Recent Developments in Accreditation: Challenges & Opportunities For Sri Lanka

1. Recent Developments in Accreditation: Challenges & Opportunities For Sri Lanka Mr. Wong Wang Wah Assistant Commissioner, Innovation and Technology Commission, Hong Kong APLAC immediate past Chair

2. Recent Developments in Accreditation: Challenges & Opportunities For Sri Lanka Wong Wang Wah APLAC immediate past Chair 21 June 2018

5. Does it compatible with others! Decisions Is it safe Products? Is it Halal Food? To Enter : Reliable Proof of Compliance required! I am what you expected! Does it perform as good as it claimed? How can I tell you that I am want you want?

6. Decisions • You need to make decisions every day • What to eat, wear, buy, do • Where to go, • How to do • It is you that make the decisions, in different roles, in office or at home • Why yes, why no, why this, why that • Accept / reject or comply or not comply • Decision making need information

7. Decisions • Need all relevant information to make a RIGHT decision • Well informed is a prerequisite for a RIGHT decision • Can I get all relevant information by myself • Possible but impractical and unrealistic • Obtaining correct information may require knowledge • Also need time as it may need many tasks to be performed • So someone has to provide you with the information

8. ? Credible Test Results  ? Reliable Decisions • So the question is – is the information provided to you reliable and accurate? ? Accurate

9. Decisions • Reliable information need to be obtained by a person with no vested interest in the matter, i.e. impartial • The information must be accurate and so need to be obtained by a competent person • A competent person needs professional knowledge and techniques • Then you can trust the information

10. Excellent! Certificate  Accredited by an ILAC MRA Signatory Accreditation and Decisions • Conformity with standards requires assessments • Accreditation provide a means to ensure that the conformity assessment bodies are competent and hence the results are accurate and reliable • Accreditation helps you to make the right decisions • A wrong decision may have serious and irrevocable consequence

11. Accredited Conformity Assessment Highest and final level ILAC & IAF purchaser, regulator, the public Is it OK if we buy it? Can we rely on the AB? Can we rely on the CAB? Product/ Service Laboratory, Inspection Body, Certification Body Accreditation Body We evaluate whether or not the AB is competent ! We check conformance on behalf of you ! We assure you of the competence of the CAB !

12. Results Testing / conformity assessment Calibration and certified reference materials competent laboratories assessment Accreditation support Metrology Standards

13. Accreditation Community’s Vision Accreditation builds competenceand credibility Competenceand credibility buildtrust and confidence Trustandconfidencebuild recognition and acceptance With global recognition andacceptance, accreditation has achieved its goal

14. IAF and ILAC – Joint Global Vision • A single programme of conformity assessment which reduces risk for businesses, regulators and the consumer by ensuring that accredited services can be relied upon • Government and regulators relying on the Arrangements to further develop or enhance trade agreements • To support world trade by eliminating technical barriers, realising the free-trade goal of ‘tested, inspected or certified once and accepted everywhere’

15. The International Picture ILAC ILAC APLAC APLAC EA EA IAAC IAAC SADCA EA European Cooperation for Accreditation APLAC Asia Pacific Laboratory Accreditation Cooperation ILAC International Laboratory Accreditation Cooperation IAAC Inter-American Accreditation Cooperation AFRAC African Regional Accreditation Cooperation Unaffiliated Bodies Peer evaluated ABs who are not eligible for membership in one of the established regions ARAC AFRAC SADCA Southern African Development Community Accreditation ARAC Arab Accreditation Cooperation

16. IAF/ILAC Multilateral MRAs • A laboratory, inspection body or certification body accredited by one partner has equivalent competence to a laboratory, inspection body or certification body accredited by the other partner(s). • The structure of the global accreditation systemis divided into two levels: the regional level (EA, ARAC, APLAC, PAC, SADCA, AFRAC and IAAC) and the global level (ILAC and IAF). • The IAF MLA recognises EA, PAC and IAAC • The ILAC MRA recognises EA, APLAC, IAAC, ARAC, and AFRAC European Cooperation for Accreditation (EA) African Accreditation Cooperation (AFRAC) Pacific Accreditation Cooperation (PAC) Inter-American Accreditation Cooperation (IAAC) Southern African Development Community Accreditation (SADCA) Asia Pacific Laboratory Accreditation Cooperation (APLAC) Arab Accreditation Cooperation (ARAC)

17. Use of Combined Mark ILAC & AB combined mark for accredited CABs to be used on their reports or certificates.

18. Status of the ILAC MRA (May 2018) • The ILAC network of members includes 154 bodies from 121 different economies (98 Full Members/MRA Signatories, 14 Associates, 12 Affiliates, 24 Stakeholders, 6 Regional Cooperation Bodies) • 98 ILAC MRA Signatories representing 101 economies • ILAC MRA covers testing, calibration and inspection • Signatories represent about 95% of Global GDP • Almost 68,000 accredited laboratories (APLAC 47,200 ~70%) • Over 9,500 accredited inspection bodies

