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[object Object],Nei ho Chinese Moni bambo Chichewa Hafa adai Chamorro
The Meal: Quality Infrastructure
The component parts … S tandards Q uality A ccreditation M etrology
 
 
 
 
 
 
Participation problems 7 most important causes of weak participation in international standardization work – all developing countries
Participation problems 7 most important causes of weak participation in international standardization work specific to Sub-Saharan Africa
Participation problems 7 most important causes of weak participation in international standardization work specific to Sub-Saharan Africa Sub-Saharan Africa All developing countries
Participation problems Additional issues specific to Sub-Saharan Africa
The (Global) Context WTO Agreement on Technical Barriers to Trade
Two basic sorts of barriers ... ,[object Object],[object Object]
Licenses, Customs clearance, Warehousing, Domestic taxation of goods, Prohibitions, Customs valuation, Quotas, Prices, International Plant Protection Convention (IPPC) standards, International Office of Epizootics (IOE) standards, Domestic requirements, National Enquiry Points, Health (HACCP), Codex Alimentarius Commission (CAC) standards, Biosafety standards (GMO), Registry procedures, Taxes, Inspection, Airport services, Harbour services, Foreign Direct Investment (FDI/DFI) regulations, Foreign exchange measures, Foreign investment taxes, Services, Banking, Subsidies, Profit repatriation limits, Enterprise’s competitiveness, Trade negotiation techniques, Trade Agreements, WTO, Agreements for Trade, Product and market development, Trade Disputes, Dumping practices, Intellectual property, Certification systems, Process inspection, Packaging and labeling, Tests and calibration, Environmental systems, Local content schemes, Product development, International Standards, Measurement standards, Storage, Accreditation of conformity assessment 50 ‘Non-Tariff’ barrier to trade ...
The basic categories of ‘Non-Tariff’ barriers to trade ... ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Non-tariff barriers affecting market access
Non-tariff barriers affecting market access
Technical Barriers to Trade (TBT) - SQAM Conformity/Certification Transparency Standards Metrology/Testing Accreditation
Technical Barriers to Trade (TBT) - Standards
A bit about the TBT agreement (1) ,[object Object],[object Object],[object Object],[object Object]
A bit about the TBT agreement (2) Basic commitments ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
A bit about the TBT agreement (3) Commitments with Acceptance of the Code of Practice ,[object Object],[object Object],[object Object],[object Object],[object Object]
A bit about the TBT agreement (4)   Commitments with Acceptance of the Code of Practice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Technical Assistance ,[object Object],[object Object],[object Object],[object Object],WTO members shall, if requested, advise other members, especially the developing country Members:
The Standards Development Process
Standards development typically …  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],* As applied in SWASA and many other standards bodies,  consensus does not equate to a requirement for unanimous agreement
 
