Internal Audit Plan

Month/Year: Jul / 2024

Auditor's Dept /
Planned Date Auditees Dept Auditee Clause Applicable ISO Procedures Auditor
Post

15 Jul 2024
QMR Fung Leng QM & QP Refer to Qualiware Nadhirah QA
to 19 Jul 2024
 Internal & External Audit Plan

Planned Date Time Agenda Party Involved Conducted by

15 Jul 2024 Internal Audit Auditees from Internal

9am - 5pm
to 19 Jul 2024' (Refer to audit plan) various dept Auditors

Management
26-Jul 10.30am - 11am Management QMR
Review

Singapore
External
27-Aug 8.30am - 5.30pm All dept Accreditation Council
Audit
(SAC)
Internal Audit Findings

Month/Year: Jul / 2024

Estimated
Dept Auditted NCR No. Description of NC Corrective and/or Preventive Action
Completion Date

No finding / observation
 CONFIDENTIAL

SINGAPORE ACCREDITATION COUNCIL

SINGAPORE LABORATORY ACCREDITATION SCHEME (SAC-SINGLAS)

Laboratory Assessment Checklist

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

Laboratory : Bossard Pte Ltd

Address : 8 Pandan Crescent, Lobby 4 #05-05/06, Singapore 128464

Tel / Fax : +6567782515

Names of persons : Ganesan, Vikraman

seen

Field : Quality laboratory

Date of visit : 23rd to 26th Jul 2024

Technical : NA
Assessor(s)/Expert(s)

Lead Assessor : Nur Nadhirah

26th Jul 2024

Name & Signature Date

LAFM03/ 02 April 2018 Page 1 of 29

References
ISO/IEC 17025: 2017, SAC-01, SAC-02, SAC-SINGLAS 001, SAC-SINGLAS 002, SAC-SINGLAS 006,
PROF 001

Description
To Produce Mandatory to meet the requirement
To Consider Guidance to meet the requirement

Clause Description Yes No N.A Remarks

No.
4. General Requirements
4.1 Impartiality
4.1.2 Does the laboratory demonstrate Yes 1) Management of Impartiality
management commitment to impartiality?
2) Code of Conduct
To consider
• Management review
• Code of conduct
• Declaration forms relating to
confidentiality / impartiality

4.1.4 Does the laboratory identify risks to its Yes BSI 2022_Riskportfolio
impartiality on an ongoing basis?

- Risk from activities

- Risk from its relationships
- Risk from the relationships of its personnel

To consider
• Risk assessment
• Risk matrix

4.1.5 Does the laboratory eliminate or minimize Yes BSI 2022_Riskportfolio

the risks identified?

4.2 Confidentiality
4.2.1 How is the laboratory responsible for the Yes Code of conduct
confidentiality of information obtained or
created during the performance of
laboratory activities, and proprietary rights
of its customers?

To consider
• Code of conduct
• Contractual agreement

4.2.2 Does the laboratory notify its customers NA No issue

when the laboratory is legally obliged to
release confidential information of its
customers?

4.2.3 Does the laboratory ensure that information NA No issue

about its customers received from sources
other than the customers are kept
confidential?

Does the laboratory ensure that the

source(s) of information about its customers

LAFM03/ 02 April 2018 Page 2 of 29

Clause Description Yes No N.A Remarks
No.
is not revealed to the customers unless
agreed by the source(s)?

LAFM03/ 02 April 2018 Page 3 of 29

4.2.4 How does the laboratory ensure that Yes Code of conduct
personnel keep confidential all information
obtained or created during the performance
of laboratory activities?

5. Structural Requirements
5.1 Is the laboratory or the organization legally Yes 1) ACRA
responsible?
2) BSI Biz Profile-3Sep19
To produce
• Valid ACRA Certificate
• Company registration number

5.2 Does the laboratory identify management Yes 1) Job Description

that has overall responsibility for the
laboratory? 2) Organization chart

To consider
• Job description
• Organisation chart

5.3 Does the laboratory define and document Yes Permanent facilities
5.4 the range of laboratory activities which
conforms to ISO 17025:2017?

Does it cover work carried out in:

• permanent facilities?
• sites away from its permanent
facilities?
• associated temporary facilities?
• mobile facilities?
• customer’s facilities?

Do these activities conform to customer and

regulatory requirements?

5.5 Does the laboratory: Yes Job Description

a) define the organization and management

structure of the laboratory

b) specify the responsibility, authority and

interrelationship of all personnel who
manage, perform or verify work affecting
the results

c) document necessary procedures to ensure

consistent application of its activities and
the validity of its results?

