Laboratory

Quality Manual
(MS-LM)
MULTI-SERVE SDN. BHD.

Rev: 00 Effective: 01 Dec 2022

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REVISION HISTORY

Revision Effective Affected Descriptions of Change(s)

Date Page
00 1 Dec 2022 All New

Prepared By Approved By

Signature

Name

Position

Date

Table of Content

No Content Page no
I Preface
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II Accreditation Body
1 Scope
2 Cross reference between AAE documents and ISO/IEC 17025: 2017
3 Normative Reference, Terms & Definitions
4 GENERAL REQUIREMENTS
4.1Impartiality
4.2 Confidentiality
5 STRUCTURAL REQUIREMENTS
6 RESOURCE REQUIREMENTS
6.1 General
6.2 Personnel
6.3 Facilities and environmental conditions
6.4 Equipment
6.5 Metrological traceability
6.6 Externally provided products and services
7 PROCESS REQUIREMENTS
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.3 Sampling
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Ensuring the validity of results
7.8 Reporting of results
7.9 Complaints
7.10 Nonconforming work
7.11 Control of data and information management
8 MANAGEMENT SYSTEM REQUIREMENTS
8.1 Option
8.2 Management system documentation
8.3 Control of management system documents
8.4 Control of records
8.5 Actions to address risks and opportunities
8.6 Improvement
8.7 Corrective actions
8.8 Internal audits
8.9 Management reviews

I) PREFACE
MULTI-SERVE SDN. BHD. started operation on 01 st January 2022. With owner renowned
background and number of years indulged in the field. It boldly sprouts out as one of the major player
in Malaysia with capture rate of not less than 12% market share which Palm Oil Refinery,
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Commercial Buildings, Glue, Palm Oil Mill, Power Plants, Wood Base, Glove, Building Material and
miscellaneous.

II) ACCREDITATION BODY

The laboratory competency is continually upgraded to maintain its trust and credibility under
Skim AkreditasiMakmal Malaysia (SAMM) which is presently managed by Standards Malaysia
(SM), presently sited at:

Century Square,
Level 1 & 2, Block 2300,
JalanUsahawan,
63000 Cyberjaya, Selangor.
Tel. No.: 03 – 8318 0002
Fax No.: 03 – 8319 3131

1 SCOPE
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The Laboratory carries out calibration on site and in laboratory’s permanent facilities. It is the
policy of the Laboratory to achieve and maintain a high quality standard in all aspect of its
functionality to ensure that the calibration services provided are always conducted through:

 Professional Integrity
 Technical Competency
 A known Level of Uncertainty
 Careful Observation and Accurate Recording
 Continually Improving Its Laboratory’s Effectiveness and compliance with MS ISO/IEC
17025: 2017and SAMM requirements
 Meeting Customer, Statutory and Regulatory Requirements

This quality document defines the requirements in the quality manual, and contains the
necessary procedures to ensure the conformance of these requirements. The Laboratory offers
to its customers, calibration services consistent with the requirements of this quality manual.

This manual defines the requirements of the laboratory quality policy with respect to the
activities performed by this laboratory in carrying out the calibration scope as listed in
Appendix I (Scope of Accreditation). It contains the cross-reference to the procedures to
ensure conformance to the quality and technical requirements as well as the requirements of
the MS ISO/IEC 17025: 2017 and SAMM with respect to the tasks in carrying out the
calibration works.

2 CROSS REFERENCE BETWEEN AAE DOCUMENTS AND MS ISO/ IEC

17025: 2017
MS ISO/ IEC Quality System Elements Applicable Documents
17025
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clauses ref.
4 General Requirements
4.1 Impartiality MS-LM
4.2 Confidentiality MS-LM
5 Structural Requirements
6 Resource Requirements
6.1 General Refer from 6.2 to 6.6
6.2 Personnel MS-P06
6.3 Facilities and Environmental Conditions MS-P11
6.4 Equipment MS-P10
6.5 Metrological Traceability MS-P16
6.6 Externally Provided Products and Service MS-P05
7 Process Requirements
7.1 Review of Requests, Tenders and Contracts MS-P04
Selection, Verification and Validation of
7.2 MS-P18
Methods
7.3 Sampling N/A
7.4 Handling of Test and Calibration Items MS-P15
7.5 Technical Records MS-P17
7.6 Evaluation of Measurement Uncertainty MS-P19
7.7 Ensuring the Validity of Results MS-P18
7.8 Reporting of Results MS-P17
7.9 Complaints MS-P07
7.10 Nonconforming Work MS-P14
7.11 Control of Data and Information Management MS-P03
8 Management System Requirements
8.1 Options B
8.2 Management System Documentation MS-P21
8.3 Control of Management System Documents MS-P21
8.4 Control of Records MS-P02
8.5 Actions to Address Risks and Opportunities MS-P12
8.6 Improvement MS-P13
8.7 Corrective Action MS-P13
8.8 Internal Audits MS-P20
8.9 Management Reviews MS-P21

3 NORMATIVE REFERENCE & TERMS AND DEFINITIONS

No Specification Description
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1 MS ISO/IEC 17025:2017 General Requirement For The Competence of Testing and

Calibration Laboratories

2 SAMM POLICY 1 (SP1) Terms and Conditions Governing the Laboratory Accreditation
Scheme of Malaysia

3 SAMM POLICY 2 (SP2) Policy on Traceability of Measurement Results

4 SAMM POLICY 3 (SP3) Policy on the use of SAMM Accreditation Symbol and Combined
ILAC MRA Mark or Reference to SAMM Accreditation

5 SAMM POLICY 4 (SP4) Policy for Participation in Proficiency Testing Activities

6 SAMM POLICY 5 (SP5) Policy on Measurement Uncertainty Requirements for SAMM

Testing Laboratories

7 SAMM POLICY 6 (SP 6) Requirements for SAMM Approved Signatory

8 SAMM POLICY 7 (SP 7) Specific Requirements on the Issue of SAMM Endorsed

Calibration Certificates.

