi location and sampling quantity;

f) 法律法规的要求;Requirements of statutes and regulations;

g) 组织管理体系覆盖的产品、活动、过程和服务的环境因素、危险源及风险评价的复杂程度和风险;

Product, service and process and the environment aspects of service and process and hazardous origin, as well as the complexity of risk evaluation and risk covered by organization management system;

h) 是否存在扩项或其他需要增加审核力度和范围因素;

Whether it needs to increasing scope or other factors which need to increasing audit efforts and scope

i) 相关方有意见的。Interested party’s comments

4.1.2审核时间的确定方法:Determining methods of audit duration

a) 公司应为审核组安排足够的审核时间,确保审核的有效性。对于所有类型的审核,公司需要在合同评审过程中综合考虑各方面的因素对审核时间可能产生的影响确定审核时间。

Our company shall arrange sufficient duration for audit team to ensure the effectiveness of audit, and our company shall determine the audit duration by considering all kinds of factors during the contract review for all types of audit.

b) 初次审核(第1 阶段+第2 阶段)、监督审核和再认证审核的审核时间计算以附件1(适用于QMS)和附件2(适用于EMS)中的图表为基础。确定审核时间时,除了考虑人员数量外,实施有效审核所需的时间还取决于其他因素。

The duration calculation of initial audit (including stage 1 and stage 2), surveillance and recertification is based on the chart of the Annex 1 (apply to QMS) and the Annex 2 (apply to EMS). When determine the audit duration, the effective audit should consider the number of organization’s employee and other factors。

4.1.3基准审核时间的确定 Determination of based audit duration

审核部项目管理人员应针对每个客户确定策划审核所需的基准时间,具体执行附件1-3的规定。

Audit programme management personnel plan the basic duration for each specific client, based on the regulations of Annex 1-3.

4.1.4审核时间的增减  Increase and reduction of audit duration

a) 审核部项目管理人员应针对每个客户并根据附件1-3表后“注”中的规定及ISMS、ITSMS、EnMS、FSMS等体系的补充程序文件要求,确定策划审核所需的时间,并记录所确定的时间的合理性(包括增加和减少审核时间的理由,每条理由的增加或删减比例不能超过10%),但考虑到所有因素,对减少某个组织的初次审核、监督或再认证审核人日的总量不能大于审核人日时间表中要求的审核人日时间的30%。

The project management personnel of the audit department should determine the time required for planning the audit for each customer and based on the provisions in the "notes" after tables 1-3 and the requirements of supplementary procedural documents such as ISMS, ITSMS, EnMS, FSMS, etc., and record the reasonableness of the determined time (including reasons for increasing or decreasing audit time, with each reason's increase or decrease ratio not exceeding 10%). However, considering all factors, the total number of audit person days for reducing an organization's initial audit, supervision, or re certification cannot exceed 30% of the audit person day time required in the audit person day schedule.

b) 用于策划与准备以及编写报告的审核时间不宜使总的现场审核时间少于附件1-3表所列时间的80%。需要更多的时间来进行策划和(或)编写报告不是减少现场审核时间的理由。

The on-site audit duration can not less than 80% of the annex chart 1-3 due to the time used for planning, it’s unacceptable to reduce the on-site audit duration because of needing more time to prepare the audit plan and / or complete the audit report.

c) 如果审核时间少于附件1-3表中给出的时间,公司应确定减少的理由。

If audit duration is less than the provided time in annex 1-3, our company shall define the reasons of reduction.

往返于审核场所之间所花费的时间不计入有效审核时间,需在有效审核时间之外另行增加路途时间。

Travel time between audit site(s)(multi location) takes no count towards the effective audit duration, need to further increase the journey outside effective audit duration.

4.2 管理体系初审(第1 阶段+第2 阶段)审核时间的要求:

Requirements of initial audit duration for management system (stage1 and stage2) :

4.2.1 审核部应针对每个认证项目的性质和风险等级,在充分考虑受审核组织管理体系、过程、活动和产品/服务等方面的特性及其复杂性因素的基础上,根据本文4.1.3有关审核时间增减的原则确定合理的审核时间,包括为确保有效地完成管理体系的第一、二阶段审核,合理的分配审核时间。

Audit department shall determine the reasonable audit duration with regard to the Based on the characteristics and risk degree of each audit project, and fully consider the characteristics and complexity of organization management system, process, activity and product/service etc, audit department shall reasonably assign the audit duration for the stage 1 and the stage 2 to ensure the effective audit.