SWASA’s  project stages … ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
SAC TC/SC SWASA TC/SC SAC Council SWASA Basic development stages Approved by … Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical)
SAC TC/SC SWASA TC/SC SAC Council SWASA Direct entry of existing standard Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical)
SAC TC/SC Proposal Receipt & review of proposal for new project [with vote] Disposal Resolution of feedback from enquiry Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) TC/SC SWASA TC/SC SAC Council SWASA Publication Publication & Gazetting Notif. 2 Notif. 3 Approval Submission of proposed final text for approval (technical) Optional stage, to provide opportunity to develop proposal Preliminary
SAC TC/SC Proposal Receipt & review of proposal for new project [with vote] Disposal Resolution of feedback from enquiry Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) TC/SC SWASA TC/SC SAC Council SWASA Publication Publication & Gazetting Notif. 2 Notif. 3 Approval Submission of proposed final text for approval (technical) Optional stage, to provide opportunity to develop proposal Preliminary
Increase of stability & consensus through  project Changes in stability of content Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical) Notification
Increase of stability & consensus through  project Changes in stability of content Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical)
Increase of stability & consensus through  project Changes in stability of content Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical) Notif.
Increase of stability & consensus through  project Changes in stability of content Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical)
Increase of stability & consensus through  project Changes in stability of content Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical) Notif.
Keeping it relevant – Systematic reviews ,[object Object],[object Object],[object Object],[object Object]
The perfect “Combo”?
Regulations Conformity Assessment Standards
Regulations, Standards, & Conformity Assessment in  Africa Based on data taken from the   ISO/DEVCO/TMB Survey on Problems Faced by Developing Countries in the Areas of Standardization and their Participation in International Standardization Work (2002)
Coordination between technical regulation (TR) and voluntary standards
Percentage of technical regulations (TR) based on standards (Sub-Saharan Africa)
Coordination between technical regulation (TR) and voluntary standards (Sub-Saharan Africa)
Main Reasons for Inadequate Technical Regulation (TR)  (Sub-Saharan Africa)
Availability of Test and Certification Services
Main Reasons for Inadequate Conformity Assessment (CA)
Problems - Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Standards   Supporting technical regulations
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Standards and Regulations Working Together (1)
Standards and Regulations Working Together (2) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
(Technical) Standard and Technical Regulation ,[object Object],[object Object]
Technical regulation …  calls up a …  the combination is mandatory but When a … (Technical) Regulations v. Standards Standard  …  the standard  retains its characteristic  of being available for  voluntary  use
[object Object],[object Object],Using Standards as a basis for Technical Regulations
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Child transport devices Focus is safety, Solution is performance-based
Requirements for wheeled child conveyances UK Statutory Instrument 1997 No. 2866 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Requirements for wheeled child conveyances Benefits & Problems ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Practical issues ,[object Object],[object Object],[object Object],[object Object]
SWASA Council: Terms of Reference ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Functions relating to standards and certification  explicitly identified in the Standards Act include:
The performance approach to standards development,  & its relevance to regulations & regulators
[object Object],[object Object],Annex 3 of the WTO/TBT Agreement “ Wherever appropriate, the standardizing body shall specify standards based on product requirements in terms of performance rather than design or descriptive characteristics.” Prescriptive v. Performance standards
Performance based regulatory model
Changing role of Regulators … ,[object Object],[object Object],[object Object],[object Object]
Recommendations to Regulators (1) … (Standards) ,[object Object],[object Object],[object Object]
Recommendations to Regulators (2) … (Standards) ,[object Object],[object Object],[object Object]
Conformity Assessment   Supporting the standards supporting the technical regulations
Conformity Assessment
Conformity Assessment* (CA) is … ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],*demonstration that specified requirements relating to a product, process, system, person or body are fulfilled (Definition taken from BS EN ISO/IEC 17000:2004
Why use CA? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
First party (“Do-It-Yourself”) assessment …  is when conformity assessment (checking) is  carried out by the supplier organization  itself. In other words, it is a self-assessment Known as a  Supplier's Declaration of Conformity (SDoC) ISO/IEC 17050 – 1 and 2:2004 Manufacturer, Supplier, Organization DIRECT PATH Confidence in the company brand Consumers, Users
CE Marking (not "CE Mark") (originally "EC Mark") ,[object Object],[object Object],[object Object],[object Object],[object Object]
Why choose  Supplier's Declaration of Conformity (SDoC)? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Third party (“Independent”) assessment ,[object Object],[object Object],[object Object],[object Object],[object Object]
Why choose ‘Third party assessment’ ,[object Object],[object Object],[object Object],Note! A  requirement  to carry out third party assessment could constitute a Technical Barrier to Trade
Certification & Marking (in USA certification is known as “Registration”) …  is when a third party (a  Conformity Assessment Body  – CAB)( Registrar  in USA) gives  written assurance  that a product (including services), process, personnel, organization or system conforms to specific requirements The written assurance is typically in the form of a  Certificate of Conformity  identifying which products or services comply with the requirements specified in standards and/or regulations  A Certificate of Conformity may entitle the marking of products or their packaging with a  mark of conformity (“certification mark”)  identifying that the product complies with requirements.
ICONTEC Certification Marks ALL voluntary but heavily promoted, particularly as marketing devices
The difference between … Certification and Accreditation ,[object Object],[object Object]
Accreditation* (“Checking The Checkers”) …  is when an authoritative body (an  Accreditation Authority )   gives formal recognition that a body (e.g. a  Conformity Assessment Body ) or person is competent to carry out specific tasks E.g. accreditation of testing laboratories, inspection bodies and product certification bodies "Accreditation" is not a synonym for "certification"   * third-party attestation, related to a conformity assessment body [or individual], conveying formal demonstration of its competence to carry out specific conformity assessment tasks (BS EN ISO/IEC 17000:2004)
Mutual Recognition Agreements (MRA) …  is when the parties involved agree to recognize the results of each other's testing, inspection, certification or accreditation Cross-border MRA MRA between or endorsed by governments - can be critical in increasing the confidence of both private and public sector purchasers and so aid exports by avoiding repeated conformity assessment controls and associated costs
Mutual Recognition ,[object Object],[object Object],[object Object],[object Object]
National Conformity Assessment Policy Basic Principles ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Source: Conformity Assessment Policy in the United Kingdom (DTI)
Recommendations to Regulators (3) … (Conformity assessment) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
To summarise … ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
SQAM & Technical Regulations Testing Metrology Conformity Assessment Standardisation Accreditation Testing Metrology Conformity Assessment Standardisation Accreditation Enforcement Inspection Monitoring Information Consultation The “Regulators” The “Standardizers” and “Checkers”
The ‘New Approach’ to Trade in Europe – An example of regulators & standards working together
Europe – The ‘New Approach’ ,[object Object],[object Object],[object Object],www.newapproach.org Europe needed a more efficient and effective approach to technical harmonization. With the adoption of the ‘New Approach’
Compliance with standards remains VOLUNTARY ,[object Object],[object Object],[object Object]
New Approach Directives www.newapproach.org/Directives/
The ‘Global Approach’ to  conformity assessment in Europe  ,[object Object],[object Object],[object Object]
Reading ,[object Object],[object Object],[object Object],[object Object],[object Object]
 