9 SAMM POLICY 8 (SP 8) Requirements and Procedures for the Accreditation of Site
Calibration and Testing Laboratories.

10 SAMM POLICY 10 (SP10) Grading of Non-conformities

11 ISO 9001:2015 Quality Management System – Requirements

TERMS AND DEFINITIONS

For the purpose of this Quality Manual, the following relevant terms and definitions are applied.

Terms Definition
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Laboratory The team of technical and non-technical personnel of the Laboratory of MS

involve in testing& calibration services
Testing A Technical operation that consists of the determination of the
characteristics or performance to a specified procedure.
Calibration The set of operations / programs which establish the relationship between
values indicated and the corresponding known values of measurements
which traceable to the International System of Units (SI).
SAMM Skim Akreditasi Makmal Malaysia (The Malaysia Laboratory Accreditation
Scheme) which using MS ISO/IEC 17025 as the basic requirements to
accredit the competence of testing and calibration laboratories.
ISO Abbreviation for International Organization for Standardization, an
institution, which coordinates the standardization internationally.
Laboratory Guidelines on the implementation of the Laboratory Management System, it
Quality describes how the company quality policy & objectives are put into effort
Manual and supported by details operational procedures and instructions.
Quality Degree to which a set of inherent characteristic fulfills requirements.

Quality Quality, administrative and technical system that govern the operation of a
Management laboratory.
System
Quality Control of the result quality by planned and systematic activity.
Control
Standard Document, which was provided with consent and by a recognized place
accepted and for general and recurring application rules, guidelines or
characteristic for activities or their results specific, whereby an optimal
order degree in a given connection is aimed at.
Standards Standards Malaysia. An agency under the ambit of Ministry of Science,
Malaysia Technology and Innovation (MOSTI). STANDARDS MALAYSIA took over the
statutory roles in standardization, formerly carried out by SIRIM. In
addition, STANDARDS MALAYSIA is also entrusted with the responsibilities
of accreditation. In performing its duties and functions, STANDARDS
MALAYSIA is governed by Standards of Malaysia Act 1996 (Act 549).
4 GENERAL REQUIREMENTS

4.1 Impartiality
a) It is the policy of the Laboratory management to commit to impartiality. All the
laboratory activities are to be taken impartially.
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b) The Laboratory shall make arrangements to ensure that its management and
personnel are free from any undue internal and external commercial, financial and
other pressures and influences that may adversely affect the quality of their work.
This is practiced through proper recruitment processes, establishment of Code of
Ethics and appropriate enforcement by management. The Laboratory is impartial
and maintains high integrity in the calibration services as in accordance with SP1-
Terms and Conditions Governing the Laboratory Accreditation Scheme of
Malaysia.

c) The Laboratory shall identify risks to its impartiality on an on-going basis, which
includes those risks that arise from its activities, or from its relationships, or from
the relationships of its personnel. The related procedures are documented in
Actions to Address Risks and Opportunities.

d) If a risk to impartiality is identified, the Laboratory shall establish the control

measures to minimize or eliminate the risk.

Reference Document:

i) xxx Code of Ethics

ii) SP1 Terms and Conditions Governing the Laboratory
Accreditation Scheme of Malaysia
iii) MS-P20 Risks Assessment & Control

4.2 Confidentiality
a) It is the policy of the Laboratory to continually protect the customers’ proprietary
rights and customers’ confidential information placed under its control or being
used by the Laboratory. It is the policy of the Laboratory to identify, protect and
safeguard customers’ confidential information to prevent leakage, lost, damage or
not suitable for use. The Laboratory has a procedure for protecting the customers’
confidential information and proprietary rights, including electronic storage and
transmission of results. The procedures are documented in Handling of Customer
Inquiry Procedure.

Reference Document:

i) xxx Handling of Customer Inquiry Procedure

ii) QP-02 Control of Records

5 STRUCTURAL REQUIREMENTS

5.1 The Laboratory is part of Multi-Serve Sdn. Bhd. which carries out calibration service of
flowmeter. The company is legally held with company registration number 1443023W
and is located at Lot 8, Lorong Kurma, Miles 5.1/2, Off Jalan Kolombong, 88450 Kota
Kinabalu, Sabah.
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5.2 The Laboratory Manager of the company has the overall responsibility for the
laboratory activities.

The key personnel that have an involvement or influence on the laboratory activities are
identified and shown in Appendix III (Company Organization Chart) and Appendix
IV (Laboratory Organization Chart). The responsibilities of the key personnel of the
Laboratory are defined in the MS-LM-JD : Job Descriptions.

5.3 The Laboratory’s main function and responsibilities is to perform service&

calibration that meet the requirement of MS ISO/IEC 17025:2017and SAMM, to
satisfy the needs of the customer (in-house service team or external customers),
regulatory authorities and the organization providing recognition.

a) The Laboratory shall not vary the terms or conditions under which the
certificate of accreditation is issued during the period of accreditation unless it
has given notice in writing to Standards Malaysia and has received approval in
writing from Standards Malaysia.

b) The Laboratory shall claim that it is recognized or accredited only in respect of

calibration scope (Appendix 1: Scope of Accreditation) for which it has been
granted accreditation and which are carried out in accordance with SAMM
requirements and criteria.

5.4 The management system covers work carried out on-site and in the laboratory’s
permanent facilities at the address as stated in 5.1.

5.5

a) The organization and management structure of MS, its place in the parent organization,
and the relationships between laboratory management, sales & marketing and service
support are shown in Appendix III: Organization Chart and Appendix IV: Laboratory
Organization Chart.

b) The Laboratory specifies the responsibility, authority and interrelationships of all

personnel who manage, perform or verify work affecting the quality of the calibration in
the Job Descriptions (MS-LM-JD).

