FORUM JABATAN STANDARD MALAYSIA BERSAMA MAKMAL

4th November 2014
Concorde Hotel, Shah Alam
1
Contents
1 World Accreditation Day Celebration
5 Information
2 SAMM Statistics
6 Reminder
SAMM Publications
• Newly Published Document
• Revised Documents
3 • Document under Revision
• Document under Development
• Withdrawn Document
7 Meetings & Events
4 Confidentiality
8 Staff
Annex: Regulators &
9 Accreditation
2
Celebrating
World Accreditation Day
“Testing, inspection and certification are
ways to ensure that a clear line is drawn
between the methodologies and activities
that are right and wrong with respect to
energy provision. Accreditation of the
organizations that are performing these
tasks ensures a consistent and reliable
approach, which will in turn result in an
industry that is conducive to the needs of the
consumer and the environment.”
-Joint Statement by Randy Dougherty, Chair
3
IAF, and Pete Unger, Chair ILAC
SAMM Statistics
APPLICANT LABORATORIES
ACTIVE LABORATORIES
83
442
9
11
Total labs: 103
Testing
73
14
Calibration
Testing & Calibration
Medical Testing
INOPERATIVE/SUSPENDED/TERMINATED
33
17
Total labs: 562
Testing
Testing & Calibration
0
0
As of 15 October 2014
0
1
Calibration
Medical Testing
Total labs: 18
Testing
Calibration
Testing & Calibration
Medical Testing
4
SAMM Statistics
800
700
573
542
500
493
Accreditation
Granted
447
400
Cummulative
Accreditation
Granted
300
200
100
37
46
49
31
2009
2010
2011
2012
53
42
2013
2014
As of 15 October 2014
626
600
668
0
Year Granted
5
SAMM Statistics
NEW ACCREDITED LABORATORIES YEARLY
53
46
50
40
49
42
37
31
30
20
As of 15 October 2014
60
10
0
2009
2010
2011
2012
2013
2014
6
SAMM Publications: Newly Published Documents
SAMM Circular 1/2014: Technical Requirements for Calibration
Laboratories
• Approved 23 July 2014
• Effective date: 1 October 2014
• Supersedes SAMM Circular 1/2007, SAMM Technical Circular 1/2008
and SAMM Technical Circular 1/2010
7
SAMM Publications: Revised Documents
SAMM Policy 1 :Terms and Conditions Governing the Laboratory
Accreditation Scheme of Malaysia (SP 1)
• Issue 4, 8 Apr 2014
• Effective date: 1 November 2014
• Inserted new requirements
SAMM Policy 2: Policy on The Traceability of Measurement Results (SP 2)
• Issue 4, 21 Jul 2014
• Effective date: 1 October 2014
• Inserted new requirements to align with ILAC P10: 01/2013
SAMM Policy 3 :Policy on The Use Of SAMM Accreditation Symbol and
Combined ILAC MRA Mark or Reference to SAMM Accreditation (SP3)
• Issue 4, 21 Jul 2014
• Effective date: 1 October 2014
• Inserted new requirements to align with ILAC P8: 12/2012
8
SAMM Publications: Revised Documents
SAMM Policy 5 : Policy on Measurement Uncertainty Requirements for
SAMM Testing Laboratories (SP 5)
• Issue 3, 11 Aug 2014
• Effective date: 1 October 2014
• Editorial amendments
SAMM Policy 6: Requirements for Approved Signatory (SP 6)
• Issue 6, 11 Aug 2014
• Effective date: 1 October 2014
• Editorial amendments
9
SAMM Publications: Revised Documents
SAMM Policy 8 : Requirements and Procedures for the Accreditation of Site
Calibration and Testing Laboratories (SP 8)
• Issue 3, 11 Aug 2014
• Effective date: 1 October 2014
• Editorial amendments
SAMM Policy 10 : Grading of Non-Conformities (SP 10)
• Issue 3, 11 Aug 2014
• Effective date: 1 October 2014
• Editorial amendments
1
0
SAMM Publications: Revised Documents
STR 2.2 - Specific Technical Requirements for Accreditation of
Anatomical Pathology (Histopathology) Laboratories
• Issue 4, 18 June 2013
• Effective date: 1 July 2015
• Inserted new requirements
STR 2.5 - Specific Technical Requirements for Accreditation of
Medical Microbiology Laboratories
• Issue 4, 9 December 2013
• Effective date: 1 July 2015
• Inserted new requirements
11
SAMM Publications: Documents under Revision
1. Specific Criteria for the Veterinary Testing
12
SAMM Publications: Documents under
Development
1. Specific Criteria for Calibration Laboratories
2. Specific Criteria for the Field of Molecular Genetics Testing
3. SAMM Policy for Branch Accreditation
13
SAMM Publications: Withdrawn Documents
1. SAMM Policy 9 (SP 9) – Specific Requirements for
Measurement and Calibration System
SP9 is withdrawn as it is redundant with SP2, SP3, SP6 and
SP7. The SP9 requirements are also to be included in the
Specific Criteria for Calibration.