To consider
Job description, Organisation chart, Roles
and Responsibilities, Standard Operating
Procedures

LAFM03/ 02 April 2018 Page 4 of 29

5.6 Does the laboratory have authorized and Yes 1) Job Description
sufficient personnel to:
2) Letter of Appointment
a) implement, maintain and improve the (Approved Signatory & QMR)
management system?

b) Identify deviations and initiate actions to

minimize or prevent such deviations?

c) Report to management on the performance

of the management system and any need
for improvements?

d) Ensure the effectiveness of laboratory

activities?

5.7 Does the laboratory communicate to staff Yes

about the effectiveness and integrity of the
management system when changes are
made to it?

6. Resource Requirements
6.1 General
Does the laboratory have sufficient Yes Sufficient resources
personnel, facilities, equipment, systems
and support services necessary to manage
and perform its laboratory activities?

6.2 Personnel
6.2.2 Does the laboratory document the Yes 1) Job Description
competence requirements for each function
that may influence the results of laboratory 2) Training evaluation
activities? - Training records
- Competence level
- Education
- Qualification
- Training required
- Technical knowledge
- Skills
- Experience

To consider
• Training and Competency Matrix
• Job description
• Training records
• Curriculum vitae

6.2.4 Are the duties, responsibilities and Yes Job Description

authorities of laboratory personnel
communicated to them?

LAFM03/ 02 April 2018 Page 5 of 29

6.2.5 Does the laboratory have procedures and Yes QP_TRG Rev 1
retain records for:

a) Determining the competence requirements?

b) to f) Selection, training, supervision,

authorization, and monitoring of
competence of personnel performing
laboratory activities?

To produce
• Procedures of the above
• Records of the above

6.2.6 Does the laboratory authorize personnel to Yes QP_TRG Rev 1

perform laboratory activities pertaining to:

a) development, modification, verification and

validation of methods?

b) analysis of results, including statements of

conformity or opinions and interpretations?

c) report, review and authorization of results?

6.3 Facilities and environmental conditions

6.3.1 Does the laboratory document and ensure Yes QP_OPS Rev 1
6.3.2 control of the facilities and environmental
conditions necessary for the performance of
the laboratory activities?

To produce
• Procedures of the above

6.3.3 Does the laboratory monitor, control and Yes Testo (Temperature & humidity
record the environmental conditions? monitoring device)

To produce
• Records of the above

6.3.4 Does the laboratory monitor and Yes 1) Authorized door access to
periodically review the measures to control lab from warehouse
facilities? For example:
2) Signs displayed at front
- Access to and use of laboratory areas? - No entry
- No Admittance Except for
- Prevention of contamination, interference Authorized Personnel
or other adverse influences?

- Effective separation between areas with

incompatible laboratory activities?

6.3.5 Does the laboratory ensure compliance to NA

Section 6.3 of ISO 17025:2017 when
laboratory activities are performed at sites
or facilities outside its permanent control?

LAFM03/ 02 April 2018 Page 6 of 29

6.4 Equipment
6.4.1 Does the laboratory have access to Yes
equipment required for the correct
performance of laboratory activities, and
which can influence results?

6.4.2 Does the laboratory ensure compliance to NA

Section 6.4 of ISO 17025:2017 when using
equipment outside its permanent control?

6.4.3 Does the laboratory have a procedure for Yes Work Instruction
handling, transport, storage, use and - WI-MT-01
planned maintenance of equipment? - WI-MT-02
- WI-MT-03
To produce - WI-MT-04
• Procedures of the above - WI-MT-05

6.4.4 Does the laboratory verify that equipment Yes

conforms to specified requirements before
being placed or returned into service?

6.4.5 Does the laboratory ensure that measuring Yes

6.4.6 equipment is calibrated and capable of
achieving the measurement accuracy or
measurement uncertainty required to
provide a valid result?

6.4.7 Does the laboratory have an established Yes Master Calibration Schedule
calibration programme and review the
suitability and frequency of calibration?

To produce
• Calibration programme
• Records of review of calibration
programme

To consider
• Equipment Master List

6.4.8 Is there a system of labelling, coding or Yes Calibration sticker on machine

identification of all equipment requiring
calibration or which has a defined period of
validity?

6.4.9 Does the laboratory have a process of Yes QP 11

handling equipment that no longer meets
specified requirements?

Does the process include examining the

effect of the deviation from specified
requirements?

6.4.10 Does the laboratory perform periodic Yes Calibration cert seen
6.4.11 checks or updates to maintain confidence in
the performance of its equipment?

Note: This includes reference values or

correction factors.