4.2.2 在任何情况下,增加第一阶段审核的审核时间,不应作为减少第二阶段审核时间的理由。

In any case, increasing the stage 1 duration can not be the reason for reducing the stage 2 duration.

4.2.3第一阶段现场审核 Site audit of the stage 1

对于多数需在受审核组织的现场实施第一阶段管理体系认证审核的情况,审核部应针对受审核组织的特点、规模和复杂程度,合理的策划和确定所需的审核时间。通常情况下,第一阶段现场审核所需的审核时间不宜少于 1 个审核人日。对于人数较少、风险较低的受审核组织可适当降低至 0.5 个人日。

As for most of application organization which the stage 1 need to be implemented on the site, audit department shall reasonably plan and determine the audit duration according to organization’s characteristic, scale and complexity. Generally, the on-site audit duration of stage 1 shall not be less than one man day, for some few employee and low risk, the stage 1 audit duration can be 0.5 man-day.

4.2.4 第二阶段现场审核 On Site audit of stage 2

第二阶段现场审核所需的审核时间,应基于第二阶段审核的目的、范围和程度,并结合第一阶段审核的结果,包括对可能影响第二阶段有效审核的潜在因素给予充分的考虑,保持充分的证据和记录以证实审核所用时间的合理性。通常情况下,对于:

The stage 2 duration shall based on the scope and extent of the stage 2, and combining with the results of the stage 1 including the sufficient consideration on the potential elements that may affect effectiveness of the stage 2, keeping sufficient evidence and record to prove the rationality of the planned duration, Generally, for following situations:

a) 已经实施了第一阶段现场审核的项目,第二阶段审核所用审核时间不宜低于第一阶段和第二阶段总的现场审核时间的70%。

For the project that has implemented the stage 1audit, the duration used for the stage 2 shall not be less than 70% of the total duration.

b) 部分非现场实施第一阶段审核的情况,鉴于可能源于对受审核组织管理体系关键绩效和运作情况的有限了解或在审核中可能遇到的不确定因素的影响,为确保审核的有效性,第二阶段现场审核所需的审核时间,不宜低于第一阶段和第二阶段总审核时间的 80%-90%。

For the situation that partial stage 1 may not carried out in client site, considering the limit acquaintance on management system performance and its operation or uncertain elements in the audit, the required on site audit duration of the stage 2 shall not be less than 80%-90% of the total duration to ensure the effectiveness of the audit.

4.3 监督审核和再认证的时间 Surveillance and recertification duration

4.3.1在初始的三年认证周期中,对获证组织实施监督审核的时间,宜与初次认证审核(第 1 阶段+第 2 阶段)的时间成比例,即每年实施监督审核的总时间约为初次认证审核时间的三分之一。同时应考虑组织所发生的变化,体系成熟程度等因素,对监督审核时间进行策划。所策划的监督审核时间应时常得到审查(至少在每次监督审核或再认证时),实施该审查(包括任何对审核时间的调整)的证据应得到记录。

In the preliminary certification cycle with three years, the duration of surveillance for certified organization shall be in proportion to the duration of initial certification audit (the stage 1 and the stage 2), that is, the duration of surveillance in every year is about one third of the initial audit duration. Meanwhile, the duration of surveillance shall be planned according to the changes of organization, system maturity etc. And the planned time shall be reviewed frequently (at the time of each surveillance and recertification at least), also the evidence on this review’s implementation (including any adjustment for audit duration) shall be recorded.

4.3.2 如果组织在初次审核和随后的监督期间向认证机构证实了其管理体系的稳定性,并持续满足标准要求的能力,认证公司可据此减少监督审核时间,但对这种情况必须有书面的理由陈述和公司领导的批准;

If organization has proved the stability of its management system and the capacity that it can continually meet the standard requirements to certification body in initial audit and following surveillances, certification body can reduce surveillance time based on that, but it must provide the written reason presentation and top management approval.