14
Confidentiality:
Policies & Procedures
• Laboratory to effectively implement their policies and procedures to
ensure the protection of their customers’ confidential information and
proprietary rights as required in ISO/IEC 17025 Clause 4.1.5 (c).
• The laboratory's policy to retain confidentiality should be stated.
Instructions must be included that all staff must take all reasonable
precautions to keep customers’ data and other information confidential.
The requirement to ensure that no such information is left out in the
laboratory overnight or in an unattended room should be stated.
15
Confidentiality: [Personnel
• All staff must be instructed that they are required to keep
confidential anything which they may learn as a result of their
work and any information which they are given in order to help
them to carry out their duties. The quality manual should
contain a statement to this effect.
• Organisations require staff to sign a confidentiality agreement.
16
Confidentiality: Test
Report Issuance & Transmission
• Electronic test reports in CD and transmission of test reports via email
 test report should be converted into non-editable format and/or
encrypted e.g in Adobe PDF format and password protected
 Microsoft Word security does not contain sufficient encryption or
protection from editing and is generally not considered to be an
acceptable method of security.
• The test report should not be circulated through social media which would
violate the confidentiality to the customers.
17
Information: New Scheme
MALAYSIA PROFICIENCY TESTING PROVIDER
ACCREDITATION SCHEME (MyPTP)
• Launched on 31st December 2013
• Based on MS ISO/IEC 17043 Conformity assessment – General requirements for
proficiency testing
• Accreditation service to Proficiency Testing Provider's which provides proficiency
testing programmes in area of testing, calibration, medical testing and inspection
• For more information on the application and fees involved, please visit our website
www.jsm.gov.my
18
Information: APLAC Peer
Re-Evaluation
• Conducted from 2 – 6 June 2014
• Re-evaluation for SAMM and extension of MRA for Standards Malaysia Inspection
Programme – MIBAS
• Evaluation team comprised of evaluators from the following Accreditation Bodies:
Evaluator
Ms. Cynthia Chen
Yuen Chen
Organisation
Taiwan
China National
International
International
Accreditation
Accreditation Service Accreditation Japan Accreditation New
Foundation (TAF),
for Conformity
(IAJapan), Japan
Zealand (IANZ),
Taiwan
Assessment (CNAS),
New Zealand
China
Field
Lead Evaluator
Testing
Ms. Hu Dongmei
Medical
Ms. Hiromi Murata
Calibration
Mr. Geoff Hallam
Inspection
19
Information: APLAC Peer
Re-Evaluation
Standards Malaysia would like to extend our appreciation to the following
laboratories and assessors that were involved during the evaluation:
Radiochemistry &
Environment
Laboratory (RAS),
Malaysian Nuclear
LA: Mr. Agency
Wan Rukiman
Wan Mamat
TA: Prof. Dr. Kwek
Kuan Hiang
LA: Lead Assessor
TA: Technical Assessor
Reliability Lab,
MIMOS Berhad
Department of
Pathology, Hospital Sg.
Buloh
Applicant Laboratory
Sendi Mahir Sdn Bhd,
Shah Alam
LA: Mr. Ng Kwan
Loong
TA: Ms. Ng Guat Peng
LA: Ms. Fariza Wan
Abdullah
TA: Datin Tunku Marina
Asyraf
TA: En Sabab Hashim
TA: A/Prof Rosline
Hassan
TA: Dr. Rohani Md Yasin
TA: Dr. Vijayamalar
Observer: Ms Carol Koo
LA: Dato’ Dr. Roshida
Hassan
TA: Prof. Dr. Datin
Noor Hamidah Hussin
TA: Prof. Dr. Nor Hayati
Othman
TA: Dr. Norazah
Ahmad TA: Dr.
Baizurah Mohd
Hussain
LA: Ir. Boey Hor
Meng
TA: Mr. Yong En Haur
TA: Mr. Woo Seng
Kee
TA: Mr. Wong Siew
Kwan
TA: Mr. Chen Soo Fatt
TA: Dr. Lim Chin
Keong
20
Information: APLAC Peer
Re-Evaluation
• Following are the feedbacks from the evaluation team:
i. Updating Standards Malaysia accreditation policies in line with
the international and regional requirements.
ii. Evaluation of assessors.
iii. The usage of accreditation symbol and ILAC MRA Mark in the
form of watermark.
iv. The categorization of accreditation scope
21
Information:
Standards Malaysia New Portal
• Website address: www.jsm.gov.my
• Best viewed in Firefox 16.0.1 and above, Chrome, Internet Explore 8 and above and
Safari.
22
Information:
Standards Malaysia New Portal
Fast access to the list &
details
of
accredited
laboratories on the portal
home page.
23
Information:
Standards Malaysia New Portal
Laboratories Directories
24
Information:
Standards Malaysia New Portal
All you need to know about accreditation
25
Information:
Standards Malaysia New Portal
Click the red triangle for drop-down menu
26
Information:
Revision ISO/IEC 17025: 2005
• A New Work Item Proposal (NWIP) submitted by ILAC, has
been launched for the revision of ISO/IEC 17025:2005,
General requirements for the competence of testing and
calibration laboratories.
