ISO9001程序文件-中英文+流程+对照表

但所开展的审核活动在一年内，

必须覆盖

ISO9001:2000

标准所要求的所

有 要素及相关部门。

The

audit

times

of

each

Dept.

or

element

shall

depend

on

the

current

operation

status

or the affections given to quality management by the relative action. The carried

audit

action

shall

refer

to

all

the

elements

and

departments in

ISO9001:2000

within

the one year.

6.2

内审员资格认定

Appointment of internal auditor

6.2.1 < /p>

本厂为有效地开展内审工作，

应在实施内审前的适当时间，

由管理者代表根据内审计

划的性质成立内内审小组，并制定组长。

For the better implementation of internal audit, management representative shall

set

up

an

internal

audit

group

and assign

the

leader

sometime

before

the

internal

audit.

6.2.2

内审小组的内审员必须同时具备如下条件：

Internal auditor shall meet following requirements:

6.2.2.1

熟悉认证的质量管理标准和有关法律、法规。

Be familiar with the law or regulation of quality management standard.

6.2.2.2

接受相关机构的培训，并持有内审员资格证书。

Has ever been trained by some training organization and owns the internal audit

qualification certificate.

6.2.2.3

能确保与被审核部门无直接关系。

Independent of the areas being audited.

6.2.2.4

经管理者代表批准。

Approved by the management representative.

6.3

内审准备

Internal audit perparation

6.3.1

具体审核计划的核定

Internal audit plan preparation6.

3.1.1

具体审核计划由审核组长负责拟定；

Audit

leader

shall

make

out

the

detail

audit

plan.

6.3.1.2

内审计划应遵守“确保内审人员与被审核的部门无关”的原则；

Audit

plan

shall

stick

to

the

principle

of

auditor

is

independent

of

the

areas

being audited

6.3.1.3

审核计划应包括所有与本次审 核目标、范围有关的相关部门和要素。

Audit Plan shall

include all the

departments and elements relative to

the goal and

scope of the audit.

6.3.1.4

审核小组应与被审核部门负责 人商定适当的审核日期，

并根据审核的重点与要求拟

定好审核路 线。

Audit group shall negotiate the appropriate audit date with audit department, and

determine the audit route according to the audit focus.

6.3.1.5

审核计划经管理者代表核准后，

应提前通知被审核单位，

以便其作相应的准备工作。

After

the

approval

of

the

management

representative,

notify

the

auditee

department

in advance for its better preparation work.

6.3.2

审核前，审核员必须事先准备与审核 程序相关的《内审检查表》

，经组长审核后报管

理者代表批准。 为顺利开展审核工作，审核员应准备适当的空白《纠正措施单》

，以便审核

时使用。

Auditor shall prepare Internal Audit Checklist before audit, after the check by

the

audit

leader,

shall

send

Internal

Audit

Checklist

to

the

management

representative for approval. In order to carry out audit smoothly, auditor shall

prepare some blank

6.4

内审的实施

Audit Execution

6.4.1

首次会议，

审核前由管理 者代表召开首次会议，

阐明此次审核的有关事项，

包括审核

目的、范围、时

间、路线安排、审核流程 以及审核的人员配合要求。首次会议的参加者应

包括内审小组成员、被审部

门负责人以及由管理者代表指定的相关人员。

The first meeting

：

management representative carry out the first meeting before

Audit

，

statethe actions including audit scope

，

purpose

，

time

，

route arrangement,

audit

flow

chart

and

auditor

cooperation

requirement.

The

attendance

shall

include

member

of

internal

auditor

group,

responsible

person

of

auditee

departm

ent

and

staff

designated

bythe

management

representative.

6.4.2

审核人员到达现场，在被 审核部门指定人员配合下，开展评审工作，审核员应以内审

检查表为指引，通过观察、面 谈、抽查有关文件记录及相关规定，以获得客观证据，并详细

记录在《内审检查表》中。

The

auditor

will

carry

out

audit

action

with

the

cooperation

of

the

designated

staff

o

f

auditee

department.

The

auditor

shall

use

the

audit

checklist

as

the

guidance,

obta

in

the

evidence

by

observation,

interview,

spot

check

of

the

document

records

and

rela

tive

regulation,

and

make

detailed

record

in

Internal

Audit

Checklist.

6.4.3

在判定质量管理体系的符 合性时，

审核员应视时机与被审核部门的相关人员进行讨论，

并 得到确认。

作出审核结果前，

审核员必须获得相关的客观证据，

以证明质量管理体系是否

被切实执行。

The

auditor

shall

make

discussion

with

auditee

department

if

necessary

when

decid

e

the

coincidence

of

the

quality

management

system

and

then

get

approval.

The

auditor

must

obtain

the

objective

evidence

to

prove

the

fully

implementation

of

quality

syste

m

when

make

the

audit

result.

6.4.4

审核员应完成《内审检查 表》的内容，当发现不符合项时，应予以记载。

Auditor

shall

finish

Internal

Audit

Checklist,

and

make

record

when

nonconforming

ite

m

is

found.

6.4.5

针对审核情况，内审小组 在每日结束时应进行小组会议，讨论当日审核遇到的各种疑

难问题，并根据

查核记录，决定不符合事项，开出《纠正措施单》

。

After

audit

of

each

day,

internal

group

shall

have

the

meeting

and

discuss

the

vari

ous

problem

during

the

audit,and

check

the

record

to

determine

the

non- conforming

ite

m,

and

issue

the

Action

Sheet

6.4.6

现场审核完成后，审核员应总结内审结果，由审核组长汇总后编制内审报告交管理者

< br>代表审批。

The

auditor

shall

make

conclusion

after

audit,

and

the

audit

leader

shall

make

interna

l

audit

report

and

send

to

management

representative

for

approval.

6.4.7

末次会议：由管理者代表 主持，参加人员与首次会议相同，由审核组长作评审结果报

告，要求有关部

门在规定的时间内提出纠正措施并按计划完成。

The

final

meeting:

be

presided

by

management

representative,

the

attendance

are

same

as

the

first

meeting,

the

audit

leader

shall

give

audit

report

and

require

the

relativ

e

department

to

take

corrective

action

and

finish

within

the

specified

time.

6.4.8

所有的纠正措施单都应记录于《纠正措施跟进检查记录表》中。

All

corrective

action

shall

be

recorded

in

Action

Follow- up

Checklist

6.4.9

被审核部门的负责人接到《纠正措施单》后，应根据审核中所发现的客观事实对《纠