<ul><li>Jum Reap Sour Cambodian   </li></ul>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 developin...
Participation problems 7 most important causes of weak participation in international standardization work specific to Sub...
Participation problems 7 most important causes of weak participation in international standardization work specific to Sub...
Participation problems Additional issues specific to Sub-Saharan Africa
The (Global) Context WTO Agreement on Technical Barriers to Trade
Two basic sorts of barriers ... <ul><li>Tariffs and quotas, and similar </li></ul><ul><li>Non-tariff barriers to trade  </...
Licenses, Customs clearance, Warehousing, Domestic taxation of goods, Prohibitions, Customs valuation, Quotas, Prices, Int...
The basic categories of ‘Non-Tariff’ barriers to trade ... <ul><li>Registration, documentation, and customs issues  </li><...
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) <ul><li>Annex 3 of the TBT Agreement is the Code of Good Practice for the Preparation, A...
A bit about the TBT agreement (2) Basic commitments <ul><li>Use international standards </li></ul><ul><li>Ensure non-discr...
A bit about the TBT agreement (3) Commitments with Acceptance of the Code of Practice <ul><li>Standards and regulatory dev...
A bit about the TBT agreement (4)   Commitments with Acceptance of the Code of Practice <ul><li>Notify the standards devel...
Technical Assistance <ul><li>On the preparation of technical regulations  </li></ul><ul><li>On establishment of regulatory...
The Standards Development Process
Standards development typically …  <ul><li>Is preceded by establishment of needs </li></ul><ul><li>Involves </li></ul><ul>...
 
SWASA’s  project stages … <ul><li>0. Preliminary stage </li></ul><ul><li>1. Proposal stage </li></ul><ul><li>2. Preparator...
SAC TC/SC SWASA TC/SC SAC Council SWASA Basic development stages Approved by … Disposal Resolution of feedback from enquir...
SAC TC/SC SWASA TC/SC SAC Council SWASA Direct entry of existing standard Disposal Resolution of feedback from enquiry Pro...
SAC TC/SC Proposal Receipt & review of proposal for new project [with vote] Disposal Resolution of feedback from enquiry P...
SAC TC/SC Proposal Receipt & review of proposal for new project [with vote] Disposal Resolution of feedback from enquiry P...
Increase of stability & consensus through  project Changes in stability of content Disposal Resolution of feedback from en...
Increase of stability & consensus through  project Changes in stability of content Disposal Resolution of feedback from en...
Increase of stability & consensus through  project Changes in stability of content Disposal Resolution of feedback from en...
Increase of stability & consensus through  project Changes in stability of content Disposal Resolution of feedback from en...
Increase of stability & consensus through  project Changes in stability of content Disposal Resolution of feedback from en...
Keeping it relevant – Systematic reviews <ul><li>Every deliverable published by SWASA must be also maintained, by the tech...
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...
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 <ul><li>In 61% of the countries more than 50% of mandatory technical regulations were  not based  on in...
Standards   Supporting technical regulations
<ul><li>Standards covering certain areas  may be made mandatory, through regulations  for legitimate objectives (such as h...
Standards and Regulations Working Together (2) <ul><li>Globally many examples of standards and regulations </li></ul><ul><...
(Technical) Standard and Technical Regulation <ul><li>Standard Document approved by a recognized body that provides, for c...
Technical regulation …  calls up a …  the combination is mandatory but When a … (Technical) Regulations v. Standards Stand...
<ul><li>text from standards  (the  actual text  or sections of the actual text) incorporated into legislation </li></ul><u...
<ul><ul><li>Stability </li></ul></ul><ul><ul><li>Braking effectiveness </li></ul></ul><ul><ul><li>Performance of integrate...
Requirements for wheeled child conveyances UK Statutory Instrument 1997 No. 2866 <ul><li>Has three choices: </li></ul><ul>...