4.3.3 再认证审核时间应根据更新的客户信息和管理体系绩效的评价结果进行计算。通常做法是:假设基于更新的信息对组织实施初次认证审核或再认证时组织的情况与初次认证审核时相同,再认证审核时间约为该初次审核所需时间的2/3。

The duration of recertification shall be calculated according to the updated client information and the evaluation result of management system performance. The general method is: on the assumption that organization’s situation on implementing initial audit and recertification based on the updated information is same as initial certification audit, and the recertification duration is about 2/3 of total duration of initial audit.

4.3.4 对获证组织第二个认证周期及其以后的认证周期,公司审核项目管理人员可根据组织管理体系的绩效设计个性化的监督和再认证方案,但审核时间若缩减到低于基准水平的70%,则应在实施前说明理由并向认可机构寻求特别批准。如果不采用高级监督和再认证程序,宜根据第4.3.1条和第4.3.2 条来计算审核时间。

For the second certification cycle and its following certification cycle, the audit programme management personnel shall design the special surveillance and recertification programme in accordance with the performance of organization’s management system. But if the audit duration reduction is lower to 70% of basis time, it shall explain the reasons and seek the special approval of accreditation body before implementation. It’s more suitable to calculate the audit duration based on clause 4.3.1 and 4.3.2 if the advanced surveillance and recertification procedures not used.

4.4临时场所和多场所的审核时间 Additional location and multi-site audit duration

4.4.1如果认证申请方或获证客户在临时场所提供其产品(包括服务),该临时场所应被纳入审核方案。审核部项目管理人员应根据本文4.1.3有关审核时间的要求和计算方法确定合理的每个场所(包括中心办公室)的人日数。

If application organization or certified client provides its product (including service) in additional location, the additional location shall be taken into account of the audit programme. The audit programme management personnel shall determine the suitable duration for each location including the office based on the clause 4.1.3 requirement and method.

4.4.2 如果中心办公室和(或)地方场所不适用标准的某些条款,可以考虑减少人日数,每次减少人日数时应记录减少人日数的理由。但对进行大多数过程或关键过程的场所进行审核时,人日数不能减少。

If some standard clauses not apply for the office or location, it can be considered to reduce the duration and record the reason for each reduction. But for the audit on sites of main processes or key processes, the audit duration shall not be reduced.

4.4.3初次审核和监督所用的总时间为用在每个场所和中心办公室的时间之和。

The total time used for initial audit and surveillance is the sum of the time of each location and central office audit.

4.5 结合审核的人日数  The duration of integration audit

4.5.1 审核部项目管理人员确保结合审核计划为每一个管理体系提供足够的审核时间。

Audit programme management personnel of audit department ensure that the sufficient audit duration shall be provided for every management system integration audit programme.

4.5.2 对于结合审核,审核部项目管理人员宜考虑以下因素(不仅限于)来确定审核人日数,而不应相对单一的管理体系认证简单地减少结合审核的人日数。即:

For integration audit, the audit programme management personnel shall determine the audit duration according to following factors (but no limit), but not simply reduce the duration because of combined audit.

a) 结合审核所涉及的管理体系的数量;  

The system quantity covered by the integration audit of management system;

b) 多个管理体系是否整合,即管理体系建立的模式(如:整合的体系文件或每个管理体系有独立的体系文件等);

Whether multiple management systems are integrated, that is the mode of management system established (such as integrated system document or each management system has independent system document etc);

c) 多个管理体系整合的可能性及其整合的方式和程度;

Possibility of multiple management systems integration and the method and extent;

d) 体系运行的成熟度(如:体系建立的时间、内审/管理评审的结果、以往外部审核的结果等);

Maturity of system operation (such as the established time of system, results of internal audit/management review, results of previous external audits);

e) 针对每一个管理体系,审核范围不一致的情况;

