Forum Jabatan Standard Malaysia Bersama Makmal SAMM 2013

Transcription

6/14/2013
Forum Jabatan
Standard Malaysia
Bersama Makmal
SAMM 2013
11 Jun 2013
Pusat Konvensyen Antarabangsa Putrajaya (PICC)
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Contents
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1 World Accreditation Day Celebration - Events
Organised by STANDARDS MALAYSIA
5 i)
ii)
iii)
iv)
v)
vi)
2
SAMM Statistics
Supplementary Requirement Documents
3•Newly
Published Documents
•Existing Documents Under Review
•Newly Revised Documents
•New Documents Under Development
4i)
ii)
iii)
iv)
v)
vi)
Information
APLAC Peer Re Evaluation
Scope of Accreditation
Online Accreditation System
New Regulated Products by KPDNKK
Makmal Panel Halal JAKIM
STANDARDS MALAYSIA website
6
Reminder
Witnessing Report
Obligation of laboratory
Assessment in December
Assessment Feedback
Outstanding Payment
Restructuring of Assessment Cycle
Meeting & Events
•Organised in 2012
•Upcoming Events
Staff
7•Strength
•Contact Details
8
Facilitating World Trade
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World Accreditation Day Celebration - Events
Organised by STANDARDS MALAYSIA
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Forum with SAMM
Laboratories 11 June 2013
Forum with
SAMM Assessor
for Medical
Testing
26 June 2013
Forum with
Certification Bodies 13 June 2013
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SAMM Statistics (As of 31 May 2013)
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Accredited
Laboratories
Active:
Full or Partially
Inoperative/
Suspended/
Terminated
Applicant
Laboratories
Testing - 5
Calibration - 3
Testing - 81
Calibration - 19
Testing & Calibration - 0
Medical Testing - 7
Medical Testing - 28
TOTAL - 15
TOTAL - 121
Testing - 385
Calibration - 67
Medical Testing - 21
TOTAL - 493
Voluntary Withdrawn:
Testing - 75
Calibration - 26
Medical Testing - 0
TOTAL - 103
Number of Certificate Issued (since 1987) - 596
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SAMM Statistics
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700
600
573
500
400
360
Accreditation Granted
300
213
222
200
94
100
119
Cummulative Accreditation
Granted
138
103
9
9
0
1987-1991
1992-1996
1997-2001 2002-2006
Year Granted
2007-2012
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SAMM Statistics
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50
45
40
35
30
25
20
15
10
5
0
46
49
37
31
29
23
21
2007
2008
2009
2010
2011
2012
2013 (as
of May)
No. of New Laboratories Acredited Yearly
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Supplementary Requirement Documents - Newly
Published Document
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•
•
•
•
•
New field offered under SAMM
Field of testing: Software Testing
Document: Specific Technical Requirements for
Accreditation of Software Testing Laboratories
(Issue 1, 10 September 2012)
Developed by TWG 49
Soft launched (website) on 18 October 2012
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- Existing Documents Under Review
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SP1 - Terms and Condition Governing the Laboratory Accreditation Scheme of Malaysia
SP4 - Policy on Proficiency Testing (PT) Requirements for SAMM Laboratories: Draft
has been circulated to assessor and laboratories for comments on 23 May 2013
STR 1.4 - Specific Technical Requirements for Accreditation of Veterinary Testing
Laboratories
STR 2.2 - Specific Technical Requirements for Accreditation of Anatomical Pathology
(Histophatology) for Medical Testing Laboratories: Draft has been circulated to TWG
members in May 2013. Document is pending for Approval by MSDAM.
STR 2.5 - Specific Technical Requirements for Accreditation of Medical Microbiology for
Medical Testing Laboratories: Draft has been circulated to assessor and laboratories on
24 April 2013 for comment.
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- Revised Document
1.
ISO 15189:2012 - Medical Laboratories: Requirements for Quality and
Competence
•
Published on 1st November 2012, replacing the 2007 edition.
•
STANDARDS MALAYSIA is adopting the 2012 edition to become a
Malaysian Standard (MS). Will be announced once the MS version is
available.