Requirements for wheeled child conveyances Benefits & Problems <ul><li>Benefits </li></ul><ul><li>Performance based </li><...
Practical issues <ul><li>Need to know what performance is required (of the product/service) </li></ul><ul><li>Need to know...
SWASA Council: Terms of Reference <ul><li>Establishing guidelines for the drafting, issuing or amendment of standards </li...
The performance approach to standards development,  & its relevance to regulations & regulators
<ul><li>ISO/IEC Directives, Part 2, Clause 4.2 Performance approach </li></ul><ul><li>“ Whenever possible, requirements sh...
Performance based regulatory model
Changing role of Regulators … <ul><li>Regulators have the novel (for them) role of: </li></ul><ul><li>establishing  perfor...
Recommendations to Regulators (1) … (Standards) <ul><li>Ensure that there is a clear National Policy regarding the interac...
Recommendations to Regulators (2) … (Standards) <ul><li>When referring to standards consider using phrases such as “[Stand...
Conformity Assessment   Supporting the standards supporting the technical regulations
Conformity Assessment
Conformity Assessment* (CA) is … <ul><li>Checking whether products, services, materials, processes, systems and personnel ...
Why use CA? <ul><li>Provide purchasers with confidence in the suppliers, products, or services that they use  </li></ul><u...
First party (“Do-It-Yourself”) assessment …  is when conformity assessment (checking) is  carried out by the supplier orga...
CE Marking (not &quot;CE Mark&quot;) (originally &quot;EC Mark&quot;) <ul><li>manufacturer's declaration (Self Declaration...
Why choose  Supplier's Declaration of Conformity (SDoC)? <ul><li>Avoids the costs of third-party assessment </li></ul><ul>...
Third party (“Independent”) assessment <ul><li>…  is when conformity assessment (checking) is  carried out by a body that ...
Why choose ‘Third party assessment’ <ul><li>Supplier  may choose it as a way of differentiating its product or service fro...
Certification & Marking (in USA certification is known as “Registration”) …  is when a third party (a  Conformity Assessme...
ICONTEC Certification Marks ALL voluntary but heavily promoted, particularly as marketing devices
The difference between … Certification and Accreditation <ul><li>Certification   is when a third party (a Conformity Asses...
Accreditation* (“Checking The Checkers”) …  is when an authoritative body (an  Accreditation Authority )   gives formal re...
Mutual Recognition Agreements (MRA) …  is when the parties involved agree to recognize the results of each other's testing...
Mutual Recognition <ul><li>Mutual recognition reduces costs of trade </li></ul><ul><li>Mutual recognition can be G2G or vo...
National Conformity Assessment Policy Basic Principles <ul><li>driven by  market demand, public interest, or regulators   ...
Recommendations to Regulators (3) … (Conformity assessment) <ul><li>Develop an understanding of the concepts of  conformit...
To summarise … <ul><li>Regulatory structures should: </li></ul><ul><ul><li>be performance based </li></ul></ul><ul><ul><li...
SQAM & Technical Regulations Testing Metrology Conformity Assessment Standardisation Accreditation Testing Metrology Confo...
The ‘New Approach’ to Trade in Europe – An example of regulators & standards working together
Europe – The ‘New Approach’ <ul><li>Legislative harmonization is  limited to essential requirements </li></ul><ul><li>Tech...
Compliance with standards remains VOLUNTARY <ul><li>Compliance with Directives (transposed into Member States National Leg...
New Approach Directives www.newapproach.org/Directives/
The ‘Global Approach’ to  conformity assessment in Europe  <ul><li>Associated with the ‘New Approach’ that makes use of ha...
Reading <ul><li>Using and referencing ISO and IEC standards for technical regulations (ISO/IEC)  </li></ul><ul><li>Standar...
