LAFM03-Mar 11 - ISO 17025 Chklist - v2

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CONFIDENTIAL

SINGAPORE ACCREDITATION COUNCIL


SINGAPORE LABORATORY ACCREDITATION SCHEME (SAC-SINGLAS)

Laboratory Assessment Checklist

Type of Assessment : Preliminary / Initial / Renewal / Surveillance / Non-Routine / Verification

Laboratory :

Address :

Tel / Fax :

Names of persons :
seen

Field :

Date of visit :

Technical :
Assessor(s)/Expert(s)

Lead Assessor :

Name & Signature Date

File Ref: LAS / /

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?

4.1.3 Does the laboratory management


system cover work carried out in:
• permanent facilities?
• sites away from its permanent
facilities?
• associated temporary facilities?
• mobile facilities ?

4.1.4 If the laboratory is part of an organization


performing activities other than testing
and/or calibration:
• are the responsibilities of key
personnel defined in order to
identify potential conflicts of
interest?

(2.1, Are policies available to define how


SAC- impartiality is assured for personnel with
SINGLAS production/ marketing related
002) responsibilities and for departments with
conflicting interests?

4.1.5a Does the laboratory have managerial and


technical personnel, who have the
authority and resources needed to:
• carry out their duties including the
implementation, maintenance and
implementation of the
management system?
• to identify the occurrence of
departures from the management
system or from procedures for
performing tests and/or
calibrations?
• to initiate actions to prevent or
minimize such departures?

4.1.5b Does the laboratory have arrangements to


ensure that its management and personnel
are free from:
• any undue internal and external
commercial pressure?
• financial pressure?
• Other pressures and influences
that may adversely affect the
quality of their work?

(2.2, Is there clear policy & instruction


SAC- implemented for countering these
SINGLAS ‘pressures”?
002)

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?

If relevant, the laboratory should have a


policy written against acceptance of gifts &
gratuities from customers?

4.1.5c have policies and procedures to ensure:


• protection of its customers’
confidential information and
propriety rights?
• protecting electronic storage and
transmission of results?

4.1.5d have policies and procedures to avoid


involvement in any activities that would
diminish confidence in its competence,
impartiality, judgment or operational
integrity?

4.1.5e define the organization and management


structure of the laboratory:
• its place in any parent
organization?
• relationships between quality
management, technical operations
and support services?

4.1.5f specify the:


• responsibility?
• authority?
• interrelationships of all personnel
who manage, perform or verify
work affecting the quality of the
tests and/or calibrations?

4.1.5g Provide adequate supervision of testing


and calibration staff, including trainees, by:
• persons familiar with methods and
procedures?
• purpose of each test and /or
calibration?
• assessment of the test or
calibration results?

4.1.5h. Is technical management available?

(2.3, Are all technical issues relating to testing &


SAC- calibration activities fully covered by the
SINGLAS technical management?
002)
4.1.5i. Is a quality manager appointed?
• with defined responsibility and
authority?
• direct access to the highest level of
management?

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?

4.1.5k. Are the personnel aware of the relevance


and importance of their activities and how
they contribute to the achievement of the
objectives of the management system?

4.1.6 Does top management ensure that


• appropriate communication
processes are established within
the laboratory?
• Communication takes place
regarding the effectiveness of the
management system?

4.2 Management System


( 2.4, Is reference to approved signatories, terms
SAC- of accreditation and policy on the use of
SINGLAS the SAC-SINGLAS endorsement included
002) in the quality documentation?

4.2.1 Is the management system appropriate to


the scope of its activities established,
implemented and maintained?

Are policies, systems, programmes,


procedures and instructions documented
to assure the quality of the test and/or
calibration results?

Is the system’s documentation:


• communicated?
• understood?
• available?
• Implemented?
by the appropriate personnel?

4.2.2 Are the management system policies,


including a quality policy statement defined
in a quality manual?

Are the overall objectives established and


reviewed during management review?

Is the quality policy statement issued under


the authority of the top management?

Does the quality policy statement include


at least the following:

4.2.2a laboratory management’s commitment to


good professional practice and service to
customers?

4.2.2b the management’s statement of the


laboratory’s standard of service?

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?

4.2.2d a requirement that all staff within the


laboratory familiarize themselves with the
quality documentation and implement the
policies and procedures in their work?

4.2.2e laboratory management’s commitment to


• comply with ISO/IEC 17025 ?
• continually improve the
effectiveness of the management
system?

4.2.3 Does the top management provide


evidence of commitment to:
• the development and
implementation of the
management system?
• continually improving its
effectiveness?

4.2.4 Does the top management communicate to


the organization the importance of meeting
customer requirements as well as statutory
and regulatory requirements?

4.2.5 Does the quality manual include or make


reference to the supporting procedures
including technical procedures?

Does it outline the structure of the


documentation used in the management
system?

4.2.6 Are the roles and responsibilities of


technical management and the quality
manager defined in the quality manual?

4.2.7 Does the top management ensure that the


integrity of the management system is
maintained when changes to the
management system are planned and
implemented?