It is the practice of the Laboratory to provide adequate supervision for calibration staffs,
including trainees, by person familiar with methods and procedures, purpose of each
calibration, and with the assessment of the calibration results.

c) The laboratory shall document its procedures to the extent necessary to ensure the
consistent application of its laboratory activities and the validity of the results.
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5.6 The Laboratory shall consist of a Laboratory Manager, and a team of technical personnel
who, irrespective of other responsibilities, have the authority and resources needed to
carry out their duties, including:

 the implementation, maintenance and improvement of the management

system,
 identification of occurrence of departures from the management system
or from the procedures for performing tests
 initiation of actions to prevent or minimize such departures.
 reporting to laboratory management on the performance of the
management system and any need for improvement
 ensuring the effectiveness of laboratory activities

5.7 The Laboratory Management shall ensure:

a) Appropriate communication takes place regarding the effectiveness of the

management system and the importance of meeting customers’ and other
requirements. Regular meeting is held to discuss the matter pertaining to
the effectiveness and efficiency of laboratory management system.
Management is responsible to ensure management review is held at least
once in every year.

b) The Laboratory ensures that its personnel are aware of the relevance and
importance of their activities and how they contribute to the achievement of the
objectives of the management system.

c) the integrity of the management system is maintained when changes to the

management system are planned and implemented.

Reference Document:

i) Appendix I Scope of Accreditation

ii) Appendix III Company Organization Chart
iii) Appendix IV Laboratory Organization Chart
iv) MS-LM-JD Job Descriptions
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6 RESOURCES REQUIREMENTS

6.1 GENERAL
The Laboratory management shall ensure adequate personnel, facilities, equipment and
support services necessary to manage and perform its laboratory activities.

6.2 Personnel
6.2.1 All personnel of the laboratory shall act impartially, be competent and work in
accordance with the laboratory’s management system.

6.2.2 The Laboratory documents the competence requirements for each functions influencing
the results of laboratory activities, including requirements for education, qualification,
training, technical knowledge, skills and experience in the Job Descriptions (MS-LM-JD).

6.2.3 The Laboratory management ensures the competency and provides adequate and
appropriate training and supervision to its technical personnel, who operate specific
equipment, perform calibration, evaluate results and sign the calibration certificates.
The Laboratory provides appropriate supervision to staff that is undergoing training.

Personnel performing tasks as above are qualified on the basis of required education,
training, experience and demonstrated skills.

The competency of personnel performing specific calibration shall be demonstrated by

the ability to achieve performance characteristics of the calibration or perform
successfully in suitable proficiency program.

No trainee is allowed to perform any calibration independently until possessing proven

competence through proper supervision and training. Permanent staffs are supervised
to ensure his/her competency and work accordance to the management system

6.2.4 Laboratory management formulates goals with respect to the education, training, and
skills of the laboratory personnel. The Laboratory has policy and procedure in
identifying training needs and providing training of personnel. Training program is
relevant to the present and anticipated task. The effectiveness of the training is
monitored and evaluated.

The Laboratory ensures the approved signatory maintain his/ her technical competence
and participate in continual professional development through in-house or external
activities.

6.2.5 The Laboratory uses personnel who are employed by, or under contract to, the
Laboratory. Where contracted and additional technical and key support personnel are
used, the Laboratory ensures that such personnel are adequately supervised and
competent and they work in accordance with the laboratory management system.
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6.2.6 Only specified personnel who are authorized by the Laboratory Manager is permitted to
perform particular types of calibration, operate particular types of equipment, develop/
modify/ verify/ validate method, analyze result and gives opinions and interpretations,
report/ review and authorize result or issue calibration certificate.

The Laboratory ensures that the approved signatory has all the qualification that is
required under SAMM Policy 6: Requirements for Approved Signatory.

The approved signatory appointed by the Laboratory has the knowledge and
understanding in:

a) Requirements of MS ISO/ IEC 17025 and all SAMM related requirements and
regulatory requirements
b) The principles of calibration and measurement
c) The standards, methods and specifications for accreditation sought
d) The estimation of measurement uncertainties for the accreditation sought

Only nominated personnel approved by the Standards Malaysia (SM) as documented in

SM records is authorized to certify test reports printed with SAMM symbol. The
laboratory has two Approved Signatories, as below:

Name Position Registered number

DOMINIC HUANG FATT VUI MANAGING DIRECTOR
JENNIFER CHONG SIEW FUI LAB MANAGER

6.2.7 The Laboratory maintains records of the relevant authorizations, competence,

educational and professional qualifications, training, skills and experience of all
technical personnel, including contracted personnel. This information is readily
available and retrievable and includes the date on which authorization and competence
is confirmed is maintained.

Reference Document:
i) xxx Human Resources Management
ii) SAMM Policy 6 Requirements for Approved Signatory

6.3 Facilities and Environmental Conditions.

6.3.1 Laboratory Manager ensures adequate laboratory facilities and accommodation and
work environment are in place to facilitate correct performance of calibration.

The Laboratory ensures the environmental conditions do not invalidate the results or
adversely affect the required quality of measurements. The Laboratory takes particular
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care when calibration is undertaken at sites other than the permanent laboratory facility
(when applicable).

The Laboratory documents the technical requirements for accommodation and

environmental conditions that can affect the results of calibration in the relevant
procedure.

6.3.2 The Laboratory monitors, controls, and records the environmental conditions as
required by the relevant specifications, methods, and procedures or where they
influence the quality of results. The Laboratory promptly stops the calibration when the
environmental conditions jeopardize the results of the calibration.

6.3.3 The Laboratory ensures that the activities from neighboring areas are compatible with
the calibration being performed. The Laboratory take measures to prevent any
interference to the performance of the calibration.

6.3.4 The access to the laboratory during calibration is controlled. The technical staff
promptly informs the customer or relevant party if this access has any potential to
adversely influence the performance of the calibration.

