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Forum Jabatan Standard Malaysia Bersama Makmal SAMM 2012 21 Jun 2012

Forum Jabatan Standard Malaysia Bersama Makmal SAMM 2012 21 Jun 2012 Dewan De’ Seri Endon Puspanitapuri Putrajaya. SAMM UPDATES. Reminder - Restructuring of Assessment Cycle - Assessment in December - Assessment Feedback - Invoice Events Staff Strength Appendix. Contents:

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Forum Jabatan Standard Malaysia Bersama Makmal SAMM 2012 21 Jun 2012

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  1. Forum Jabatan Standard Malaysia BersamaMakmal SAMM 2012 21 Jun 2012 Dewan De’ Seri EndonPuspanitapuri Putrajaya

  2. SAMM UPDATES • Reminder - Restructuring of Assessment Cycle - Assessment in December - Assessment Feedback - Invoice • Events • Staff Strength • Appendix Contents: • World Accreditation Day • Amendments Standards of Malaysia Act (Act 549) • Accreditation Online (e-Accreditation) • SAMM Statistics • New Field • New Documents • Revised Documents • Documents Under Revision • Amended Forms • Information - Food Analysts Act 2011 - Assessment - Role of Consultant - Annual Report - National Acceptance

  3. STANDARDS MALAYSIA PROGRAMMES Forum with Certification Bodies 19 June 2012 Petaling Jaya Forum with SAMM Laboratories 21 June 2012 Putrajaya

  4. AMENDMENTS (A1425)Standards of Malaysia Act 1996 (Act 549)Standards of Malaysia Act Amendments 2012 (Act A1425) • Gazetted on 9th February 2012 • In force starting 15th April 2012 • Amendments include: • Section 10: International accreditation activities • Section 16: Granting of accreditation • Section 17: Restriction on the words/references to STANDARDS MALAYSIA • Section 18: Miscellaneous offences • Section 21: Enforcement

  5. AMENDMENTS (A1425)Standards of Malaysia Act 1996 (Act 549)Standards of Malaysia Act Amendments 2012 (Act A1425) Section 10: International Accreditation Activities • Providing accreditation to foreign conformity assessment bodies • Potential applicants from countries such as Bangladesh, India, Iran and Uganda • Initial stage of development

  6. AMENDMENTS (A1425)Standards of Malaysia Act 1996 (Act 549)Standards of Malaysia Act Amendments 2012 (Act A1425) Section 16: Granting of Accreditation • Revision of current fees structure • Include application fee, application fee for branch, annual fee, assessment fee and deposit for appeal • Currently working on proposal paper for Fees Regulation to be approved by the Minister

  7. AMENDMENTS (A1425)Standards of Malaysia Act 1996 (Act 549)Standards of Malaysia Act Amendments 2012 (Act A1425) • Proposed amendments to the fee structure are as follows:

  8. AMENDMENTS (A1425)Standards of Malaysia Act 1996 (Act 549)Standards of Malaysia Act Amendments 2012 (Act A1425) • Continued…

  9. AMENDMENTS (A1425)Standards of Malaysia Act 1996 (Act 549)Standards of Malaysia Act Amendments 2012 (Act A1425) Section 18: Miscellaneous Offences Any person who— • makes any statement or representation, whether in writing or otherwise, with reference to any conformity assessment that conveys or is likely to convey the impression that a person who is not accredited under this Act with reference to that conformity assessment activity is so accredited; • makes any statement or representation, whether in writing or otherwise, that conveys or is likely to convey the impression that a conformity assessment complies with the requirements of accreditation when it does not so comply; or

  10. AMENDMENTS (A1425)Standards of Malaysia Act 1996 (Act 549)Standards of Malaysia Act Amendments 2012 (Act A1425) (cont..) • having been accredited to use the accreditation symbol, uses the accreditation certificate after its withdrawal, or during its suspension, or otherwise in contravention of the terms and conditions of the accreditation certificate If found guilty and convicted shall be fined not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding five years or to both and, for a second or subsequent offence, to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding ten years or to both.

  11. AMENDMENTS (A1425)Standards of Malaysia Act 1996 (Act 549)Standards of Malaysia Act Amendments 2012 (Act A1425) Section 21: Enforcement • Given the mandate to carry out the enforcement activities • Authorize to investigate, search and seize • Currently developing procedures and undergoing training

  12. Accreditation Online (e-ACCREDITATION) • The e-Accreditation is an online intergrated accreditation management system aimed to provide : • End to end online accreditation services involving application, reporting and monitoring of accreditation via PCs, table PCs and smartphones 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

  13. Accreditation Online (e-ACCREDITATION) • Target to go live in January 2013 • Laboratories to have basic internet facility to access the system • Manual interventions is allowed at the minimum

  14. SAMM STATISTICS As of 31 May 2012 Accredited: Active: Testing Laboratories : 352 Calibration Laboratories : 60 Calibration & Testing Laboratories : 12 Medical Laboratories : 26 TOTAL : 450 Voluntary withdrawal: Testing Laboratories : 71 Calibration Laboratories : 26 Calibration & Testing Laboratory : 2 TOTAL : 99 Inoperative/suspension/termination: Testing Laboratories : 7 Calibration Laboratory : 4 Medical Testing :1 TOTAL : 12 Number of SAMM Certificates issued : 554 (since 1987) Applicant: Testing Laboratories : 64 Calibration Laboratories :16 Medical Laboratories : 15 TOTAL : 95

