A brief report to study the
feasibility of enhancing
current lab facilities to a
service laboratory
INTRODUCTION
The purpose of this report is to study the feasibility of enhancing our current lab
facilities to as service laboratory. The term service laboratory is defined as to give
testing and calibration reports on various fields according to the available standards.
This report consists of three aspects which are:
1. Requirements of service laboratories
2. Potentials fields of services
3. Approximate cost of implementation
1.0 Requirements of service laboratories
Laboratories of any institution which are planning to offer any type of services needs to
be accredited and in the case of AIMST University, the appropriate standard to be used
is the ISO/IEC 17025 or MS (Malaysian Standard) ISO/IEC 17025.
ISO/IEC 17025 specifies general requirements for the competence to carry out tests
and/or calibrations, including sampling. It is applicable for all organization that
performing tests and/or calibrations. MS ISO/IEC 17025 consists of 15 management
clauses and 10 technical clauses. This ISO standard is use to develop the laboratory
quality management system and technical operations. In order to get MS ISO/IEC
17025 accreditation, we have to satisfy the requirements of the ISO/IEC 17025 on the
basis of their technical and management requirements (Appendix 1).
The required documentations are quality manual, master plans, standard operation
procedures and records. The quality manual is to document the laboratory strategy and
planning on how to comply with MS ISO/IEC 17025. Next are the procedures, templates
and checklist for the implementation. The records consist of the calibration records,
maintenance, training records and test results.
Under the Department of Standards Malaysia (Standards Malaysia), there is a
laboratory accreditation scheme know as Skim Akreditasi Standards Malaysia
(SAMM). This scheme is based on the ISO/IEC 17025 and provides a platform for any
institution to apply for accreditation and up registering in their database as a valid ISO
certified service provider.
1.1 Skim Akreditasi Standards Malaysia (SAMM
The primary objective of SAMM is to provide a credible accreditation service to testing
and calibration laboratories including medical testing laboratories such that ultimately
SAMM endorsed test reports and calibration certificates are accepted internationally.
SAMM is unified national laboratory accreditation scheme and is multi-disciplinary in its
scope of accreditation activities. It covers both calibration and testing including medical
testing. Accredited laboratories may use Accreditation Symbol and combined ILAC MRA
Mark or make reference to SAMM accreditation. Below is the flow chart of applying for
SAMM:
Source:
[Link]
akreditasi-makmal-
malaysia-samm-#.Vx8FCtR97cs
2.0
Potential
Fields
of
Services
The complete list of existing
fields
under
(Appendix
SAMM
as
attached
From the given list, below are
fields of services that can be considered to be accredited:
I.
Chemical
Chemical tests and analysis on products and materials.
II.
Biological
the
currently
2).
potential
Biological, microbiological and biomedical, testing and measurement, including
examinations of foods, drugs and pharmaceuticals.
This potential field of services is suggested based on the current academic experts to
give inputs in the university and not considering on the subject of equipment availability
(based on ISO Standards) and staff requirement.
Attached are two samples of SAMM accredited laboratory offering services from a
public and private university (Appendix 3).
3.0 Approximate cost of implementation
The breakdown of approximate cost of is given in the table below:
Details
Cost
Training of ISO 17025 for laboratory personnel (total
RM 6,000.00
of 5 modules & RM 1,200.00 per module)*
SAMM Accreditation Process Fees **
Purchase of Equipment (analytical equipment such
RM 8,000.00(approx.)
RM 700,000.00 (approx..)
ICP-MS,UV-VIS)
Yearly Maintenance of Equipment
Consumables
Salary for staff (per month)
TOTAL COST
RM 10,000.00 (approx..)
RM 5,000.00 (approx..)
RM 3,000.00
RM 732,000.00 (approx.)
* Please refer Appendix 4
** Please refer Appendix 5
4.0 Recommendations
i. To focus only on one field which is biological testing (microbiology) and taking
into consideration on the cost factor of purchasing new equipment. Chemical
testing might require purchasing new equipment.
ii. To visit government agencies such Jabatan Kesihatan Negeri which are SAMM
accredited to learn more on implementing ISO 17025.
iii. To carry out market study based on the suggested field and potential
customers to carry out service in AIMST University.