TS16949内部质量体系审核(中英文)

Representative

acts

as

the

audit

team

leader

and

establishes

the audit team and assigns the audited area to each auditor. Auditors

shall not audit their own work.

5.2.2

内部质量管理体系审核员 应经过内部或外部的权威机构培训，

考核合格并持有相

应的资格 证书方可具备内审员资格。

All

internal auditors must

be trained

by our company or external qualified training organization and pass

their test and gets the certification of auditor.

5.3

内审准备

Preparation

5.3.1

内部审核实施日程计划的制定：

ISO

系统工程师应在每次审核前制定本次

审核实施日程安排计划交管理代表审核，厂长批准 ，此计划必须覆盖

TS16949:

2000

&

ISO13485

的所有要素及产品安全性的要求。

Prepare

each

internal

audit

schedule:

ISO

system

engineer

should

make

each

internal quality audit schedule and detailed arrange, and it must

.

.

.

be

covered

all

elements

and

requirements

of

TS16949:

2000

&

ISO13485

and

Products

Safety. The

internal

audit

schedule

shall

be

reviewed

by the Management Representative and approved by Plant Manager

5.3.2

审核组应提前至少一周将 内部审核实施日程计划发给受审部门。受审部门

按日程计划做好接待人员的资料

/

证据的贮备工作。

The audit agenda

should be forwarded to the department that to be audited at least

one week before, so that the department prepare the file/evidence

for audit according to the plan.

5.3.3

同时提早通知审核员以免与其它活动发生冲突。要求：

At

the

same time,

the

auditors

should

be

informed

in

advance

to

ensure

no

conflict

with

their

schedule

as

well

as

the

audited

area.

Following

are

required to do:

5.3.3.1

复查审核区域以前的 审核记录

,

以前发生的所有不符合项的相应纠

< br>正措施是否完成和验证

OK

；

R e-check the former audit records

of the area to ensure the corrective actions to former

nonconforming items

have been accomplished and assessed OK.

5.3.3.2

调阅

《质量手册》

、

程序文件的有关章节；

Reading

the

related

chapters

and sections of and procedure documents.

5.3.3.3

审核员准备审核检查表

,

此审核检查表必须覆盖计划中规定要素。

Auditors

shall

prepare

an

audit

check

list

according

to

the

agenda,

and the check list should cover all elements in the agenda.

5.4

实施审核

Carrying out audit

5.4.1

见面会

the Open meeting:

由审核小组成员与被审核部门的负责人共同召开

,

双 方将澄清审核的要求

,

明确审核中易发生的问题

,

一般只需

10~20

分钟。

Audit

team hold the open meeting with the head of audited dept to clarify the

audit

requirements

and

ascertain

the

problems

that

may

be

happen

in

audit.

The meeting lasts for about 10-20 minutes normally.

5.4.2

现场审核

:

审核员按审核检查表进行 审核，由审核组长控制审核全过程。审核

员通过与受审部门人员面谈、查阅文件、检查记 录、现场观察、进行抽样检查

.

.

.

等方法。审核员应该将审核依据的文件记录于审核检查表中。

On-site

audit:

The audit shall be carried out according to the checklist, through

talking

with

relevant

person,

scanning

documents,

checking

records,

spot

or

sample

check,

etc.

Audit

team

leader

should

control

the

whole

audit.

Auditor shall identify the document name and number for process they

audited in checklist.

5.4.3

若发现不合格时，审核员 应当场取得受审核部门责任人对不合格事实的确认，

若有异议可由审核组长或其提请管理 者代表仲裁。

Person

who

is

in

charge

of

the

audited

department

shall

confirm

the

NC

at

spot

if

such

NC

is

found,

and any objection can be put forward to the audit team leader or the

Management Representative to mediate.

5.4.4

审核员分析观察结果，< /p>

确定不符合项，

由审核员填写

《不符合项 报告》

QF-QA-004

，

交被审核 部门负责人确认。

《不符合项报告》

QF-QA-004

由审核组长批准，

在审核中或审核结束后发 给被审核部门。

After

analyzing check results

and

ascertaining

the

nonconforming

items,

auditors

fill

the

and Corrective Action Report>QF-QA-004 will be filled by auditors and

acknowledged by the audited dept. The report is to be approved by team

leader and distribute to the audited dept during or after audit

5.4.5

召开末次会议，宣布审核结果。

The

Close

meeting

is

held

for

announcing

the

audit results.

5.5

审核结果﹑报告

/Audit results and reporting

5.5.1

每 次审核活动，

ISO

系统工程师在审核员的协助下编写“内部审 核报告”，在

审核结束的两个星期内完成。

ISO

system

engineer

shall

finish

to

initiating

“

Internal

audit

report

”

with

the

cooperation

of

auditors

within

2

week

after the audit.

5.5.2

要求阐述所审核范围质量 体系运行情况，

并作出总的结论。

Descriptions

about

the

performing

status

of

quality

management

system

that

have

been

audited

and general conclusion are necessary.

.

.

.

5.5.3

“内部质量体系审核报告 ”完成后需交管理代表和厂长审核并需传递给被审核

部门。

Finished

“

Internal audit report

”

shall be submit to Management

Representative

and

Plant

Manager

to

review

and

distributed

to

the

audited

dept .

5.6

纠正和预防措施

Corrective and preventative actions.

被审核部门负责人应在接到审核员分 发的

《不符合项报告》

QF-QA-004

后

7

个工作日

内进行原因分析，决 定纠正与预防措施及完成日期和责任人，将填写完毕的《不符

合项报告》

QF-QA-004

送回审核员

/ISO

系统工程师，并及时导入纠正与预防措施。

After

receiving

“Nonconformance

and

Corrective

Action

Report>

（

QF- QA-004

）

，

the leader of the audited dept analyzes the causes of nonconformity and

carries

out

corrective

actions

as

well

as

determines

the

due

date

of

rectify

and

fill

up

and

Corrective

Action

Report>

QF-QA-004

and

sent

it to the auditor/ISO system engineer within 7 days.

5.5

跟踪及验证

Following up and verification:

ISO

系统工程师跟踪内审不符 合项的纠正和预防措施的实施状况，并验证有效性后记

录于《不符合项报告》中的“复查 情况”栏。若措施无效，

ISO

系统工程师应再次发