Product concerns. Product concerns Dag Björklöf. Methodology used in the EU to ensure compliance with essential requirements

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1 ASEAN-EU Programme for Regional Integration Support (APRIS) Phase II CE Design: Dag Björklöf EUROPEAID/123203/C/SER/MULTI Workshop on the transposition of the AHEEERR and the finalization of the list of harmonized standards of the AHEEERR Methodology used in the EU to ensure compliance with essential requirements Project funded by the European Union Implemented by IBF in consortium with CEN, Crown Agents and ACE Dr. Prof. Dag Björklöf, Sweden ltu.se Product concerns Product concerns As products are produced and used they may give rise to many different concerns, which can involve safety and compatibility, durability, suitability for intended purposes or for stated conditions, health & environmental impacts, and similar considerations. A very frequent concern is simply whether a product is what it is expected to be. Ref.: ISO/IEC Guide 67 Product concerns can be addressed through a conformity assessment procedure, (e.g. verification by testing or certification) to prove that a product is in conformity with all essential requirements of applicable expectations / regulations with a dual purpose: Users and consumers are able to make better decisions about products in the marketplace By demonstrating conformity, suppliers may more effectively achieve market acceptance.

2 Ensuring compliance with Essential Requirements (ESR) Conformity Assessment procedures in the EU Compliance with the ESR as defined in the European New Approach Directive LVD and EMCD may be fulfilled by the manufacturer without involvement of a 3rd party, but the manufacturer may use a Notified Body to confirm compliance with ESR or part of the ESR Global Approach to testing & certification Compliance procedures (8 modules) for showing compliance in line with New Approach Directives Principal guidelines for affixing and use of CE marking Conformity Assessment Body requirements related to modules Module Applicable EN standards A EN 17025, EN or EN B EN or EN C EN 17025, EN or EN D & E EN plus product related knowledge F EN 17025, EN or EN G EN or EN H EN plus product related knowledge (eventually also EN or EN 45011) Product conformity assessment The type of activity undertaken to demonstrate conformity of a product with relevant regulations is often determined by the consequences of nonconformity. When consequences are insignificant or not severe, society may expect little or no demonstration of conformity of the product. However, where the consequences of nonconformity are significant, society may demand completion of activities that demonstrate conformity to requirements prior to allowing the product to be placed on the market. Ref.: ISO/IEC 17000

3 Priori vis-à-vis posteriori surveillance European Member States have turned from surveillance regimes based on controlling products according to national regulations before they were to be placed on the market (mandatory certification) to a common system based on harmonised regulations and market surveillance of products placed on the internal market EC EU:s New Approach (NA) New Approach to technical harmonization and use of standards Products must comply with essential requirements of applicable NA Directives Standards are not mandatory but can be used to show compliance with essential requirements Essential requirements according to the LVD Low Voltage Directive 06/95/EEC: Products must be constructed in accordance with good engineering practice in safety matters Products may not endanger the safety of persons, domestic animals or property when properly installed and maintained and used in the applications for which it is made Constructed in accordance with the Principal Elements of the Safety Objectives (ESRs) Covers all risks Essential EMC requirements The EMC Directive 04/108/EC: An apparatus shall be so constructed that the electromagnetic disturbances it generates does not exceed a level allowing radio & telecoms equipment or other electrical/electronic apparatus to operate as intended that it has an adequate level of intrinsic immunity to electromagnetic disturbances to enable it to operate as intended

4 Examples of European NA Directives covering EEE LVD: Safety of EEE EMCD: Electromagnetic compatibility R&TTED: Radio & Telecom equipment ATEX: El. equipment & protective systems to be used in potentially explosive atmospheres MD: Machinery (when electrical) Lift Directive: Lifts (when electrical) MID: Measuring instruments (when electrical) NAWI: Weighing instruments (when electrical) GAD: Gas appliances (when electrical) MDD: Medical devices (when electrical) TOY Directive: Toys (when electrical) Additional Directives affecting el. equipment Eco design (92/42/EEC) & EuP (2005/32/EC).. Eco requirements for Energy using Products WEEE (2002/96/EC & 2003/108/EC).. Waste Electrical & Electronic Equipment RoHS (2002/95/EC)..Restriction of the use of. certain hazardous substances in el. equipment 94/62/EC amended by 2005/20/EC..Packaging and packaging waste Electrical Energy Labelling Directives Additional EU legislation for electrical household appliances LVD product family std 03/66/EC Refrigerators & freezers (94/2/EC & 92/75/EC) 02/40/EC Ovens 02/31/EC Air conditioners 98/11/EC Lamps 97/17/EC Dishwashers 96/60/EC Combined washer-driers 95/13/EC Tumble driers 95/12/EC Washing machines 92/75/EEC Household appliances EN EN EN EN Some product family standards covering Electrical Safety IT equipment (incl. business eq.) Audio, video etc. ( brown goods ) Household apparatus ( white goods ) Uninterruptible power systems (UPS)

5 EMC product family std Standards give guidance Some product family EMC standards covering Emission / Immunity EN / 024 EN / 020 IT equipment Broadcast equipment (radio & TV) EN / 2 Household apparatus EN Uninterruptible power systems (UPS) A product may have to comply with safety and protection requirements of several NA directives! In case there is an overlap between the safety aspects of two different NA directives both directives or only one of the two directives might be applicable. E.g. is the safety aspects of a hand-held electrical operated tool to be covered by the machinery directive or/and the low voltage directive. The lists of standards harmonized under respective directive can then be used to indicate which directive is applicable. A hand-held held el. drill has to comply with MD & EMCD Harmonized with MD: EN EN N EN Safety of hand-held motor operated electrical tools Product specific machine requirements Particular requirements for drills and impact drills Safety aspects of hand-held held and transportable el. drive tools, such as a domestic drill, are covered by standards harmonized with the Machinery Directive but not with the LVD! An electrical sewing machine has to comply with LVD, MD & EMCD Harmonized with LVD: EM Safety of household and similar electrical appliances Particular requirements for sewing machines Harmonized with MD & EMCD: EN Safety of machines Particular safety and EMC* requirements for sewing machines, units and systems * immunity requirements Emission requirements to be covered by EMC directive