 
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Processes associated with standards & standards development (2 of 2)

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The second of two talks given to the Council of the Swaziland Standards Authority (SWASA), ti introduce procedures associated with standards development, together with introductions to conformity assessment, metrology, and mutual recognition agreements

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  • one standard, one test accepted everywhere
  • 24
  • one standard, one test accepted everywhere
  • Processes associated with standards & standards development (2 of 2)

    1. 1. <ul><li>Jum Reap Sour Cambodian </li></ul>Nei ho Chinese Moni bambo Chichewa Hafa adai Chamorro
    2. 2. The Meal: Quality Infrastructure
    3. 3. The component parts … S tandards Q uality A ccreditation M etrology
    4. 10. Participation problems 7 most important causes of weak participation in international standardization work – all developing countries
    5. 11. Participation problems 7 most important causes of weak participation in international standardization work specific to Sub-Saharan Africa
    6. 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
    7. 13. Participation problems Additional issues specific to Sub-Saharan Africa
    8. 14. The (Global) Context WTO Agreement on Technical Barriers to Trade
    9. 15. Two basic sorts of barriers ... <ul><li>Tariffs and quotas, and similar </li></ul><ul><li>Non-tariff barriers to trade </li></ul>
    10. 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 ...
    11. 17. The basic categories of ‘Non-Tariff’ barriers to trade ... <ul><li>Registration, documentation, and customs issues </li></ul><ul><li>Sanitary and Phytosanitary measures (SPS) </li></ul><ul><li>Transportation and transit </li></ul><ul><li>Investment and financial related matters </li></ul><ul><li>International rules for trade </li></ul><ul><li>Technical Barriers to Trade </li></ul>
    12. 18. Non-tariff barriers affecting market access
    13. 19. Non-tariff barriers affecting market access
    14. 20. Technical Barriers to Trade (TBT) - SQAM Conformity/Certification Transparency Standards Metrology/Testing Accreditation
    15. 21. Technical Barriers to Trade (TBT) - Standards
    16. 22. A bit about the TBT agreement (1) <ul><li>Annex 3 of the TBT Agreement is the Code of Good Practice for the Preparation, Adoption and Application of Standards (WTO Code of Good Practice) </li></ul><ul><li>WTO Members must accept and comply with the WTO Code of Good Practice </li></ul><ul><li>Standardizing bodies that have accepted its terms notify this fact to the ISO/IEC Information Centre </li></ul><ul><li>WTO member governments are required to establish national enquiry points to ensure that manufacturers and exporters can identify what the latest standards are in their respective markets </li></ul>
    17. 23. A bit about the TBT agreement (2) Basic commitments <ul><li>Use international standards </li></ul><ul><li>Ensure non-discrimination towards imported products </li></ul><ul><li>Participate in international standards activities whenever possible </li></ul><ul><li>Ensure that standards do not create unnecessary barriers to international trade </li></ul><ul><li>Publish work programs every 6 months </li></ul><ul><li>Allow for submission of comments on draft standards and take those comments into account </li></ul>
    18. 24. A bit about the TBT agreement (3) Commitments with Acceptance of the Code of Practice <ul><li>Standards and regulatory development process that is open, transparent, and includes participants from all interested parties </li></ul><ul><li>Conformity assessment system that upholds the principles of most-favoured nation treatment and national treatment </li></ul><ul><li>Publish proposed technical regulations and conformity assessment procedures </li></ul><ul><li>Establish a Notification Authority </li></ul><ul><li>Notify the development of new technical regulations </li></ul>
    19. 25. A bit about the TBT agreement (4) Commitments with Acceptance of the Code of Practice <ul><li>Notify the standards development programme </li></ul><ul><li>Establish an Enquiry Point </li></ul><ul><li>Provide full texts of proposals </li></ul><ul><li>Accept and consider comments on notifications </li></ul><ul><li>Comply with the Code of Good Practice </li></ul><ul><li>Provide technical assistance to other member countries </li></ul>
