1. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Training on standardisation Support to the Modernisation of the Mongolia’s Standardisation System (SMMSS) CONFORMITY ASSESSMENT STAKHOLDERS AND THEIR ROLES

2. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Conformity Assessment stakeholders and their roles

3. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Conformity Assessment stakeholders and their roles EU legislation is based on two kinds of control: 1.Controls before products are placed on the market - known as Conformity Assessment 2.Controls after products are placed on the market – known as Market Surveillance This presentation will look at the roles of those involved in Conformity Assessment

4. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Important principle for manufacturers to note Manufacturers are always responsible for ensuring that their products comply with EU legislation even where that legislation requires a Third Party Conformity Assessment Procedure and the use of a Notified Body. If a product is non-compliant when it is placed on the market, the manufacturer is still responsible and accountable for that situation, even if it has used a Notified Body and even if that Body has certified the product as being compliant with the legislation. The manufacturer must ensure that, in that situation, it takes all necessary action to rectify the situation and bring the product into conformity or take it off the market

5. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN A manufacturer’s Authorised Representative (AR) - 1 Much EU legislation envisages a manufacturer’s discretion to appoint an authorised representative (AR). This is a different role from that of an Importer. There are certain responsibilities that a manufacturer CANNOT delegate to an AR – i)Ensuring that products have been designed and manufactured in accordance with the requirements of applicable legislation ii)Drawing up the technical documentation for the product

6. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN A manufacturer’s Authorised Representative (AR) - 2 Decision 768/2008/EC states that if a manufacturer does decide to appoint an AR, then the appointment must be by a written mandate and must allow the AR to do at least the following: a)keep the EU Declaration of Conformity and the technical documentation at the disposal of the national surveillance authorities b)further to a reasoned request from a competent national authority provide that authority with the information and documentation necessary to demonstrate the conformity of the product c)cooperate with such authorities on any action taken to eliminate risks posed by products covered by the mandate Decision 768/2008/EC’s provisions will be incorporated into individual Directives as they are renegotiated and aligned with its provisions

7. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN The Stakeholders The main stakeholders regarding Third Party Conformity Assessment are: The Notifying Authorities of the Member States The Accreditation Bodies of the Member States Notified Bodies -(Conformity Assessment Bodies) Their respective responsibilities are laid down in Decision 768/2008/EC on a common framework for the marketing of products and in individual Directives

8. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN The Notifying Authorities The Notifying Authorities are the Government Departments or Public Bodies that appoint Notified Bodies to administer Third Party Conformity Assessment Procedures under the Member States’ legislation transposing EU product-regulating Directives They must Notify the European Commission and other Member States of the bodies they authorize to perform third party conformity assessment under the relevant EU legislation

9. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Responsibilities of Notifying Authorities Responsible for 1.Setting up and carrying out procedures for the assessment and notification of conformity assessment bodies (CAB) and then monitoring their performance 2.Deciding whether assessment and monitoring shall be carried out by a national accreditation body (NAB) and,if so, ensuring the NAB has the necessary status in law to fulfil these roles. Notifying Authority must take responsibility for the work of the NAB

10. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Requirements of Notifying Authorities 1.A Notifying Authority must be established in such a way that no conflict of interest occurs 2.It shall be organized in such a way as to safeguard the objectivity & impartiality of its activities 3.It shall be organized in such a way that each decision on notifying a CAB is taken by competent persons different from those who carried out the assessment 4.It must not offer activities that CABs perform 5.It must safeguard the confidentiality of information 6.It must have enough competent personnel to perform its duties 7.It must inform the European Commission of its procedures for assessing, notifying & monitoring Notified Bodies (CAB). The Commission must make this information publicly available

11. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Requirements of Notified Bodies - 1 To be Notified Bodies (NB), CABs must: Be established under national law and have legal personality Be a Third Party Body, independent of the organization or product it assesses Not be the designer, manufacturer, supplier, installer of the products they assess nor have any other kind of vested interest in the products they assess Carry out conformity assessment activity with the highest degree of professional integrity and requisite technical competence, and be free from all pressures which might influence their judgement or the results of their assessment activities

12. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Requirements of Notified Bodies - 2 To be Notified Bodies, CAB’s must also: Be capable of performing all the conformity assessment tasks assigned to them by the relevant legislation Have personnel with the necessary training, knowledge of assessments and authority to carry them out; knowledge of legislation, essential requirements and standards, and the ability to draw up the necessary certificates, records and reports on their assessments

13. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Requirements of Notified Bodies - 3 They shall guarantee their impartiality and that of their personnel They shall take out liability insurance (unless the Member State concerned assumes liability for their work) Their personnel shall observe professional secrecy with regard to all information obtained in carrying out their tasks (except in relation to the competent authorities of the Member State in which their activities are carried out)

14. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Requirements of Notified Bodies - 4 They must take part in standardization or ensure their personnel are aware of standardization activities. Similar requirements regarding European Notified Body Coordination group activity established under legislation and must apply as general guidance the administrative decisions & documents produced by that group Note 1 - Under Decision 768/2008/EC’s Article R20, there are rules on subsidiaries of and subcontracting by NBs Note 2 – Under its Article R21 there are rules on “Accredited in house bodies” (which can be explained if this specialist area is of interest to anyone)

15. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Application for Notification and Notification Procedure - 1 1.A CAB wanting to be an NB must apply to the the notifying authority of the Member State in which it is established, describing the Conformity Assessment activities and modules and products for which it claims to be competent, submitting its Accreditation certificate - if it has one - attesting it fulfils the requirements described in 768/2008/EC’s Article R17 (see slides 7-10 above) 2.Where it has no Accreditation certificate, it must provide other satisfactory documentary evidence

16. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Application for Notification and Notification Procedure -2 Notifying authorities must only notify bodies that meet the requirements of 768/2008/EC’s Article R 17 (as transposed into the relevant EU sectoral legislation) They must use the E. Commission’s electronic notification procedure “NANDO” to notify Special provisions apply when Member States are not using Accreditation as the basis of Notification (extra time for other Member States to scrutinise notifications) If no objections made to Notifications, Commission must issue NB with an identification number and publish the list of bodies notified and their numbers

17. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Other important considerations Notifying Authorities must inform E. Commission and other Member States when an NB no longer meets the requirements or is failing to fulfil its obligations, and it must take action accordingly (Decision 768/2008/EC Art. R25) The Commission must investigate challenges to the competence of NB’s (Article R26)

18. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Obligations of Notified Bodies (NBs) NBs must carry carry out conformity assessments (CA) in accordance with the CA procedures laid down in the applicable legislation They must do it in a proportionate manner – avoiding unnecessary burdens for economic operators They shall require manufacturers to take any necessary action to bring products into compliance with the legislation before issuing a conformity certificate If subsequently, NBs find products no longer comply, they must require manufacturers to take corrective action, and - if necessary - restrict, suspend or withdraw certificates

19. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Information obligations of Notified Bodies NBs must inform their notifying authorities of; Refusals etc of certificates Circumstances affecting the scope of & conditions for notification Any request for information from market surveillance authorities regarding C.A. activities On request, C.A. activities performed

20. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN European Commission obligations E. Commission must provide for exchanges of experience between Member States on Notification Policy E. Commission must ensure appropriate coordination and cooperation between Notified bodies takes place in sectoral or cross-sectoral groups Member States must ensure their NB’s take part in such activity or are represented in it

21. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Conformity Assessment Procedures Before Products are placed on the market they must comply with the Conformity Assessment Procedures (CAP) laid down in the Directives the apply to them (may well be more than one Directive) Depending on the particular Conformity Assessment Procedures (CAP) specified in applicable Directive(s), the CAP may involve examination by a Notified Body of the design of the product, the production of the products or Quality Assurance system for design and/or manufacture of the product

22. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Choice of conformity assessment procedures in product legislation - 1 Some basic principles apply when legislators are drafting EU product legislation: The choice of conformity assessment procedures by legislators should follow the Modules laid down in 768/2008/EC unless there are good sector-specific reason for modifying them The procedures chosen should be based on rational considerations, such as risk assessment The choice should avoid putting unnecessary burdens on manufacturers. In a lot of cases “Module A” – manufacturer’s Internal Production Control - is deemed to be sufficient e.g. for the majority of machinery types produced under the Machinery Directive 2006/42/EC

23. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Choice of conformity assessment procedures in product legislation -2 If procedures involving Third Party Conformity assessment are necessary, wherever risk assessment and other rational considerations allow for it, a choice of procedures should be made available under legislation – notably between e.g Type Examination procedure and Quality Assurance procedure (or a mix of them) It is legitimate for legislators to decide that Type Examination is always necessary, if that is the conclusion of rational risk assessment of the product sector type, e.g the Gas Appliances Directive, 2009/142/EC

24. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Design

25. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Production

26. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Questions often asked Q: How do I find out which conformity assessment procedure applies to my product? A: You have to study the legislation and make sure you comply. Many Directives make extensive use of “Module A” – e.g. low voltage electrical equipment; many types of machinery. But remember Module A does not mean no controls apply – manufacturers must have satisfactory systems of internal production control to comply with it Q: How do I find a Notified Body? A: They are listed in the E. Commission’s NANDO database http://ec.europa.eu/enterprise/newapproach/nando/index. cfm

27. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Any Other Questions?

28. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Thank you for your kind attention Richard Lawson richard.lawson@btinternet.com Support to the Modernisation of the Mongolian Standardisation System (SMMSS) This project is supported by the European Union