LAFM03/ 02 April 2018 Page 7 of 29

6.4.12 Does the laboratory take practicable Yes No issue as equipment cannot
measures to prevent unintended be adjusted
adjustments of equipment from invalidating
results?

6.4.13 Does the laboratory retain records for Yes

equipment which can influence laboratory
activities? For example:

a) the identity of equipment, including software

and firmware version;

b) the manufacturer’s name, type

identification, and serial number or other
unique identification;

c) evidence of verification that equipment

conforms with specified requirements;

d) the current location;

e) calibration dates, results of calibrations,

adjustments, acceptance criteria, and the
due date of the next calibration or the
calibration interval;

f) documentation of reference materials,

results, acceptance criteria, relevant dates
and the period of validity;

g) the maintenance plan and maintenance

carried out to date, where relevant to the
performance of the equipment;

h) details of any damage, malfunction,

modification to, or repair of, the equipment.

To produce
• Records of the above

6.5 Metrological traceability

6.5.1 Does the laboratory establish and maintain Yes
metrological traceability of its measurement
results by means of a documented
unbroken chain of calibrations, each
contributing to the measurement
uncertainty, linking them to an appropriate
reference?
6.5.2 Does the laboratory ensure that Yes SAC accredited lab, SI units
6.5.3 measurement results are traceable to the use
International System (SI) of Units where
possible?

To consider
• Calibration provided by competent
laboratory
• Certified reference materials by
competent producer
• Direct realization of SI units

LAFM03/ 02 April 2018 Page 8 of 29

6.6 Externally provided products and services
6.6.1 Does the laboratory ensure the suitability of Yes
externally provided products and services?

6.6.2 Does the laboratory have procedures and Yes QP 6

records for the following?

a) defining, reviewing and approving the

laboratory’s requirements for externally
provided products and services;

b) defining the criteria for evaluation,

selection, monitoring of performance and
re-evaluation of the external providers;

c) ensuring that externally provided products

and services conform to the laboratory’s
established requirements, or when
applicable, to the relevant requirements of
Section 6.6 of ISO 17025:2017, before they
are used or directly provided to the
customer;

d) taking any actions arising from evaluations,

monitoring of performance and re-
evaluations of the external providers.

To produce
• Procedures of the above
• Records of the above

6.6.3 Does the laboratory communicate its Yes Purchase order

requirements to external providers for the
following?

a) the products and services to be provided;

b) the acceptance criteria;

c) competence, including any required

qualification of personnel;

d) activities that the laboratory, or its

customer, intends to perform at the external
provider’s premises.

To Consider
• Tenders
• Contracts
• Specifications
• Purchase Orders

LAFM03/ 02 April 2018 Page 9 of 29

7. Process Requirements
7.1 Review of requests, tenders and contracts
7.1.1 Does the laboratory have a procedure for Yes QP 3
the review of requests, tenders and
contracts? The procedure shall ensure that:

a) the requirements are adequately defined,

documented and understood;

b) the laboratory has the capability and

resources to meet the requirements;

c) where external providers are used, the

requirements of Section 6.6 are applied and
the laboratory advises the customer of the
specific laboratory activities to be
performed by the external provider and
gains the customer’s approval;

d) the appropriate methods or procedures are

selected and are capable of meeting the
customers’ requirements.

7.1.2 Does the laboratory notify the customer of NA No outdated method

7.1.4 any inappropriate or outdated methods, and
ensure that the contract shall be acceptable
to both the laboratory and the customer?

Does the laboratory ensure that deviations

requested by the customer do not impact
the integrity of the laboratory or the validity
of the results?

7.1.3 Is the decision rule clearly defined, Yes

communicated, and agreed by both the
laboratory and the customer when a
statement of conformity is required to be
appended on the test/calibration/sampling
report?

7.1.5 Does the laboratory notify customers of any Yes Email

7.1.6 deviations from the contract and, if the
7.1.8 deviations occur after work has
commenced, repeat the contract review and
notify all affected personal?

To produce
• Records of contract review
• Records of any changes and
pertinent discussions on customer’s
requirements

7.1.7 Does the laboratory cooperate with Yes Email

customers or their representatives in
clarifying the customer’s request and in
monitoring the laboratory’s performance in
relation to the work performed?

LAFM03/ 02 April 2018 Page 10 of 29

7.2 Selection, verification and validation of methods
7.2.1 Selection and verification of methods
7.1.2.1 Are all methods, procedures, and Yes 4 test methods are up to date
7.2.1.2 supporting documentation appropriate to and available in Qualiware
laboratory activities, relevant, up to date,
and readily available to personnel?

7.2.1.3 Does the laboratory ensure that it uses the Yes

most appropriate version of a method?
7.2.1.4 Does the laboratory select and inform the Yes
customer of the method chosen if the
customer does not specify the method?