    20. 26. Technical Assistance <ul><li>On the preparation of technical regulations </li></ul><ul><li>On establishment of regulatory bodies, or bodies for the assessment of conformity with technical regulations </li></ul><ul><li>On establishment of bodies for the assessment of conformity with standards </li></ul><ul><li>Grant them technical assistance regarding the establishment of national standardization bodies, and participation in the international standardizing bodies (e.g. twinning in ISO) </li></ul>WTO members shall, if requested, advise other members, especially the developing country Members:
    21. 27. The Standards Development Process
    22. 28. Standards development typically … <ul><li>Is preceded by establishment of needs </li></ul><ul><li>Involves </li></ul><ul><ul><li>Negotiation </li></ul></ul><ul><ul><li>Consultation </li></ul></ul><ul><ul><li>Compromise </li></ul></ul><ul><ul><li>Prioritisation </li></ul></ul><ul><li>Is structured, typically project-based </li></ul><ul><li>Is consensus-based * </li></ul><ul><li>Includes for open/‘public’ consultation mechanisms </li></ul><ul><li>Involves meetings, including on-line/virtual meetings </li></ul><ul><li>Needs active participation by stakeholders </li></ul>* As applied in SWASA and many other standards bodies, consensus does not equate to a requirement for unanimous agreement
    23. 30. SWASA’s project stages … <ul><li>0. Preliminary stage </li></ul><ul><li>1. Proposal stage </li></ul><ul><li>2. Preparatory stage </li></ul><ul><li>3. Committee stage </li></ul><ul><li>4. Enquiry stage </li></ul><ul><li>5. Disposal stage </li></ul><ul><li>6. Approval stage </li></ul><ul><li>7. Endorsement stage </li></ul><ul><li>8. Publication stage (includes Gazetting) </li></ul>
    24. 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)
    25. 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)
    26. 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
    27. 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
    28. 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
    29. 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)
    30. 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.
    31. 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)
    32. 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.
    33. 40. Keeping it relevant – Systematic reviews <ul><li>Every deliverable published by SWASA must be also maintained, by the technical committee or subcommittee responsible </li></ul><ul><li>The timing of a maintenance ( systematic review ) is normally based either on the year of publication or, where a document has already been confirmed, on the year in which it was last confirmed </li></ul><ul><li>SWASA procedures specify a review at a maximum of 5 years. This is the default if a deliverable is not subject to change earlier </li></ul><ul><li>Changes to SWASA deliverables may be proposed at any time not only at 5 year intervals </li></ul>
    34. 41. The perfect “Combo”?
    35. 42. Regulations Conformity Assessment Standards
    36. 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)
    37. 44. Coordination between technical regulation (TR) and voluntary standards
    38. 45. Percentage of technical regulations (TR) based on standards (Sub-Saharan Africa)
    39. 46. Coordination between technical regulation (TR) and voluntary standards (Sub-Saharan Africa)
    40. 47. Main Reasons for Inadequate Technical Regulation (TR) (Sub-Saharan Africa)
    41. 48. Availability of Test and Certification Services
    42. 49. Main Reasons for Inadequate Conformity Assessment (CA)
    43. 50. Problems - Summary <ul><li>In 61% of the countries more than 50% of mandatory technical regulations were not based on international standards </li></ul><ul><li>In 59% of the countries more than 50% of the technical regulations were not even based on national standards differing from international ones </li></ul><ul><li>i.e. over 50% or technical regulations are not based on ANY standard ! </li></ul><ul><li>Lack of coordination between standardizers and regulators </li></ul><ul><li>Little coordination exists between different regulators </li></ul><ul><li>In 31% of the countries the NSB also issues mandatory technical regulations , blurring the line separating voluntary standardization and mandatory regulation </li></ul><ul><li>Lack of capabilities to support regulations in testing, certification, and inspection </li></ul>