4.3 Document Control


4.3.1 General
Does the laboratory establish and maintain
procedures to control all documents that
form part of its management system?

4.3.2 Document Approval and Issue


4.3.2.1 Are all documents issued to personnel
reviewed and approved for use prior to
issue?

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?

4.3.2.2 Does the procedure(s) adopted ensure


that:
4.3.2.2a appropriate documents are available at all
appropriate locations?

4.3.2.2b documents are periodically reviewed?

4.3.2.2c invalid or obsolete documents are:


• promptly removed from all points
of issue or use?
• assured against unintended use?

4.3.2.2d obsolete documents retained for either


legal or knowledge preservation purposes
are suitably marked?

4.3.2.3 Is the management system documents


generated by the laboratory uniquely
identified?

Do such identification include:


• date of issue and/or revision
identification?
• page numbering?
• the total number of pages or a
mark to signify the end of the
document?
• the issuing authority(ies)?

4.3.3 Document Changes


4.3.3.1 Are changes to documents reviewed and
approved by the same function that
performed the original review unless
specifically designated otherwise?

Does designated staff have access to


pertinent background information upon
which to base their review and approval?

4.3.3.2 Where practicable, is the altered or new


text identified?

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?

Are these amendments clearly marked,


Initialed and dated?

Is a revised document formally re-issued


as soon as practicable?

4.3.3.4 Are procedures established to describe


how changes in documents maintained in
computerized systems are made and
controlled?

4.4 Review of Requests, Tenders and Contracts


4.4.1 Are procedures established and
maintained for the review of requests,
tenders and contracts?

Are policies and procedures for these


reviews ensure that:

4.4.1a the requirements, including the methods to


be used, are defined, documented and
understood?

4.4.1b the laboratory has the capability and


resources meet the requirements?

4.4.1c the appropriate method is selected and


capable of meeting the customers’
requirements?

(2.5, NB: During contract review, calibration


SAC- laboratories should specifically discuss
SINGLAS their measurement uncertainty with their
002) customers to ensure they can meet the
customers’ specifications.

Are differences between the request /


tender/ contract resolved before any work
commences?

Is each contract acceptable to both the


laboratory and customer?

4.4.2 Are records of these reviews and any


significant changes maintained?

Are records of pertinent discussions


relating to the customer’s requirements or
the results of the work during the period of
contract maintained?

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?

4.4.4 Is the customer informed of any deviation


from the contract?

4.4.5 If a contract needs to be amended after


work has commenced:
• is the same contract review
process repeated?
• are any amendments
communicated to all affected
personnel?

4.5 Subcontracting of Tests and Calibrations


4.5.1 When a laboratory needs to subcontract
work, is this work placed with a competent
subcontractor?

(2.6, Are policies and procedures documented


SAC- for engaging subcontractors?
SINGLAS
002)
Are result reported by the subcontractor
covered by an endorsed report?

(2.6.1, For non-accredited subcontractor, does


SAC- laboratory record its assessment of that
SINGLAS subcontractor’s capability to meet ISO/IEC
002) 17025 requirements?

(2.6.1, Are the results of the subcontracted work


SAC- expressed in a SAC-SINGLAS endorsed
SINGLAS report?
002)

4.5.2 Does the laboratory:


• advise the customer of the
arrangement in writing?
• when appropriate, gain the
approval of the customer,
preferably in writing?

4.5.3 Is the laboratory responsible to the


customer for the subcontractor’s work,
except in the case where the customer or a
regulatory authority specifies which
subcontractor is to be used?

4.5.4 Does the laboratory maintain a:


• register of all subcontractors that it
uses for tests and/or calibrations?
• record of the evidence of
compliance with ISO/IEC 17025 for
the work in question?(accreditation
status should be current)

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.

4.6.1 Are policy and procedure(s) available for


• selection?
• purchasing of services and
supplies it uses?
that affect the quality of the tests and/or
calibrations.

Do procedures exist for the:


• purchase?
• reception?
• storage?
of reagents and laboratory consumable
materials relevant for the tests and
calibrations.

4.6.2 Are purchased supplies/ reagents/


consumable materials inspected before
use?

Are records of inspections / verifications


maintained?

4.6.3 Do purchasing documents for items


contain data describing the services and
supplies ordered?

Are these purchasing documents reviewed


and approved for technical content prior to
release?

4.6.4 Does the laboratory evaluate:


• suppliers of critical consumables?
• supplies and services which affect
the quality of testing and
calibration?
• maintain approved list and records
of these evaluations?

4.7 Service to the Customers


4.7.1 Is the laboratory willing to cooperate with
customers or their representatives in
• clarifying the customer’s request?
• monitoring the laboratory’s
performance in relation to the work
performed?

Ensure confidentiality to other customers

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?

Is the feedback used and analyzed to


improve the management system,
testing/calibration activities and customer
service?

(2.8, If applicable, are the feedback from the


SAC- internal clients sought?
SINGLAS
002)

4.8 Complaints
Are policy and procedure for the resolution
of complaints received from customers or
other parties available?