Aim at the insistency of audit scope for each management system;

f) 就组织所提供的产品/服务,针对不同的管理体系认证存在的关键过程 (活动)、场所的差异和每个管理体系的要求和关注方面的差异,所导致的审核抽样方案的差异情况;

According to provided product/service, the different key process (activity) for different management system certification, difference of location and each management system requirement and different focus which cause the difference of the audit sampling programme.

g) 受审核组织所提供的产品(服务)的种类及其差异。

The type and difference of the provided product (service);

h) 受审核组织所提供的产品(服务)的实现过程或业务活动的复杂程度;

The complexity of the provided product (service) realization process or business activity.

i) 受审核组织所涉及的认证业务范围的风险程度;

Risk degree of certification business scope that refers to audited organization;

j) 受审核组织的结构及其业务活动;

Structure of audited organization and its business activity;

k) 审核组长和审核组成员所具备的审核能力,如:组长的策划、组织和协调结合审核的能力,每个成员所具备的对多个管理体系的审核能力,以及必要时,审核员资格等。

Audit competence possessed by lead auditor and its members such as the lead auditor’s planning, organization and coordination, every member’s audit competence for multiple management system, the auditor qualification (if necessary) etc.

4.5.3 结合审核时间的确定 The determination of combined audit duration

一般情况下,在考虑各体系审核时间增减的基础上,可按以下规定确定多体系结合审核时间。两个管理体系结合审核,第一个体系审核人日数按 100% 计算,第二个管理体系审核人日数按 70% 计算;三个管理体系结合审核,第一个体系审核人日数按 100% 计算,第二、第三个管理体系审核人日数按 60% 计算;四个以上管理体系结合审核时, 从第四个管理体系起按 50% 计算。

Generally, based on the consideration of audit duration’s increase and reduction of every system, it can determine the audit duration of multiple system integration as followings. For the integrated audit with two systems, the duration of the first system is calculated by 100% and the second system is calculated by 70%. For the integrated audit with three systems, the duration on the first system is calculated by 100% and the second and third systems are calculated by 60%. And for the integrated audit with four systems, it is calculated by 50% from the fourth management system.

4.6 审核时间管理 Auditor duration management

4.6.1 现场审核的时间,每个审核人日应不低于8小时,当审核人日为8小时时,其中审核组内部的交流和沟通每天所占用的时间应不超过1个小时。

For the on site audit duration, each audit man day shall not be less than eight hours. When the audit duration is eight hours, the time used for internal exchanges and communication with audit team shall not exceed an hour.

4.6.2审核项目管理人员在审查审核任务书、审核计划及日程安排和审核资料时,应将审核人日数是否满足规定要求作为必查内容。

Audit programme management personnel must review that whether the audit duration meet stipulated requirements when reviewing audit notification, audit plan, audit schedule and documents.

5  引用文件和记录表单 References and records

5.1  IAF MD5:2019《确定 QMS EMS 审核时间》

IAFMD5: 2019 “QMS and EMS Audit duration”

5.2  IAF MD1《多场所组织的管理体系审核与认证》

IAF MD1 “Management System Audit and Certification of Multi-site Organizations”

 

Annex 1           

质量管理体系审核时间标准

                  QMS Audit duration Standard

根据认可准则及相关要求的规定,深圳华凯检验认证有限公司ISO9001的审核时间执行下列标准:

In accordance with the rules of accreditation criteria and relevant requirements, ISO9001 audit duration of HIC executes following standards:

 

有效人数

Effective  Number of personnel

审核员时间

1 阶段+第2 阶段(天)

Audit duration stage 1+ stage 2(days)

有效人数

Effective  Number of personnel

审核员时间

1 阶段+第2 阶段(天)

Audit duration stage 1+ stage 2(days)

1-5

1.5

626-875

12

6-10

2

876-1175

13

11-15

2.5

1176-1550

14

16-25

3

1551-2025

15

26-45

4

2026-2675

16

46-65

5

2676-3450

17

66-85

6

3451-4350

18

86-125

7

4351-5450

19

126-175

8

5451-6800

20

176-275

9

6801-8500

21

276-425

10

8501-10700

22

426-625

11

>10700

遵循上述递进规律

Follow progression above

注:Note:

● 组织员工人数低于10人的,不能减少人日,只能视情况增加人日数;

For the organization that the employee is lower than ten persons, the duration cannot be reduced and only be increased as actual situation.