7.2.1.5 Has the laboratory verified that it can Yes Email confirmation
properly perform the methods and achieve
the required performance before
introducing them?

To produce
• Records of verification

7.2.1.6 Does the laboratory have a formal plan for Yes Inter-lab reports
method development, performed by
competent personnel with adequate
resources?

Are periodic reviews carried out to ensure

that the needs of the customer are fulfilled?

7.2.1.7 Does the laboratory document, justify, Yes Email

authorize and seek acceptance from the
customer for any deviations to methods
prior to performing them?

7.2.2 Validation of methods

7.2.2.1 Does the laboratory validate any non- Yes Inter-lab reports
7.2.2.2 standard methods, laboratory developed
7.2.2.4 methods, standard methods used outside
their intended scope, or any validated
methods that have since been modified?

To produce
Records of validation
- validation procedure used
- specification of the requirements;
- determination of the performance
characteristics of the method;
- results obtained;
- a statement on the validity of the method,
detailing its fitness for the intended use

7.2.2.3 Are the performance characteristics of Yes Email / Contract

validated methods relevant to customer’s
needs and consistent with specified
requirements?

LAFM03/ 02 April 2018 Page 11 of 29

7.3 Sampling
7.3.1 Does the laboratory have a sampling plan NA NA as company do not need to
7.3.2 and method for performing of sampling perform sampling
activities?

Is the sampling plan and method available

at the site where sampling is performed?

Does the sampling method address the

factors to be controlled to ensure the
validity of subsequent testing or calibration
results?

To Produce
Sampling method describing:
- selection of samples or sites

- the sampling plan (where reasonable, this

shall be based on statistical methods)

- preparation and treatment of sample(s)

from a substance, material or product to
yield the required item for subsequent
testing or calibration

7.3.3 Does the laboratory retain records of NA

(a) to (h) sampling data that forms part of the testing
or calibration that is undertaken?

To produce
• Sampling records

7.4 Handling of test or calibration items

7.4.1 Does the laboratory have procedures for Yes QP_OPS Rev 1
the transportation, receipt, handling,
protection, storage, retention, and disposal
or return of test or calibration items?

Does the procedure document the

necessary measures to protect the integrity
of the test or calibration item, and the
interests of the laboratory and the
customer?

To produce
Procedures for the above

7.4.2 Does the laboratory have a system for Yes QP_OPS Rev 1
unambiguous identification of test or
calibration items that ensures no physical
confusion or when referred to in records or
documents?

Is the identification retained whilst under the

responsibility of the laboratory?

LAFM03/ 02 April 2018 Page 12 of 29

7.4.3 Upon receipt of test or calibration items Yes QP_13
which have deviated from specified
conditions, does the laboratory record these
deviations?

Are the deviations notified to customers for

their instructions and the results of this
consultation recorded?

To produce
• Records for the above

7.4.4 For items requiring storage under specific NA

environmental conditions, does the
laboratory maintain, monitor and record
these conditions?

To produce
• Records for the above

7.5 Technical records

7.5.1 Does the laboratory retain and maintain Yes Original observation are kept in
technical records containing sufficient respective test system
information to enable repetition of the
laboratory activity under conditions as close
as possible to the original?

To produce
Records for the above containing (but not
limited to):
- date and identity of personnel responsible
for the laboratory activity and checking of
data and results

- factors affecting measurement results

and its associated measurement
uncertainty

- Evaluation of measurement uncertainty

7.5.2 Are amendments to technical reports Yes Original observation are kept in
trackable to previous versions or original respective test system
observations?

Are the original and amended data and files

kept?

To produce
Records for the above containing:
- Date of alteration

- Indication of altered aspects

- Personnel responsible for the alterations

7.6 Evaluation of measurement uncertainty

7.6.1 Does the laboratory identify the Yes
contributions to measurement uncertainty
using appropriate methods of analysis,
including those arising from sampling?

LAFM03/ 02 April 2018 Page 13 of 29

7.6.2 For laboratories performing calibrations, NA
including of its own equipment, is the
measurement uncertainty for all calibrations
evaluated?

7.6.3 For laboratories performing testing, has the Yes

measurement uncertainty been evaluated?

NB: If it is not possible to evaluate the

measurement uncertainty, an estimation of
the uncertainty must be made.

7.7 Ensuring the validity of results

7.7.1 Does the laboratory have a procedure for Yes QP_OPS Rev 1
monitoring the validity of results?

Is the monitoring planned and reviewed

periodically?