(2.9, Does the laboratory inform SAC-SINGLAS


SAC- when a complaint involving any technical
SINGLAS competency or integrity of test/calibration
002) result relating to the scope of accreditation
is not resolved within 90 days from the
date of receipt of the complaint?

Are records maintained for all complaints


and of the investigations and the corrective
actions taken by the laboratory?

4.9 Control of Non-Conforming Testing and/or Calibration work


4.9.1 Are policy and procedures implemented
when the results do not conform to its own
procedures or the agreed requirements of
the customer?

Do the policy and procedures ensure that:

4.9.1a responsibilities, authorities and actions are


defined and taken?

4.9.1b an evaluation of the significance of the


nonconforming work is made?

4.9.1c correction and decisions are taken


immediately about the acceptability of the
nonconforming work?

4.9.1d Where necessary, the customer is notified


and work is recalled?

4.9.1e the responsibility for authorizing the


resumption of work is defined?

4.9.2 Does evaluation reveal possible


recurrence?
If YES, see 4.11 for compliance.

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?

(2.10, Is the laboratory able to show evidences


SAC- on how continuous improvement are
SINGLAS sought in the workplace?
002)

4.11 Corrective Action


4.11.1 Does the laboratory establish a policy and
a procedure and designate appropriate
authorities for implementing corrective
action?

4.11.2 Is cause analysis done to determine the


root cause(s) of the problem?

4.11.3 Where corrective action is needed, does


the laboratory:
• identify potential corrective
actions?
• select and implement the action(s)
to prevent recurrence?

Are corrective actions appropriate to the


magnitude and risk of the problem?

Does the laboratory document and


implement any required changes resulting
from the above corrective action?

4.11.4 Are corrective actions monitored for


effectiveness?

4.11.5 Are the appropriate areas of activity


audited in accordance with 4.14 when
there is a doubt(s) on the laboratory’s
compliance?

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?

If preventive action is required, are action


plans developed, implemented and
monitored to take advantage of the
opportunities for improvement?

4.12.2 Are procedures for preventive actions


effective?

4.13 Control of Records


4.13.1 General
4.13.1.1 Does the laboratory establish and maintain
procedures for:
• identification
• collection
• indexing
• access
• filing
• storage
• maintenance
disposal of quality and technical records

4.13.1.2 Are all records:


• legible?
• stored and retained?
• to prevent damage or
deterioration?
• to prevent loss?

Is retention time of records established?

4.13.1.3 Are all records held secure and in


confidence?

4.13.1.4 Are procedures available to:


• to protect?
• back-up records stored
electronically?
• to prevent unauthorized access to
or amendment of these record?

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?

Do the records for each test or calibration


contain sufficient information to:
• identification of factors affecting
the uncertainty?
• enable the test or calibration to be
repeated under original
conditions?

4.13.2.2 Are observations, data and calculations


recorded at the time they are made and
identifiable to the specific task?

4.13.2.3 When mistakes occur in records, is each


mistake:
• crossed out?
• not erased?
• made illegible or deleted, and the
correct value entered alongside?
• signed or initialed by the person
making the correction?

Are equivalent measures taken for records


stored electronically?

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?

(2.12.1, Is this cover over a twelve-month period?


SAC-
SINGLAS
002)
Are all elements of the management
system, testing and/or calibration activities
addressed?

(2.12.1, NB: The audit should determine if


SAC- • procedures described in the
SINGLAS management system are being
002)
followed;
• objectives (as defined in the
management system) are being
achieved;
• designated duties are being
carried out satisfactorily and
• there are opportunities for
improvements.

(2.12.2, Is an audit checklist used? Are all


SAC- evidences of areas audited recorded?
SINGLAS
002)

Are such audits carried out by trained and


qualified personnel who are, however
resources permit, independent of the
activity to be audited?

4.14.2 When audit findings cast doubts, does the


laboratory take:
• timely corrective action?
• where necessary, notify customers
in writing?

4.14.3 Are the following recorded:


• the area of activity audited?
• the audit findings?
• corrective actions that arise from
them?

4.14.4 Are follow-up audit activities verified for the


implementation and effectiveness of the
corrective action taken recorded?

(2.12.3, Are the corrective actions verified and


SAC- accepted by the relevant internal auditor?
SINGLAS
002)

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?

(2.13, Is this carried out at least once every


SAC- twelve months?
SINGLAS
002)
Does the review take account of:
• the suitability of policies and
procedures?
• reports from managerial and
supervisory personnel?
• the outcome of recent internal
audits?
• corrective and preventive actions?
• assessments by external bodies?
• the results of inter-laboratory
comparisons or proficiency tests?
• changes in the volume and type of
the work?
• Customers feedback?
• complaints?
• Recommendations for
improvement?
• other relevant factors? (e.g. quality
control activities, resources and
staff training)

4.15.2 Are findings and actions from management


reviews recorded and carried out within an
appropriate and agreed time scale?

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

(3.1, NB: Criteria for evaluation should be based


SAC- on the range, complexity and frequency of
SINGLAS performing of calibrations/tests for which
002) accreditation is sought

Are staff undergoing training supervised?

Does the laboratory have qualified


personnel for the required:
• education?
• training?
• experience and/or demonstrated
skills?