    44. 51. Standards Supporting technical regulations
    45. 52. <ul><li>Standards covering certain areas may be made mandatory, through regulations for legitimate objectives (such as health, safety, environmental protection, …) </li></ul><ul><li>Examples: – Fire-prevention and fighting </li></ul><ul><li> – Food and health </li></ul><ul><li> – Transport of hazardous goods </li></ul><ul><li> – Electric appliances </li></ul><ul><li> – Gas appliances </li></ul>Standards and Regulations Working Together (1)
    46. 53. Standards and Regulations Working Together (2) <ul><li>Globally many examples of standards and regulations </li></ul><ul><li>working together. Examples from Europe include </li></ul><ul><li>Safety of toys, bicycles, etc </li></ul><ul><li>Construction codes </li></ul><ul><li>Safety of machinery </li></ul><ul><li>Medical devices </li></ul><ul><li>Personal protective equipment </li></ul><ul><li>Automotive safety and performance </li></ul><ul><li>Measuring instruments </li></ul><ul><li>Child transport devices (cots, pushchairs, car seats, etc) </li></ul><ul><li>Noise emission </li></ul><ul><li>Food safety </li></ul><ul><li>Energy efficiency of household equipment </li></ul>
    47. 54. (Technical) Standard and Technical Regulation <ul><li>Standard Document approved by a recognized body that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is voluntary </li></ul><ul><li>Technical regulation Document which lays down product characteristics or their related processes and production methods (i.e. provides technical requirements) with which compliance is mandatory </li></ul>
    48. 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
    49. 56. <ul><li>text from standards (the actual text or sections of the actual text) incorporated into legislation </li></ul><ul><li>references to standards incorporated into legislation (often using the clause “as amended from time to time”) </li></ul>Using Standards as a basis for Technical Regulations
    50. 57. <ul><ul><li>Stability </li></ul></ul><ul><ul><li>Braking effectiveness </li></ul></ul><ul><ul><li>Performance of integrated safety harnesses </li></ul></ul><ul><ul><li>Resistance to flammability </li></ul></ul><ul><ul><li>Trapping hazards (fingers) </li></ul></ul><ul><ul><li>Safety of paint and treatments (toxicity) </li></ul></ul><ul><ul><li>Labelling </li></ul></ul><ul><ul><li>Instructions for use </li></ul></ul>Child transport devices Focus is safety, Solution is performance-based
    51. 58. Requirements for wheeled child conveyances UK Statutory Instrument 1997 No. 2866 <ul><li>Has three choices: </li></ul><ul><li>1) Must comply with BS 7409; or </li></ul><ul><li>1) Must comply with BS BS 4792; or </li></ul><ul><li>3) Must meet technical requirements embedded in the regulation </li></ul><ul><ul><li>parking device .... clause 3.3 of BS 4139 ... Appendix D </li></ul></ul><ul><ul><li>stability ... clause 3.4 of BS 4139 ... Appendix E </li></ul></ul><ul><ul><li>harness anchorage points ... clause 3.6 of BS 4139 ... Appendix A </li></ul></ul><ul><ul><li>a folding chassis ... main locking device ... additional safety device ... test dummy ... Appendix F to BS 4139 ... does not cause or permit movement ... passes over the seat of the perambulator. </li></ul></ul>
    52. 59. Requirements for wheeled child conveyances Benefits & Problems <ul><li>Benefits </li></ul><ul><li>Performance based </li></ul><ul><li>Refers to separate technical characteristics in published national standard to permit definition of requirements </li></ul><ul><li>Potential Problems </li></ul><ul><li>Refers to specific clauses </li></ul><ul><li>Refers to undated references </li></ul><ul><li>References may be up-dated or become obsolete (new standard now BS EN 1888: 2003, but BS 7409:1996 remains current as it is referred to in the regulation) </li></ul>
    53. 60. Practical issues <ul><li>Need to know what performance is required (of the product/service) </li></ul><ul><li>Need to know how to determine achievement of requirements, including how to document them </li></ul><ul><li>Need to ensure accessibility of referenced materials </li></ul><ul><li>Require enforcement, monitoring, and inspections </li></ul>