6 marking of an el. equipment may require compliance with 3 NA Directives Directives - LVD 06/95/EC The Low Voltage Directive - EMCD 04/108/EC CE marking The EMC Directive - MD 06/42/EC The Machinery Directive implies that a product has to comply Standards with all applicable NA directives Safety EMC Machinery EN EN EN 292-1, -2 EN EN EN 294 EN EN EN EN EN EN 1050 Reference to harmonized standards Harmonised standards reflect the generally acknowledged state of the art as regards to technical requirements harmonizing with the ESR of New Approach Directives (e.g. electrical safety (LVD) and EMC respectively). Once the reference to such standards has been published in the Official Journal of the European Union, harmonized standards can be used to show compliance with Essential Requirements of applicable NA Directives although other means of demonstrating such conformity should be permitted. Publication of standards Ex.: ASEAN proposal for EMC CISPR 15 {Ed 5.2} Lists of generic, general and product (family) standards are published in the Official Journal as harmonized to a certain New Approach Directive. Basic standards are not published in the O.J. If no product or product family standard exists a general or generic standard takes preference. Note that a product may fall under several standards. CISPR 15: 2000 = CISPR 15: Am 1: Am 2: 1999 with identical scope

7 Ex.: CISPR 15 {Ed 7.2} Consolidated version of CISPR 15 = CISPR: Am 1: Am 2: 2008 Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment (radiated & conducted RF emission) from: all lighting equipment with a primary function of generating and/or distributing light intended.for illumination purposes, and intended either for connection to the low voltage electricity supply or for battery operation; the lighting part of multi-function equipment where a primary function is illumination; independent auxiliaries exclusively for use with lighting equipment; UV and IR radiation equipment; neon advertising signs; street/flood lighting intended for outdoor use; transport lighting (installed in buses and trains). The limits in this standard have been determined on a probabilistic basis to keep the suppression of disturbances within economically reasonable limits while still achieving an adequate level of radio protection and electromagnetic compatibility. In exceptional cases, additional provisions may be required. Revised / Consolidated std CENELEC CENELEC EN 55015: 2000 Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment Amendment A1:2001 to EN 55015: 2000 Amendment A2:2002 to EN 55015: 2000 EN 55015: 2006 Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment Amendment A1:2007 to EN 55015: 2006 Reference CISPR 15: A1: A2: 1999 CISPR 15: 2000 /A1: 2001 CISPR 15: 2000 /A2: 2002 CISPR 15: 2005 CISPR 15: 2005 /A1: 2006 DOC Date expired ( ) Date expired ( )

8 ASEAN-EU Programme for Regional Integration Support (APRIS) Phase II CE Design: Dag Björklöf EUROPEAID/123203/C/SER/MULTI Technical Assistance for the ASEAN Programme for Regional Integrated Support (AQPRIS Phase 2) EC Regulations, Standards & Procedures and their application on EEE (Electrical / Electronic Equipment) Project funded by the European Union Implemented by IBF in consortium with CEN, Crown Agents and ACE Dr. Prof. Dag Björklöf, Sweden ltu.se EC The European Community Millions of inhabitants Europe Year of membership / Millions of inhabitants Dag 1958 Björklöf Belgium 10 France 58 Italy 57 Luxembourg 0.4 Netherlands 15 Germany Denmark 5 Ireland 4 UK Greece Portugal 10 Spain Finland 5 Sweden 9 Austria

9 EU / EEA Parties involved in the development/revision of regulations Austria European Austria Union / Belgium Italy Iceland European Economic Area Denmark Finland France Germany Great Britain Greece EEA EU Ireland Luxembourg Netherlands Portugal Spain Sweden EFTA: Norway Liechtenstein Bilateral agreement: EU/Switzerland Industry organizations Notified Bodies ADMINISTRATIVE COOPERATION Market surveillance WORKING PARTIES General Policy Issues MRA TASKFORCE MRA-related matters Standards organizations O.J. O.J. O.J. O.J. Official Journal Regulations to protect consumers EUR-LEX provides free access to European laws: Decisions, Regulations & Directives and Lists of harmonized standards. published in the Official Journal of the European Communities (O.J.E.C.) Information of NA directives can be found at: Safety, Health & Protection requirements, Safe harmonized within EEA, are regulated product by National Laws, Acts, Decrees Made in? China and other regulations based on EC Directives: Product Liability Directive General Product Safety Directive Product Directives of old and new type Control of third country import (93/339/EEC)

10 New & Global Approach Council Resolution of 7 May 1985 on a New Approach to technical harmonization & standards Commission Communication of 15 June 1989 on a Global Approach to testing and certification Council Resolution of 21 December 1989 on a Global Approach to conformity assessment Council Decision of 22 July 1993 (93/465/EEC) on the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in technical harmonization directives 1985 EC EU:s New Approach (NA) New Approach to technical harmonization and use of standards Products must comply with the essential requirements of applicable NA Directives Standards are not mandatory but can be used to show compliance with essential requirements New Approach exclusion Equipment for the security of Member States, arms, ammunitions and war material is generally excluded from the scope of New Approach Directives. Directives of New Approach type 2006/95/EC Low Voltage equipment (LVD) (73/23/EEC) 87/404/EEC Simple pressure vessels 88/378/EEC Safety of Toys 89/106/EEC Construction products 2004/108/EC Electromagnetic Compatibility (EMCD) (89/336/EEC) ( 20 July 2009) 2006/42/EC Safety of Machinery (MD) (98/37/EC) ( 29 December 2009) 89/686/EEC Personal protective equipment (PPE)