27
Information: Accreditation Fees
• Standards Malaysia has revised and in the process to gazette the
fee structure. The revised fee is will be in force once approved.
• All the fees related to accreditation services is exempted from
Goods & Services Tax (GST) as all government services are
exempted from GST.
28
Information: Survey on
Benefit of Accreditation to Industry
• Standards Malaysia will conduct a survey on the importance of
accreditation particularly to the customers of laboratories involved in the
export & import industry.
• Will look on how accreditation and the mutual recognition arrangement
facilitate trades.
• Data on acceptance of accredited test report is very essential to develop
Standards Malaysia accreditation strategy.
29
Information: Herbs & Herbal Products Testing
• Malaysia Quarantine and Inspection Services (MAQIS) required all the exporters for herbs and
herbal products to be tested before export. This will be a mandatory requirement in 2015 and
MAQIS recognised the CoA produced by SAMM accredited laboratories.
• Specimen tested:
1. Tongkat Ali
2. Dukung Anak
3. Mas Cotek
4. Kacip Fatimah
5. Mengkudu
6. Ubi Jaga
• Detection/determination of the above by:
1. Plant Descriptions (taxonomy identification): morphological and microscopic examination
2. Thin Layer Chromatography
3. Gas Chromatography Mass Spectrometry
4. DNA Profiling
5. Fourier Transform Infra Red
Please visit www.maqis.gov.my for more information.
30
Information: Primary Batteries Testing
• Ministry of Domestic Trade, Co-Operatives and Consumerism
has enforced the mandatory safety standard for primary
batteries effective since 2013 to ensure the safety of the
consumers. This includes battery of the size AA, AAA, AAAA, C,
D, 9V and etc. that are made of zinc-carbon and alkaline.
• Products owners are required to declare that their products
are safe and one of the requirements for the declaration is to
have their products tested by accredited laboratories.
• For more information please visit
http://www.kpdnkk.gov.my/kpdnkkv3/images/KPDNKK/PDF/P
eraturan_GarisPanduan/Peraturan/PerihalDagangan/BATERI/G
ARIS_PANDUAN_BATERI.pdf
31
Information: Halal Testing
• Malaysian Halal Hub Division, JAKIM is inviting
laboratories to apply as panel laboratory for the
purpose of halal certification.
• Followings are the list of halal testing:
 Chemical:
i. Determination of ethanol & methanol
ii. Determination of alcohol percentage
iii. Identification of pig skin/bristle
product/brushes
 Nucleic Acid:
i. Porcine DNA extraction and detection
in
leather
32
Information:
Food Analyst Act 2011 & Food Analyst Regulation 2013
• Food Analyst Act 2011 & Food Analyst Regulation 2013 were in-force on 15 March 2014.
• Under this Act, only registered food analyst is allowed to issue and endorsed report for
food analysis.
• All food analysts (government and private sector) shall apply as registered food analysis
within 12 months from the in-force date of the Act & Regulation.
• Food analyst is allowed to continue performing their activities while waiting for approval
• IKM registered chemists are excluded from the Act & Regulation
• For more information, please go to Food Safety & Quality Division portal
http://fsq.moh.gov.my/v4/index.php/aktiviti-perkhidmatan/2013-04-01-07-5159/juruanalisis-makanan
33
Information: Reference Material Producers (RMP)
• Standards Malaysia will be establishing the accreditation
scheme for reference material producers (RMP).
• Currently studying the demands and needs of accredited RMP
and potential laboratories.
• RMP will be assessed according to the requirements of ISO
Guide 34.
34
Information: Control Copy Document
• There is no need to produce and maintain a control copy of laboratory
quality documents (e.g. quality manual and procedures) for Standards
Malaysia. However during assessment, the laboratory to provide the
latest version of the documents to the assessment team. If requested,
laboratory has to provide the document prior to assessment.
35
Information: Exemption of
Adequacy Audit
Only if the laboratories fulfil the following criteria:• All Laboratory under the group share a common documentation system and
have submitted application for accreditation at the same time.
• Part of Laboratory under the group have undergone adequacy audit conducted
by the same Lead Assessor.
• The Lead Assessor has reviewed the laboratory/PTP’s documentation to ensure
that the laboratory/PTP's documentation is similar (e.g Quality Manual and
Procedures) and confirms that the Laboratories/PTP under the group of
company/organisation share a common documentation system.
• Decision to exemption may be granted at Standards Malaysia’s discretion.
36
Information: Exemption of
Pre-Assessment
Only if the laboratories fulfil the following criteria:• the headquarters shall be currently accredited
• the branch shall be operating a matured management system.