    54. 61. SWASA Council: Terms of Reference <ul><li>Establishing guidelines for the drafting, issuing or amendment of standards </li></ul><ul><li>Establishing certification marks and register and protect them under the Trade Marks Act 1981 </li></ul><ul><li>Establishing licensing (certification) schemes to manage the use of its certification marks </li></ul><ul><li>Maintaining consultative systems with national, regional, and international standards bodies and similar bodies </li></ul><ul><li>Making recommendations to the Minister regarding the identification of potential mandatory standards </li></ul><ul><li>Ensuring that it is practicable to apply a proposed mandatory standard </li></ul>Functions relating to standards and certification explicitly identified in the Standards Act include:
    55. 62. The performance approach to standards development, & its relevance to regulations & regulators
    56. 63. <ul><li>ISO/IEC Directives, Part 2, Clause 4.2 Performance approach </li></ul><ul><li>“ Whenever possible, requirements shall be expressed in terms of performance rather than design or descriptive characteristics. This approach leaves maximum freedom to technical development .” </li></ul>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
    57. 64. Performance based regulatory model
    58. 65. Changing role of Regulators … <ul><li>Regulators have the novel (for them) role of: </li></ul><ul><li>establishing performance parameters or thresholds i.e. not prescriptive, with all details ; </li></ul><ul><li>the granting of status to third party domestic and foreign conformity assessment bodies i.e. sharing with and trusting others ; </li></ul><ul><li>re-establishing themselves to focus on post-market surveillance functions i.e. monitoring and enforcement mechanisms </li></ul>
    59. 66. Recommendations to Regulators (1) … (Standards) <ul><li>Ensure that there is a clear National Policy regarding the interactions and relationships between regulations and standards (including ensuring clarity in the Standards Act) </li></ul><ul><li>Establish a cooperative effort between the regulatory authority and the standards development committee from the outset </li></ul><ul><li>Recognise that regulator participation greatly assists rendering the standards suitable for application in regulation </li></ul>
    60. 67. Recommendations to Regulators (2) … (Standards) <ul><li>When referring to standards consider using phrases such as “[Standard #] as amended” </li></ul><ul><li>Define law frameworks giving a recognized, “special status” to standards e.g. through “Deemed-to-satisfy” provisions pointing to alternative ways to comply (see “New Approach” in Europe) </li></ul><ul><li>Encourage the use of standards on the basis that their voluntary take-up by the market would mean that regulators’ objectives are met. Such measures would not imply the creation of legal instruments </li></ul>
    61. 68. Conformity Assessment Supporting the standards supporting the technical regulations
    62. 69. Conformity Assessment
    63. 70. Conformity Assessment* (CA) is … <ul><li>Checking whether products, services, materials, processes, systems and personnel meet the requirements of standards, regulations, or other specifications </li></ul><ul><li>Includes </li></ul><ul><ul><li>Testing </li></ul></ul><ul><ul><li>Inspection </li></ul></ul><ul><ul><li>Certification </li></ul></ul><ul><ul><li>Accreditation </li></ul></ul>*demonstration that specified requirements relating to a product, process, system, person or body are fulfilled (Definition taken from BS EN ISO/IEC 17000:2004
    64. 71. Why use CA? <ul><li>Provide purchasers with confidence in the suppliers, products, or services that they use </li></ul><ul><li>May be an element in indicating compliance with regulations e.g. CE Marking </li></ul><ul><li>Help business to be competative </li></ul><ul><li>Facilitate trade </li></ul><ul><li>Create market advantage </li></ul><ul><li>Provide a visible link between standards and the market </li></ul>
    65. 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