11 Directives of New Approach type 90/384/EEC Non-automatic weighing instruments (NAWI) 90/385/EEC Active implantable medical devices & 2007/47/EC 90/396/EEC Appliances burning gaseous fuels (GAD) 92/42/EEC Efficiency requirements for new hot water & 2005/32/EC boilers fired with liquid or gaseous fuels 93/15/EEC Explosives for civil uses 93/42/EEC Medical devices (MDD) & 2007/47/EC 98/79/EC In vitro diagnostic medical devices 94/9/EC Equipment & protective systems. in potentially explosive atmospheres (ATEX) Directives of New Approach type 94/25/EC & 2003/44/EC 96/98/EC 95/16/EC & 2006/42/EC 97/23/EC 99/5/EC 2000/9/EC 2004/22/EC 2000/14/EC Recreational craft Marine equipment Lifts Pressure equipment (PED) Radio & TTE equipment (R&TTED) Cableway designed to carry persons Measuring instruments (MID) Noise emission by equipment used outdoors (No CE marking!) Additional EU legislation for EEE Besides New Approach Directives for CE marking of el. equipment like LVD and EMCD there is additional EU legislation affecting specific el. products Electrical Energy Labelling Directives Additional EU legislation for electrical household appliances 03/66/EC Refrigerators & freezers (94/2/EC & 92/75/EC) 02/40/EC Ovens 02/31/EC Air conditioners 98/11/EC Lamps 97/17/EC Dishwashers 96/60/EC Combined washer-driers 95/13/EC Tumble driers 95/12/EC Washing machines 92/75/EEC Household appliances

12 Minimum Efficiency Requirements Additional EU legislation for electrical household appliances 00/55/EC Energy efficiency requirements for ballasts for fluorescent lighting 96/57/EC Energy efficiency for household electric refrigerators & freezers 92/42/EEC Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels Additional Directives affecting EEE Eco design (92/42/EEC) & EuP (2005/32/EC)..Eco requirements for Energy using Products WEEE (2002/96/EC & 2003/108/EC). Waste Electrical & Electronic Equipment RoHS (2002/95/EC)..Restriction of the use of. certain hazardous substances in el. equipment 94/62/EC amended by 2005/20/EC..Packaging and packaging waste Overlapping NA directives Directives concerning EEE with safety & health requirements Machine with control system PC with modem Vehicles (cars) Machinery Directive EMC Directive (Low Voltage Directive ) Pressure Directives ATEX... LVD & EMCD R&TTE Directive A series of Old Approach Directives Civil Explosives Directive R&TTE Directive LVD ATEX MD (Machinery Directive) Lifts Directive R&TTED MDD (Medical Devices Directive) Toy Directive GAD

13 Product specific directives including electrical safety aspects Product specific NA directives (CE) 99/5/EC Radio and TTE equipment (R&TTED). 94/9/EC Equipment & protective systems in. potentially explosive atmospheres (ATEX) 93/42/EECº Medical devices directive (MDD) 04/22/EC Measuring instruments (MID) 95/16/EC Lifts directive 06/42/EC Safety of Machinery (MD)* º & 07/47/EC * Machinery may also have to comply with ATEX MD Annex I MD vis-à-vis LVD Electricity supply Where machinery has an electricity supply, it must be designed, constructed and equipped in such a way that all hazards of an electrical nature are or can be prevented. The safety objectives set out in LVD shall apply to machinery. However, the obligations concerning conformity assessment and the placing on the market and/or putting into service of machinery with regard to electrical hazards are governed solely by MD Static electricity Machinery must be designed and constructed to prevent or limit the build-up of potentially dangerous electrostatic charges and/or be fitted with a discharging system. Product specific directives including EMC aspects CE marking Directives (New Approach) 93/42/EECº Medical devices 90/385/EECº Active implantable medical devices 98/79/EC In vitro diagnostic medical devices 90/384/EEC Non-automatic weighing instruments* * 04/22/EC Measuring instruments* * 96/98/EC Marine equipment 99/5/EC Radio and TTE equipment º & 07/47/EC * includes immunity requirements only Product specific directives including EMC aspects e - marking directives (Old Approach) 95/54/EC amended amended by...05/83/ec05/83/ec 97/24/EC 95/56/EC EMC Directive for motor vehicles and separate technical units (STU) / el. subassemblies (ESA) EMC Directive for two or three- wheel motor vehicles and separate technical units Alarm systems & immobilizers

14 Horizontal Directives EMC Directive (EMCD) Electrical apparatus and systems (no limits regarding power) Low Voltage Directive (LVD) 04/108/EC 06/95/EC El. apparatus VAC & VDC Machinery Directive (MD) 06/42/EC Assembly of linked parts (at least one moving) or linked machines, joined together for a specific application incl. appropriate actuators, control and power circuits marking of an el. equipment may require compliance with 3 NA Directives Directives - LVD 06/95/EC The Low Voltage Directive - EMCD 04/108/EC CE marking The EMC Directive - MD 06/42/EC The Machinery Directive implies that a product has to comply Standards with all applicable NA directives Safety EMC Machinery EN EN EN 292-1, -2 EN EN EN 294 EN EN EN EN EN EN 1050 MD vis-à-vis LVD Some electrical machines have to comply with MD & EMCD The revised MD (2006/42/EC) states that: Where machinery has an electricity supply, it must be designed, constructed and equipped in such a way that all hazards of an electrical nature are or can be prevented. The safety objectives set out in the LVD shall apply to machinery, However, the obligations concerning conformity assessment and the placing on the market and/or putting into service of machinery with regards to electrical hazards are governed solely by this Directive (MD). Safety aspects of hand-held and transportable el. drive tools, such as a domestic drill, are covered by standards harmonized with the Machinery Directive but not with the LVD!

15 Dag Björklöf Standards give guidance A product may have to comply with safety and protection requirements of several NA directives! In case there is an overlap between the safety aspects of two different NA directives both directives or only one of the two directives might be applicable. Ex.: The old Machinery Directive states that where the electrical risks predominates over all other risks on any machine the Low Voltage Directive will apply. In practice this might be difficult to apply because of the judgmental process involved in deciding which is the dominant risk. E.g. is the safety aspects of a hand-held electrical operated tool to be covered by the machinery directive or/and the low voltage directive? The lists of standards harmonized under respective directive can then be used to indicate which directive to apply. EN Machinery safety standards Harmonized with the MD and LVD: Safety of machinery; Electrical equipment of machines Part 1: General requirements Harmonized with the MD and LVD: EN Harmonized with the MD only: EN Harmonized with LVD only: EN EN Safety of household & similar el. appliances; Part 1: General requirements Particular requirements for pedestrian controlled mains-operated lawn movers Particular requirements for washing machines Particular requirements for sewing machines Machinery safety standards LVD product family std Harmonized with MD: EN EN N Example: EN Safety of hand-held motor operated electrical tools Product specific requirements Particular requirements for drills/impact drills Harmonized with the MD and EMCD: EN Particular safety and EMC requirements for sewing machines, units & systems Some product family standards covering Electrical Safety EN IT equipment (incl. business eq.) EN Audio, video etc. ( brown goods ) EN Household apparatus ( white goods ) EN Uninterruptible power systems (UPS)