6.3.5 It is the responsible of the technical staff to ensure the cleanliness and tidiness of the
laboratory and site. Housekeeping of laboratory is carried out at a daily basis.

Reference Document:

i) xxx Control of Accommodation and Environmental Conditions

6.4 Equipment

6.4.1 The Laboratory ensures it is equipped and furnished with the required equipment for
the correct performance of the calibration. Equipment includes measuring or calibration
instruments, software, measurement standards, reference materials, reference data,
reagents, consumables or auxiliary apparatus. Reference materials should be used from
producers that meet ISO 17025 (whenever applicable).

6.4.2 The Laboratory ensures that all equipment used and its software is capable to perform
and achieve the result required and comply with the specification relevant to the
calibration concerned.
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A calibration programs is established for the equipment where it may give significant
effect on the calibration results. The Laboratory ensures that the equipment used is
calibrated and checked so that it meets the specification requirements and comply with
relevant standard specification before being placed into service.

6.4.3 Only authorized personnel is permitted to operate the specific equipment. Up-to-date
instructions on the use and maintenance of equipment are readily available for use by
appropriate personnel.

6.4.4 Each item of equipment and its software used is uniquely identified.

6.4.5 The Laboratory maintains record of all equipment and software used which includes:

a) The identity of the equipment and its software.

b) The manufacturer’s name, type identification, serial number and other unique
identification.
c) Checks that equipment complies with the method / standard specification.
d) The current location.
e) The manufacturer’s instruction (operation manual) and their location.
f) Data, results and copies of calibration certificates (including adjustment, acceptance
criteria and due date of next calibration).
g) Documentation of reference materials, results, acceptance criteria, relevant dates
and the period of validity
h) Maintenance plan and maintenance carried out
i) Details of any damage, malfunction, modification or repair of the equipment.
j) Equipment verification or internal calibration.

6.4.6 The Laboratory has procedures for safe handling, transport, storage, use and planned
maintenance of measuring equipment to ensure proper functioning and in order to
prevent contamination or deterioration.

6.4.7 Equipment that subjected to overloading or mishandling, gives suspect results, or has
been shown to be defective or outside specified limits, is taken out of service.

It is isolated to allocated area to prevent its use or clearly marked or labeled as being out
of service until it has been repaired and shown by calibration or verification to perform
correctly. The effects of the defect from specified limits on previous calibration are
examined and “Control of Non-Conforming Work” procedure is instituted.

6.4.8 All equipment under the control of the Laboratory and requiring calibration is labeled,
coded and identified by its calibration status, including the date of calibration and the
due date of calibration.

6.4.9 The Laboratory ensures that the function and calibration status of the equipment goes
outside the direct control of the laboratory is checked and shown to be satisfactory
before the equipment is returned to service.
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6.4.10 The Laboratory carries out intermediate check as according to the defined procedure
when needed to maintain confidence in the calibration status of the equipment.

6.4.11 The Laboratory has procedures to ensure that copies are correctly updated when
calibration gives rise to a set of correction factors.

6.4.12 The calibration equipment, including both hardware and software, is safeguarded from
adjustments, in order to ensure the equipment does not invalidate the results.

Reference Document:

i) xxx Handling of Equipment

6.5 Metrological Traceability

6.5.1 The Laboratory ensures all equipment used for calibration, including equipment for
subsidiary measurements having significant effect on the accuracy or validity of the
calibration is calibrated before being put into service. The Laboratory has established a
program and procedure for the calibration of its equipment.

The calibration interval is reduced or extended based on factors such as history on

stability, accuracy required and ability of staffs to perform regular check.

The Laboratory adheres to the policy of the measurement traceability as stated in SP2
Policy on Traceability of Measurement Results.

6.5.2 The laboratory ensures that the calibration conducted is traceable to the International
System of Units (SI). This means of an unbroken chain of calibration or comparisons
linking them to relevant primary standards of the SI units of measurement.

6.5.2.1 The link to SI units may be achieved by reference to national measurement

standards. National measurement standards may be primary standards, which
are primary realization of the SI units or agreed representations of SI units
based on fundamental physical constants, or they may be a secondary
standards which are standards calibrated by another national metrology
institute.

6.5.2.2 When using external calibration services, traceability of measurement is

assured by the use of calibration services from laboratories that can
demonstrate competence, measurement capability and traceability. The
calibration certificates issued by these laboratories shall contain the
measurement results, including the measurement uncertainty and a statement
of compliance with an identified metrological specification.
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The Laboratory does not allow calibration to be carried out by a service

company whose calibration standards have no known history of calibration or
traceability.
6.5.2.3 The calibration is performed by a laboratory which traceable to national or
international standard, where applicable accredited under ISO/IEC 17025
management system or equivalent.
6.5.2.4 If a calibration is not a dominant factor in the calibration result, the laboratory
shall have quantitative evidence to demonstrate that the associated
contribution of a calibration contributes little (insignificantly) to the
measurement result and the measurement uncertainty of the test and therefore
traceability does not need to be demonstrated.
6.5.2.5 If certain calibration cannot be strictly made in SI units, the calibration provides
confidence in measurements by establishing traceability to appropriate
measurement standards:
- The use of certified reference material provided by a competent supplier to
give a reliable physical characterization of a material. The use of certified
reference material shall be agreed by the laboratory, customer and other
interested parties;
- The use of specified methods or consensus standards that are clearly
described and agreed by all parties concerned;
- Participation in a suitable program of inter-laboratory comparisons.

6.5.2.5 The Laboratory ensures the SAMM policy on in-house calibration as stated in
SAMM Policy 2 is adhered to if in-house calibration is carried out.

6.5.3 The laboratory maintains a calibration program for its reference standard.

6.5.3.1 The reference standard is calibrated by a competent laboratory that can

provide traceability.