•
Available for purchase from the ISO website:
http://www.iso.org/iso/home.htm > ISO Store > Standards Catalogue.
•
Effective implementation date:1 March 2016.
2.
SC 2 - Specific Criteria For Accreditation in the Field of Medical Testing
•
Issue 4: 31 December 2011
•
Effective date: 25 May 2013
3.
STR 2.1 - Specific Technical Requirements for Accreditation of Anatomical
Pathology (Cytopathology) Laboratories
•
Issue 4: 31 December 2011
•
Effective date: 25 May 2013 for accredited laboratories
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- Revised Document
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4.
STR 2.3 - Specific Technical Requirements for Accreditation of Chemical Pathology
Laboratory
• Issue 4: 20 December 2012
• Effective date: 30 March 2014
5. STR 2.4 - Specific Technical Requirements for Accreditation of Haematology
Laboratories
• Effective date: 30 March 2014
6. STR 2.8 - Specific Technical Requirements for Accreditation of Cytogenetic Testing
• Effective date: 25 May 2013
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- Revised Document
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7.
SC 1.3 - Specific Criteria for Accreditation in the Field of Microbiological Testing
•
•
•
Effective date: 1 August 2013
Signatory for microbiological testing to have at least a degree or higher in
microbiology or related fields
Related fields mean degree in food technology, biomedical science,
veterinary, fisheries, biotechnology etc. which has microbiology subject in
their study syllabus.
Note:
•
Documents listed from 2 - 6 can be downloaded from STANDARDS MALAYSIA
website.
•
Applicant laboratories will be assessed based on the new revised documents
(where applicable).
•
NCRs will be raised should the laboratory fails to comply to the requirement of
the documents after the effective date.
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Supplementary Requirement Documents - New
Documents Under Development
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1. Specific Criteria for the Field of Calibration
2. Specific Criteria for the Field of Molecular Genetics Testing
3. SAMM Policy for Branch Accreditation
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Information - APLAC Peer Re Evaluation
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Scheduled
in June 2014
Design
• Extension of MRA for STANDARDS MALAYSIA Inspection Programme MIBAS
• Evaluation team will comprise of evaluators from the following economies:
• Lead - Chinese Taipei
• Testing - Thailand
• Medical - Australia
• Calibration - India
• Inspection - Singapore
• Several assessments scheduled to be conducted in June will be selected to
be witnessed by the evaluation team
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Information - Scope of Accreditation
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STANDARDS MALAYSIA does not provide accreditation services
for laboratories that apply for sampling activities
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Information - Online Accreditation System
(E-Accreditation)
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Online integrated accreditation management system aimed to
provide:
• End to end online accreditation services involving application,
reporting and monitoring of accreditation via PCs, tablet PCs,
smart phones and any preferred web browser
• Centralised information for easy retrieval
• Empowerment of information access and update for laboratories
• Faster and reliable response time and accreditation services
• Easy and better monitoring of accreditation status
• Online payment procedure
• Environmental friendly
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Information - Online Accreditation System
(E-Accreditation)
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• Target to go live in 2014
• Laboratories to have
basic internet facility to
access the system
• Manual interventions is
allowed at the minimum
Target to go live
in 2014
Laboratories is
required to have
a basic internet
facility to access
the system
Manual
intervention is
allowed at the
minimum
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Information - New Regulated Products by KPDNKK
•
i.
ii.
iii.
iv.
KPDNKK will enforce the following products:
Primary battery (based on MS IEC 60086 Part 1, 2, 4 & 5)
Vehicle spare part (headlamp & windscreen)
Children and baby products
Stationeries
•
All products above shall be tested in laboratory
•
For more information, please contact:
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THIAGALETCHUMI V.MANIAM, (Ms.)
Policy and Implementation Unit
Consumerism Standards Division
Ministry of Domestic Trade,
Co-operatives and Consumerism Malaysia
Tel : +603-8882 5500 (General line)
+603-8882 5862 (Direct line)/+603-8882 6965/5959/5886
Fax : +603-8882 6960
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Information - Makmal Panel Halal JAKIM
•
Bagi proses Pensijilan Halal Malaysia, pihak JAKIM melantik makmal-makmal
pengujian yang menjalankan pengujian halal yang berkelayakan sebagai makmal
panel halal.