● 无论是初审、监审、或再认证审,第二阶段现场审核时间不得少于一天。

Whatever the initial audit, surveillance or recertification, stage 2 on-site audit duration cannot be less than one man-day.

● 考虑到所有因素,审核人日数减少量最多不得超过审核标准人日数的30%。

for all audits, the duration reduction can not exceed 30% of total duration such as initial, surveillance or re-assessment.

 

可增加审核人日的因素(但不限于这些因素):

Factors (but not limited) which may require additional duration:

● 组织的工作在多于一处的建筑物或地点实施,审核时需要复杂的后勤安排,例如必须对一个单独的设计中心实施审核;

Complicated logistics involving more than one building or location where work is carried out, eg a separate design centre must be audited.

● 员工使用多于一种的语言(需要翻译或妨碍单个审核员独立工作);

Staff  speaking  in  more  than  one  language  (requiring  interpreter(s)  or  preventing

individual auditors from working independently);

● 与人员数量相比,现场很大(例如森林);

 Very large site for the number of personnel (e.g., a forest);

● 受法规管制的程度较高(例如食品、药品、航天、核能等领域);

High degree of regulation (eg. food, drugs, aerospace, nuclear power etc);

● 体系覆盖着高度复杂的过程或数量较多的互不相同的活动;

System covers highly complex processes or relatively high number of unique activities;

● 需要访问临时场所,以确认拟认证管理体系中的常设场所的活动。

Activities that require visiting temporary sites to confirm the activities of the permanent

Site (s) whose management system is subject to certification.  

 

可减少审核人日的因素(但不限于这些因素):

Decrease factors (but not limited) in audit duration:  

● 客户不负责设计工作,或体系的范围删减了标准的其他要素;

Client is not "design responsible" or other standard elements are not covered in the scope

(QMS only);

● 与人员数量相比,现场很小(例如仅有综合办公区);

Very small site for number of personnel (e.g. office complex only);

● 体系成熟;

Maturity of management system;

● 对客户管理体系已有的了解(例如同一认证机构已依据另一标准认证了该客户);

Prior  knowledge  of  the  client  management  system  (e.g.,  already  certified  to  another

standard by the same CAB);

● 客户为认证所作的准备(例如已经获得另一个第三方合格评定制度的认证或承认);

Client preparedness for certification (e.g., already certified or recognized by another 3rd

party scheme);

● 活动的复杂程度低,例如:

过程仅包含单一的一般性活动(例如仅包含服务);

以往审核(内部审核和认证机构审核)显示,所有班次都实施相同的活动,且有适当证据表明所有班次的表现相同;

相当一部分员工从事相似的简单职能;

Low complexity activities, e.g.

Processes involve a single generic activity (e.g., Service only);  

Identical activities performed on all shifts with appropriate evidence of equivalent

performance on all shifts based on prior audits (internal audits and CAB audits);

Where a significant proportion of staff carry out a similar simple function.

● 有一部分员工在组织的场所外工作,例如销售人员、司机、服务人员等,并且有可能通过记录审查来对其活动是否符合体系要求进行充分地审核。

Where  staff  include  a  number  of  people  who  work  “of  location”  e.g.  sales persons,

drivers, service personnel, etc. and it is possible to substantially audit compliance of their

activities with the system through review of records.

