Procedures ISOIEC17025

advertisement
<<Insert the
logo of your
Laboratory
(click twice
here)>>
Procedure for ensuring the integrity of
laboratory equipment
<< Insert the name of your laboratory>>
Identification:
PROC-TC-004
Revision: 0
Valid after:
YYYY-MM-DD
Procedure for ensuring the
integrity of laboratory
equipment
<<INSERT THE NAME OF YOUR
LABORATORY>>
Total or partial reproduction of this document without permission of the Laboratory is not allowed.
Page 1 of 5
<<Insert the
logo of your
Laboratory
(click twice
here)>>
Identification:
PROC-TC-004
Procedure for ensuring the integrity of
laboratory equipment
Revision: 0
<< Insert the name of your laboratory>>
Valid after:
YYYY-MM-DD
CONTROLLED DOCUMENT
PROC-TC-004 Procedure for ensuring the integrity of laboratory
equipment.
Controlled Copy No.: <<Insert number of copy or original>>
Name
Position
Signature
Date
Prepared
by:
Revised
by:
Approved
by:
Location of this document:
Document Changes
Status
Date of Issue
Revision
Description of the
performed changes
Active
YYYY-MM-DD
0
None (original version).
Prepared
by
Revised
by
Total or partial reproduction of this document without permission of the Laboratory is not allowed.
Approved
by
Page 2 of 5
<<Insert the
logo of your
Laboratory
(click twice
here)>>
Procedure for ensuring the integrity of
laboratory equipment
<< Insert the name of your laboratory>>
Identification:
PROC-TC-004
Revision: 0
Valid after:
YYYY-MM-DD
[…]
4.3 Identification of laboratory equipment.
The Laboratory uniquely identifies each item of equipment and software, as
follows:
<<Insert methodology for identification of equipment, e.g. LAB-A-001, etc.>>
<<Comment→ Select the option that applies to your Laboratory and delete the
non applicable one, from the following two options :>>
<<Comment option 1→ if the Laboratory has equipment which requires periodic
calibration :>>
This identification includes the status of calibration of equipment, including
dates of last and next calibration. This identification is made on the equipment
packaging or storage place, if marks directly on the equipment are not possible.
The following tag format is used:
<<Insert the name or logo of your
Laboratory>>
Equipment Identification: ##-##-##
Date of last calibration:
YYYY - MM - DD
Date of next calibration:
YYYY - MM - DD
Approved by:
___________
<<Comment option 2→ if the Laboratory does not have equipment which
requires periodic calibration :>>
The Laboratory does not have equipment which requires periodic calibration.
See form for record of Laboratory equipment <<Insert identification and name of
the form, e.g. FOR-TC-004 "Form for ensuring the integrity of laboratory
equipment">>.
4.4 Laboratory equipment which is out of specification or damaged.
If an item of Laboratory equipment is damaged and/or out of the specification
required by that activity, or if it generates unreliable results, it is immediately
taken out of operation and is <<Insert action to take, e.g. isolated and labeled>>
to avoid unintended use until proven suitable to return to its proper functioning.
The following label format will be used to identify equipment out of operation:
<<Insert the name or logo of your
Laboratory>>
Equipment Identification: ##-##-##
INSTRUMENT OUT OF
OPERATION
Approved by:
___________
Total or partial reproduction of this document without permission of the Laboratory is not allowed.
Page 3 of 5
<<Insert the
logo of your
Laboratory
(click twice
here)>>
Procedure for ensuring the integrity of
laboratory equipment
<< Insert the name of your laboratory>>
Identification:
PROC-TC-004
Revision: 0
Valid after:
YYYY-MM-DD
If this anomaly identified in the equipment could produce invalid results in one
or more of the previous services performed by the Laboratory, the procedure
<<Insert name and identification of the procedure, e.g. PROC-GC-006
"Procedure for complaints and nonconforming work">> should be immediately
applied.
4.5 Equipment temporarily out of control of the laboratory.
If one or more items of Laboratory equipment are out of its control (e.g. loan or
on-site services), there is a verification program to ensure that the equipment is
returned to service properly and has not been damaged. This verification is
detailed in the procedure <<Insert name and identification of the procedure, e.g.
PROC-TC-005 "Procedure for intermediate checks of laboratory equipment
(and/or reference materials)">>
<<Comment→ this point refers to key equipment of the Laboratory which is out
of sight of the Laboratory and could endager its integrity>>
4.6 Protection of laboratory equipment against unwanted changes.
The Laboratory takes the following steps to protect its equipment and software
from unwanted changes:
<<Comment→ Select, modify, delete or add as required:>>

Password for access only to authorized personnel,

Stamp indicators of violation of access,

Access levels,

Locks,

Protected enclosures,

Periodic checks,

etc.
5. RESPONSIBILITIES.
<<Insert responsibilities of the key positions, e.g.:>>
<<Comment→ Select, modify, delete or add as required:>>
5.1 Quality Manager.
To assist in the conduction of this document.
5.2 Laboratory Manager.
To assist in the conduction of this document, if required.
5.3 Technicians.
Application of this document.
<<Insert other responsibilities>>
Total or partial reproduction of this document without permission of the Laboratory is not allowed.
Page 4 of 5
<<Insert the
logo of your
Laboratory
(click twice
here)>>
Procedure for ensuring the integrity of
laboratory equipment
<< Insert the name of your laboratory>>
Identification:
PROC-TC-004
Revision: 0
Valid after:
YYYY-MM-DD
6. RELATED FORMS.
<<Insert identification and name of the form, e.g. FOR-TC-004 "Form for
ensuring the integrity of laboratory equipment ">>
7. ANNEXES.
<<Insert annexes as required>>
Sample Document
Purchase the ISO/IEC 17025 full Quality Manual Template, Procedures, Forms
and Spreadsheets at www.metrycal.com
Guide for implementing a quality system
ISO/IEC17025
METRyCAL
www.metrycal.com
Metrology and Quality
Successful Accreditation!
Total or partial reproduction of this document without permission of the Laboratory is not allowed.
Page 5 of 5
Download