•
Tawaran permohonan peringkat pertama telah dijalankan bagi makmal yang telah
diakreditasi SAMM yang berkelayakan sehingga 5 April 2013.
•
Makmal - makmal yang menawarkan pengujian halal boleh cuba memohon di
masa akan datang.
•
Untuk maklumat lanjut berkenaan syarat-syarat kelayakan, boleh hubungi pihak
JAKIM:
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En. Kamarudzaman Ahmad & Cik Anis
Bahagian Hab Halal
Jabatan Kemajuan Islam Malaysia
Aras Bawah, Blok 2200
Bangunan Enterprise 3, Persiaran APEC
63000 Cyberjaya, Selangor.
Tel: 03-8315 0260 / 0230
Fax: 03-8318 7044
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Information - STANDARDS MALAYSIA Website
• The Department’s website has been upgraded from
Joomla Platform from 1.5.2 to 6.1.0.1 Liferay which was
completed in Feb 2013.
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• Website specifications: best viewed in Firefox 16.0.1 and
above, Chrome, Internet Explore 8 and above and Safari.
• Website address: www.standardsmalaysia.gov.my
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Information - STANDARDS MALAYSIA Website New
Display
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Display
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Display
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Display
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Shortcut for
Laboratory
Directories
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Display
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To search and view
accredited laboratory
information and scope by
SAMM No., Organisation
Name or Field of Testing
Example:
SAMM No. 008
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Reminder
Witnessing Report
• A copy of witnessing reports will be given to the laboratory during closing
meeting
• Different aspect/activities of test/method shall be witnessed for each assessment
• Laboratory to maintain copy of the witnessing report for reference during the
next assessment
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Laboratory Obligation
• Laboratories are advised to submit the evidence of corrective within the timeline
and sufficiently adequate for STANDARDS MALAYSIA to process the report. There
will be no special treatment for late submission (especially when the expiry date
is drawing near and customer has requested for the latest accredited scope)
• Laboratory to consider STANDARDS MALAYSIA assessment schedule before any
major activities of the laboratory are carried out (e.g.: renovation, relocation
exercise)
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Reminder
Assessment in December
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• 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.
Outstanding Payment
• It is the responsibility of the laboratory to pay such fees for application,
assessment, surveillance 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 payment is not received within 4 months from the
date of the invoice.
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Reminder
Assessment Feedbacks
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• As of 31st May 2013, STANDARDS MALAYSIA has only received 33% of the
feedback form sent to laboratories.
• Laboratories are encouraged to submit the feedback form via email or fax.
• STANDARDS MALAYSIA appreciates your feedback for further
improvement
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Reminder - Restructuring of Assessment Cycle
11ststCycle
Cycle
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Granting of
Accreditation
Surveillance 1
9
months
Surveillance 2
12
months
Reassessment
3
months
The Following Cycle
The Following Cycle
Renewal
Surveillance
Reassessment
18 months
6 months
Certificate
expiry/renewal
of certificate
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Reminder - Restructuring of Assessment Cycle
Activity
Cycle 1
(3 yrs)
Cycle 2
(3 yrs)
Total assessment per
cycle
3 assessments / cycle
2 assessment / cycle
Reassessment
3 months before
certificate expiry
6 months before
certificate expiry
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• Cycle 1: Newly accredited labs/labs that obtained certificate of renewal in 2010
(expire in 2013)
• Cycle 2: Laboratories that has completed cycle 1 and renew their certificate in
2011, subject to the performance of the laboratory
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Events & Meetings - Organised & Attended in 2012
Briefings:
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May 22:
Awareness
Talk on Accreditation & GLP Compliance Programme, UPM. Collaboration with UIA.
May 23-24: Briefing on Understanding of OECD GLP Principles, UPM. Collaboration with CCM.
May 28: Briefing on SAMM Policy Requirements to Nuclear Malaysia, Kajang.
June 19: Forum with Certification Bodies, Eastin Hotel, Petaling Jaya, Selangor. Smart partnership programme with UIA.