5.2.2 Does the laboratory formulate goals with


respect to:
• education?
• training?
• skills?
of the staff?

Does the laboratory have policies and


procedures for:
• identifying training needs?
• providing training of personnel?

Does the laboratory evaluate the


effectiveness of the training actions taken?

(3.1.1, Does the laboratory has proper procedures


SAC- for training new technical personnel and for
SINGLAS developing the expertise of existing
002) technical personnel in new or rarely used
techniques?

Are criteria defined, records available and


validity of results monitored?

5.2.3 If contracted staff are used, are they:


• evaluated for competency?
• supervised?

5.2.4 Are current job descriptions available?

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?

(3.1.4, Does the personnel responsible for giving


SAC- opinions and interpretation have in-depth
SINGLAS knowledge of the relevant technical
002) discipline?
NB: They should comply with Note 2 of
Clause 5.2.1 of ISO/IEC 17025.

(3.1.5, NB: Site laboratory should be under


SAC- adequate technical control.
SINGLAS
002)

Does the laboratory maintain records of:


• relevant authorization (s)?
• competence?
• educational and professional
qualifications?
• training?
• skills and experience of all
technical personnel, including
contracted personnel?
• date on which authorization and/or
competence is confirmed?

5.3 Accommodation and Environmental Conditions


5.3.1 Are the following environmental conditions
fulfilled:
• energy sources?
• accommodation e.g. lighting?
• others?

Do the following laboratory environmental


conditions invalidate the results or
adversely affect the required quality of any
measurement:
• during sampling?
• at site laboratories?
• others?

(3.2, NB: Testing sites should be chosen to


SAC- minimise the effects of environmental
SINGLAS conditions and contamination. All relevant
002) environmental conditions should be
recorded and retained with other data.

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?

5.3.2 Does the laboratory monitor, control and


record environmental conditions?

When the environmental conditions


jeopardize results of the tests and/or
calibrations has the testing and/or
calibration activities stopped?

5.3.3 Is there effective separation between


neighbouring areas where incompatible
activities are performed?

If No, are appropriate measures taken to


prevent cross-contamination?

5.3.4 Is access to and use of areas affecting the


quality of tests and/or calibration
controlled?

Is the extent of control determined?

5.3.5 Are measures taken to ensure good


housekeeping?

Are special procedures prepared, where


necessary?

5.4 Test and Calibration Methods and Method Validation


5.4.1 General
Is the laboratory using appropriate
methods and procedures for:
• all tests/calibration within its
scope?
• sampling?
• handling?
• transport?
• storage and preparation of items?
• where appropriate, an estimation
of measurement uncertainty?
• statistical techniques for analysis
of test and/or calibration data?

Does the laboratory have instructions on


the:
• use and operation of relevant
equipment?
• handling and preparation of items
for testing/calibration?

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?

(3.3, Is there a formalized system to issue,


SAC- review and update methods and
SINGLAS specifications?
002)

When deviations from test/calibration


methods occur, are these:
- documented?
- technically justified?
- authorised?
- accepted by customer?

(3.3.1, NB: Laboratory may be required to show


SAC- records of test/calibration which are done
SINGLAS infrequently to demonstrate the
002) competence of the laboratory’s staff.
Laboratory is required to set up a regular
schedule of performance checks to verify
and demonstrate their continuing
competence.

5.4.2 Selection of methods


Is the laboratory using test/calibration
methods (including sampling) which meet
the needs of the customer?

Is the laboratory using the latest valid


edition of the test method?

Is the laboratory selecting appropriate


methods published from:
• international, regional, national
standards
• reputable technical organization
• relevant scientific text/journals
• manufacturer’s specifications

Are laboratory-developed methods or non-


standard methods, adopted by the
laboratory used?
• are they appropriate for their
intended use?
• are these methods validated?
• is the customer informed?

Are the standard methods confirmed


before use?

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.

5.4.3 Laboratory-developed Methods


Does the laboratory ensure that the
methods developed (for its own use) is:
• a planned activity?
• assigned to qualified personnel
with adequate resources to
manage this planned activity?
• updated on its developmental
plans and this is communicated?

5.4.4 Non-Standard Methods


When methods not covered by standard
methods are used, then:
• is the purpose identified?
• are the methods developed
validated before use?
• is customer agreement obtained
and this shall include customer
specifications?

5.4.5 Validation of Methods


5.4.5.2 Does the laboratory validate the methods
to confirm their fit for the intended use?

Are the following documented:


• results of the validation?
• procedure used for validation?
• statement as to whether the
method is fit for its intended use?

5.4.5.3 Are the range and accuracy of the values


obtained relevant to the customer’s
needs?

5.4.6 Estimation of Uncertainty of Measurement


5.4.6.1 Does the laboratory perform its own
calibrations?

Are procedures applied for estimation of


measurement uncertainty for all
calibrations?

(3.5, Is ISO GUM being used by calibration


SAC- laboratory to determine measurement
SINGLAS uncertainties? (NB: SAC-SINGLAS
002) Technical Guide 1 may be used for
guidance)

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.