    66. 73. CE Marking (not &quot;CE Mark&quot;) (originally &quot;EC Mark&quot;) <ul><li>manufacturer's declaration (Self Declaration Of Conformity – SDOC) that the product complies with the essential requirements of the relevant European legislation (EC-Declaration of Conformity (EC-DoC) </li></ul><ul><li>Indicates to governmental officials that the product may be legally placed on the market in their country. </li></ul><ul><li>Ensures the free movement of the product within the EFTA & European Union (EU) single market </li></ul><ul><li>Permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities </li></ul><ul><li>'Agreements on Mutual Recognition of Conformity Assessment' between the European Union and other countries such as the USA, Japan, Canada, Australia, New Zealand and Israel & CE marking is now found on many products from these countries. </li></ul>
    67. 74. Why choose Supplier's Declaration of Conformity (SDoC)? <ul><li>Avoids the costs of third-party assessment </li></ul><ul><li>An option where a supplier it enjoys a sufficiently high market reputation for it to dispense with independent confirmation of conformity </li></ul><ul><li>May not be appropriate in all cases, particularly where the health, safety or environmental risks of the product concerned are higher </li></ul><ul><li>SDoC does not exempt the supplier from its responsibility to meet relevant regulations </li></ul><ul><li>Generally need to be accompanied by effective post-market surveillance </li></ul><ul><li>May not be a suitable option for developing countries </li></ul>
    68. 75. Third party (“Independent”) assessment <ul><li>… is when conformity assessment (checking) is carried out by a body that is independent of both supplier and customer organizations </li></ul><ul><ul><li>May be carried out on behalf of an organization for its own needs, E.g. ISO 9000 certification; or </li></ul></ul><ul><ul><li>May be carried out in order to provide an independent (thus ‘neutral’) assessment of a product, service, etc </li></ul></ul><ul><ul><li>May be voluntary </li></ul></ul><ul><ul><li>May be prescribed as a contractual requirement </li></ul></ul>
    69. 76. Why choose ‘Third party assessment’ <ul><li>Supplier may choose it as a way of differentiating its product or service from others on the market </li></ul><ul><li>Customer may require it as a part of a contractual agreement </li></ul><ul><li>Government regulations may require it e.g. of the protection of the consumer, public health, safety, environment etc. </li></ul>Note! A requirement to carry out third party assessment could constitute a Technical Barrier to Trade
    70. 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.
    71. 78. ICONTEC Certification Marks ALL voluntary but heavily promoted, particularly as marketing devices
    72. 79. The difference between … Certification and Accreditation <ul><li>Certification 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 </li></ul><ul><li>Accreditation 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 </li></ul>
    73. 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 &quot;Accreditation&quot; is not a synonym for &quot;certification&quot; * 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)
    74. 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
    75. 82. Mutual Recognition <ul><li>Mutual recognition reduces costs of trade </li></ul><ul><li>Mutual recognition can be G2G or voluntary, but most often is both </li></ul><ul><li>There are ISO/IEC Guides and Standards that underpin this system (often referred to as the “ISO/CASCO Toolkit”) </li></ul><ul><li>A number of regional and international peer review and accreditation systems that provide the basis for voluntary MRAs </li></ul>
    76. 83. National Conformity Assessment Policy Basic Principles <ul><li>driven by market demand, public interest, or regulators not by those with a commercial interest in conformity assessment </li></ul><ul><li>a free-market, competitive activity </li></ul><ul><li>measurements or test results should be traceable to national or international measurement standards </li></ul><ul><li>when in support of regulation, the infrastructure developed for non-regulatory conformity assessment should be used </li></ul><ul><li>conducted to recognised standards </li></ul><ul><li>CA schemes and any associated marks should be developed and used so that they facilitate, not discourage, innovation and trade </li></ul><ul><li>procedures that impose the lightest burden on business, should be preferred </li></ul><ul><li>CA bodies should preferably demonstrate competence by seeking accreditation </li></ul><ul><li>national accreditation bodies need to operate against recognised criteria </li></ul><ul><li>National accreditation bodies should cooperate </li></ul>Source: Conformity Assessment Policy in the United Kingdom (DTI)