7.7.2 Does the laboratory compare its results with Yes Inter lab reports
other laboratories, for example through
participation in proficiency testing or inter-
laboratory comparisons?

7.7.3 Does the laboratory analyse the data or Yes

results of the monitoring activities and take
appropriate actions when these results fall
outside pre-defined criteria?

7.8 Reporting of results

7.8.1 General
7.8.1.1 Does the laboratory review and authorize Yes
7.8.1.2 the results prior to release? Are any results
not reported to the customer made readily
available?

7.8.2 Common requirements for reports

7.8.2.1 Does the report contain at least the Yes 2023 BSI Interlab Coating
following information? Thickness

a) A title (e.g. “Test Report”, “Calibration

Certificate” or “Report of Sampling”);

b) Name and address of the laboratory;

c) Location of performance of the laboratory
activities, including when performed at a
customer facility or at sites away from the
laboratory’s permanent facilities, or in
associated temporary or mobile facilities;

d) Unique identification that all its components

are recognized as a portion of a complete
report and a clear identification of the end;

e) Name and contact information of the

customer;

f) Identification of the method used;

LAFM03/ 02 April 2018 Page 14 of 29

g) A description, unambiguous identification,
and, when necessary, the condition of the
item;

h) Date of receipt of the test or calibration

item(s), and the date of sampling, where
this is critical to the validity and application
of the results;

i) Date(s) of performance of the laboratory

activity;

j) Date of issue of the report;

k) Reference to the sampling plan and

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

l) A statement to the effect that the results

relate only to the items tested, calibrated or
sampled;

m) The results with, where appropriate, the

units of measurement;

n) Additions to, deviations, or exclusions from

the method;

o) Identification of the person(s) authorizing

the report;

p) Clear identification when results are from

external providers.

7.8.2.2 When applicable, does the laboratory Yes

clearly identify in its reports which
information and/or sample is provided by
the customer?

7.8.3 Specific requirements for test reports

7.8.3.1 Does the test report issued by the Yes 2023 BSI Interlab Coating
laboratory contain the following where Thickness
necessary?

a) Information on specific test conditions, such

as environmental conditions;

b) Where relevant, a statement of conformity

with requirements or specifications;

c) Where applicable, the measurement

uncertainty presented in the same unit as
that of the measurand or in a term relative
to the measurand (e.g. percent) when:

— it is relevant to the validity or application

of the test results;
— a customer’s instruction so requires, or

LAFM03/ 02 April 2018 Page 15 of 29

 — the measurement uncertainty affects
conformity to a specification limit;
d)
Where appropriate, opinions and
interpretations;
e)
Additional information which may be
required by specific methods, authorities,
customers or groups of customers.

7.8.4 Specific requirements for calibration reports

7.8.4.1 Does the calibration report issued by the Yes
calibration laboratory contain the following:

a) The measurement uncertainty of the

measurement result presented in the same
unit as that of the measurand or in a term
relative to the measurand (e.g. percent);

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

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

c) A statement identifying how the

measurements are metrologically traceable;

d) The results before and after any adjustment

or repair, if available;

e) Where relevant, a statement of conformity

with requirements or specifications;

f) Where appropriate, opinions and

interpretations

7.8.4.3 Does the calibration laboratory ensure that Yes

calibration certificates or labels issued do
not contain any recommendation on the
calibration interval?

If a certificate or label contains any

recommendation on the calibration interval,
has this been agreed with the customer?

7.8.5 Specific requirements for sampling reports

Does the sampling report contain the NA NA
following information?

a) The date of sampling;

b) Unique identification of the item or material

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

c) The location of sampling, including any

diagrams, sketches or photographs;

LAFM03/ 02 April 2018 Page 16 of 29

d) A reference to the sampling plan and
sampling method;

e) details of any environmental conditions

during sampling that affect the
interpretation of the test results;

f) Information required to evaluate

measurement uncertainty for subsequent
testing or calibration.

7.8.6 Reporting statements of conformity

7.8.6.1 Does the laboratory document the decision Yes 2023 BSI Interlab Coating
rule employed when making statements of Thickness
conformity in the report?

7.8.6.2 When reporting on the statement of Yes 2023 BSI Interlab Coating
conformity, does the statement clearly Thickness
identify:

a) to which results the statement of conformity

applies?

b) which specifications, standards or parts

thereof are met or not met?

c) the decision rule applied?

7.8.7 Reporting opinions and interpretations

7.8.7.1 Does the laboratory ensure that opinions NA NA
and interpretations are made and released
by authorized personnel?

Does the laboratory document the basis on

which the opinions and interpretations are
made?

7.8.7.2 Is it clearly identifiable in the reports when NA NA

the laboratory makes opinions and
interpretations based on the results
obtained from the tested or calibrated item?