16 EMC product family std A product with a Bluetooth transmitter has to comply with the R&TTE Directive Some product family EMC standards covering Emission / Immunity EN / 024 EN / 020 IT equipment Broadcast equipment (radio & TV) EN / 2 Professional audio & video equipment EN / 2 Household apparatus EN Uninterruptible power systems (UPS) R&TTED refers to LVD and EMCD why standards harmonized under LVD and EMCD might be referred to if no suitable standard covering EMC and El. Safety is harmonized under RTTED Harmonised Standards - HS European harmonised standards (published in the Official Journal as harmonised with a Directive) e) play a key role, not just because they simplify the conformity assessment procedure if used in full, but also because they provide a harmonised technical solution for analysis of Safety, EMC, Radio & Telecom parameters Harmonized EN standard lists are available at: newapproach/standardization/harmstds/reflist.html Essential Requirement - ER Each NA Directive prescribes Essential Requirements - ERs ERs are defined as rather general safety and/or protection requirements for all products under the scope of the Directive

17 Presumption principle HS vis-à-vis ER Products must comply with the essential.requirements of relevant NA directives Compliance with relevant harmonized..standard(s) gives presumption for..compliance with the essential requirements Note that the presumption principle is not reversible! Compliance with Essential Requirements (ER) does not necessary imply compliance with Harmonized Standards (HR) CE marking All CE marking requirements must be fulfilled when CE marking placing a product on the market the first making available against payment or free of charge, on the internal market, for the purpose of distribution and/or use within EU putting a product into service the A sign first of use compliance on the EU with territory essential product by the safety final and user protection of the product requirements! CE marking applies to products which are to be placed or put into service on the internal market for the first time. Consequently the directives apply to new products manufactured in the Member States, and to new, as well as used and second-hand products imported from a third country.

18 CE marking Safeguard Clause CE marking is information to the authorities within EU/EEA, indicating that a product fulfils the requirements of applicable New Approach Directives Unless there is evidence to the contrary, therefore, authorities will assume that a product with the CE marking correctly applied is in conformity with the New Approach legislation New Approach Directives include a Safeguard Clause providing means for authorities to act if a CE marked product, when used as intended, is found noncompliant with the protection requirements Any Member State finding such a product must take all necessary steps to prohibit its free movement within the Common Market The various measures taken must also be notified to the Commission Essential safety and protection requirements a comparison electric/electronic equipment radio & telecom equipment measuring instruments toys

19 ASEAN-EU Programme for Regional Integration Support (APRIS) Phase II CE Design: Dag Björklöf EUROPEAID/123203/C/SER/MULTI Technical Assistance for the ASEAN Programme for Regional Integrated Support (AQPRIS Phase 2) Common conformity assessment procedures and their application on EEE Electrical / Electronic Equipment Project funded by the European Union Implemented by IBF in consortium with CEN, Crown Agents and ACE Dr. Prof. Dag Björklöf, Sweden ltu.se Product concerns Product concerns As products are produced and used they may give rise to many different concerns, which can involve safety, compatibility, durability, suitability for intended purposes or for stated conditions, health & environmental impacts, and similar considerations. A very frequent concern is simply whether a product is what it is expected to be. Such concerns can be addressed through product certification, with a dual purpose: Users and consumers are able to make better decisions about products in the marketplace By demonstrating conformity, suppliers may more effectively achieve market acceptance. Ref.: ISO/IEC Guide 67 Ref.: ISO/IEC Guide 67

20 Product certification Product certification should address concerns of all interested parties (distributors, consumers, users ) to give them confidence that the product fulfils expected requirements. It may be used by suppliers to show third party involvement. It should not require excessive resources that result in product costs beyond what the society is willing to bear. Product conformity assessment Product conformity assessment concerns assurance that a product is in conformity with specified normative documents (specifications, standards, regulations etc). It can be carried out in different ways and by different parties (first party, second party or third party). Product certification* is a means by which a third party provides written assurance that a product conforms to specified requirements. The type of activity undertaken to demonstrate conformity of a product is often determined by the consequences of nonconformity. When consequences are insignificant or not severe, society may expect little or no demonstration of conformity of the product. However, where the consequences of nonconformity are significant, society may demand completion of activities that demonstrate conformity to requirements prior to allowing the product to be placed on the market. Ref.: ISO/IEC Ensuring compliance with Essential Requirements (ESR) Compliance with the ESR as defined in the European New Approach Directive LVD and EMCD may be fulfilled by the manufacturer without involvement of a 3rd party, but the manufacturer may use a Notified Body to confirm compliance with ESR or part of the ESR. Reference to harmonized standards Harmonised standards reflect the generally acknowledged state of the art as regards to technical requirements (e.g. electrical safety and EMC respectively). Once the reference to such a standard has been published in the Official Journal of the European Union, compliance with it should raise a presumption of conformity with the relevant essential requirements, although other means of demonstrating such conformity should be permitted. Compliance with a harmonised standard means conformity with its provisions and demonstration thereof by the methods the harmonised standard describes or refers to.

21 Conformity Assessment Body CAB Certification Body Designated body Notified / Competent Body Definitions according to the Asian Agreement on EEE (Article 3/Annex A) Conformity Assessment Body (CAB) means a body whose activities and expertise include performance of all or any stage of the conformity assessment process except for accreditation, designation and registration. Designating Body means body appointed by a Member Country, with the responsibility to identify, designate and monitor Conformity Assessment Bodies as specified under this Agreement. Notified Body Type approved / certified by a Notified Body: About 25 % of all products placed on EU:s internal market requires CE marking! NB Notified Body ID Number Lists of EC Notified Bodies can be found at the Nando Info System: % of all CE marked products placed on the internal market requires third party involvement of a Notified Body!

