LAFM03-Mar 11 - ISO 17025 Chklist - v2
LAFM03-Mar 11 - ISO 17025 Chklist - v2
LAFM03-Mar 11 - ISO 17025 Chklist - v2
Laboratory :
Address :
Tel / Fax :
Names of persons :
seen
Field :
Date of visit :
Technical :
Assessor(s)/Expert(s)
Lead Assessor :
References
ISO/IEC 17025: 2005, SAC-01, SAC-SINGLAS 001, SAC-SINGLAS 002, SAC-SINGLAS 006, PROF 001
LAFM03/Mar 11 Page 1 of 41
Clause Description Yes No N.A. Remarks
No.
4. Management Requirements
4.1 Organization
4.1.1 Is the laboratory or the organization legally
responsible?
LAFM03/Mar 11 Page 2 of 41
Clause Description Yes No N.A. Remarks
No.
Are precaution taken to ensure that there
is no conflict of interest between staff and
customers?
LAFM03/Mar 11 Page 3 of 41
Clause Description Yes No N.A. Remarks
No.
4.1.5j. Are deputies for key managerial personnel
appointed?
LAFM03/Mar 11 Page 4 of 41
Clause Description Yes No N.A. Remarks
No.
4.2.2c The purpose of the management system
related to quality?
LAFM03/Mar 11 Page 5 of 41
Clause Description Yes No N.A. Remarks
No.
Is a master list or an equivalent document
control procedure available to:
• identifying the current revision
status?
• distribution of documents in the
management system established?
• readily available to preclude the
use of invalid and/or obsolete
documents?
LAFM03/Mar 11 Page 6 of 41
Clause Description Yes No N.A. Remarks
No.
4.3.3.3 If the laboratory’s document control system
allows for the amendment of documents by
hand pending the re-issue of the
documents:
• are the procedures for such
amendments defined?
• are the authorities for such
amendments defined?
LAFM03/Mar 11 Page 7 of 41
Clause Description Yes No N.A. Remarks
No.
4.4.3 Does the review cover any work that is
subcontracted by the laboratory?
LAFM03/Mar 11 Page 8 of 41
Clause Description Yes No N.A. Remarks
No.
4.6 Purchasing Services and Supplies
(2.7, NB: when purchasing calibration services,
SAC- laboratories should refer to the SAC-
SINGLAS SINGLAS 006 to ensure that traceability
002) requirements are met.
LAFM03/Mar 11 Page 9 of 41
Clause Description Yes No N.A. Remarks
No.
4.7.2 Does the laboratory seek feedback, both
positive and negative, from its customers?
4.8 Complaints
Are policy and procedure for the resolution
of complaints received from customers or
other parties available?
LAFM03/Mar 11 Page 10 of 41
Clause Description Yes No N.A. Remarks
No.
4.10 Improvement
Does the laboratory continually improve
the effectiveness of its management
system through the use of the
• quality policy and objectives?
• audit results?
• analysis of data?
• corrective and preventive actions?
• management review?
LAFM03/Mar 11 Page 11 of 41
Clause Description Yes No N.A. Remarks
No.
4.12 Preventive Action
4.12.1 Are needed improvements and potential
sources of non-conformances identified?
LAFM03/Mar 11 Page 12 of 41
Clause Description Yes No N.A. Remarks
No.
4.13.2 Technical Records
4.13.2.1 Does the laboratory for a defined period
retain records of:
• original data?
• derived data?
• sufficient information to establish
an audit trail?
• calibration records?
• staff records?
• copy of test / calibration report?
• identity of personnel responsible
for
- Sampling?
- Performance of each test
/calibration?
- Checking of results?
LAFM03/Mar 11 Page 13 of 41
Clause Description Yes No N.A. Remarks
No.
4.14 Internal Audits
4.14.1 Are internal audits conducted periodically
and in accordance with a predetermined
schedule?