6.5.3.2 The reference standard only can be used for calibration and not for other
purpose, unless it can be shown that their performance as reference standards
would not be invalidated. Reference standard is calibrated before and after any
adjustment.

6.5.3.3 Reference material is traceable to SI units of measurement, or to certified

reference material. Policy for the traceability of reference material and certified
reference material shall be in accordance with SAMM Policy 2: Policy on the
Traceability of Measurement Results.

6.5.3.4 The laboratory carries out intermediate check when needed to maintain
confidence in the calibration status of reference through internal calibration /
verification at planned interval and check the equipment against a known value
of QC sample. The laboratory needs to identify the range of equipment
measurement and select the intermediate range for checking.
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6.5.3.5 The reference standards and reference material shall be properly and safe
handled, transported, stored, used and maintained to ensure proper functioning
and in order to prevent contamination or deterioration.

Reference Document:

i) xxx Handling of Equipment

ii) SP 2 Policy on Traceability of Measurement Results

6.6 Externally Provided Products and Services

6.6.1 It is the policy of the Laboratory to use services and purchase supplies from the
suppliers which has been properly evaluated, approved and proven to be able to fulfill
requirements.

6.6.2 A purchasing procedure is developed for:

 defining, reviewing and approving the lab’s requirement for externally provided
products and services
 defining the criteria for evaluation, selection, approval, monitoring of
performance and re-evaluation of the suppliers
 taking any actions arising from the evaluations of the suppliers

The Laboratory maintains the record of supplier evaluation and the registration of the
approved suppliers is maintained in Approved Supplier List.

6.6.3 The laboratory shall communicate its requirement to the suppliers for:

 products/ services to be provided

 the acceptance criteria
 competence
 activities that the laboratory intends to perform at the external provider’s
premises

6.6.4 The Laboratory ensures the purchasing documents for item affecting the quality of
laboratory calibration results contain sufficient data describing the services and supplies
ordered. The authorized personnel reviews and approves the technical content prior to
release the purchasing documents.

6.6.5 The Laboratory carries out inspection and verification on the purchased items that affect
the quality of calibration prior to use in order to ensure the purchased items comply with
standard specifications or requirements defined in method for the calibration concerned.
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The Laboratory ensures the purchased items used for calibration comply with specified
requirements. Record of inspection and verification is maintained.

Reference Document:

i) xxx Control of Subcontracting

ii) xxx Control of Purchasing

7 PROCESS REQUIREMENTS

7.1 Review of requests, tenders and contracts

7.1.1 The Laboratory establishes and maintains the procedures for review of requests,
tenders and contracts. The procedures ensure that:

a) the requirements, including the methods to be used, 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 6.6 are applied and the
laboratory advises the customer of the specific laboratory activities to be
performed by the external provider and gains customer’s approval

d) the appropriate calibration method is selected and is capable of meeting the

customers’ requirements

7.1.1.1 The Laboratory resolves any differences between the request and tender and
the contract before any work commences. The Laboratory ensures each
contract is acceptable to both Laboratory and customer.

7.1.1.2 The Laboratory makes it clear in the contract with its customers that the
laboratory’s accreditation or any of its accredited calibration report/
certificate by itself does not constitute or imply product certification/ product
processes or system so tested is approved or certified by STANDARDS
MALAYSIA or any other body.

7.1.1.3 The Laboratory Manager reviews customer’s request, tender or contract to

ensure that all requirements are within the capabilities of the calibration
laboratory. For those requirements which are beyond the laboratory’s
capabilities, the Laboratory Manager duly rejects the contract and sends the
acknowledgement to the customer.

7.1.2 Records of review include any significant changes to the customers’ requirements is
maintained by the Laboratory. The Laboratory also maintains the records of pertinent
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discussions with a customer relating to the customer’s requirements of the results of

calibration works during the period of execution of the contract.

7.1.3 The review process covers any work performed by the laboratory including work which
is subcontracted.

7.1.4 The Laboratory informs the customer if there is any deviation from the contract; either
verbally or via written correspondent.

7.1.5 If a contract needs to be amended after work has commenced, the Laboratory carries
out the same contract review process. Any amendment is communicated to all affected
personnel.

Reference Document:

i) xxx Control of Subcontracting

ii) xxx Handling of Customer Enquiry

7.2 Selection, Verification and Validation of Methods

7.2.1 Selection and verification of methods

7.2.1.1 The Laboratory uses calibration methods, which meet the customer
requirements and appropriate to the calibration it undertakes. The Laboratory
(where appropriate) uses the latest valid edition of international recognizes
standard methods or validated non-standard method.

7.2.1.2 The Laboratory confirms that it can properly and is competent to operate the
standard methods before introducing and commencing calibration. Record of
verification shall be retained.

7.2.1.3 If the customer does not specify the calibration method, the Laboratory selects
the method such as follows:

a) the international or standard calibration method, or

b) method developed by reputable technical organizations, or
c) method published in relevant texts or journals or
d) method as specified by the manufacturer of the equipment or
e) validated laboratory-developed method which is proven to be fit for use

7.2.1.4 The Laboratory duly informs the customer pertaining to the method used for the
calibration.

7.2.1.5 If the method proposed by the customer is considered to be inappropriate or

invalid (out of date), the Laboratory duly informs the customer and provide
necessary technical advice.

7.2.1.6 For Laboratory-developed method:

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Laboratory Manager and authorized technical personnel with proven

competency are responsible to carry out method development. They carry out
adequate planning and ensure resources needed for method development are
sufficient.

Laboratory Manager and authorized technical personnel updates the plan

based on the progress of the method development. Periodical discussion is held
to communicate the progress of method development among relevant parties.

7.2.1.7 For non-standard method:

Any application of calibration methods that is not covered by the standard

methods is subjected to agreement with customer and includes a clear
specification of the customer’s requirements and the purpose of the calibration
(if requested by customer).