22 Priori vis-à-vis posteriori surveillance Notified bodies and market surveillance authorities European Member States have turned from surveillance regimes based on controlling products according to national regulations before they were to be placed on the market (mandatory certification) to a common system based on harmonised regulations and market surveillance of products placed on the internal market. Market surveillance authorities: State appointed public authorities Provide a check that manufacturers.are fulfilling their responsibilities Independent of commercial interest Notified bodies: Designated to assess conformity of products with essential requirements Only needed in certain circumstances Work on behalf of the manufacturer Private companies Profit-making CAB definitions according to SPRING CAB requirements according to SPRING CAB (Local) means CAB that is located in Singapore and is designated by SPRING Singapore, the Designating Authority to issue COC for products or controlled goods supplied in Singapore specified in the First Schedule to the Consumer Protection (Safety Requirements) Regulations CAB (Local-MRA) means CAB that is located in Singapore and is designated by SPRING Singapore, the Designating Authority to perform testing and/or certification of any regulated products supplied to the requirements of MRA partner s requirements. CAB (Foreign-MRA) means CAB that is located in the MRA partner country and is designated by the Designating Authority of the MRA partner to issue COC (Certificate of Conformity). Criteria for Accreditation for CAB (17.2) To qualify as CAB (Local) or CAB (Local-MRA), the CAB must first be accredited by SAC in accordance with the following ISO/IEC standards: (a) For Product Certification Bodies ISO/IEC Guide 65: General Requirements for Bodies Operating Product Certification Systems. (b) For Testing Laboratories ISO/IEC 17025: 2005 General Requirements for the Competence of Testing and Calibration Laboratories.

23 Terms & conditions of Designating CAB according to SPRING Singapore Obligations of the CAB (Local) / CAB (Local-MRA) 1. CAB (Local) / CAB (Local-MRA) shall ensure that it maintains its accreditation status with SAC. It shall also ensure that it maintains its memberships with IECEE CB Scheme and IECEE CB-FCS if its designation was granted, partly on the basis of these memberships. 2. CAB (Local) / CAB (Local-MRA) shall ensure that its testing or certification of equipment is in accordance with the procedures, rules and policies of SPRING. The duties of CAB (Local) shall include publishing, maintaining, and making available to SPRING on request: (a) A list of product certifications, submission of testing/evaluation/certification reports and other information (such as circuit diagram, photographs in technical file); (b) Evidence of participation in appropriate proficiency testing programs; and (c) Evidence that it carries out all other tasks stipulated in the Terms and Conditions of Designation. Terms & conditions of Designating CAB according to SPRING Singapore Obligations of the CAB (Local) / CAB (Local-MRA) 4. CAB (Local) must keep technical files on each and every Conformity Assessment Certification done by it and make such information available on request by SPRING Singapore. The files shall be kept for a further period of 10 years after the expiry of the Certificate of Conformity. CAB (Local-MRA) may be required to keep and maintain a technical file on each and every product certified by them. The Technical File shall include such documents and information, and shall be kept for such period of time, as may be required for the purposes of the relevant MRA. 5. In the event CAB (Local) having certified a controlled good, subsequently realises that the product fails to comply with the applicable technical regulations, the CAB (Local) shall immediately notify the Registered Supplier, and SPRING Singapore in writing. Terms & conditions of Designating CAB according to SPRING Singapore Controlled goods Obligations of the CAB (Local) / CAB (Local-MRA) 6. CAB (Local) shall notify SPRING Singapore of any of the following no later than 2 weeks prior to the date on which it intends to effect such change: (a) Changes in its legal, commercial, organisation or accreditation status; (b) Changes in key personnel; (c) Changes to its business address; (d) Changes, which may affect continuing compliance with any of the criteria or requirements, specified by SPRING Singapore or the relevant MRA partner 7. The designation of CAB (Local) / CAB (Local-MRA) is valid for a period of 3 years. CAB (Local) / CAB (Local-MRA) shall apply for renewal of designation to SPRING Singapore 6 months before the expiry date. SPRING Singapore is appointed by the Ministry of Trade and Industry as the Safety Authority to administer the Consumer Protection (Safety Requirements) Registration Scheme (CPS Scheme). Its objective is to ensure that consumer products denominated as controlled goods meet the specified safety standards and are safe for normal use.[1] Currently, there are 45 categories of electrical, electronics and gas home appliances and accessories listed as controlled goods, e.g. cooking ranges, electric irons, hair dryers, microwave ovens, televisions, video display units, video cassette recorders, table fans, kettles, refrigerators, rice cookers, room air-conditioners, vacuum cleaners and washing machines.[2] [1]: [2]: 41ba-82cc-4b84b85c2bcd.

24 Product Certification Systems according to ISO Guide 67 1a) 1b) Samples requested by Certification Body Determination of characteristics by testing or assessment Evaluation of testing or assessment report Decision Samples requested by Certification Body Determination of characteristics by testing or assessment Evaluation of testing or assessment report Decision License 2) 3) 4) Product Certification Systems according to ISO Guide 67 Samples requested by Certification Body Determination of characteristics by testing or assessment Initial assessment of the production process or the quality system Evaluation of testing or assessment report Decision License Surveillance by testing or inspection of samples from the market Surveillance by testing or inspection of samples from the factory and assessment of the production process Surveillance by testing or inspection of samples from the factory and assessment of the production process Surveillance by testing or inspection of samples from the market Product Certification Systems according to ISO Guide 67 Conformity Assessment procedures in the EU 5) 6) Samples requested by Certification Body Determination of characteristics by testing or assessment Initial assessment of the production process or the quality system Evaluation of testing or assessment report Decision License Surveillance of the production process or quality system or both Surveillance by testing or inspection of samples from the factory or the open market or both Surveillance by audits of the quality system Surveillance by assessment of processes or services 1989 Global Approach to testing & certification Compliance procedures (8 modules) for showing compliance in line with New Approach Directives Principal guidelines for affixing and use of CE marking