    77. 84. Recommendations to Regulators (3) … (Conformity assessment) <ul><li>Develop an understanding of the concepts of conformity assessment system </li></ul><ul><li>Consider the characteristics of the envisaged conformity assessment system to support the regulations </li></ul><ul><li>Where conformity assessment is required in support of regulation, the infrastructure developed for non-regulatory conformity assessment should be used as far as is possible </li></ul><ul><li>Develop a National Conformity Assessment Policy </li></ul><ul><li>Be familiar with the opportunities offered by MRA, including cross-border MRA </li></ul><ul><li>Be aware of the existing global accreditation system </li></ul><ul><li>In parallel to developing regulations determine needs for enforcement of regulations, e.g. receipt of complaints, monitoring, inspections </li></ul>
    78. 85. To summarise … <ul><li>Regulatory structures should: </li></ul><ul><ul><li>be performance based </li></ul></ul><ul><ul><li>allow for mutual recognition of conformity assessment </li></ul></ul><ul><ul><li>use (international) standards as a means of compliance </li></ul></ul><ul><li>Existing international and regional voluntary systems are used to underpin G2G MRAs </li></ul><ul><li>Relying on standards as a means of compliance with technical regulations provides the basis for mutual recognition of conformity assessment and increased trade </li></ul><ul><li>Regulators should be involved in developing standards & CA </li></ul><ul><li>TBT obliges signatories to report to the WTO all activities relating to technical regulations, standards, and conformity assessment that affect international trade </li></ul><ul><li>Technical trade barriers need to be analysed carefully </li></ul>
    79. 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”
    80. 87. The ‘New Approach’ to Trade in Europe – An example of regulators & standards working together
    81. 88. Europe – The ‘New Approach’ <ul><li>Legislative harmonization is limited to essential requirements </li></ul><ul><li>Technical specification of essential requirements elaborated in harmonized standards developed by European standards organizations (CEN, CENELEC, etc.) </li></ul><ul><li>In CEN a core principle is to base harmonization on International Standards , through joint ISO/CEN working procedures established by the Vienna Agreement </li></ul>www.newapproach.org Europe needed a more efficient and effective approach to technical harmonization. With the adoption of the ‘New Approach’
    82. 89. Compliance with standards remains VOLUNTARY <ul><li>Compliance with Directives (transposed into Member States National Legislation) is compulsory, but … </li></ul><ul><li>Compliance with standards is VOLUNTARY.  </li></ul><ul><li>I.e. Manufacturers are free to choose any other technical solution that provides (… is deemed to satisfy … ) compliance with the essential requirements. </li></ul>
    83. 90. New Approach Directives www.newapproach.org/Directives/
    84. 91. The ‘Global Approach’ to conformity assessment in Europe <ul><li>Associated with the ‘New Approach’ that makes use of harmonized standardsmanufacturers have a choice of conformity assessment procedures, but to work effectively, reliable conformity assessment conditions are necessary. </li></ul><ul><li>The European ‘Global Approach’ describes a series of guiding principles for Community policy on conformity assessment, including reference to the EN ISO 9000 series. </li></ul><ul><li>Addresses issues such as core descriptions of the conformity assessment process, and mutual recognition agreements </li></ul>
    85. 92. Reading <ul><li>Using and referencing ISO and IEC standards for technical regulations (ISO/IEC) </li></ul><ul><li>Standards and Technical Regulations and Firms in Developing Countries: New Evidence from A World Bank Technical Barriers to Trade Survey (World Bank) </li></ul><ul><li>Survey on Problems Faced by Developing Countries in the Areas of Standardization and their Participation in International Standardization Work (ISO/DEVCO) </li></ul><ul><li>Conformity Assessment Policy in the United Kingdom (DTI) - January 2007 - URN 07/594 </li></ul><ul><li>Guide to the implementation of directives based on the New Approach and the Global Approach </li></ul>

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