The non-standard calibration method is validated appropriately before use. It

only can be performed by qualified, competent and authorized personnel
equipped with adequate resources. The validated non-standard method is
approved by authorized personnel prior to implementation.

Reference Document:

i) xxx Method Validation

7.2.2 Validation of Methods

7.2.2.1 The validation applies to non-standard methods, laboratory-developed methods,

standard methods used outside their intended scope and amplifications and
modifications of standard methods to confirm that the methods are fit for the
intended use.

7.2.2.2 The validation procedure used, specification of the requirements, determination

of the performance characteristics of the method, results obtained, and a
statement as to whether the method is fit for the intended use is recorded and
maintained.

7.2.2.3 The range and accuracy of the values obtainable from validated methods
(measurement uncertainty, method repeatability and reproducibility,
proficiency testing), as assessed for the intended use, is relevant to the
customer’s needs and approved prior to implementation.

Reference Document:

i) xxx Method Validation

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7.3 Sampling
7.3.1 The laboratory does not carried out any sampling activities. All laboratory analysis is
carried out based on the sample or equipment received from the customer. The
laboratory’s responsibility is therefore will not cover the sampling activity. The
uncertainty of the sampling is notified however it is not being quantified. Therefore, it is
not estimated to a figure.

7.4 Handling of Calibration Items

7.4.1 The Laboratory has a procedure for the receipt, handling, protection, storage, and
retention of calibration items, including all provisions necessary to protect the integrity
of the calibration item, and to protect the interests of the laboratory and the customer.

7.4.2 The Laboratory has a system for identifying calibration items. The identification is
retained throughout the life of the calibration item in the laboratory. Each of the
calibration items is uniquely identified as to ensure the item is not confused physically or
when referred to in records or other documents.

7.4.3 Upon receipt of the calibration item, the laboratory records any abnormality or
departure from the specified conditions. When there is a doubt as to the suitability and
conformity of the calibration item or the calibration is not specified insufficient detail,
the laboratory clarifies or consults the customer for further instruction before
proceeding. The discussion made with customer is recorded.

7.4.4 The Laboratory has the precautionary procedure for avoiding deterioration, loss or
damage to the calibration item during collection, handling and preparation. The
Laboratory follows the handling instruction provided with the calibration item.

7.4.5 The Laboratory is equipped with the necessary facilities to ensure the calibration item is
in proper condition upon receiving until completion of calibration.

7.4.6 When items need to be stored or conditioned under specified environmental condition,
these environmental conditions are maintained, monitored, controlled and recorded
accordingly.

7.4.7 For calibration item which needs to be held secure, the Laboratory has arrangements for
storage and security measure to protect the integrity and condition of the said item.

Reference Document:

i) xxx Handling of Calibration Item

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7.5 Technical Records

7.5.1 The Laboratory retains all records of original observations, derived data and sufficient
information to establish an audit trail, calibration records, staff records and a copy of
reports issued, for a defined period as stated in Master List of Records (xxx).

All technical records provide sufficient information to facilitate the identification of

factors affecting uncertainty and to enable the calibration to be repeated under
conditions as close as possible to the original. The technical records include the identity
of personnel responsible for the performance of each calibration and checking of results.

The Laboratory retains records of all calibration reports, original observations,

calculations and derived data for at least 7 years or as required by statutory and
regulatory requirement, organizational or contractual arrangement.

7.5.2 Observations, data and calculations are recorded at the time the calibration is conducted
and is identifiable to the specific task.

7.5.3 Data generated by equipment affecting the calibration result shall be retained to provide
evidence for traceability.

7.5.4 When mistakes occur on the technical record, the mistake is crossed out and the correct
value recorded alongside. The alterations shall be signed or initialed, dated and
indicated the altered aspects by the person making the correction. Both the original and
amended data and files shall be maintained. If correction is made to the records stored
electronically, the Laboratory takes equivalent measures to avoid loss or change of
original data.

7.6 Evaluation of Measurement Uncertainty

7.6.1 The Laboratory establishes and applies a procedure to estimate the uncertainty of
measurement for the calibration performed.

7.6.2 All identified uncertainty components are taken into account and analyzed when
estimating the uncertainty of measurement.

7.6.3 Where the calibration method precludes rigorous evaluation of measurement

uncertainty, estimation shall be made based on an understanding of the theoretical
principles or practical experience of the method performance.

7.6.4 The Laboratory ensures the policy as stated in SAMM Policy 5: Policy on Measurement
Uncertainty Requirements for SAMM Testing Laboratories is followed when
estimating the measurement uncertainty.

The result, x is stated together with the expanded uncertainty U calculated using
coverage factor k = 2, such as follows:
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“(Result): (x ± U)(unit)”

Reference Document:

i) xxx Estimation of Measurement Uncertainty

ii) SP 5 Policy on Measurement Uncertainty Requirements for SAMM
Testing Laboratories

7.7 Ensuring the Validity of Results

7.7.1 The Laboratory has a quality control procedure for the monitoring the validity of
calibration undertaken. Calibration data is recorded in a way that trends are detectable,
and where applicable, enables proper statistical techniques to be applied to review the
results. The monitoring of the quality of calibration results are planned and reviewed,
which includes (but not limited to)

a) regular use of certified reference materials and/ or internal quality control using
secondary reference material
b) use of alternative instrumentation that has been calibrated
c) functional check of measuring and calibration equipment
d) use of check or working standards with control charts
e) intermediate checks on measuring equipment
f) participation in inter-laboratory comparison or proficiency-testing (PT)
program
g) intralaboratory comparisons
h) replicate calibration using the same or different methods
i) retest retained items
j) correlation of results for different characteristics of an item
k) review of reported results
l) testing of blind sample

7.7.2 The Laboratory analyses the quality control data. Where the quality control data is
outside pre-defined criteria, the Laboratory takes action to correct the problem and to
prevent results from being reported.