LAFM03/Mar 11 Page 14 of 41
Clause Description Yes No N.A. Remarks
No.
4.15 Management Reviews
4.15.1 Are management reviews conducted
periodically by the top management and in
accordance with a predetermined
schedule?
LAFM03/Mar 11 Page 15 of 41
Clause Description Yes No N.A. Remarks
No.
5. Technical Requirements
5.2 Personnel
5.2.1 Ensure the competence of all who
• operate specific equipment,
• perform tests / calibrations
• evaluate results
• sign test reports / calibration
certificates
LAFM03/Mar 11 Page 16 of 41
Clause Description Yes No N.A. Remarks
No.
5.2.5 Has the management authorised specific
personnel to:
• perform particular types of
sampling?
• perform test and/or calibration?
• issue test reports and calibration
certificates?
• give opinions and interpretations?
• operate particular types of
equipment?
LAFM03/Mar 11 Page 17 of 41
Clause Description Yes No N.A. Remarks
No.
Are the technical requirements for
accommodation and environmental
conditions that can affect the results of
tests and calibrations documented?
LAFM03/Mar 11 Page 18 of 41
Clause Description Yes No N.A. Remarks
No.
Are all instructions, standards, manuals
and reference data relevant to the work of
the laboratory:
• kept up-to-date?
• made available to personnel?
LAFM03/Mar 11 Page 19 of 41
Clause Description Yes No N.A. Remarks
No.
(3.4, NB: Confirmation of methods may include
SAC- verification of performance of equipment,
SINGLAS availability of the required reference
002) materials/standard, suitability of the
laboratory environment, skills and
competence of staff, ability to achieve
required precision detection limit,
proficiency testing.
LAFM03/Mar 11 Page 20 of 41
Clause Description Yes No N.A. Remarks
No.
(3.6, NB: The laboratory should have suitable
SAC- qualified personnel, procedures,
SINGLAS equipment and a traceability programme
002) available to perform its in-house
calibration.
LAFM03/Mar 11 Page 21 of 41
Clause Description Yes No N.A. Remarks
No.
If Yes, then has the laboratory attempted
to:
• identify all the components of
uncertainty?
• make a reasonable estimation?
• ensure that the reporting of the
result does not give the wrong
impression of the uncertainty?
• make use of previous experience
and validation data?
LAFM03/Mar 11 Page 22 of 41
Clause Description Yes No N.A. Remarks
No.
5.5 Equipment
5.5.1 Are all the appropriate equipment and its
software (including that outside the
laboratory’s permanent control) required
for all testing and/or calibration activities:
• available and functioning properly?
LAFM03/Mar 11 Page 23 of 41
Clause Description Yes No N.A. Remarks
No.
5.5.5f. Dates, results and copies of reports and
certificates of all calibrations, adjustments,
acceptance criteria (e.g. NDT) and due
date of next calibration?
LAFM03/Mar 11 Page 24 of 41
Clause Description Yes No N.A. Remarks
No.
5.5.11 Where calibrations give rise to a set of
correction factors, does the laboratory
have procedures to ensure that copies
(wherever used) are correctly updated?
LAFM03/Mar 11 Page 25 of 41
Clause Description Yes No N.A. Remarks
No.
Is participation in a suitable inter-laboratory
comparison carried out (where possible)?
5.6.2.2 Testing
5.6.2.2.1 For testing laboratories, the requirements
in 5.6.2.1 apply for measuring and test
equipment unless it can be established
that the associated contribution from the
calibration contributes little to the total
uncertainty of the test result.
LAFM03/Mar 11 Page 26 of 41
Clause Description Yes No N.A. Remarks
No.
5.6.3.2 Reference Materials
Are all reference materials (where
possible) traceable to:
• SI units of measurement?
• Certified reference materials?
5.7 Sampling (Note: This clause is applicable when the laboratory (staff) does the sampling)
Is laboratory fully or partially involved in the
sampling process?