June 21: Forum with SAMM Laboratories, Puspanitapuri, Putrajaya.
September 4-5: Briefing on MS ISO 15189 to MKA, Kota Kinabalu, Sabah. Smart partnership programme with MPMA.
October 15: Forum with MIBAS, STANDARDS MALAYSIA, Selangor.
October 23: Briefing on Accreditation to Malaysian Rubber Export Promotion Council, Kuala Lumpur. Smart partnership programme
with IEM.
Events:
February 25: PUSPAKOM receives MS ISO/IEC 17020:1998 Accreditation, Shah Alam, Selangor.
May 29: Accreditation Certificate Presentation Ceremony to Pusat Ujian Biosetara (UBAT), University of Malaya.
June 11: Halal Global Support System Launch, Putra World Trade Centre, Kuala Lumpur
July 6: Accreditation Certificate Presentation Ceremony to Universal Testing Machine (UTM) Laboratory, University
Technology Petronas, Bandar Seri Iskandar, Tronoh, Perak.
September 13-14: 4th Halal Certification Bodies Convention, Mariott Hotel, Putrajaya.
September 25: The Launching of Animal Food Act 2009, Bangunan LPP, Kuala Lumpur.
October 1-2: 1st Technical Meeting for Harmonisation of Standards for Vaccines and Pharmaceuticals among OIC
Countries, Putra World Trade Centre, Kuala Lumpur.
October 9: Accreditation Certificate Presentation Ceremony to Veterinary Laboratory for Kuantan Region,
Veterinary Services Department, Kuantan, Pahang.
November 22: National Standards and Accreditation Awards Night, PICC, Putrajaya.
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Events & Meetings - Organised and Attended in 2012
Training & Forum:
September
26-27, STANDARDS MALAYSIA, Cyberjaya: Measurement Uncertainty (MU) Workshop for
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Microbiology Lab (Session 1).
October 4, PICC, Putrajaya: Forum with SAMM Assessors.
October 15, STANDARDS MALAYSIA, Cyberjaya: Forum with MIBAS Inspection Bodies.
October 16, STANDARDS MALAYSIA, Cyberjaya: Forum with MIBAS Assessors.
November 26-27, STANDARDS MALAYSIA, Cyberjaya: Trainee Technical Assessor Course for SAMM Assessors.
December 3-4, PICC, Putrajaya: Workshop on Harmonising the Requirements Pertaining to Measurement
Uncertainty as Contained in the MS ISO/IEC 17025:2005 Document.
December 4, STANDARDS MALAYSIA, Cyberjaya: Forum with ACB Assessors.
December 4-5, STANDARDS MALAYSIA, Cyberjaya: Adequacy Audit Training under SAMM.
December 4-5, STANDARDS MALAYSIA, Cyberjaya: Measurement Uncertainty (MU) Workshop for Microbiology
Lab (Session 2).
International Meetings:
February 29-March 1, Manila, The Philippines: Attended the 28th Meeting of the ACCSQ Working Group on
Standards and MRA (WG1).
March 1-3, Melbourne, Australia: Attended Malaysia-Trans-Pacific Partnership (TPP) 11th Round Meeting.
March 12-17, Bandar Seri Begawan, Brunei Darussalam: Attended the 38th Meeting of ACCSQ.
March 20-22, June 13-15 & November 26-29, Geneva Switzerland: Attended World Trade Organisation/Technical
Barriers to Trade (WTO/ TBT) Meetings.
April 17-20, Los Angeles, USA: Attended Malaysia-Trans-Pacific Partnership (TPP) 12th Round Meeting.
April 30-May 1, Frankfurt, Germany: Attended International Accreditation Forum (IAF) Technical Committee
Meeting.
May 7-10, Dallas, USA: Attended Malaysia-Trans-Pacific Partnership (TPP) 13th Round Meeting.
May 14-18, Nadi, Fiji: Attended the ISO Committee on Consumer Policy (COPOLCO) Meeting.
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International Meetings:
May 21-23,
Jakarta,
Indonesia: Attended ACCSQ Working Group on Accreditation and Conformity Assessment (WG
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2) Meeting.