7.7.3 The level and type of quality control carried out by the Laboratory depends on the
criticality, nature of the analysis, frequency of analysis, batch size, degree of automation
and calibration difficulty and reliability. The level adopted is sufficient to ensure the
validity of results.

7.7.4 Quality control samples shall be typical sample of the test procedure.

Reference Document:

i) xxx Control of Validity of Results

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7.8 Reporting of Results

7.8.1 General

7.8.1.1 The results shall be reviewed and authorized prior to release.

The Laboratory reports the results of each calibration accurately, clearly,

unambiguously and objectively, and in accordance with the specific instructions
in the calibration methods. All SAMM endorsed reports are signed by a signatory
approved by STANDARDS MALAYSIA.

The Laboratory shall have full control of the issuance of accredited calibration
report or certificate. It shall therefore assume full liability on the issue of all
calibration result / report/ certificate.

The Laboratory reports the calibration result in a Calibration Certificate. The

Test Report or Calibration Certificate includes all the information requested by
the customer and necessary for the interpretation of the calibration results and
all information required by the method used.

7.8.2 Common requirements for reports

7.8.2.1 Each Test Report includes at least the following information:

a) a title
b) the name and address of the laboratory
c) the location where the calibration were carried out, if different from the
address of the laboratory
d) unique identification of the test report, and on each page an identification in
order to ensure the page is recognized as a part of the test report, and a clear
identification of the end of the test report
e) the name and contact information of the customer
f) identification of method used
g) a description of, the condition of, an ambiguous identification of the item(s)
tested
h) the date of receipt of the calibration item where this is critical to the validity
and application of the results
i) the date of performance of the calibration
j) the date of issue of the report
k) 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
l) a statement to the effect that the result relate only to the items tested
m) the calibration results with, where appropriate, the units of measurement
n) the identification of person(s) authorizing the test report
o) signature or initial of approved signatory
p) clear identification when results are from external providers
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Test Report shall conform to the requirements of SAMM Policy 3: Policy on the
Use of SAMM Accreditation Symbol or Reference to SAMM Accreditation.

All SAMM endorsed test report use the SAMM endorsement in the form of SAMM
symbol and the identification of accreditation certificate number.

A statement specifying that the test report shall not be reproduced except in full,
without written approval of the laboratory is added to the test report.

7.8.2.2 The laboratory shall be responsible for all the information provided in the
report, except when information is provided by the customer. Date provided by
the customer shall be clearly identified. In addition, a disclaimer shall be put on
the report when the information is supplied by the customer and can affect the
validity of results.

7.8.2.3 When the laboratory has not been responsible for the sampling stage, it shall
state in the report that the results apply to the sample as received.

7.8.3 Specific requirements for reports

7.8.3.1 Where deemed necessary, Test Report shall include the following:

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 estimation of measurement
uncertainty; information on uncertainty is needed in test reports when it is
relevant to the validity or application of the test results, when a customer’s
instruction so requires, or when the uncertainty affects compliance to a
specification limit
d) opinions and interpretations
e) additional information which may be required by specific methods,
customers or group of customers

7.8.4 Specific requirements for calibration certificates

7.8.4.1 In addition to the requirements listed in 7.8.2, calibration certificates shall

include 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

b) the conditions (eg: 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

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d) the results before and after any adjustment or repair, if available

e) where relevant, a statement of conformity with requirements or specifications

(refer 7.8.6)

f) where appropriate, opinions and interpretations

7.8.4.2 A calibration certificate or calibration label shall not contain any

recommendation on the calibration interval, except where this has been agreed
with the customer.

7.8.5 Reporting sampling-specific requirements

The Laboratory does not perform sampling and thus does not report sampling.

7.8.6 Reporting statements of conformity

7.8.5.1 When a statement of conformity to a specification or standard is provided, the

laboratory shall document the decision rule employed, taking into account the
level of risk associated with the decision rule employed.

If the decision rule is prescribed by the customer, regulation or normative

documents, a further consideration of the level of risk is not necessary.

7.8.5.2 The laboratory shall report on the statement of conformity, such that the
statement clearly identifies:

 to which results the statement of conformity applies

 which specifications, standards, or parts thereof are met or not
met
 the decision rule applied

7.8.7 Reporting opinions and interpretations

7.8.7.1 When opinions and interpretations are expressed, the Laboratory shall ensure
that only personnel authorized for the expression of opinions and
interpretations releases statement. The Laboratory shall document the basis
upon which the opinions and interpretations have been made.

7.8.7.2 The opinions and interpretations expressed shall be based on the results
obtained from the tested item and are clearly marked in Test Report or
Calibration Certificate.
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7.8.7.3 When opinions and interpretations are directly communicated by dialogue with
the customer, a record of the dialogue shall be retained.

7.8.8 Amendment to reports

7.8.8.1 When an issued report or certificate needs to be changed, amended or re-issued,

any change of information shall be clearly marked.

7.8.8.2 Amendments to a Test Report or Calibration Certificate after issuance is made

only in the form of a further document, or data transfer, which includes the
statement:

“Amendment to Test Report, serial number…… [or as otherwise identified]”

7.8.8.3 When it is necessary to issue a complete new Test Report or Calibration

Certificate, the new test report is uniquely identified and contains a reference to
the original that it replaces.

7.8.9 Calibration Results Obtained from Subcontractors

7.8.9.1 When the Test Report or Calibration Certificate contains results performed by
subcontractors, these results are clearly identified.

The Laboratory issues a SAMM endorsed report that includes calibration

subcontracted to another laboratory provided that:

a) a Test Report or Calibration Certificate has been issued to the accredited

laboratory by the subcontractor laboratory
b) the subcontracted result(s) are identified with appropriate disclaimer(s) in
the SAMM endorsed report issued by the Laboratory

Test Report or Calibration Certificate incorporating SAMM symbol, or reference

to SAMM accreditation, and containing the results from above accredited and
non-accredited calibration contains the following disclaimer:

‘Tests marked “Not SAMM Accredited” in this Report/ Certificate are not
included in the SAMM Accreditation Schedule of our Laboratory’.