Are the following requirements being met?


a. Methods or procedures employed for
the purpose of in-house calibration
should be either published standards
or consensus methods which are fit for
their intended purpose.

b. Measurement uncertainty shall be


reported in the in-house calibration
report.

c. To ensure the technical competence of


staff performing in-house calibration.

d. The in-house calibration report shall


include information where appropriate
as listed in clause 5.10.2 and clause
5.10.4 of ISO/IEC 17025. It shall
include detailed information on but not
limited to:
i. The intended use of the
calibrated equipment
ii. The specification limits of the
calibrated equipment
iii. The measurement range of the
calibrated equipment
iv. A statement of compliance of
the calibrated equipment
whether it meets the specified
requirements.
v. The traceability of the
reference standard to
International System of Units
(SI)

5.4.6.2 For Testing Laboratories Only


Are procedures available for estimating
uncertainty of measurement in test results?

(3.7, Are measurement uncertainty estimated


SAC- for all quantitative tests?
SINGLAS
002)

(3.5.1, NB: Testing laboratories may use ISO


SAC- GUM, ISO 5725, SAC-SINGLAS Technical
SINGLAS Guide 2 or other international documents
002) such as Eurachem Guide to estimate
measurement uncertainty.

Are test methods precluded from the


calculation of uncertainty of measurement
justified?

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?

(3.7.1, Are measurement uncertainty reported for


SAC- borderline results where the uncertainty
SINGLAS may affect compliance to a specification
002) limit?

5.4.6.3 Are all uncertainty components of


importance taken into account?

(3.7.3, Are all sources of uncertainty evaluated


SAC- and recorded?
SINGLAS
002)

(3.7.4, Does the applicant laboratory work


SAC- towards estimation of measurement
SINGLAS uncertainty for all parameters under its
002) scope?

5.4.7 Control of Data


5.4.7.1 Are calculations and data transfers
checked?

5.4.7.2 Are computers or automated equipment


used for acquisition, processing, recording,
reporting, storage, retrieval, of
test/calibration data?

5.4.7.2a. Does the laboratory ensure that the


computer software developed by the user
is documented and validated?

5.4.7.2b. Are procedures established and


implemented for protection of data?

5.4.7.2c. Are the computers and automated


equipment maintained in the appropriate
environmental and operating conditions?

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?

5.5.2 • achieving the accuracy required?


• comply with specifications relevant
to the test and/or calibrations
concerned?
• are calibration programmes
established? (where key quantities
or values of the instruments have
a significant effect on the results)
• calibrated and checked before
being placed in service?
• calibrated and checked before
use?

(3.8.1, Is there a monitoring system in operation


SAC- to alert the laboratory staff on the due
SINGLAS dates of calibration, verification and
002) maintenance for all items of equipment?

(3.8.2, Is the laboratory able to show that the


SAC- calibration reports are reviewed after
SINGLAS calibration of equipment?
002)

5.5.3 • Equipment operated by authorised


personnel?
• having up-to-date instructions on
the use and maintenance?

5.5.4 • Equipment is uniquely identified


(where practicable)?

5.5.5 Are the following records of each item of


equipment and its software maintained:

5.5.5a. Identity of the item of equipment and its


software?

5.5.5b. Manufacturer’s name, type identity, and


serial number or other unique
identification?
5.5.5c. Check of equipment for compliance with
specification (see 5.5.2)?

5.5.5d. Current location, where appropriate?

5.5.5e. Manufacturer’s instructions, if available, or


reference to their location?

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?

5.5.5g. Maintenance plan, where appropriate, and


maintenance carried out to date?

5.5.5h. Any damage, malfunction, modification or


repair to the equipment?

5.5.6 Are procedures to ensure proper


functioning and to prevent contamination
or deterioration of measuring equipment
available for:
• safe handling?
• transport?
• storage?
• use and planned maintenance?

5.5.7 Are equipment giving suspected results or


defective or outside specified limits due to
overloading or mishandling:
• taken out of service?
• isolated?
• clearly labeled?
• marked as being out of service?

Has the laboratory examined the effect of


the defect or departure from specified
limits on previous tests and/or calibrations?

If Yes, is the procedure for the “Control of


nonconforming work” implemented (see
4.9)

5.5.8 Are all equipment under the control of the


laboratory and requiring calibration
identified to:
• indicate the status of last
calibration and next calibration?
• expiration criteria when
recalibration is due?

5.5.9 When equipment goes outside the direct


control of the laboratory, does the
laboratory ensure that the function and
calibration status of the equipment are
checked and shown to be satisfactory
before the equipment is returned to
service?

5.5.10 Where intermediate checks are needed to


maintain confidence, are these checks
carried out in accordance to a defined
procedure?

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?

5.5.12 Are test and calibration equipment


(including both hardware and software)
safeguarded from adjustments, which
would invalidate the test or calibration
results?

5.6 Measurement Traceability


5.6.1 General
Is all equipment including equipment for
subsidiary measurements having a
significant effect on the accuracy or validity
of the result of the test, calibration or
sampling calibrated before being put into
service?