25 Modules A - H Ref.: 93/465/EEC Modules for conformity assessment Combination procedures and Assessment rules for Modules CE conformity marking A: Stand-Alone B: Third Internal party Assessment control type or of Modules design examination and production B&C: A: plus one Manufacturer s Type of the examination following: internal & monitoring control conformity to type B&D: C: of Manufacturer s Type design examination and production internal & production production control QA control * B&E: G: D: Third Type Third party examination party unit approval verification & production QA * B&F: of of Type design production examination and production QA assurance & product systems examination G: H: E: Third Individual Third party party approval product examination approval H: of of Full full QA quality systems assurance, for final inspection systems QA * and testing * ISO 9000 EC Type Examination (Module B) A Notified Body is responsible for assessing whether the product according to the manufacturer s specification meets the applicable requirements In the absence of test methods provided by harmonized standards the Notified Body has to decide what will be the basis for testing against essential requirements of a Directive Conformity Assessment Procedures DESIGN PHASE Low risk products High risk products Module B PRODUCTION PHASE Module A & Module G Module H Module C Module D Module E Module F Low risk products High risk products Module A Manufacturer s obiligations establishes a technical file (documentation as regards design, manufacture and safe operation) operates a quality system (ensures that the manufacturing process assures compliance with documentation) Manufacturer s or Auth. Repr. s obligations ensures that products concerned satisfy relevant requirements draws up and signs a Declaration of Conformity (DoC) affixes the CE marking keeps a copy of DoC and technical file Notified Body s obligations

26 Manufacturer s Module Manufacturer s Notified Body s or Auth. Repr. s obiligations obligations obligations applies ascertains by for EC typeexamination and tests that examinations establishes a technical file places the specimen(s) (documentation at the disposal to meet the the Notified Body provisions B as regards design, specimen(s) issues manufacture representative of an EC-type and operation the production examination of the product) envisaged certificate keeps all keeps a copy documentation of the certificate informs the NB and relevant of modifications technical info Module C Cbis Manufacturer s obiligations takes measures necessary to ensure that the manufacturing process assures compliance of the products according to the EC typeexamination certificate = C and Aa1/2 Manufacturer s or Auth. Repr. s obligations ensures that products concerned satisfy relevant requirements draws up and signs a DoC affixes the CE marking keeps a copy of DoC and relevant info = C and Aa1/2 Notified Body s obligations = Aa1/Aa2 Module D Manufacturer s obiligations operates an approved quality system for production, final product inspection & testing keeps quality system documentation ensures that products are in line with the EC type-examination Manufacturer s or Auth. Repr. s obligations draws up and signs a Declaration of Conformity (DoC) affixes the CE marking followed by the NB Nº N keeps a copy of DoC and relevant info Notified Body s obligations assesses the quality system controls the manufacturer by means of periodic and unexpected inspections keeps a record of relevant technical info Module E Manufacturer s obiligations As in Mod. D except for operating an approved quality system for just final product inspection & testing* * the quality system does not cover production Manufacturer s or Auth. Repr. s obligations as in Mod. D Notified Body s obligations as in Mod. D

27 Module Manufacturer s Manufacturer s Notified Body s or Auth. Repr. s obiligations obligations obligations operates applies for draws up a quality system to ensure that a Certification of Conformity a Certificate of Conformity products are in checks that carries out line with the EC products are examinations type-examination conform and tests on F ensures the draws up every product homogeneity of and signs a DoC or produced lots affixes the CE on every lot on - in case the marking followed statistical bases Notified Body by the NB Nº N keeps is to perform keeps a record of statistical a copy of DoC relevant verification and relevant info technical info Module Manufacturer s Manufacturer s Notified Body s or Auth. Repr. s obiligations obligations obligations establishes applies for examines a technical documentation a Certification of Conformity and tests the individual as regards the draws up product design, and signs a DoC draws up manufacture and affixes the CE a Certificate of G operation of the marking followed Conformity product by the NB Nº N concerning the ensures keeps tests and that the product a copy of DoC examinations concerned and relevant info keeps conforms to the a record of applicable relevant requirements technical info Manufacturer s Module Manufacturer s Notified Body s or Auth. Repr. s obiligations obligations obligations operates draws up assesses an approved and signs the quality quality system a Declaration of system for design, Conformity (DoC) controls manufacture, affixes the CE manufacturer final product marking followed by means of H inspection by the NB Nº N periodic and & testing keeps unexpected ensures that a copy of DoC inspections products conform and relevant info keeps with applicable a record of requirements relevant keeps QS technical info documentation Conformity Assessment Standards EN EN ISO/IEC 17011:2004 EN EN ISO/IEC 17020:2004 EN EN ISO/IEC 17021:2006 EN ISO/IEC 17024:2003 EN EN ISO/IEC 17025:2000/05 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies (formerly ISO/IEC Guide 58 or EN 45003) General criteria for the operation of various types of bodies performing inspection (formerly EN 45004) Conformity assessment Requirements for bodies providing audit and certification of management systems (formerly ISO Guide 62 and 66) General requirements for bodies operating certification of persons (formerly EN 45013) General requirements for the competence of testing and calibration laboratories (formerly EN & ISO Guide 25)

28 Conformity Assessment Standards EN ISO Guide 61 EN EN 45011:98 ISO Guide 65:96 EN EN 45012:98 ISO Guide 62:96 General requirements for assessment & accreditation of certificationbodies (withdrawn std / guide EN 17011) General requirements for bodies operating product certification system (to be revised as EN ISO/IEC 17065) General requirements for bodies operating assessment and certification/registration of quality systems EN ISO/IEC General requirements for peer assessment 17040: 2005 of conformity assessment bodies & accreditation bodies EN ISO/IEC Conformity assessment; : 2004 Vocabulary and general principles (replaces EN 45020) Conformity Assessment Body requirements related to modules Module Applicable EN standards A EN 17025, EN or EN B EN or EN C EN 17025, EN or EN D & E EN plus product related knowledge F EN 17025, EN or EN G EN or EN H EN plus product related knowledge (eventually also EN or EN 45011) Accreditation of testing & calibration laboratories EN/ISO/IEC Management requirements EN/ ISO/ IEC 17025: 1999/2005 (supersedes EN 45001: 1989) General requirements for the competence of testing and calibration laboratories EN does not change technical accreditation requirements as compared to EN 45001, but implies new & enhanced requirements (in line with ISO 9001) concerning: 4 Management requirements 5 Technical requirements 4 This paragraph concerns: Review of requests, tenders and contracts Subcontracting of testing and calibration Corrective and preventive actions Control of records Clarifications: Impartiality, independence and integrity Control of non-conforming work Internal audits Management reviews