7.8.7.3 Does the laboratory keep records of any NA NA

communications of opinions and
interpretations with the customer?

7.8.8 Amendments to reports

7.8.8.1 When the laboratory makes any changes to NA NA
a report, is this clearly identified in the
report?

Where appropriate, are the reasons for the

changes clearly identified?

7.8.8.2 When changes are made to a report after it NA NA

has been issued, does the laboratory issue
it as a further document which includes the
statement “Amendment to report, serial
number or other equivalent form of
wording?

LAFM03/ 02 April 2018 Page 17 of 29

7.8.8.3 When issuing a completely new report, NA NA
does the laboratory issue a unique
identification to this report and include a
reference to the original report?

7.9 Complaints
7.9.1 Does the laboratory have a documented Yes QP_14
7.9.3 process to receive, evaluate and make
decisions on complaints?

Does the process for handling complaints

contain at least the following elements?

a) description of the process for receiving,

validating, investigating the complaint, and
deciding what actions are to be taken in
response to it;

b) tracking and recording complaints, including

actions undertaken to resolve them;

c) ensuring that any appropriate action is

taken.

7.9.2 Is the handling process for complaints Yes QP_14

7.9.4 available to any interested party upon
request?

When receiving the complaint, does the

laboratory gather and verify all action to
validate the complaint, and take action to
deal with any complaints that it is
responsible for?

To produce
• Handling process for complaints

7.9.5 Does the laboratory, where possible, Yes

acknowledge receipt of the complaint, and
provide the complainant with progress
reports and the outcome?

7.9.6 Is the individual(s) who reviews, approve or Yes

communicate the outcomes of the
complaint investigation to the complainant
involved in the original laboratory activities?

7.9.7 Does the laboratory (where possible) give NA No complaint

formal notice of the end of the complaint
handling to the complainant?

To produce
• Records for Clauses 7.9.5 to 7.9.7

LAFM03/ 02 April 2018 Page 18 of 29

7.10 Nonconforming work
7.10.1 Does the laboratory have a procedure for Yes QP_13
dealing with nonconforming work?
No non-conforming work
Does the procedure ensure that:

a) The responsibilities and authorities for the

management of nonconforming work are
defined;

b) actions (including halting or repeating of

work and withholding of reports, as
necessary) are based upon the risk levels
established by the laboratory;

c) an evaluation is made of the significance of

the nonconforming work, including an
impact analysis on previous results;

d) a decision is taken on the acceptability of

the nonconforming work;

e) where necessary, the customer is notified

and work is recalled;

f) the responsibility for authorizing the

resumption of work is defined.

7.10.2 To produce
Records for Clause 7.10.1 (b) to (f)

7.10.3 Does the laboratory take corrective action Yes

when it is found that nonconforming work
could recur or that there is doubt about the
conformity of the laboratory’s operations
with its own management system?

7.11 Control of data and information management

7.11.1 Does the laboratory have access to Yes
necessary data and information to perform
its laboratory activities?

7.11.2 Does the laboratory validate its laboratory NA Off the shelf software
information management systems for
functionality and proper functioning of
interfaces before introduction?

Does the laboratory authorize, document

and validate any modifications to its
laboratory software?

7.11.3 Is the laboratory information management Yes Drive access by QA dept only
system

a) protected from unauthorized access?

b) safeguarded against tampering and loss?

LAFM03/ 02 April 2018 Page 19 of 29

c) operated in an environment that complies
with supplier or laboratory specifications or,
in the case of non-computerized systems,
provides conditions which safeguard the
accuracy of manual recording and
transcription?

d) maintained in a manner that ensures the

integrity of the data and information?

e) able to record system failures and the

appropriate immediate and corrective
actions?

7.11.4 Does the laboratory ensure that external Yes

providers or operator of the laboratory
information management system complies
with the requirements of section 7.11 if it is
managed offsite?

7.11.5 Does the laboratory ensure that Yes Qualiware

instructions, manuals and reference data
relevant to the laboratory information
management system(s) are made readily
available to personnel?

7.11.6 Does the laboratory ensure that Yes

calculations and data transfers are checked
in an appropriate and systematic manner?

8. Management system requirements

8.1 Options
8.1.2 Option A Yes
8.1.3 The management system of a laboratory
shall address the following:

- management system documentation (8.2)

- control of management system documents
(8.3)
- control of records (8.4)
- actions to address risks and opportunities
(8.5)
- improvement (8.6)
- corrective action (8.7)
- internal audits (8.8)
- management reviews (8.9)

Option B
The laboratory has established and
maintained a management system in
accordance to ISO 9001:2015, and that is
capable of supporting and demonstrating
the consistent fulfilment of the requirements
of Sections 4 to 7, also fulfils at least the
intent of the management requirements
specified in 8.2 to 8.9.