Is a programme and procedure for the


calibration of its equipment established?

5.6.2 Specific Requirements


5.6.2.1.1 Calibration
Are calibrations and measurements
traceable to the International System of
Units (SI)?

Where the laboratory is using external


calibration services, is traceability of
measurement assured by these external
calibration laboratories? (refer to SAC-
SINGLAS 006)

Do the external calibration certificates


contain:
• measurement results, including the
measurement uncertainty?
• and/or statement of compliance
with an identified metrological
specification?

5.6.2.1.2 Where traceability of calibrations that


cannot be strictly made in SI units, is
confidence in measurement established by
use of:
• certified reference materials
(CRM)?
• specified methods and/or
consensus standards that are
clearly described and agreed by all
parties concerned?

(3.9.1, NB: It is the responsibility of the laboratory


SAC- to ensure that traceability of the reference
SINGLAS materials or reference standards is
002) established.

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.

(3.10, Are reference standards and equipment


SAC- calibrated over the intended range and to
SINGLAS the appropriate level of accuracy specified
002) in the relevant test methods?

Does the laboratory ensure that the


equipment used can provide the
uncertainty of measurement needed?

5.6.2.2.2 Note: Where traceability of measurements


to SI units is not possible and/or not
relevant, the same requirements for
traceability to are required as for
calibration laboratories (Refer to 5.6.2.1.2.)

(3.10.1, NB: A laboratory performing its own


SAC- calibration will also be subjected to
SINGLAS technical assessment to ensure all the
002) relevant requirements of ISO/IEC 17025
are met.

5.6.3 Reference Standards and Reference


Materials
5.6.3.1 Reference Standards
Does the laboratory have a programme
and procedure for the calibration of its
reference standards?

Are these reference standards calibrated


by a body that can provide traceability as
described in 5.6.2.1?

Are these standards of measurement:


• only used for calibration?
• If standards are used for other
purposes then the laboratory has
to show that the performance as
reference standards is not
invalidated?

Are the reference standards calibrated


before and after adjustment?

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?

Are internal reference materials (where


possible) checked periodically?

(3.11, NB: For laboratories using reference


SAC- materials, all precautions have to be taken
SINGLAS to match the matrices of the reference
002) materials to those encountered in the
laboratory’s test samples.

Are the effects of any non-matching


matrices determined?

5.6.3.3 Are intermediate checks carried out in


according to defined procedures and
schedules on:
• reference, primary standards,
transfer or working standards?
• reference materials?

5.6.3.4 Are there procedures to prevent


contamination /deterioration/ to protect
integrity for the following:
• safe handling?
• transport?
• storage?
• use of reference standards and
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?

5.7.1 Are a sampling plan and procedures for


sampling available?

Are sampling plan and procedures


available at the location where sampling is
undertaken?

Are the sampling plans based on


appropriate statistical methods (wherever
reasonable)?

Does the sampling process address


factors that need to be controlled in order
to ensure validity of the test and calibration
results?

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?

5.7.3 Does the laboratory have procedures for


recording relevant data and operations
relating to sampling that forms part of the
testing or calibration that is undertaken?

Do these records include the following:


• sampling procedure used
• identification of the sampler
• environmental conditions (if
relevant)
• identification of sampling location
• statistics used in the sampling
procedures

(3.12.1, When the laboratory has partial or no


SAC- control over sampling, are the following
SINGLAS issues addressed?
002)
a. Test records shall include details of the
supplier of the sample and other
relevant historical information such as
condition on receipt, reported date of
sampling. If a sample has a
characteristic that cast doubt on its
validity, but is not possible to reject the
sample, a clear statement of the
perceived deficiency shall be made on
the report.

b. When customer, suppliers or factory


personnel take samples, they should
be provided with written sampling
instructions. It may be necessary for
the laboratory to supply appropriate
clean and labeled sampling containers
and/or training in sampling technique.
Sample containers shall be free from
any source of contamination;

c. If a test method specifies the use of a


particular sampling method, and the
laboratory has no evidence as to
whether the sampler followed the
method, this fact shall be
acknowledged on the report.

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

Does the laboratory have the necessary


provisions to protect the:
• integrity of the test or calibration
item?
• interests of the laboratory and the
customer?

5.8.2 Does the laboratory have a system for


identifying test and/or calibration items
both physically and in the records and
accommodate subdivision of groups of
items, if applicable?

5.8.3 Upon receipt, are abnormalities or


departures recorded?

If there is doubt as to the suitability of an


item or does not conform to the description
provided or the test/calibration is not
specified in sufficient detail does the
laboratory consult the customer for further
instructions before proceeding?

Is the customer consulted and the


discussion recorded?

5.8.4 Does the laboratory have procedures and


appropriate facilities for:
• avoiding deterioration?
• loss or damage to the test
/calibration item during storage?
• handling and preparation?

Does the laboratory follow the handling


instructions provided with the item?

When items have to be stored, are these


conditions monitored, maintained and
recorded?
Where a test or calibration item or a
portion of an item is to be held secure,
does the laboratory have arrangements
for:
• storage and security to protect the
condition?
• integrity of the secured items or
portions concerned?