• must implement similar management system with HQ system
• must apply the same or closely resembling the existing field/scope of
accreditation in HQ. For calibration laboratory, it must has similar CMC to the
existing accredited field/scope in HQ
• the internal audit of the branch laboratories shall be conducted
• personnel must be adequately trained and technically competent
• effective or strong in quality control and proficiency testing activities
• have effective management review both at their HQ and the branch
37
laboratories/inspection bodies
Reminder: Laboratories’ Obligation
• To take into consideration Standards Malaysia assessment schedule
before carrying out any major activities of the (e.g.: renovation,
relocation exercise).
• To prioritise the assessments especially involving renewal of
accreditation.
• To inform Standards Malaysia any changes that would affect the
testing/calibration laboratory's capability, competence, integrity,
independence or scope of activity (SAMM Policy 1 Clause 4.6).
38
Reminder: Laboratories’ Obligation
• To submit the evidence of corrective actions within the timeline. Lab
will be suspended for late submission and there won’t be any exception
especially when near the expiry of certificate and customer has
requested for the latest accredited scope.
• The assessment team will require time to review the evidence of
corrective action, thus submission on time is critical to close the report.
• Any application for extending scope or nominating new approved
signatory must be done before the assessment. Any application during
assessment is not allowed.
39
Reminder: Appointing Consultant
• Appointment of suitable and competent consultant
• Consultant shall not be appointed as contact person
• Consultant shall not participate in assessment
40
Reminder:
Outstanding Payment
• It is the responsibility of the laboratory to pay such fees for
application, assessment, annual fee and other services,
from time to time as determined by Standards Malaysia.
• Laboratories are advised to settle any outstanding payment
due as soon as possible.
• Suspension will be initiated if no payment received within
4 months from the date of the invoice.
41
Reminder: Outstanding Payment
Invoice
Assessment fees: issued after each assessment; Annual fees: based on term
1st Reminder Letter
If payment is not received within 2 months from the date of invoice
Final Reminder Letter
If payment is not received within 4 months from the date of invoice
Note:
The laboratory will be
suspended
for
1
month
although
payment is remitted
during the suspension
period.
Suspension of Accreditation
After 14 working days (from the final reminder)
Withdrawal of Accreditation
Failure of remitting payment within 1 month after letter of suspension
42
Reminder: Assessment Cycle
Activity
First Cycle
(3 yrs)
Subsequent
Cycle
(3 yrs)
Total assessment
per cycle
Reassessment
3 assessments /
cycle
3 months before
certificate expiry
2 assessment /
cycle
6 months before
certificate expiry
• First cycle: Newly accredited laboratories
• Subsequent cycle: Laboratories that has completed first cycle and renewed
their certificate
• Standards Malaysia reserves the right to revert the cycle of accreditation
depending on the performance of the laboratory arising from the results
of the assessment (SAMM Policy 1 Clause 3.4 b)
43
Reminder: Assessment in December
• Assessment will not be scheduled in December.
• Any scheduled assessment (forward plan schedule) which
falls in December will be rescheduled to November /
January the following year.
44
Reminder: Assessment
• All medical testing laboratories are assessed according to
the requirements of standard ISO 15189: 2012 beginning
July 2014
• Transition period to the new standard is by December 2015
45
Reminder: NCR Category 1
and Witnessing
• For NCR Cat 1, laboratory is to be put inoperative
immediately and formal suspension letter will then be issued
by Standards Malaysia.
• Witnessing
i. Assessors should conduct witnessing in every assessment.
Different test methods/aspect/activities should be witnessed
in the laboratory.
ii. Assessors should refer to previous witnessing activities
before performing next assessment
46
Reminder: Scope
• Existing scope and extension of scope to be prepared and
signed using the format provided by Standards Malaysia (e.g
Copy of the existing scope or Appendix A of LA 202 EXT)
• Standards for product should not be included in the scope;
only standards test methods will be listed in the scope
• Check all the details during the closing meeting before
signing the scope
47
Reminder: Scope
• All scope applied/accredited are to be covered and assessed
during initial assessment
• Even if the scope involved only one test; suitable assessors
which has the required knowledge and technical competency
will assess the specific fields/scope.
48
Reminder: The Usage of SAMM Symbol and ILAC-MRA
Mark
• Common misuse
i. Incomplete symbol (without the standard and/or field of accreditation
and/or SAMM number)
ii. Wrong symbol displayed (e.g. laboratories using the accredited certification
MS ISO/IEC 17025
bodies symbol)
TESTING/CALIBRATION
SAMM NO. 000
• Some laboratories are issuing test reports/certificate of analysis with SAMM
symbol with results which are outside of the scope of accreditation without
placing the disclaimers on such results.
• ILAC-MRA Mark is not allowed on business card. (ILAC-R7 09: 2009).
• Usage of SAMM symbol in laboratory publication, certificate of analysis etc
should be assessed and reported by assessor in the LA and TA report. (SAMM
Policy 3).
MS ISO 15189
MEDICAL TESTING
SAMM NO. 000
49
Reminder: Requirements of
SC 1.3
• Effective from 1st January 2014, SAMM microbiological testing
laboratories must comply with requirements in of Specific
Criteria for Accreditation of Microbiological Testing Laboratories
(SC 1.3) issued on 28 June 2011.
