ISO9001：2015仪器设备校准程序英文版

[Full Client Name Reg Caps]

Procedure: [Calibration Proc. Title]

Rev. [Rev Number]

Procedure: [Calibration Proc. Title]

1.0

SUMMARY

1.1.

1.2.

The

purpose

of

this

procedure

is

to

define

the

requirements

for

calibration

or

verification

of

equipment used to determine the acceptability of product.

Typically,

this

is

limited

to

inspection

or

test

equipment

used

to

“buy

off”

product

prior

to

movement

to

a

subsequent

process

or

prior

to

final

delivery.

However,

at

the

discretion

of

management, calibration or verification may also be applied to critical process equipment.

The [who?] is responsible for implementation and management of this procedure.

1.3.

2.0

REVISION AND APPROVAL

Rev.

[Rev

Number]

Date

[Date of Issue]

Original issue.

Nature of Changes

Approved By

[Procedure

Approver Name]

3.0

PROCEDURE: CALIBRATION

3.1.

3.2.

3.3.

3.4.

3.5.

Devices subject to calibration shall be calibrated by an approved outside service provider, or by

trained [Short Client Name] employees.

Third party calibration laboratories should be accredited to ISO 17025 whenever possible, as this

provides the best control of calibration activities, and traceability to national standards.

When

employees

perform

in-house

calibration,

this

shall

be

performed

in

accordance

with

documented procedures for each type of calibration performed.

Traceability to the national standards will be maintained for all devices where such traceability is

possible by the current state of the art.

Approved

calibration

service

providers

must

maintain

suitable

environmental

conditions

for

calibration, and report temperature and relative humidity on any calibration test certificates or

other

calibration

documentation.

For

in-house

calibration,

the

[who?]

will

ensure

suitable

environmental conditions for calibration.

The Calibration Log [

?

rename if necessary] will be maintained by the [who?]. This document

will list all devices, their serial number, date of last calibration, and next scheduled calibration

date. The frequency of calibration for each device shall be adjusted based on the history of the

device

and

its

impact

on

product

quality.

NOTE:

third

party

calibration

providers

may

not

establish calibration frequencies; this must be determined by [Short Client Name].

For

tools

calibrated

by

third

party

laboratories,

these

shall

be

returned

with

a

certificate

of

calibration

showing

the

status of

the

calibration,

as

well

as

the

condition

the

equipment

was

found in (e.g., “defective,” “out of tolerance”, “in tolerance”, etc.) Such certificates must have

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3.6.

3.7.