  15. SAMM STATISTICS As of 31 May 2012

  16. NEW SUBFIELD • New field under development • Software Testing • TWG 49, document is now circulated for public comment • Targeted to be published by end of this year

  17. NEW DOCUMENTS SC 1.3 – Specific Criteria for Accreditation in the Field of Microbiological Testing (Issue 1, 28 June 2011) Effective 1 August 2013 Implication of SC 1.3 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)

  18. REVISED DOCUMENTS SC 2.0 Specific Criteria for Accreditation in the Field of Medical Testing (approved by the Minister on 31 December 2011; effective date: 25 May 2012) STR 1.2 Specific Technical Requirements for Accreditation of Toxicity Testing (approved by the Minister on 3 January 2012; effective date: 1 June 2012) STR 2.1 Specific Technical Requirements for Accreditation of Anatomical Pathology (Cytopathology) for Medical Testing Laboratories (approved by the Minister on 31 December 2011; effective date: 25 May 2012) STR 2.8 Specific Technical Requirements for Accreditation of Cytogenetic for Medical Testing Laboratories (approved by the Minister on 31 December 2011; effective date: 25 May 2012) The implementation of the criteria and requirements is effective immediately for applicant laboratories

  19. DOCUMENTS UNDER REVISION STR 2.3 STR 2.4 STR 2.5

  20. DOCUMENTS UNDER REVISION SP4 – Policy on Proficiency Testing (PT) Requirements for SAMM Laboratories • Major changes:- • CABs to submit PT plan – PT frequency decide by CABs (ILAC P9) • Criteria of selecting participation in proficiency testing activities

  21. INFORMATION

  22. FOOD ANALYSTS ACTS 2011 (ACT 727) • Section 31: Registered food analysts may issue food analysis report for the purpose of determining the composition or specification of any substance or product consumed or used by, or intended for the consumption or the use of public… • Therefore, food analysts registered with MOH can sign test report for food analysis. The Food Analysts Act 2011 (Act 727) can be assessed here http://www.federalgazette.agc.gov.my/outputaktap/20110602_727_BI_Food%20Analysts%20Act%202011.pdf

  23. ASSESSMENT • Exemption of Adequacy Audit or Pre-Assessment for branches • Verification visit to lab will be conducted if the lab submit corrective actions more than 6 months from the date of assessment (EOS & Compliance)

  24. LABORATORY’S CONSULTANT • Appointment of suitable and competent consultant • Consultant shall not be appointed as contact person • Consultant shall not participate in assessment

  25. ANNUAL REPORT • STANDARDS MALAYSIA 2011 Annual Report can be accessed via this link http://www.standardsmalaysia.gov.my/v3a/index.php?option=com_content&view=article&id=77&Itemid=216&lang=en

  26. National Acceptance Acceptance of Accreditation by : 1) Inland Revenue Board of Malaysia 2) Energy Commission 3) Construction Industry Development Board Malaysia (CIDB) pnrosnieh 4) SME Corp. Malaysia 6) Ministry of Domestic, Co-operatives & Consumerism • Department of Environment (DOE) • SuruhanjayaPerkhidmatan Air Negara (SPAN) • Malaysia Palm Oil Board (MPOB)

  27. REMINDER

  28. RESTRUCTURING OF ASSESSMENT CYCLE Granting of Accreditation 1st Cycle 9 mths Surveillance 1 12 mths Surveillance 2 12 mths Reassessment 3 mths The Following Cycle Renewal 12 mths Surveillance 18 mths Reassessment Certificate expiry 6 mths

  29. RESTRUCTURING OF ASSESSMENT CYCLE • Cycle 1: Newly accredited labs/Labs that obtain certificate of renewal in 2010 (expire in 2013) • Cycle 2: Laboratories that has completed cycle 1 and renew their certificate in 2011

  30. ASSESSMENT IN DECEMBER Assessment will not be scheduled in December. Any scheduled assessment (forward plan schedule) which falls in December will be rescheduled in November / January the following year.

  31. ASSESSMENT FEEDBACK • STANDARDS MALAYSIA received only 61% of feedback form sent on the performance of the assessment team • Labs are encouraged to send the feedback • Feedback is critical for improvement

  32. INVOICE 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 3 months from the date of invoice Suspension As of June 2012, the total outstanding payment is RM 78, 800.00 If payment is not received within 4 months from the date of invoice

  33. EVENTS

  34. STAFF STRENGTH

  35. ACCREDITATION DIVISION SAMM Accreditation Officers: 18 Supporting Staffs: 7 Lead Assessors: 27 Technical Assessors: 185

  36. SAMM CLINIC • Meet up session with Accreditation Officers • Time : 2.30 p.m. • Venue: Foyer Dewan De’ Seri Endon

  37. Department of Standards Malaysia (STANDARDS MALAYSIA) Century Square Level 1 & 2, Block 2300, JalanUsahawan 63000 Cyberjaya, Selangor Website: www.standardsmalaysia.gov.my Tel: 03-8318 0002 Fax: 03-8318 9339

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