• Microbiological testing shall only be assessed by technical
assessor who has qualification in microbiology or related field.
50
Reminder: Requirements of
SC 1.3
• Where decision were made on the approval of signatory before the effective date
of the document, the signatory status of the approved signatory for Microbiology
scope will remain with conditions as follows:
No Scope
.
Type of Signatory
Decision
1 Scope - Simple diagnostic water Registered chemist who is
test i.e.:
currently an approved
 Total Coliform Test
signatory.
 E. coli using APHA 9221 D &
F, 21st Edition
 Total Plate Count
Accreditation status is maintained.
Chemist should understand the
fundamental
or
principle
of
microbiology as required by Standards
Malaysia.
2 Scope - Water/Food/Other tests Registered chemist who is
currently an approved
signatory.
Accreditation status for Microbiology
scope will be suspended. Lab shall
employ a microbiologist.
51
Reminder: Requirements of
SC 1.3
• For tests other than water and food testing under microbiology field, the
requirements of SC 1.3 shall apply. If laboratory is conducting other than
water testing, signatory for the test report shall comply with the SC 1.3
requirements and/or any other regulations and laws of the country e.g.
Food Analyst Act 2011.
• Applicant laboratories need to comply with requirements SC 1.3 with for
microbiological testing effectively from the date of application.
52
Meetings & Events
Date
Event
26 – 27 February 2014 Workshop on Establishment and Operations of ASEAN Food
Testing Laboratory (AFRL) Network, Bandar Seri Begawan, Brunei
24 -27 March 2014
National Institute of Standards and Technology (NIST) Standards
in Trade (SIT) Conference for Association of Southeast Asian
Nations (ASEAN) On Conformity Assessment in The Electric And
Electronics Sector’, Maryland, US
12 – 13 August 2014
Training on Standards ISO/IEC 17021
14 – 15 August 2014
Workshop on Standards ISO/IEC 15189: 2012
22 August 2014
Training on Standards ISO/IEC 17020
9 – 10 September
2014
Trainee Technical Assessor Course for SAMM
28 – 29 October 2014
ISO 15189: 2012 for Medical Testing Laboratories
October 2014
MIBAS Forum
5 – 6 November 2014
Method Validation Workshop for Microbiological Testing
53
Meetings & Events
Date
Meetings
18 – 20 March 2014
ASEAN Consultative Committee For Standards And Quality
(ACCSQ) Working Group On Accreditation And Conformity
Assessment (WG2) 26th Meeting, Bali, Indonesia
21 – 27 June 2014
Joint General Assembly APLAC-PAC 2014, Guadalajara, Mexico
11 – 13 November
2014
ASEAN Consultative Committee For Standards And Quality
(ACCSQ) Working Group On Accreditation And Conformity
Assessment (WG2) 27th Meeting, Cambodia
54
Accreditation Division
Accreditation Officers with Standards Malaysia Director-General, YBhg. Datuk Fadilah Baharin and
the APLAC Peer Evaluation Team 2014
55
Accreditation Division:
Staff Strength
SAMM
Accreditation
Officers
(20)
Support
Staffs
Technical
Assessor
(185)
(6)
Lead
Assessor
(27)
56
Accreditation Division:
Contact Details
No.
Officer
Seksyen
1.
En. Shaharul Sadri Alwi
Pengarah Akreditasi
8318 2227
[email protected]
2.
Pn. Saadiah Sulaiman
Setiausaha
8319 1303
[email protected]
3.
En. Wan Rukiman Wan Mamat
8319 1308
[email protected]
4.
Pn. Fariza Wan Abdullah
Ketua Seksyen Akreditasi Makmal
Pengujian & Penentukuran
Ketua Seksyen Akreditasi Bersekutu
8319 1317
[email protected]
5.
En. Roslan Alias
8319 1318
[email protected]
6.
Pn. Rosnieh Eggat
8319 1382
[email protected]
7.
En. Mohd. Hamzaini Hashim
Ketua Seksyen Akreditasi Badan
Pemeriksaan
Seksyen Akreditasi Makmal Pengujian &
Penentukuran
Seksyen Akreditasi Badan Pemeriksaan
8319 1391
[email protected]
8.
Pn. Rohasmizah Ismail
Seksyen Akreditasi Bersekutu
8319 1369
[email protected]
9.
Cik Siti Norehan Ishak
Seksyen Akreditasi Bersekutu
8319 1355
[email protected]
10.
En. Ainol Azizul Rosli
8319 1395
[email protected]
11.
Pn. Wong Fei Ting
Seksyen Akreditasi Makmal Pengujian &
Penentukuran
Seksyen Akreditasi Makmal Pengujian &
Penentukuran
Seksyen Akreditasi Makmal Pengujian &
Penentukuran
8319 1357
[email protected]
8319 1377
[email protected]
12.
Pn. Siti Rohaya Omar
Phone No.
Email
57
Accreditation Division:
Contact Details
No.