19. Coverage of the ILAC MRA (March 2018) ILAC MRA Signatories ILAC Associate Members ILAC Affiliate Members

20. Coverage of the IAF MLA (August 2017) IAF MLA Signatories IAF Members not yet Signatories

25. Asia Pacific Laboratory Accreditation Cooperation (APLAC)

26. APLAC’s Vision • To be a leading and respected authority providing reliable global solutions for the recognition of technical competence

27. APLAC • Established in 1992 • Incorporated in 2006: APLAC Constitution • Membership (as at May 2018): • Opens to all economies in Asia Pacific region • All APEC economies except Chile • Also Bangladesh, Bhutan, Cambodia, Gulf Region, India, Mongolia, Pakistan, Saudi Arabia, Sri Lanka • 47 full members • 14 associate members 27

28. APLAC Milestones • 1997 - Mutual Recognition Arrangement (MRA) inaugural signed • 2003 - Inaugural signing of extended MRA for inspection • 2006 – Incorporated with APLAC Constitution • 2007 - Inaugural signing of extended MRA for RMP • 2014 – Inaugural signing of extended MRA for PTP

29. APLAC • 39 signatories to APLAC MRA from 24 economies and 1 regional accreditation body representing 7 economies • 37 for testing • 29 for calibration • 20 for inspection • 18 for ISO 15189 • 15 for RMP • 14 for PTP 29

30. APLAC GA RES. 22.8 That the APLAC General Assembly approved the creation of a new joint entity (regional cooperation body) within three years, as discussed at the third APLAC PAC Joint General Assembly

31. unity in purpose and one voice of a bigger and more influential entity, • single body provides clarity for members, regulators and stakeholders, • broader foundation for maintaining relevance to stakeholders, • greater financial security for future viability

32. New name – Asia Pacific Accreditation Cooperation • New APAC Constitution approved on 8 June 2018 in Kyoto, Japan • APAC will formally be established on 1 January 2019

33. SLAB Expansion of Accreditation Scope • Schemes focused on promoting export • Personnel Certification • Scheme for training institutions and higher education institutions • Public Sector medical labs (already signatory to ISO 15189)

34. Hong Kong Accreditation Service (HKAS) • Part of Innovation and Technology Commission of the Hong Kong Special Administration Region (HKSAR) Government. • Set up in 1998 (previously known as HOKLAS since 1985) • Official accreditation bodyaccrediting conformity assessment bodies in Hong Kong • Provides independent and impartial accreditation services

35. Medical Testing • All public sector medical labs are accredited • Challenges facing HKAS when establishing the programme

36. Milestones Publishing of ISO 15189:2012 2012 30 20 10

37. Number of laboratories accredited

38. * One hospital got both CAP and HKAS accreditation (as at 2015)

39. HOW WELL ARE THE ACCREDITED MEDICAL TESTING LABORATORIES DOING

40. 2004-2006 40 laboratory assessments 2009 61 laboratory assessments

41. performance comparison of 27 laboratories in their initial assessments and in their second reassessments S: significant non-conformity M: minor non-conformity R: recommendation Bella Ho, Eric Ho. The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria. Biochemia Medica 2012;22(2):247-57.

42. PERFORMANCE OF ACCREDITED MEDICAL TESTING LABORATORIES IN PROFICIENCY TESTING / EQAP

43. MORE EDUCATIONAL OPPORTUNITIES • Before 2004 – No local full time Bachelor and only one Master course in Medical Science offered by HKU – others are top-up overseas Master courses or distant learning courses • In 2004 – First full time Bachelor course offered by HK Polytechnic University • Thereafter– Apart from the HKU MMedSc course, relevant Master courses are also available from HKPoly U, and CUHK • Number of medical technologists eligible to be Laboratory Directors has increased

45. Potential assessors taking the post-course assessment after the medical assessor training course

46. Total: 156 technical assessors As of January 2015

48. Continual improvement Seminars/workshops to enhance testing capability and raise quality standard: • For testing laboratories, • QA/QC workshops • Interpretation of EQAP results • Evaluation of autoanalysers • Measurement uncertainty for medical testing • For technical assessors, • Annual assessor seminar • Workshop on calibration of general equipment (e.g. thermometers, balances) • Workshops on harmonisation of accreditation standards • For all of us,

49. What do we do in the next 10 years • Cultivate close partnership with different stakeholders • Maintain high quality standard of accredited laboratories • Encourage more medical laboratories to get accreditation • Promote the benefits of accreditation

50. “Ensure the development and maintenance of a framework of quality assurance to support the consistent delivery of quality health services based on knowledge and centred on patients” • (2001 Policy Address) Health and Welfare Bureau