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Processes associated with standards & standards development (2 of 2)

  • 1.
  • 2. The Meal: Quality Infrastructure
  • 3. The component parts … S tandards Q uality A ccreditation M etrology
  • 4.  
  • 5.  
  • 6.  
  • 7.  
  • 8.  
  • 9.  
  • 10. Participation problems 7 most important causes of weak participation in international standardization work – all developing countries
  • 11. Participation problems 7 most important causes of weak participation in international standardization work specific to Sub-Saharan Africa
  • 12. Participation problems 7 most important causes of weak participation in international standardization work specific to Sub-Saharan Africa Sub-Saharan Africa All developing countries
  • 13. Participation problems Additional issues specific to Sub-Saharan Africa
  • 14. The (Global) Context WTO Agreement on Technical Barriers to Trade
  • 15.
  • 16. Licenses, Customs clearance, Warehousing, Domestic taxation of goods, Prohibitions, Customs valuation, Quotas, Prices, International Plant Protection Convention (IPPC) standards, International Office of Epizootics (IOE) standards, Domestic requirements, National Enquiry Points, Health (HACCP), Codex Alimentarius Commission (CAC) standards, Biosafety standards (GMO), Registry procedures, Taxes, Inspection, Airport services, Harbour services, Foreign Direct Investment (FDI/DFI) regulations, Foreign exchange measures, Foreign investment taxes, Services, Banking, Subsidies, Profit repatriation limits, Enterprise’s competitiveness, Trade negotiation techniques, Trade Agreements, WTO, Agreements for Trade, Product and market development, Trade Disputes, Dumping practices, Intellectual property, Certification systems, Process inspection, Packaging and labeling, Tests and calibration, Environmental systems, Local content schemes, Product development, International Standards, Measurement standards, Storage, Accreditation of conformity assessment 50 ‘Non-Tariff’ barrier to trade ...
  • 17.
  • 20. Technical Barriers to Trade (TBT) - SQAM Conformity/Certification Transparency Standards Metrology/Testing Accreditation
  • 21. Technical Barriers to Trade (TBT) - Standards
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 28.
  • 29.  
  • 30.
  • 31. SAC TC/SC SWASA TC/SC SAC Council SWASA Basic development stages Approved by … Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical)
  • 32. SAC TC/SC SWASA TC/SC SAC Council SWASA Direct entry of existing standard Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical)
  • 33. SAC TC/SC Proposal Receipt & review of proposal for new project [with vote] Disposal Resolution of feedback from enquiry Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) TC/SC SWASA TC/SC SAC Council SWASA Publication Publication & Gazetting Notif. 2 Notif. 3 Approval Submission of proposed final text for approval (technical) Optional stage, to provide opportunity to develop proposal Preliminary
  • 34. SAC TC/SC Proposal Receipt & review of proposal for new project [with vote] Disposal Resolution of feedback from enquiry Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) TC/SC SWASA TC/SC SAC Council SWASA Publication Publication & Gazetting Notif. 2 Notif. 3 Approval Submission of proposed final text for approval (technical) Optional stage, to provide opportunity to develop proposal Preliminary
  • 35. Increase of stability & consensus through project Changes in stability of content Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical) Notification
  • 36. Increase of stability & consensus through project Changes in stability of content Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical)
  • 37. Increase of stability & consensus through project Changes in stability of content Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical) Notif.
  • 38. Increase of stability & consensus through project Changes in stability of content Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical)
  • 39. Increase of stability & consensus through project Changes in stability of content Disposal Resolution of feedback from enquiry Proposal Receipt & review of proposal for new project [with vote] Preparatory/ Committee Development of internal consensus amongst experts Enquiry Submission of envisaged publication for public review Endorsement Submission of endorsed final text for approval (procedural) Publication Publication & Gazetting Approval Submission of proposed final text for approval (technical) Notif.