Officer
13.
Pn. Siti Raikhan Aina Binti Bogal
14.
En. Mohamad Hafanizam Bin Hassan
15.
En. Mohd Azrul Bin Che Aziz
16.
Cik Jessica Sawai Anak Jues
17.
Cik Noraidah Binti Subakin
18.
19.
20.
21.
22.
Seksyen
Seksyen Akreditasi Makmal Pengujian
& Penentukuran
Seksyen Akreditasi Makmal Pengujian
& Penentukuran
Seksyen Akreditasi Badan
Pemeriksaan
Seksyen Akreditasi Makmal Pengujian
& Penentukuran
Seksyen Akreditasi Makmal Pengujian
& Penentukuran
En. Mohammad Yusof Bin Ismail
Pn. Nabilah Binti Ahmad Kamal
Phone No.
Email
8319 2126
[email protected]
8318 0034
[email protected]
8319 1781
[email protected]
8319 1427
[email protected]
8319 1388
[email protected]
Seksyen Akreditasi Bersekutu
8319 1426
[email protected]
Seksyen Akreditasi Bersekutu
8319 1462
[email protected]
8319 1372
[email protected]
8319 1434
[email protected]
8319 1361
[email protected]
En. Muhammad Asyraf Bin Mahmood Seksyen Akreditasi Makmal Pengujian
Dean
& Penentukuran
Seksyen Akreditasi Makmal Pengujian
Pn. Saidatul Atyah Binti Mohd Apendi
& Penentukuran
Seksyen Akreditasi Bersekutu
Pn. Norsheda Binti Mohd. Bahari
58
23.
Pn. Norhabibah binti Mohamad
Seksyen Akreditasi Bersekutu
8319 1340
[email protected]
Regulators & Accreditation
BIL.
1.
BADAN
PENGUATKUASA/
PENGAWALSELIA/
PEMBUAT DASAR
Suruhanjaya Tenaga (ST)
AKTA / PERATURAN / PERINTAH / PEKELILING /
GARIS PANDUAN YANG DIKUATKUASAKAN
Surat Pekeliling Suruhanjaya Tenaga Bilangan 1
Tahun 2003 (BIL. 1/2003) “Prosidur Serta SyaratSyarat Untuk Mendapatkan Perakuan Kelulusan
Mengilang, Mengimport, Mempamer, Menjual, Atau
Mengiklan Bagi 31 Kelengkapan Elektrik”. Semakan
semula telah dibuat pada tahun 2012 dengan
penambahan 3 kategori lagi menjadikan 34 kategori
keseluruhannya.
Notis
pemberitahu
telah
dikeluarkan pada 31 Julai 2012 kepada semua
pengilang,
pengimport,
persatuan-persatuan
berkaitan dan agensi-agensi kerajaan yang
berkenaan.
HASIL PENGUATKUASAAN
Pengawalan
proses
mengilang,
mengimport, mempamer, menjual atau
mengiklan kelengkapan elektrik melalui
sokongan laporan pengujian oleh makmal
yang diakredit di bawah Standards
Malaysia atau makmal-makmal yang
diakredit oleh badan-badan akreditasi
yang telah menandatangani Asia Pacific
Laboratory Accreditation Cooperation
(APLAC) MRA serta disahkan oleh
Standards Malaysia.
59
Regulators & Accreditation
BIL.
2.
BADAN
AKTA / PERATURAN / PERINTAH /
PENGUATKUASA/
PEKELILING / GARIS PANDUAN YANG
PENGAWALSELIA/
DIKUATKUASAKAN
PEMBUAT DASAR
Suruhanjaya
a) Perenggan 4.3 & 4.5, Garis Panduan
Perkhidmatan Air Negara
untuk Pendaftaran sebagai Pembekal di
bawah Seksyen 180(m), Akta Industri
(SPAN)
Perkhidmatan Air 2006.
b) Seksyen 5.4, Garis Panduan Secara
Sukarela bagi Skim Pelabelan Produk
Kecekapan Air.
HASIL PENGUATKUASAAN
a) Pengawalan proses membekal kelengkapan,
peranti, bahan, sistem atau kemudahan
(secara kolektif dipanggil sebagai produk)
untuk bekalan air dan sistem pembetungan di
Semenanjung Malaysia, Wilayah-Wilayah
Persekutuan Putrajaya dan Labuan melalui
sokongan pensijilan produk oleh badan
pensijilan yang diakredit Standards Malaysia
atau diiktiraf oleh Pacific Accreditation
Cooperation
(PAC)
and
International
Accreditation Forum (IAF) Multilateral
Recognition Arrangement (MRA).
b) Peningkatan langkah-langkah pemuliharaan
air dengan menggalakkan pembekal untuk
membangunkan dan memasarkan produk
yang cekap air melalui sokongan pengujian
penggunaan air oleh makmal yang diakredit
dan diiktiraf oleh Standards Malaysia.
60
Regulators & Accreditation
BIL.
3.