7.8.9.2 Wherever non-accredited calibration appears, they are marked “Not SAMM
Accredited”.

Where the Test Report or Calibration Certificate incorporating SAMM symbol

includes subcontracted calibration results from SAMM accredited laboratory
having the specified calibration in its scope of accreditation, the Laboratory uses
the disclaimer ‘Tests marked “Subcontracted and Accredited”’.
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Where the Test Report or Calibration Certificate incorporating SAMM symbol

includes subcontracted calibration results from SAMM accredited laboratory not
having the specified calibration in its scope of accreditation, the Laboratory uses
the disclaimer ‘Tests marked “Subcontracted but not accredited”’.

When the Laboratory issues Test Report or Calibration Certificate containing

opinions, interpretations, or other materials relating to investigational activities,
the Laboratory incorporate the disclaimer ‘Opinions and interpretations
expressed herein are outside the scope of SAMM accreditation’.

Reference Document:

i)SAMM Policy 3 Policy on the Use of SAMM Accreditation Symbol or

Reference to SAMM Accreditation

7.9 Complaints
7.9.1 It is the policy of the Laboratory to attend to any customer complaints associated with
the calibration services without any undue delay and carry out correction, corrective
action and preventive action as deemed appropriate.

7.9.2 The Laboratory establishes procedure to receive, evaluate and make decisions on
complaints and this procedure shall be available to any interested party on request.

The Laboratory Manager duly initiates proper plan to investigate, analyse and take
remedial action and corrective action (where necessary) to resolve customers’
complaints. Records of complaints, investigations and action taken are maintained.

7.9.3 The laboratory receiving the complaints is responsible to gather and verify all necessary
information to validate the complaint.

7.9.4 When necessary, the Laboratory shall acknowledge receipt of complaint and provide the
complainant with progress reports and outcome.

7.9.5 The outcome to be communicated to the complainant shall be made by or reviewed and
approved by individuals not involved in the original laboratory activities in question.

Reference Document:

i) xxxx Handling of Customer Complaint

7.10 Nonconforming Work

7.10.1 It is the policy of the Laboratory to ensure non-conforming calibration work is identified
and rectified adequately and parties involved are notified where appropriate.
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The Laboratory establishes procedure that is implemented when any aspect of its
calibration or the results of the calibration, do not conform to its own procedures or the
agreed requirements of the customer. The policy and procedure ensures that:

a) responsibilities and authorities for the management of nonconforming work are

designated
b) actions, which includes halting of calibration work and withholding reports are
defined and taken when nonconforming work is identified
c) an evaluation of the significance of the nonconforming work is made
d) correction is taken immediately and decision is made about the acceptability of the
nonconforming work
e) where necessary, the customer is notified and work is recalled
f) the responsibilities for authorizing the resumption of work is defined

The laboratory shall retain records of nonconforming work and actions as specified
above.

7.10.2 If the evaluation indicates that the non-conforming work could recur or there is a doubt
about the compliance to the laboratory’s operation with its own policies and
procedures, the Laboratory ensures corrective action is taken without undue delay as
according to the Nonconformity &Corrective Action procedure.

Reference Document:

i) xxxx Control of Non-conforming Work

ii) QP-06 Nonconformity & Corrective Action

7.11 Control of Data and Information Management

7.11.1 The laboratory shall have access to the data and information needed to perform
laboratory activities.
7.11.2 The laboratory information management system(s) used for the collection, processing,
recording, reporting, storage or retrieval of data shall be validated for functionality,
including the proper functioning of interfaces within the laboratory information
management system(s) by the laboratory before introduction. Whenever there are any
changes, including laboratory software configuration or modifications to commercial off-
the-shelf software, they shall be authorized, documented and validated before
implementation.
7.11.3 The laboratory information management system(s) shall:
a) be protected from unauthorized access;
b) be safeguarded against tampering and loss;
c) be operated in an environment that complies with provider or laboratory
specifications or, in the case of non-computerized systems, provides conditions which
safeguard the accuracy of manual recording and transcription;
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d) be maintained in a manner that ensures the integrity of the data and information;
e) include recording system failures and the appropriate immediate and corrective
actions.
7.11.4 The laboratory shall ensure that instructions, manuals and reference data relevant to the
laboratory information management system(s) are made readily available to personnel.
7.11.5 Calculations and data transfers shall be checked in an appropriate and systematic
manner.

Reference Document:

i) xxxx Control of Data

8 MANAGEMENT SYSTEM REQUIREMENTS

The laboratory shall establish, document, implement and maintain a management system
that is capable of supporting and demonstrating the consistent achievement of the
requirements of this document and assuring the quality of the laboratory results.

In addition to meeting the requirements of Clauses 4 to 7, the laboratory implements a

management system in accordance with the requirements of ISO 9001, which includes and
can cross reference to below:

Clause
Requirements Cross reference to ISO 9001:2015
No
8.1 Options Option B
8.2 Management system documentation Appendix II – Quality Policy & Objectives
8.3 Control of management system documents QP-01 Control of Documents
8.4 Control of records QP-02 Control of Record
8.5 Actions to address risks and opportunities QP-05 Risk Assessment
8.6 Improvement
8.7 Corrective actions QP-06Corrective Action
8.8 Internal audits QP-04Internal Audit
8.9 Management reviews QP-03Management Review
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APPENDIX I: SCOPE OF ACCREDITATION

REFER ATTACHMENT
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APPENDIX II: QUALITY POLICY AND QUALITY OBJECTIVES

REFER ATTACHMENT
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APPENDIX III: COMPANY ORGANISATION CHART

REFER ATTACHMENT
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APPENDIX IV: LABORATORY ORGANIZATION CHART

REFER ATTACHMENT