LAFM03/Mar 11 Page 27 of 41
Clause Description Yes No N.A. Remarks
No.
5.7.2 Where the customer requires deviations,
additions or exclusions from the
documented sampling procedure, then
does the laboratory:
• record in detail the appropriate
sampling data?
• Include this information in all
documents containing test or
calibration results?
• communicated to the appropriate
personnel?
LAFM03/Mar 11 Page 28 of 41
Clause Description Yes No N.A. Remarks
No.
5.8 Handling of Test and Calibration Items
5.8.1 Does the laboratory have procedures for:
• Transportation
• Receipt
• Handling
• Protection
• Storage
• Retention
• disposal of test/calibration items
LAFM03/Mar 11 Page 29 of 41
Clause Description Yes No N.A. Remarks
No.
5.9 Assuring the Quality of Test and Calibration Results
5.9.1 Does the laboratory have quality control
procedures for monitoring the validity of
tests and calibrations undertaken?
LAFM03/Mar 11 Page 30 of 41
Clause Description Yes No N.A. Remarks
No.
5.10 Reporting the Results
5.10.1 Are the results accurately, clearly,
unambiguously and objectively reported in
accordance with any specific instructions in
the test or calibration methods?
LAFM03/Mar 11 Page 31 of 41
Clause Description Yes No N.A. Remarks
No.
(3.14.2, Does the laboratory seek approval by
SAC- writing to SAC-SINGLAS on the use of
SINGLAS photographic, electronic and mechanical
002) means of reproduction of signatures or
names of signatories?
a) Date of sampling
LAFM03/Mar 11 Page 32 of 41
Clause Description Yes No N.A. Remarks
No.
c) Location of sampling, including any
diagrams, sketches or photographs
LAFM03/Mar 11 Page 33 of 41
Clause Description Yes No N.A. Remarks
No.
k) Where relevant, a statement to the effect
that the results relate only to the items
calibrated
LAFM03/Mar 11 Page 34 of 41
Clause Description Yes No N.A. Remarks
No.
(3.15, Are the measurement uncertainties
SAC- associated with the measurand reported
SINGLAS with the expanded uncertainty, coverage
002) factor k and level of confidence of
approximately 95%?
LAFM03/Mar 11 Page 35 of 41
Clause Description Yes No N.A. Remarks
No.
5.10.9 Amendments to Test Reports and
Calibration Certificates
Does the laboratory make amendments to
the test reports or calibration certificates
after issue in the form of a further
document or data transfer which includes
the statement “Supplement to Test Report
[or Calibration Certificate], serial number
…[or as otherwise identified, or an
equivalent form of wording?
SAC-SINGLAS Requirements
A Existing Approved Signatory
1. Do the signatories still occupy appropriate SAC-SINGLAS 001, Clause
positions in the staff structure to be 5.1
responsible for the adequacy of test or
calibration results?
LAFM03/Mar 11 Page 36 of 41
Clause Description Yes No N.A. Remarks
No.
C. Obligations of the accredited laboratory
3.1(d) Not to use the accreditation status in such Refer to Clause 14 in SAC 01
a manner as to bring SAC into disrepute
and not make any statement related to the
accreditation which SAC may consider
misleading or unauthorized.
LAFM03/Mar 11 Page 37 of 41
Clause Description Yes No N.A. Remarks
No.
3.1(e) Provide reasonable facilities, such as
accommodation, cooperation, and access
to documentation, test/calibration
standards, personnel and
calibration/testing areas for assessors and
SAC staff to discharge their duties during
assessments and resolution of complaints;
LAFM03/Mar 11 Page 38 of 41
F. Additional Notes
LAFM03/Mar 11 Page 39 of 41
F. Additional Notes
LAFM03/Mar 11 Page 40 of 41
F. Additional Notes
LAFM03/Mar 11 Page 41 of 41