 

Annex 2              

ISO14001审核时间标准

ISO14001 Audit Duration Standard

根据认可准则及相关要求的规定,深圳博瀚检测认证集团有限公司ISO14001的审核时间执行下列标准:

In accordance with the rule of accreditation criteria and relevant requirements, ISO14001 audit duration of HIC executes following standards:

有效人数

Effective  Number of personnel

审核员时间

1 阶段+第2 阶段(天)

Audit duration stage 1+ stage 2(days)

有效人数

Effective  Number of personnel

审核员时间

1 阶段+第2 阶段(天)

Audit duration stage 1+ stage 2(days)

 

High

Med

Low

Lim

 

High

Med

Low

Lim

1-5

3

2.5

2.5

2.5

626-875

17

13

10

6.5

6-10

3.5

3

3

3

876-1175

19

15

11

7

11-15

4.5

3.5

3

3

1176-1550

20

16

12

7.5

16-25

5.5

4.5

3.5

3

1551-2025

21

17

12

8

26-45

7

5.5

4

3

2026-2675

23

18

13

8.5

46-65

8

6

4.5

3.5

2676-3450

25

19

14

9

66-85

9

7

5

3.5

3451-4350

27

20

15

10

86-125

11

8

5.5

4

4351-5450

28

21

16

11

126-175

12

9

6

4.5

5451-6800

30

23

17

12

176-275

13

10

7

5

6801-8500

32

25

19

13

276-425

15

11

8

5.5

8501-10700

34

27

20

14

426-625

16

12

9

6

>10700

遵循上述递进规律

Follow progression above

 

注:Note:考虑到所有因素,现场审核人日数减少量最多不得超过现场审核标准人日数的30%。

For all audits, the duration reduction can not exceed 30% of total duration such as initial, surveillance or re-assessment.

可增加审核人日的因素(但不限于这些因素):

● 组织的工作在多于一处的建筑物或地点实施,审核时需要复杂的后勤安排,例如必须对一个单独的设计中心实施审核;

Complicated logistics involving more than one building or location where work is carried out, eg a separate design centre must be audited.

● 员工使用多于一种的语言(需要翻译或妨碍单个审核员独立工作);

Staff  speaking  in  more  than  one  language  (requiring  interpreter(s)  or  preventing

individual auditors from working independently);

● 与人员数量相比,现场很大(例如森林);

Very large site for the number of personnel (e.g., a forest);

● 受法规管制的程度较高(例如食品、药品、航天、核能等领域);

High degree of regulation (eg. food, drugs, aerospace, nuclear power etc);

● 体系覆盖着高度复杂的过程或数量较多的互不相同的活动;

System covers highly complex processes or relatively high number of unique activities;

● 需要访问临时场所,以确认拟认证管理体系中的常设场所的活动。

Activities that require visiting temporary sites to confirm the activities of the permanent

site(s) whose management system is subject to certification.  

● 与同行业典型情况相比,受纳环境的敏感度较高;

Higher  sensitivity  of  receiving  environment  compared  to  typical  location  for  the

industry sector;

● 利益相关方的意见;

Views of interested parties;

● 有必要增加审核时间的间接因素;

Indirect aspects necessitating increase in auditor time;

● 组织所属行业有附加的或特殊的环境因素或法规要求。

Additional or unusual environmental aspects or regulated conditions for the sector.

 

可减少审核人日的因素(但不限于这些因素):

Decrease factors (but not limited) in audit duration:  

● 与人员数量相比,现场很小(例如仅有综合办公区);

Very small site for number of personnel (e.g. office complex only);

● 体系成熟;

Maturity of management system;

● 对客户管理体系已有的了解(例如同一认证机构已依据另一标准认证了该客户);

Prior  knowledge  of  the  client  management  system  (e.g.,  already  certified  to  another

standard by the same CAB);

● 客户为认证所作的准备(例如已经获得另一个第三方合格评定制度的认证或承认);

Client preparedness for certification (e.g., already certified or recognized by another 3rd

party scheme);

● 活动的复杂程度低,例如:

过程仅包含单一的一般性活动(例如仅包含服务);

以往审核(内部审核和认证机构审核)显示,所有班次都实施相同的活动,且有适当证据表明所有班次的表现相同;

相当一部分员工从事相似的简单职能;

Low complexity activities, e.g.

  Processes involve a single generic activity (e.g., Service only);  

  Identical activities performed on all shifts with appropriate evidence of equivalent

performance on all shifts based on prior audits (internal audits and CAB audits);

  Where a significant proportion of staff carry out a similar simple function.