BADAN
PENGUATKUASA/
PENGAWALSELIA/
PEMBUAT DASAR
Bahagian Keselamatan
dan Kualiti Makanan
AKTA / PERATURAN / PERINTAH / PEKELILING
/ GARIS PANDUAN YANG DIKUATKUASAKAN
HASIL PENGUATKUASAAN
a) Peraturan-peraturan
Makanan
(Pengeluaran Sijil Kesihatan Bagi Eksport
Ikan dan Keluaran Ikan ke Kesatuan
Eropah) 2009.
a) Pengawalan kualiti ikan yang dieksport ke
Eropah melalui pengeluaran Sijil Kesihatan
yang disokong oleh laporan pengujian makmal
yang diakredit di bawah Standards Malaysia
b) Garis Panduan Bagi Pengiktirafan Makmal
Swasta Untuk Perkhidmatan Analisis
Makanan Bagi Pengeluaran Sijil Kesihatan
oleh Kementerian Kesihatan Malaysia.
b) Pengiktirafan terhadap makmal swasta yang
diakredit di bawah Standards Malaysia dalam
menjalankan perkhidmatan analisis makanan
melalui pengeluaran sijil kesihatan oleh
Kementerian Kesihatan Malaysia.
b) Perenggan 8.1.2, Garis Panduan Skim
Pensijilan
Makanan
Selamat
Tanggungjawab Industri (MeSTI).
c) Penambahbaikan mutu perkhidmatan dan
keselamatan makanan oleh pihak industri
makanan terutamanya Enterpris Kecil dan
Sederhana (EKS) yang mempunyai pensijilan
sistem jaminan keselamatan makanan oleh
badan pensijilan yang diakredit Standards
Malaysia atau pensijilan oleh KKM melalui
program jaminan keselamatan makanan.
61
Regulators & Accreditation
BIL.
4.
BADAN
PENGUATKUASA/
PENGAWALSELIA/
PEMBUAT DASAR
Bahagian Kawalan
Peranti Perubatan
AKTA / PERATURAN / PERINTAH / PEKELILING /
GARIS PANDUAN YANG DIKUATKUASAKAN
Jadual Keempat, Perenggan 13(1),
peraturan Peranti Perubatan 2012.
HASIL PENGUATKUASAAN
Peraturan-
Pengawalan terhadap peranti perubatan
melalui penilaian pematuhan untuk
menunjukkan pematuhannya terhadap
prinsip-prinsip keselamatan dan prestasi
yang perlu bagi peranti perubatan.
5.
Lembaga Minyak Sawit
Malaysia (MPOB)
Perenggan 3.3, Tambahan Syarat Lesen yang
Dikenakan ke Atas Kategori Makmal, Pekeliling
Penguatkuasaan (Pelesenan) MPOB 01/2007.
Penguatkuasaan ke atas lesen kategori
makmal
bagi
aktiviti
pengujian
pengeluaran kelapa sawit di mana
pemegang lesen kategori makmal perlu
mendapat akreditasi daripada Standards
Malaysia.
6.
Jabatan Pengajian Tinggi
(JPT)
Seksyen I, No. 1, Borang Soal Selidik Universiti
Penyelidikan di bawah Pelan Strategik Pengajian Tinggi
Negara (PSPTN) 2007 untuk memperteguh
penyelidikan dan inovasi.
Penambahbaikan
kualiti
universiti
penyelidikan dengan menetapkan salah
satu kriteria permohonan universiti
penyelidikan adalah makmal-makmal perlu
mendapatkan
akreditasi
di
bawah
Standards Malaysia.
62
Regulators & Accreditation
BIL.
7.
BADAN PENGUATKUASA/
PENGAWALSELIA/
PEMBUAT DASAR
Kementerian Perdagangan
Dalam Negeri, Koperasi dan
Kepenggunaan (KPDNKK)
AKTA / PERATURAN / PERINTAH / PEKELILING / GARIS
PANDUAN YANG DIKUATKUASAKAN
HASIL PENGUATKUASAAN
a)
Peraturan 4(1) Deklarasi Pematuhan, Peraturan- a)
peraturan Pelindungan Pengguna (Perakuan
Pematuhan dan Tanda Pematuhan Standard
Keselamatan) 2010 di bawah Akta Perlindungan
Pengguna 1999.
Perlindungan kepada pengguna melalui produk
yang dibekalkan, diiklankan untuk dibekalkan,
ditawar atau diimport oleh pemilik produk
haruslah diuji oleh makmal yang diakredit di
bawah Standards Malaysia.
b)
Peraturan 2(1) Standard Keselamatan Bagi Mainan, b)
Peraturan-peraturan
Pelindungan
Pengguna
(Standard Keselamatan Bagi Mainan) 2009; dan
Peraturan-peraturan
Pelindungan
Pengguna
(Standard Keselamatan Bagi Mainan) (Pindaan) 2010
di bawah Akta Pelindungan Pengguna 1999.