29 EN/ISO/IEC Technical requirements 5 This paragraph concerns: Personnel ( contracted and additional ) Methods validation Classification of methods Standard methods Non-standard methods Laboratory developed methods Comments, opinions and interpretations Clarifications: Estimation of measurement uncertainties Measurement traceability Sampling Control of data Handling of Reference materials Requirements for assessing a Notified Body (NB) Accreditation alone is considered insufficient to assess a NB. Not only the competence & experience in their field of activity, but also the provisions taken to maintain its competence. National authorities usually set-up criteria for NBs like: The NB must have genuine experience of the necessary products, tests and examinations. This can be testified by their volume of activity and experience in product certification. The NB must prove their ability to follow-up standardization covering their field of technical activity and they must participate in European co-ordination groups of NBs. The NB must guarantee separation of activities carried out in relation to their destination from those concerning voluntary testing, certification, auditing and consultancy work General Notified Body requirements NB requirements according to the revised EMC Directive 2004/108/EC Impartial (not involved in design or consulting) Experience in the industry Competence in conformity assessment Independent company Quality system in line with EN/ISO standards Appointed by a Member State Government

30 ASEAN-EU Programme for Regional Integration Support (APRIS) Phase II CE Design: Dag Björklöf Technical File EUROPEAID/123203/C/SER/MULTI Technical Assistance for the ASEAN Programme for Regional Integrated Support (AQPRIS Phase 2) Technical files Dr. Prof. Dag Björklöf, Sweden ltu.se Project funded by the European Union Implemented by IBF in consortium with CEN, Crown Agents and ACE Manufacturer s legal proceedings for marking A signed Declaration of Conformity (DoC) with reference It is recommended to applicable that directives manufacturers (LVD, undertake EMCD ) a A hazard Technical assessment file (technical at the prototype documentation) stage to decide A whether system to there ensure are compliance any aspects with of safety the legislation that are (reasonable outside precautions) the scope of and applicable a method standards to ensure that this system is followed correctly (due diligence) in order to ensure that the products are manufactured in accordance to the technical documentation.(internal production control) easy route EC route Declaration of Conformity (DoC) Identification of the product and the manufacturer Reference to Directive(s) Reference to standard(s) or other reference documents Signature (by manufacturer or an authorized representative) Date Technical File CE Marking

31 Authorized representative EC route An authorized representative is a person expressly appointed by the manufacturer to act on his behalf within the European Community. A manufacturer in a country outside the EEA is not obliged to have an authorized representative in the EEA. However, if the manufacturer appoints an authorized representative to fulfil administrative formalities on his behalf, this person must be resident in the EEA. Note however, that this representative may not modify a product at his own initiative in order to bring it in line with essential requirements of a New Approach Directive. It is important to distinguish the concept of the authorized representative from the person responsible for placing the product on the market (importer, retailer or end-user importing directly), who may have no mandate from the manufacturer. Declaration + Certificate where appropriate; the DoC may include a reference to an EC typeexamination certificate issued by a Notified Body (Name and address of the NB also to be included) Essential content of the EC declaration of conformity Type of equipment: Brand name or trade mark: Type designation: Country of origin: Reference: Manufacturer: EN ISO/IEC 17050: 2004 Manufacturers authorized representative (if relevant): Address: Conformity assessment Essential requirements according to directive(s): Standards applied: Supplier's declaration of conformity Other normative references: Test reports/certificates issued by: Part 1: General requirements As manufacturer/manufacturers authorized representative within EEA, we declare under our sole responsibility that the equipment follows the provisions of the Directive(s) as stated above: Part 2: Supporting documentation Date and Signature:... Clarification of name: Position of signatory: The Declaration of Conformity shall be held at the disposal for Market Surveillance Authorities and has to be shown upon request without delay (usually within a few working days)

32 Who shall keep the DoC? Documentation The EC Declaration of conformity shall be held at the disposal of the competent authority for ten years after the date on which such apparatus was last manufactured. For a manufacturer established outside the Community (EEA), and who has no authorized representative, the above obligation to keep the EC declaration of conformity available, shall be the responsibility of the person who places the apparatus on the Community market. There is no reason why the DoC should be kept secret why it is recommended to include a copy of the DoC in the product documentation! A Technical File (TF) must be available within EU/EEA when the product is released on the common market and retained for ten years after cessation of manufacture of the product A TF is not required when compliance is to be certified through a Quality Assurance System (ISO 9001) Technical file requirements according to SPRING Documentation As a CAB (Local), it is required to keep and maintain a technical file on each and every product certified by them. The Technical file shall be kept for a further period of 10 years after the expiry of the Certificate of Conformity. Appendix H states the list of documents to be kept as technical file. As for CAB (Local-MRA), it may be required to keep and maintain a technical file on each and every product certified by them. The Technical File shall include such documents and information, and shall be kept for such period of time, as may be required for purposes of the relevant MRA. The Technical File shall be made available within 7 days to SPRING Singapore upon request. Ok can be just a few lines for a simple product or a thick documentation for a complex product

33 Documentation The Technical File may be divided into subparts: A summary part with general product info & test results incl. installation and operation instructions A detailed part with complete product information incl. drawings and component lists Technical construction File In the case of apparatus for which the manufacturer has not applied, or has applied only in part, harmonized standards or failing such standards, the manufacturer shall hold at the disposal of the relevant competent authorities, as soon as the apparatus is placed on the market, a Technical Construction File. This file shall describe the apparatus, set out the procedures used to ensure conformity of the apparatus with the essential protection requirements and include a technical report or certificate, one or other obtained from a Competent Body. (Ref: The old EMC Directive 89/336/EEC) Product documentation Intended conditions for use Instructions on installation & cabling adjustment & taking into use operation maintenance Warnings, when necessary Who shall keep the Technical File? The manufacturer or his authorized representative established in EC/EEA must retain/keep the documentation for at least ten years after cessation of manufacture of the product A copy of all product documentation should be included in the Technical File