● 有一部分员工在组织的场所外工作,例如销售人员、司机、服务人员等,并且有可能通过记录审查来对其活动是否符合体系要求进行充分地审核。

Where  staff  include  a  number  of  people  who  work  “of  location”  e.g.  sales persons,

drivers, service personnel, etc. and it is possible to substantially audit compliance of their

activities with the system through review of records.

 

Annex 3           

OHSMS 审核时间标准

OHSMS  Audit Duration Standard

根据认可准则及相关要求的规定,深圳博瀚检测认证集团有限公司ISO45001的审核时间执行下列标准:

In accordance with the rule of accreditation criteria and relevant requirements, ISO45001 audit time of Seri executes following standards:

 

有效人数

审核员时间

1 阶段+第2 阶段(天)

有效人数

审核员时间

1 阶段+第2 阶段(天)

 

 

1-5

3

2.5

2.5

626-875

17

13

10

6-10

3.5

3

3

876-1175

19

15

11

11-15

4.5

3.5

3

1176-1550

20

16

12

16-25

5.5

4.5

3.5

1551-2025

21

17

12

26-45

7

5.5

4

2026-2675

23

18

13

46-65

8

6

4.5

2676-3450

25

19

14

66-85

9

7

5

3451-4350

27

20

15

86-125

11

8

5.5

4351-5450

28

21

16

126-175

12

9

6

5451-6800

30

23

17

176-275

13

10

7

6801-8500

32

25

19

276-425

15

11

8

8501-10700

34

27

20

426-625

16

12

9

>10700

遵循上述递进规律

 

注:Note:考虑到所有因素,现场审核人日数减少量最多不得超过现场审核标准人日数的30%。

For all audits, the duration reduction can not exceed 30% of total duration such as initial, surveillance or re-assessment.

可增加审核人日的因素(但不限于这些因素):

● 组织的工作在多于一处的建筑物或地点实施,审核时需要复杂的后勤安排,例如必须对一个单独的设计中心实施审核;

Complicated logistics involving more than one building or location where work is carried out, eg a separate design centre must be audited.

● 员工使用多于一种的语言(需要翻译或妨碍单个审核员独立工作);

Staff  speaking  in  more  than  one  language  (requiring  interpreter(s)  or  preventing

individual auditors from working independently);

● 与人员数量相比,现场很大(例如森林);

Very large site for the number of personnel (e.g., a forest);

● 受法规管制的程度较高(例如食品、药品、航天、核能等领域);

High degree of regulation (eg. food, drugs, aerospace, nuclear power etc);

● 体系覆盖着高度复杂的过程或数量较多的互不相同的活动;

System covers highly complex processes or relatively high number of unique activities;

● 需要访问临时场所,以确认拟认证管理体系中的常设场所的活动。

Activities that require visiting temporary sites to confirm the activities of the permanent

site(s) whose management system is subject to certification.  

● 与同行业典型情况相比,受纳环境的敏感度较高;

Higher  sensitivity  of  receiving  environment  compared  to  typical  location  for  the

industry sector;

● 利益相关方的意见;

Views of interested parties;

● 有必要增加审核时间的间接因素;

Indirect aspects necessitating increase in auditor time;

● 组织所属行业有附加的或特殊的环境因素或法规要求。

Additional or unusual environmental aspects or regulated conditions for the sector.

 

可减少审核人日的因素(但不限于这些因素):

Decrease factors (but not limited) in audit duration:  

● 与人员数量相比,现场很小(例如仅有综合办公区);

Very small site for number of personnel (e.g. office complex only);

● 体系成熟;

Maturity of management system;

● 对客户管理体系已有的了解(例如同一认证机构已依据另一标准认证了该客户);

Prior  knowledge  of  the  client  management  system  (e.g.,  already  certified  to  another

standard by the same CAB);

● 客户为认证所作的准备(例如已经获得另一个第三方合格评定制度的认证或承认);

Client preparedness for certification (e.g., already certified or recognized by another 3rd

party scheme);

● 活动的复杂程度低,例如:

过程仅包含单一的一般性活动(例如仅包含服务);

以往审核(内部审核和认证机构审核)显示,所有班次都实施相同的活动,且有适当证据表明所有班次的表现相同;

相当一部分员工从事相似的简单职能;

Low complexity activities, e.g.