LAFM03/ 02 April 2018 Page 20 of 29

8.2 Management system documentation
8.2.1 Does the laboratory establish, document Yes Policy & Objectives
8.2.2 and maintain policies and objectives for the
fulfillment of ISO 17025:2017 and ensure
that these policies are acknowledged and
implemented at all levels of the laboratory
organization?

Do the policies and objectives address he

competence, impartiality and consistent
operation of the laboratory?

8.2.3 How does the laboratory provide evidence Yes

that the management is committed to the
development and implementation of the
management system and continually
improving its effectiveness

To consider
ISO 9001:2015 clause 5.1
- communicating to the organisation the
importance of meeting customer as well as
statutory and regulatory requirements
- establishing the quality policy
- ensuring that quality objectives are
established
- conducting management reviews
- ensuring the availability of resources

8.2.4 Are all documentation, processes, systems, Yes Quality Manual

records, etc included, referenced or linked
to f the management system?

To consider
ISO 9001:2015 clause 4.2.1

8.2.5 Do all personnel involved in laboratory Yes Qualiware

activities have access to the parts of the
management system documentation and
related information that are applicable to
their responsibilities?

To consider
Doc control, access rights to inspectors and
contracted inspectors

8.3 Control of management system documents

8.3.1, Does the laboratory have procedures to Yes Approved on physical copies
8.3.2 control the documents (internal and
external)? QP_5

Does the laboratory ensure that:

a) documents are approved for adequacy prior

to issue by authorized personnel;

b) documents are periodically reviewed, and

updated as necessary;

LAFM03/ 02 April 2018 Page 21 of 29

c) changes and the current revision status of
documents are identified;

d) relevant versions of applicable documents

are available at points of use and, where
necessary, their distribution is controlled;

e) documents are uniquely identified;

f) the unintended use of obsolete documents

is prevented, and suitable identification is
applied to them if they are retained for any
purpose.

To produce
• Procedures on control of
documents

To consider
• Documentation can be in any form
or any type of medium (include
propriety and in-house developed
software).
• ISO 9001:2015 Clause 4.2.3

8.4 Control of records

8.4.1 Does the laboratory establish and retain Yes QP_16
8.4.2 legible records to demonstrate fulfilment to
Section 8.4?

Does the laboratory implement the controls

needed for the identification, storage,
protection, back-up, archive, retrieval,
retention time and disposal of its records?

Is access to these records readily available

and consistent with the confidentiality
arrangements?

To consider
• As a guide, important records
should be kept at least through 1
accreditation cycle.
• ISO 9001:2015 Clause 4.2.4

8.5 Actions to address risks and opportunities

8.5.1 Does the laboratory consider the risks and Yes BSI 2022_Risk portfolio
8.5.2 opportunities associated with laboratory
activities?

a) Does the laboratory plan

actions to address these risks and
opportunities;
b)
How to:
- integrate and implement the actions into
its management system;
- evaluate the effectiveness of these
actions.

LAFM03/ 02 April 2018 Page 22 of 29

 To produce
Records of identification of risks and
opportunities and associated action plans

8.5.3 Are the actions taken to address risks and

opportunities proportional to the potential
impact on the validity of laboratory results?

8.6 Improvement
8.6.1 Does the laboratory identify and select
opportunities for improvement and
implement any necessary actions?

8.6.2 Does the laboratory seek feedback, both Yes CSI Questions
positive and negative, from its customers?

Does the laboratory analyse the feedback

for purposes of improving the management
system, laboratory activities and customer
service?

8.7 Corrective Action

8.7.1 In the event of a nonconformity, does the Yes No NC raised
laboratory

a) react to the nonconformity and, as

applicable:
- take action to control and correct it;
- address the consequences;

b) evaluate the need for action to eliminate the

cause(s) of the nonconformity, to prevent
recurrence or occurance elsewhere, by:
- reviewing and analysing the
nonconformity;
- determining the causes of the
nonconformity;
- determining if similar nonconformities
exist, or could potentially occur;

c) implement any action needed;

d) review the effectiveness of any corrective

action taken;

e) update risks and opportunities determined

during planning, if necessary;

f) make changes to the management system,

if necessary.

8.7.2 Are the corrective actions appropriate to the Yes No NC raised

8.7.3 effects of the nonconformities encountered?