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?

Is the resulting data recorded in such a


way that trends are detectable?

Where applicable, are statistical


techniques applied to the reviewing of the
results?

Is the monitoring planned and periodically


reviewed?

Tick the appropriate quality control activity


used by the laboratory?

5.9.1a. Regular use of certified reference material


and/or internal quality control using
secondary reference materials;

5.9.1b. Participation in interlaboratory comparison


or proficiency-testing programmes;

5.9.1c. Replicate tests or calibrations using the


same or different methods;

5.9.1d. Retesting or recalibration of retained items;

5.9.1e. Correlation of results for different


characteristics of an item;

5.9.2 Is quality control data analyzed?

If they are found to be outside pre-defined


criteria, is planned action taken to correct
the problem and to prevent incorrect
results from being reported?

Does the laboratory comply with the


requirements stated in PROF 001 on
- participation?
- investigation of outlier?

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?

If the results are in a simplified form, is the


information listed in 5.10.2 to 5.10.4
available in the laboratory?

5.10.2 Test reports only


Does the laboratory have at least the
following information in the test report:

a) A title (e.g. “Test Report” )

b) Name and address of the laboratory, and


the location where the tests are carried out,
if different from the address of the
laboratory

c) Unique identification of the test report (such


as serial number) and on each page an
identification in order to ensure that the
page is recognised as a part of the test
report, and a clear identification of the end
of the test report

d) Name and address of the customer

e) Identification of the method used

f) A description of, the condition of, and


unambiguous identification of the item(s)
tested

g) The date of receipt of the test item(s) where


this is critical to the validity and application
of the results, and the date(s) of
performance of the test

h) Reference to the sampling plan and


procedures used by the laboratory or other
bodies where these are relevant to the
validity or application of the results

i) The test results with, where appropriate,


the units of measurement

j) The name(s), function(s) and signature(s)


or equivalent identification of person(s)
authorising the test report

k) Where relevant, a statement to the effect


that the results relate only to the items
tested

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?

Is the system safeguarded and the identity


of the person taking responsibility for the
report clearly identified?

NB: Unendorsed reports and the


associated work on tests/calibration within
the terms of accreditation are expected to
be of the same standard as endorsed
reports.

5.10.3.1 In addition to 5.10.2, does the test report


have also the following, when necessary
for the interpretation of the test results:

a) Deviations from, additions to, or exclusions


from the test method, and information on
specific test conditions such as
environmental conditions

b) Where relevant, a statement of


compliance/non-compliance with
requirements and/or specifications

c) Where applicable, a statement on the


estimated uncertainty of measurement;
information on uncertainty is needed in test
reports when it is relevant to the validity or
application of the test results, when a
customer instruction so requires, or when
the uncertainty affects compliance to a
specification limit

d) Where appropriate and needed, opinions


and interpretations (see 5.10.5)

e) Additional information which may be


required by specific methods, customer or
group of customers.

5.10.3.2 In addition if the test report contains the


results of sampling, does the test report
have the following, when necessary for
the interpretation of the test results:

a) Date of sampling

b) Unambiguous identification of the


substance, material or product sampled
(including the name of the manufacturer,
the model or type of designation and serial
numbers as appropriate)

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

d) A reference to the sampling plan and


procedures used

e) Details of any environmental conditions


during sampling that may affect the
interpretation of the test results

f) Any standard or other specification for the


sampling method or procedure, and
deviations, additions to or exclusions from
the specification concerned

5.10.2 / Calibration Certificates Only


5.10.4 Does the laboratory have at least the
following information in the calibration report

a) A title (e.g. “Calibration Certificate”)

b) Name and address of the laboratory, and


the location where the calibrations are
carried out, if different from the address of
the laboratory

c) Unique identification of the calibration


report (such as serial number) and on each
page an identification in order to ensure that
the page is recognised as a part of the
calibration report, and a clear identification
of the end of the calibration report

d) Name and address of the customer

e) Identification of the method used

f) A description of, the condition of, and


unambiguous identification of the item(s)
calibrated

g) The date of receipt of the calibration item(s)


where this is critical to the validity and
application of the results, and the date(s) of
performance of the calibration

h) Reference to the sampling plan and


procedures used by the laboratory or other
bodies where these are relevant to the
validity or application of the results

i) The calibration results with, where


appropriate, the units of measurement

j) The name(s), function(s) and signature(s)


or equivalent identification of person(s)
authorising the calibration report

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

5.10.4.1 In addition, does the calibration report


have also the following, when necessary
for the interpretation of the calibration
results:

a) The conditions (e.g. environmental) under


which the calibrations were made that
have an influence on the measurement
results

b) The uncertainty of measurement and/or


statement of compliance with an identified
metrological specification or clauses
thereof

c) Evidence that the measurements are


traceable (see note 2 in 5.6.2.1.1)

5.10.4.2 Does the calibration certificate relate only


to the quantities and the results of
functional tests?

If a statement of compliance with a


specification is made, are the clauses of
the specification identified?

If a statement of compliance with a


specification is made omitting the
measurement results and associated
uncertainties does the laboratory record
and maintain the results for possible future
reference?