  Processes involve a single generic activity (e.g., Service only);  

  Identical activities performed on all shifts with appropriate evidence of equivalent

performance on all shifts based on prior audits (internal audits and CAB audits);

  Where a significant proportion of st aff carry out a similar simple function.

 

ANNEX 4 – REDUCTION OF AUDIT TIME

附件4,结合体系审核时间的减少

                                        

 

该数值代表该区域可缩减的结合审核人日数占结合审核人日数起始点(T)的百分数。

Figure 1: This figure illustrates the reduction (%) in integrated audit duration and its relationship to:

纵坐标为组织管理体系整合水平。其包括对受审核方对多方面问题回复能力的考虑。一体化管理体系指的是组织采用一个管理体系来管理涉及多方面的组织绩效,其特点为(但不限于):

Vertical axis: the level of integration of an organization’s management system (see below), which should include a consideration of the auditee’s ability to respond to multi-aspect questions. An Integrated Management System results when an organi- zation uses one single management system to manage multiple aspects of organ- izational performance. It is characterized by (but not limited to):

1. 适宜并有效地制定和管理了整合的管理体系文件(也包括作业指导文件)

An integrated documentation set, including work instructions to a good level of de- velopment, as appropriate;

2. 管理评审关注了整体组织业务战略和计划

Management Reviews that consider the overall business strategy and plan;

3. 内部审核采用了结合审核的方法

An integrated approach to internal audits;

4. 制定了整合的管理体系方针和目标

An integrated approach to policy and objectives;

5. 确定了整合的管理体系过程

 An integrated approach to systems processes;

6. 建立了整合的持续改进机制(包括纠正/预防措施、测量和持续改进)

An integrated approach to improvement mechanisms, (corrective and pre- ventive action; measurement and continual Improvement); and,

7. 具有统一的管理支持和管理责任

Integrated management support and responsibilities.

认证机构需依据上述组织管理体系整合程度确定整合百分比

The Certification Body must decide the percentage level of integration based upon the extent to which the organization’s management system meets the above criteria.

And和横坐标为审核组承担结合审核能力水平

Horizontal axis: The extent, given as a ratio to be multiplied by a factor of 100 in order to achieve the extent given as percentage, to which individual audit team members are qualified:

100 ((X1-1) + (X2-1) + (X3-1) + (Xn-1)) Z(Y-1)

 

Where

 

X1, 2, 3…n is the number of standards for which an auditor is qualified relevant for the scope of the integrated audit;

X1,2,3 代表审核组中每位审核员有能力承担管理体系审核领域的数量;

Y is the number of management system standards to be covered by integrated audit;

Y 为结合审核所覆盖的整合管理体系的数量。

Z is the number of auditors.

Z 为结合审核组中审核员的数量;

 

Example: 案例

 

An integrated audit team of three auditors covering three different management sys- tem standards. One auditor is qualified for all three standards; one auditor is quali- fied for two of the standards and the other auditor is qualified for one standard.

The percentage figure to be used for the horizontal axis is:

结合审核组由三位审核员组成,覆盖三个不同的管理体系标准。一位审核员为三体系审核员,一位审核员为两体系审核员, 一位是一体系审核员,横坐标的百分比为:

 

100 ((3-1) + (2-1) + (1-1)) = 50 %

3(3-1)

 

Due to available competence of each auditor to more than one set of audit crite- ria/standards, efficiencies are gained and go into the calculation of the possible reduction of time in the formula above. These include:

 由于每位审核员在两个或多个审核准则或标准上能力富余,效率提高,在以上公式中 计算出可能会减少的时间,其包括:

Time saved due to one opening and one closing meeting;

从首末次会议中节省的时间

Time saved as one integrated audit report is produced;

从结合审核报告的制作中节省的时间

Time saved in optimized logistics;

从优化的后勤服务中节省的时间

Time saved in auditor team meetings; and,

从审核组会议中节省的时间

5、Time saved auditing common elements simultaneously, e.g. document control.

从同时审核通用要素中节省的时间, 比如文审。

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