Perlindungan kepada kanak-kanak bawah umur
14 tahun dengan mewajibkan pembekal mainan
supaya menerima pakai dan mematuhi standard
keselamatan berdasarkan penentuan standard di
bawah Seksyen 15, Akta Standard Malaysia 1996
[Akta 549].
c)
Jadual di bawah Perintah 3 Penandaan Topi Keledar c)
Motosikal, Perintah Perihal Dagangan (Penandaan
Topi Keledar Motosikal) 2012 di bawah Akta Perihal
Dagangan 2011.
Peningkatan kualiti dan ciri-ciri keselamatan topi
keledar terhadap pengguna dengan mewajibkan
pembekal untuk mematuhi MS 1 dan meletakkan
tanda MS pada topi keledar.
d)
Jadual di bawah Perintah 3 Penandaan Tayar d)
Pneumatik, Perintah Perihal Dagangan (Penandaan
Tayar Pneumatik) 2012 di bawah Akta Perihal
Dagangan 2011.
Peningkatan kualiti dan ciri-ciri keselamatan tayar
pneumatik
terhadap
pengguna
dengan
mewajibkan pembekal untuk mematuhi MS 1394
dan meletakkan tanda MS pada tayar pneumatik.
63
Regulators & Accreditation
BADAN PENGUATKUASA/
AKTA / PERATURAN / PERINTAH / PEKELILING /
PENGAWALSELIA/
BIL.
HASIL PENGUATKUASAAN
GARIS PANDUAN YANG DIKUATKUASAKAN
PEMBUAT DASAR
Jabatan Perkhidmatan
Perenggan 4(1), Peraturan-peraturan Makanan Penyelarasan dalam kaedah menganalisis makanan
8.
Veterinar
Haiwan (Kaedah Menganalisis Makanan Haiwan dan haiwan dengan mewajibkan pegawai yang diberi
Bentuk Perakuan Analisis) 2011.
kuasa mengambil sampel makanan haiwan atau
bahan tambahan makanan haiwan untuk
menyerahkan sampel tersebut kepada makmal yang
diakredit.
9.
Jabatan Keselamatan dan
Kesihatan Pekerjaan
Malaysia (DOSH)
Perenggan 4.4 (a), Garis Panduan Tentang Pengurusan pendedahan merkuri dalam industri
Pengurusan Merkuri dalam Industri Minyak dan Gas minyak dan gas dengan melantik makmal yang
2011.
kompeten dan diakredit di bawah Standards
Malaysia bagi menjalankan persampelan higien
industri khususnya untuk analisis merkuri.
10.
Lembaga Pembangunan
Industri Pembinaan
Malaysia (CIDB)
Perenggan 6.1 (a) dan (b), Tatacara Mengimport Pengawalan pengimportan produk binaan iaitu
mestilah mendapat pensijilan produk daripada
Produk Binaan 2008.
badan pensijilan yang diluluskan oleh CIDB dan
diakredit oleh Standards Malaysia atau makmalmakmal yang diakredit oleh badan-badan akreditasi
yang telah menandatangani Asia Pacific Laboratory
Accreditation Cooperation (APLAC) MRA serta
disahkan oleh Standards Malaysia.
64
Regulators & Accreditation
BIL.
11.
BADAN
PENGUATKUASA/
PENGAWALSELIA/
PEMBUAT DASAR
Jabatan Alam Sekitar
(JAS)
AKTA / PERATURAN / PERINTAH /
PEKELILING / GARIS PANDUAN YANG
DIKUATKUASAKAN
HASIL PENGUATKUASAAN
a) Para
2
(i),
Jadual
Kesepuluh,
Subperaturan 7 (2), P.U.(A) 434, Akta
Kualiti Alam Sekeliling 1974, PeraturanPeraturan Kualiti Alam Sekeliling (Efluen
Perindustrian) 2009.
a) Pemantauan yang lebih cekap terhadap premis
yang membuang atau melepaskan efluen
perindustrian atau efluen bercampur ke atas atau
ke dalam mana-mana tanah melalui rekod data
pembuangan efluen oleh premis yang dipantau
oleh makmal yang diakredit.
a) Perkara 4.5.1, para 1, muka surat 30,
Contaminated Land Management and
Control Guidelines No. 2: Assessing and
Reporting Contaminated Sites, Edisi
Pertama, Jun 2009, terbitan: Jabatan
Alam Sekitar.
b) Pengawalan tanah yang tercemar dengan
melakukan penyiasatan dan penilaian di kawasan
terbabit di mana sampel akan dianalisis oleh
makmal yang diakredit.
b) Para 2 (i), Jadual Kelima , Peraturan 10,
P.U.(A) 432, Akta Kualiti Alam Sekeliling
1974, Peraturan-Peraturan Kualiti Alam
Sekeliling (Kumbahan ) 2009.
c) Pemantauan yang lebih cekap terhadap premis
yang membuang atau melepaskan kumbahan ke
atas atau ke dalam mana-mana tanah melalui
rekod data pembuangan efluen oleh premis yang
dipantau oleh makmal yang diakredit.
65
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