When statements of compliance are made,


does the laboratory take into account the
uncertainty of measurement?

5.10.4.3 Does the laboratory report the calibration


results before and after adjustment or
repair of the instrument for calibration (if
available)?

5.10.4.4 Does the calibration certificate (or


calibration label) contain any
recommendation on the calibration
interval?

If Yes, then has this been agreed with the


customer? (Note this requirement may be
superseded by legal regulations)

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%?

(3.15.1, NB: The numerical value of the uncertainty


SAC- of measurement should be given to at
SINGLAS most two significant figures.
002)

(3.15.2, NB: The numerical value of the


SAC- measurement result should in the final
SINGLAS statement normally be rounded to the least
002) significant figure in the value of the
expanded uncertainty assigned to the
measurement result.

5.10.5 Opinions and Interpretations


Does the laboratory document the basis on
which the opinions and interpretations
have been made? (see 5.2.1 and Note 2)

Are these opinions and interpretations


clearly marked as such in the test report?

5.10.6 Testing and Calibration Results Obtained


from Subcontractors
Are the results in the test reports
performed by subcontractors clearly
identified?

Does the subcontractor report the results


in:
• writing
• electronically

Does the laboratory performing the work


where the calibration has been
subcontracted, issue a calibration
certificate to the contracting laboratory?

5.10.7 Electronic Transmission of Results


Does the laboratory meet the requirements
of this International Standard when
transmitting test or calibration results by
telephone, telex, facsimile, or other
electronic or electromagnetic means?

5.10.8 Formats of Reports and Certificates


Does the design of the format
accommodate each type of test or
calibration carried out and minimizes the
possibility of misunderstanding or misuse?

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?

Do these amendments meet the


requirements of ISO/IEC 17025?

When a completely new test report or


calibration certificate is to be issued, does
the laboratory uniquely identify and make a
reference to the original that it replaces?

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?

2. Do the signatories still retain sufficient SAC-SINGLAS 001, Clause


contact time with testing/calibration 5.10
procedures to maintain the ability for
critical evaluation of results?

3. For approved signatories including SAC-SINGLAS 001, Clause


nominees, are the requirements stated in 5.
Clause 5 of SAC-SINGLAS 0 01 being
met?

B. New Nominees for Signatory Approval


1. Does/Do the nominee(s) occupy SAC-SINGLAS 001, Clause
appropriate positions in the staff structure 5.1
to be responsible for the adequacy of test
or calibration results?

2. Does/Do the nominee(s) spend sufficient SAC-SINGLAS 001, Clause


time in the laboratory in order to exercise 5.10
adequate supervision?

3. Is/are the nominee(s) familiar with the SAC-SINGLAS 001, Clause


quality system as documented in the 5.5
quality manual and SINGLAS
requirements?

4. Comments from technical assessor on the SAC -SINGLAS 001, Clause


nominee(s) technical qualification, 5.1, 5.6, 5.9
experience, knowledge of test/calibration
methods, competency in making critical
evaluation of test/calibration results (See
requirements in A.3)

LAFM03/Mar 11 Page 36 of 41
Clause Description Yes No N.A. Remarks
No.
C. Obligations of the accredited laboratory

4.6.3 Submit a copy of the internal audit report to SAC-SINGLAS 001


SAC prior to the assessment.

3.1(a) Offer to all customers a standard of service SAC 01


consistent with the SAC terms and
conditions and maintain impartiality and
integrity in all operations;

3.1 (b) Immediately notify SAC-SINGLAS on:

(i) Any change in its legal, commercial or


organisational status;

(ii) Any changes in organisation, top


management and key personnel e.g. key
managerial staff, management
representative and approved signatories
who could affect the performance or
competence of the laboratory;

(iii) Plans to conduct any accredited activities


outside the Republic of Singapore;

(iv) Change of resources and premises, where


the accredited laboratory has the
responsibility to inform SAC at least 3
months in advance; The accreditation will
be inoperative once the relocation begins
and will be re-instated when competency
has been verified on a case by case basis;

(v) Any lawsuit or criminal investigation of the


laboratory or its staff;

(vi) Any changes to the scope of accreditation;

(vii) Any significant changes in main policies;

(viii) Any other matters that may affect the


ability of the laboratory to fulfil
requirements for accreditation;

3.1(c) Adhere to the rules for the use of the SAC


Accreditation Marks and reference to
accreditation status

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;

3.1(f) Make prompt payment to SAC of all


necessary fees levied by SAC;

3.1(g) Upon the withdrawal of accreditation


forthwith discontinue its use of reference to
accreditation and withdraw all advertising
materials which contains any reference to
accreditation;

3.1(h) Make a clear and unequivocal statement in


all contacts with its customers that a
certificate of accreditation in no way
implies that the product or service is
approved by SAC; and

3.1 (i) Not represent or hold itself out as being the


agent or partner of SAC or make any
representations on behalf of SAC.

D. Follow up on last year findings

E. Other Observation and Comments


Safety (SAC-SINGLAS 001, Clause 7)

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

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