May 28-30, Paris, France: Attended the 26th Organisation for Economic Cooperation and Development (OECD)
Working Group on Good Laboratory Practice (GLP).
June 6-9, Bangkok, Thailand: Attended Asia Pacific Laboratory Accreditation Cooperation Mutual Recognition
Arrangement (APLAC MRA) Council meeting.
July 7-10, San Diego, California, USA: Attended Malaysia-Trans Pacific Partnership (TPP) 14th Round Meeting.
August 22-24: Berlin, Germany: Attended ISO/Technical Committee (TC) 212 Meeting.
September 11-12, Grand Millennium Hotel, Kuala Lumpur: Attended ACCSQ Working Group on Accreditation and
Conformity Assessment
(WG 2) Meeting.
October 16-26, Rio de Janeiro, Brazil: Attended International Laboratory Accreditation Cooperation (ILAC) and
International Accreditation Forum (IAF) General Assembly.
October 18 - 19, Singapore: Attended the 29th Meeting of the ACCSQ Working Group on Standards and MRA (WG1).
October 21-22, Rio de Janeiro, Brazil: Attended IAF Technical Committee (concurrent with ILAC & IAF GA).
November 29-October 2, Bandung, Indonesia: Attended the 39th Meeting of ACCSQ.
December 1-7: Sydney, Australia: Attended APLAC General Assembly and Technical Meetings.
December 7-10: Auckland, New Zealand: Attended Malaysia-Trans-Pacific Partnership (TPP) 15th Round Meeting.
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Events & Meetings - Upcoming Events
• Forum STANDARDS MALAYSIA with SAMM Assessor (MS ISO/IEC 17025)
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• Trainee Technical Assessor Workshop
• ISO 15189: 2012 Training (25 - 27 November 2013)
• Majlis Anugerah Standard dan Akreditasi Kebangsaan (22 November 2013)
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STAFF (Accreditation Division)
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Accreditation Staff Strength
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SAMM
Accreditation
Officers
(18)
Support
Staffs
Technical
Assessor (185)
(7)
Lead Assessor
(27)
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Accreditation Staff - Contact Details
No.
Nama
Tel. No
Email
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1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
En. Shaharul Sadri Alwi
Pengarah Akreditasi
Saadiah Sulaiman
Pembantu Khas
Pn. Fariza Wan Abdullah
Ketua Penolong Pengarah Kanan
En. Roslan Alias
En. Wan Rukiman Wan Mamat
Pn. Rosnieh Eggat
Ketua Penolong Pengarah
En. Mohd. Hamzaini Hashim
Penolong Pengarah Kanan
Pn. Rohasmizah Ismail
Pn. Nor Faezah Mohamad Arif
Cik Siti Norehan Ishak
8318 2227
shaharul@standardsmalaysia.gov.my
8319 1303
saadiah@standardsmalaysia.gov.my
8319 1317
fariza@standardsmalaysia.gov.my
8319 1318
roslan@standardsmalaysia.gov.my
8319 1308
wr@standardsmalaysia.gov.my
8319 1382
rosnieh@standardsmalaysia.gov.my
8319 1391
hamzaini@standardsmalaysia.gov.my
8319 1369
rohasmizah@standardsmalaysia.gov.my
8319 1361
norfaezah@standardsmalaysia.gov.my
8319 1355
norehan @standardsmalaysia.gov.my
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Accreditation Staff - Contact Details
No.