  • 40.
  • 43. Regulations, Standards, & Conformity Assessment in Africa Based on data taken from the ISO/DEVCO/TMB Survey on Problems Faced by Developing Countries in the Areas of Standardization and their Participation in International Standardization Work (2002)
  • 44. Coordination between technical regulation (TR) and voluntary standards
  • 45. Percentage of technical regulations (TR) based on standards (Sub-Saharan Africa)
  • 46. Coordination between technical regulation (TR) and voluntary standards (Sub-Saharan Africa)
  • 47. Main Reasons for Inadequate Technical Regulation (TR) (Sub-Saharan Africa)
  • 48. Availability of Test and Certification Services
  • 49. Main Reasons for Inadequate Conformity Assessment (CA)
  • 50.
  • 51. Standards Supporting technical regulations
  • 52.
  • 53.
  • 54.
  • 55. Technical regulation … calls up a … the combination is mandatory but When a … (Technical) Regulations v. Standards Standard … the standard retains its characteristic of being available for voluntary use
  • 56.
  • 57.
  • 58.
  • 59.
  • 60.
  • 61.
  • 62. The performance approach to standards development, & its relevance to regulations & regulators
  • 63.
  • 65.
  • 66.
  • 67.
  • 68. Conformity Assessment Supporting the standards supporting the technical regulations
  • 70.
  • 71.
  • 72. First party (“Do-It-Yourself”) assessment … is when conformity assessment (checking) is carried out by the supplier organization itself. In other words, it is a self-assessment Known as a Supplier's Declaration of Conformity (SDoC) ISO/IEC 17050 – 1 and 2:2004 Manufacturer, Supplier, Organization DIRECT PATH Confidence in the company brand Consumers, Users
  • 73.
  • 74.
  • 75.
  • 76.
  • 77. Certification & Marking (in USA certification is known as “Registration”) … is when a third party (a Conformity Assessment Body – CAB)( Registrar in USA) gives written assurance that a product (including services), process, personnel, organization or system conforms to specific requirements The written assurance is typically in the form of a Certificate of Conformity identifying which products or services comply with the requirements specified in standards and/or regulations A Certificate of Conformity may entitle the marking of products or their packaging with a mark of conformity (“certification mark”) identifying that the product complies with requirements.
  • 78. ICONTEC Certification Marks ALL voluntary but heavily promoted, particularly as marketing devices
  • 79.
  • 80. Accreditation* (“Checking The Checkers”) … is when an authoritative body (an Accreditation Authority ) gives formal recognition that a body (e.g. a Conformity Assessment Body ) or person is competent to carry out specific tasks E.g. accreditation of testing laboratories, inspection bodies and product certification bodies "Accreditation" is not a synonym for "certification" * third-party attestation, related to a conformity assessment body [or individual], conveying formal demonstration of its competence to carry out specific conformity assessment tasks (BS EN ISO/IEC 17000:2004)
  • 81. Mutual Recognition Agreements (MRA) … is when the parties involved agree to recognize the results of each other's testing, inspection, certification or accreditation Cross-border MRA MRA between or endorsed by governments - can be critical in increasing the confidence of both private and public sector purchasers and so aid exports by avoiding repeated conformity assessment controls and associated costs
  • 82.
  • 83.
  • 84.
  • 85.
  • 86. SQAM & Technical Regulations Testing Metrology Conformity Assessment Standardisation Accreditation Testing Metrology Conformity Assessment Standardisation Accreditation Enforcement Inspection Monitoring Information Consultation The “Regulators” The “Standardizers” and “Checkers”
  • 87. The ‘New Approach’ to Trade in Europe – An example of regulators & standards working together
  • 88.
  • 89.
  • 90. New Approach Directives www.newapproach.org/Directives/
  • 91.
  • 92.
  • 93.  

Editor's Notes

  1. one standard, one test accepted everywhere
  2. 24
  3. one standard, one test accepted everywhere