To produce
• Records of nonconformities,
cause(s) and any subsequent
actions taken
• Records of the results of any
corrective action

LAFM03/ 02 April 2018 Page 23 of 29

8.8 Internal audits
8.8.1 Does the laboratory conduct internal audits Yes Internal Audit on 26 Jul 2024
to determine if the management system

a) conforms to:
- the laboratory’s own requirements for its
management system, including the
laboratory activities;
- the requirements of ISO 17025;

b) is effectively implemented and maintained.

8.8.2 Does the laboratory Yes Internal Audit Plan

a) plan, establish, implement and maintain an

audit programme including the frequency,
methods, responsibilities, planning
requirements and reporting, which shall
take into consideration the importance of
the laboratory activities concerned,
changes affecting the laboratory, and the
results of previous audits;

b) define the audit criteria and scope for each

audit;

c) ensure that the results of the audits are

reported to relevant management;

d) implement appropriate correction and

corrective actions without undue delay;

e) retain records as evidence of the

implementation of the audit programme and
the audit results.

To produce
• Records of Internal audits

8.9 Management reviews

8.9.1 Does the laboratory management review its Yes Management Review meeting
management system to ensure its on 26 Jul 2024
continuing suitability, adequacy and
effectiveness, including the stated policies
and objectives related to the fulfilment of
ISO 17025?

8.9.2 Does the laboratory record the following Yes

inputs to management review?

a) changes in internal and external issues that

are relevant to the laboratory;

b) fulfilment of objectives;

c) suitability of policies and procedures;

d) status of actions from previous

management reviews;

LAFM03/ 02 April 2018 Page 24 of 29

e) outcome of recent internal audits;

f) corrective actions;

g) assessments by external bodies;

h) changes in the volume and type of the work

or in the range of laboratory activities;

i) customer and personnel feedback;

j) complaints;

k) effectiveness of any implemented

improvements;

l) adequacy of resources;

m) results of risk identification;

n) outcomes of the assurance of the validity of

results; and

o) other relevant factors, such as monitoring

activities and training.

8.9.3 Does the laboratory record the outputs of Yes

the management review pertaining to:

a) the effectiveness of the management

system and its processes;

b) improvement of the laboratory activities

related to the fulfilment of the requirements
of this document;

c) provision of required resources;

d) any need for change.

Requirements
A Existing Approved Signatory
1. Do the signatories still occupy appropriate SAC-SINGLAS 001, Clause 5
positions in the staff structure to be
responsible for the adequacy of test or
calibration results?

2. Do the signatories still retain sufficient

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

3. For approved signatories including

nominees, are the requirements stated in
Clause 5 of SAC-SINGLAS 001 being met?

LAFM03/ 02 April 2018 Page 25 of 29

B. New Nominees for Signatory Approval
1. Does/Do the nominee(s) occupy SAC-SINGLAS 001, Clause 5
appropriate positions in the staff structure to
be responsible for the adequacy of test or
calibration results?

2. Does/Do the nominee(s) spend sufficient

time in the laboratory in order to exercise
adequate supervision?

3. Is/are the nominee(s) familiar with the

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

Comments from technical assessor on the

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

C. Obligations of the accredited laboratory

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

(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;

LAFM03/ 02 April 2018 Page 26 of 29

3.1(c) Adhere to the rules for the use of the SAC
Accreditation Marks and reference to
accreditation status as stipulated in SAC
02;

Is the laboratory using Combined ILAC

MRA Mark on accredited report?

3.1(e) Not to use the accreditation status in such a

manner as to bring SAC into disrepute and
not make any statement related to the
accreditation which SAC may consider
misleading or unauthorized;

3.1(f) 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 throughout
assessments and resolution of complaints;

Make prompt payment to SAC of all

3.1(g) necessary fees levied by SAC;

Upon the withdrawal of accreditation

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

Make a clear and unequivocal statement in

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

Not represent or hold itself out as being the

3.1 (j) agent or partner of SAC or make any
representations on behalf of SAC.

Ensure the standard of service and integrity

3.1 (k) of reports are maintained during relocation.
Accredited reports can continue to be issued
prior to SAC verification of continual
compliance at the new location.

(NB: Should subsequent findings from SAC

during the reassessment show the
accreditation requirements are
compromised, this may warrant for recall of
reports issued.)

LAFM03/ 02 April 2018 Page 27 of 29

 D. Follow up on last year findings

E. Other Observation and Comments

Safety (SAC-SINGLAS 001, Clause 8)

LAFM03/ 02 April 2018 Page 28 of 29

 F. Additional Notes

Auditee: Ganesan, Vikraman

Auditor: Nur Nadhirah

Audit Date: 26 Jul 2024

LAFM03/ 02 April 2018 Page 29 of 29