Nama
Tel. No
Email
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11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
En. Ainol Azizul Rosli
Penolong Pengarah
Pn. Wong Fei Ting
Penolong Pengarah
Pn. Siti Rohaya Omar
Penolong Pengarah
Mohamad Hafanizam Bin Hassan
Penolong Pengarah
En. Ahmad Husaini Bin Mohamed
Penolong Pengarah
Pn Siti Raihan Aina Bogal
Cik Jessica Sawai Anak Jues
Penolong Pengarah
Cik Noraidah Binti Subakin
Penolong Pengarah
En. Mohammad Yusof Bin Ismail
Penolong Pengarah
Pn. Nabilah Binti Ahmad Kamal
Penolong Pengarah
Pn. Norhabibah binti Mohamad
Pekerja Sambilan Harian (PSH)
8319 1395
ainol@standardsmalaysia.gov.my
8319 1357
wongft@standardsmalaysia.gov.my
8319 1377
sitirhy@standardsmalaysia.gov.my
8318 0034
hafanizam@standardsmalaysia.gov.my
8319 1781
husaini@standardsmalaysia.gov.my
8319 2126
aina@standardsmalaysia.gov.my
8319 1427
jessica@standardsmalaysia.gov.my
8319 1388
noraidah@standardsmalaysia.gov.my
8319 1426
yusofismail@standardsmalaysia.gov.my
8319 1462
nabilah@standardsmalaysia.gov.my
8319 1340
norhabibah@standardsmalaysia.gov.my 38
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1.
STANDARDS MALAYSIA played a major role in leading bilateral and multilateral negotiations for
(FTAs), specifically for the Technical Barrier to Trade (TBT) chapter. In
2012, STANDARDS MALAYSIA was involved in the following FTAs as lead negotiator:
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Free Trade
Agreements
•
•
Malaysia - Australia: MAFTA Agreement was signed between Malaysia-Australia on May 22, 2012 in
Kuala Lumpur. The agreement will come into effect on January 1, 2013.
Malaysia - Trans-Pacific Partnership (TPP): STANDARDS MALAYSIA participated in five
negotiation rounds as at the end of 2012 and is still in the process of finalising the text for the
agreement.
2.
Other FTAs in which STANDARDS MALAYSIA were involved were as follows:
•
Malaysia-European Union (EU): The 6th and 7th rounds were held from February 8 -11 in Kuala
Lumpur and from April 17-20 in Brussels, respectively. During both rounds, discussions were held on
the TBT chapter. The 8th round was held from September 25-28 in Kuala Lumpur with no discussion
on the TBT chapter STANDARDS MALAYSIA attended a discussion on Renewable Energy Annex for
The Trade in Goods chapter.
•
Malaysia-Turkey: The TBT Chapter was finalised last year. In 2012, STANDARDS MALAYSIA was
involved in the discussion on the Economic Co-operation chapter related to halal activities and
standards.
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3.
STANDARDS MALAYSIA also monitored the implementation of the TBT chapter of the FTAs that have
been signed,
as listed below:
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•
Malaysia-Japan: Two project proposals were submitted through MOSTI under the Economic
Partnership Programme (EPP) for the Japan-Malaysia Economic Partnership Agreement (JMEPA).
•
ASEAN-Japan: The 1st Meeting of the ASEAN-Japan Comprehensive Economic Partnership
Agreement Sub-Committee on Standards, Technical Regulations and Conformity Assessment
Procedures (AJCEP SC-STRACAP) was held on March 16, 2012 in Bandar Seri Begawan, Brunei.
4.
Facilitating WTO/TBT Agreement
In managing the national WTO/TBT Committee, STANDARDS MALAYSIA also facilitated the
implementation of the provisions of the WTO/TBT Agreement. Three National Mirror Committee on WTO
TBT meetings were held on March 12, June 5 and November 20, 2012 in preparation for the three WTO
TBT meetings in Geneva.
STANDARDS MALAYSIA attended all three WTO TBT Meetings in Geneva from March 20-22, June 13-15
and November 26-29, 2012, as the main agenda for 2012 was to conclude the Sixth Triennial Review of
The Operation and Implementation of the Agreement on Technical Barriers to Trade Under Article 15.4.
STANDARDS MALAYSIA participated actively in giving comments and inputs to ensure that Malaysia's
interests would be considered by the Committee. The Sixth Triennial Review was concluded on November
29, 2012 and it will be implemented in the next three years.
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SAMM CLINIC
Meet up session with Accreditation Officers
Time : 3.00 p.m.
Venue: Foyer Dewan PICC, Putrajaya
Thank You
STANDARDS_MY
standardsmalaysia
www.standardsmalaysia.gov.my
21

Forum Jabatan Standard Malaysia Bersama Makmal SAMM 2013

Transcription

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