34 Language The DoC may be written in any official EU language Some Directives*, however, require a DoC to accompany each product. In these cases the DoC must be written in the national language where the product is to be used: * the directives for Machinery, Lifts, Pressure equipment, Gas appliances, Equipment to be used in potentially explosive atmospheres, Recreational crafts and High-speed rail systems. CE marking User and installation manuals as well as eventual warnings shall be written in the official language of the intended country of use The mark shall have a height of at least 5 mm and be clearly visible, easy to read and permanent Product marking Type No Manufacturer Country of origin Ratings (Voltage, Current, Power) Protective earth (when relevant)

35 ASEAN-EU Programme for Regional Integration Support (APRIS) Phase II CE Design: Dag Björklöf EUROPEAID/123203/C/SER/MULTI Technical Assistance for the ASEAN Programme for Regional Integrated Support (AQPRIS Phase 2) Market Surveillance Project funded by the European Union Implemented by IBF in consortium with CEN, Crown Agents and ACE Dr. Prof. Dag Björklöf, Sweden ltu.se Priori vis-à-vis posteriori surveillance European Member States have turned from surveillance regimes based on controlling products according to national regulations before they were to be placed on the market (mandatory certification) to a common system based on harmonised regulations and market surveillance of products placed on the internal market. Market Surveillance Controlling products on the market Member States must take all necessary measures to ensure that products may be placed on the market and put into service only if they do not endanger the safety and health of persons, or other interests covered by the applicable legislation, - when correctly constructed, installed and maintained, and used in accordance with their purpose.

36 EC Guidedance Principles of market surveillance is layed out in the Blue Book, a Guide to the implementation of directives based on New and Global Approach The purpose of market surveillance is to ensure that the provisions Further,, market of applicable surveillance directives is is important are complied with across the Community. for the interest of of economic operators, Citizens are entitled to an equivalent level of protection because throughout it it helps to to the eliminate single unfair market, competition regardless of the origin of the product. Market Surveillance co-operation operation Member States need to ensure effective communication and co-ordination at national level between market surveillance authorities and other authorities in the field of product safety. One essential element of effective enforcement is co-operation between customs officers and market surveillance inspectors. Accident data analysis is to be used to develop a strategic market surveillance programme, and, whenever useful, should be conducted in co-operation with other Member States. CE marking CE marking is information to the authorities within EU/EEA, indicating that a product fulfils the require- ments of applicable New Approach Directives It is the duty of the Member States of EU/EEA to actively monitor that products on the market fulfil the essential protection requirements as specified in relevant Directives, and that prescribed procedures for conformity assessment have been followed The manufacturer is responsible The manufacturer has the responsibility for fulfilling essential safety and protection requirements according to applicable New Approach Directives, whether the product is manufactured in EU, in USA or in China! The manufacturer or his authorized representative has to declare that a product complies with applicable Directive(s) when placing the product on the internal market of the European Community.

37 Responsibilities Responsibilities For products made in the EU and branded by the manufacturer, all responsibilities for the product is on the manufacturer / producer. For products made in the EU and branded by the distributor, the responsibilities of producer should be shared between the manufacturer and the distributor. For products which have been reconditioned, the responsibilities of manufacturer is overtaken by the person who reconditions the product. For products made outside the EU and branded by the manufacturer, the responsibilities of the producer is on the manufacturer s representative within EU. In case no authorized representative is appointed by the manufacturer the responsibilities of producer should be on the company that imports the product into the EU (which may be the manufacturer s agent in EU). In practice the importer will generally need to involve the manufacturer in any corrective action. For products made outside the EU and branded by the EU distributor, the responsibilities of the producer should be on the distributor. Manufacturer s legal proceedings for marking A signed Declaration of Conformity (DoC) with reference to applicable directives (LVD, EMCD ) A technical file (technical documentation) A system to ensure compliance with the legislation (reasonable precautions) and a method to ensure that this system is followed correctly ( due diligence ) Due Diligence Example of factors relevant for a manufacturer to show that due diligence has been exercised Evidence of tests and checks undertaken Evidence that established procedures have been in place and followed Evidence of actions taken concerning eventual faults in the past

38 Approaches to market surveillance Market surveillance Use available information! Information sources of importance for efficient market surveillance planning: Accident details and injury statistics Statistics concerning non-compliant product types Statistics concerning suppliers of non-compliant products RAPEX reports Monitor safety and protection requirements Check products according to their potential risk:... Toys, Electrical household appliances,...handheld tools, Lighting equipment... Check markings Check Declarations Check Certificates Check test results Check manuals Control products Perform screen testing Take samples for testing Perform partial or full testing Check corrective actions Look at statistics: Products, Manufacturers, Dealers... Check markings and declarations Content of the DoC Is there a CE marking affixed on the product? Is the marking correct? Is there information about the manufacturer? Is the DoC available (or a copy thereof in the manuals)? Does the DoC include references to relevant Directives/Laws? Does the DoC include references to relevant standards? Identification of the apparatus Reference to specifications Standards or other reference documents Result of tests / verifications EC type-examination certificate, where appropriate Manuals in the official language of use The last two digits of the year for CE marking Signature with identification of the signatory.empowered.to bind the manufacturer or his.authorised representative

39 Check the Product Corrective actions Sanctions Does the product seem to be well made? Are there protection arrangements to prevent electrocusion? Are there easily detachable protection arrangements? Are there protections against eventual heat hazards? Are there adequate warnings on the product (if relevant)? Does it look robust enough can any part easily be twisted off? In case of an electrical product attractive for children what is the supply voltage? product corrections remarks (requiring corrections) compliance procedure corrections sales or delivery ban document corrections prohibity to use verification references warning to persons that may be at risk installation & user manuals product recall correction of advertisment destruction of dangerous products correction of markings Level of action If the level of risk is judged to be high corrective action is likely to involve products in the hands of consumers and the producer should and take immediate action to: Inform and warn Isolate producer s stocks Ask distributors to isolate affected products Inform suppliers of any affected components Set up a programme to contact consumers. If the level of risk is judged to be moderate and the corrective action only involves products in the distribution chain, it may be enough to withdraw these and give the authorities details of what has been done. Safeguard Clause New Approach Directives include a safeguard clause providing means for authorities to act if a CE marked product, when used as intended, is found noncompliant with essential requirements Any Member State finding such a product must take all necessary steps to restrict or prohibit its free movement within the Common Market The various measures taken must also be notified to the European Commission