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Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (Text with EEA relevance)

EU Directive 2006/42 · Adopted 17 May 2006 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Directive 2006/42/EC of the European Parliament and of the Council

of 17 May 2006

on machinery, and amending Directive 95/16/EC (recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commissionf1,

Having regard to the opinion of the European Economic and Social Committeef2,

Acting in accordance with the procedure laid down in Article 251 of the Treatyf3,

Whereas:

(1)

Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machineryf4 codified Directive 89/392/EECf5. Now that new substantial amendments are being made to Directive 98/37/EC, it is desirable, in order to clarify matters, that that Directive should be recast.

(2)

The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Community economy. The social cost of the large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and by proper installation and maintenance.

(3)

Member States are responsible for ensuring the health and safety on their territory of persons, in particular of workers and consumers and, where appropriate, of domestic animals and goods, notably in relation to the risks arising out of the use of machinery.

(4)

In order to ensure legal certainty for users, the scope of this Directive and the concepts relating to its application should be defined as precisely as possible.

(5)

The Member States' mandatory provisions governing construction site hoists intended for lifting persons or persons and goods, which are often supplemented by de facto compulsory technical specifications and/or by voluntary standards, do not necessarily lead to different levels of health and safety but, because of their disparities, do nevertheless constitute barriers to trade within the Community. Moreover, the national systems for the conformity assessment and certification of these machines diverge considerably. It is therefore desirable not to exclude from the scope of this Directive construction site hoists intended for lifting persons or persons and goods.

(6)

It is appropriate to exclude from the scope of this Directive weapons, including firearms, that are subject to Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weaponsf6; the exclusion of firearms should not apply to portable cartridge-operated fixing and other impact machinery designed for industrial or technical purposes only. It is necessary to provide for transitional arrangements enabling Member States to authorise the placing on the market and putting into service of such machinery manufactured in accordance with national provisions in force upon adoption of this Directive, including those implementing the Convention of 1 July 1969 on the Reciprocal Recognition of Proofmarks on Small Arms. Such transitional arrangements will also enable the European standardisation organisations to draft standards ensuring the safety level based on the state of the art.

(7)

This Directive does not apply to the lifting of persons by means of machines not designed for the lifting of persons. However, this does not affect the right of Member States to take national measures, in accordance with the Treaty, with respect to such machines, with a view to implementing Council Directive 89/655/EEC of 30 November 1989 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)f7.

(8)

In relation to agricultural and forestry tractors, the provisions of this Directive concerning the risks currently not covered by Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical unitsf8 should no longer apply when such risks are covered by Directive 2003/37/EC.

(9)

Market surveillance is an essential instrument inasmuch as it ensures the proper and uniform application of Directives. It is therefore appropriate to put in place the legal framework within which market surveillance can proceed harmoniously.

(10)

Member States are responsible for ensuring that this Directive is effectively enforced on their territory and that the safety of the machinery concerned is, as far as possible, improved in accordance with its provisions. Member States should ensure their capacity to carry out effective market surveillance, taking account of guidelines developed by the Commission, in order to achieve the proper and uniform application of this Directive.

(11)

In the context of market surveillance, a clear distinction should be established between the disputing of a harmonised standard conferring a presumption of conformity on machinery and the safeguard clause relating to machinery.

(12)

The putting into service of machinery within the meaning of this Directive can relate only to the use of the machinery itself for its intended purpose or for a purpose which can reasonably be foreseen. This does not preclude the laying down of conditions of use external to the machinery, provided that it is not thereby modified in a way not specified in this Directive.

(13)

It is also necessary to provide for an adequate mechanism allowing for the adoption of specific measures at Community level requiring Member States to prohibit or restrict the placing on the market of certain types of machinery presenting the same risks to the health and safety of persons either due to shortcomings in the relevant harmonised standard(s) or by virtue of their technical characteristics, or to make such machinery subject to special conditions. In order to ensure the appropriate assessment of the need for such measures, they should be taken by the Commission, assisted by a committee, in the light of consultations with the Member States and other interested parties. Since such measures are not directly applicable to economic operators, Member States should take all necessary measures for their implementation.

(14)

The essential health and safety requirements should be satisfied in order to ensure that machinery is safe; these requirements should be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements.

(15)

Where the machinery may be used by a consumer, that is to say, a non-professional operator, the manufacturer should take account of this in the design and construction. The same applies where a machine is normally used to provide a service to a consumer.

(16)

Although the requirements of this Directive do not apply to partly completed machinery in their entirety, it is nevertheless important that the free movement of such machinery be guaranteed by means of a specific procedure.

(17)

For trade fairs, exhibitions and such like, it should be possible to exhibit machinery which does not satisfy the requirements of this Directive. However, interested parties should be properly informed that the machinery does not conform and cannot be purchased in that condition.

(18)

This Directive defines only the essential health and safety requirements of general application, supplemented by a number of more specific requirements for certain categories of machinery. In order to help manufacturers to prove conformity to these essential requirements, and to allow inspection of conformity to the essential requirements, it is desirable to have standards that are harmonised at Community level for the prevention of risks arising out of the design and construction of machinery. These standards are drawn up by private-law bodies and should retain their non-binding status.

(19)

In view of the nature of the risks involved in the use of machinery covered by this Directive, procedures for assessing conformity to the essential health and safety requirements should be established. These procedures should be devised in the light of the extent of the danger inherent in such machinery. Consequently, each category of machinery should have its appropriate procedure in conformity with Council Decision 93/465/EEC of 22 July 1993 concerning 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 the technical harmonisation directivesf9, taking account of the nature of the verification required for such machinery.

(20)

Manufacturers should retain full responsibility for certifying the conformity of their machinery to the provisions of this Directive. Nevertheless, for certain types of machinery having a higher risk factor, a stricter certification procedure is desirable.

(21)

The CE marking should be fully recognised as being the only marking which guarantees that machinery conforms to the requirements of this Directive. All other markings which are likely to mislead third parties as to the meaning or the form of the CE marking, or both, should be prohibited.

(22)

In order to ensure the same quality for the CE marking and the manufacturer's mark, it is important that they be affixed according to the same techniques. In order to avoid confusion between any CE markings which might appear on certain components and the CE marking corresponding to the machinery, it is important that the latter marking be affixed alongside the name of the person who has taken responsibility for it, namely the manufacturer or his authorised representative.

(23)

The manufacturer or his authorised representative should also ensure that a risk assessment is carried out for the machinery which he wishes to place on the market. For this purpose, he should determine which are the essential health and safety requirements applicable to his machinery and in respect of which he must take measures.

(24)

It is essential that, before drawing up the EC declaration of conformity, the manufacturer or his authorised representative established in the Community should prepare a technical construction file. However, it is not essential that all documentation should be permanently available in material form, but it must be possible to make it available on request. It need not include detailed plans of subassemblies used for the manufacture of machinery, unless knowledge of such plans is essential in order to ascertain conformity with the essential health and safety requirements.

(25)

The addressees of any decision taken under this Directive should be informed of the reasons for such a decision and of the legal remedies open to them.

(26)

Member States should provide for penalties applicable to infringements of the provisions of this Directive. Those penalties should be effective, proportionate and dissuasive.

(27)

The application of this Directive to a number of machines intended for lifting persons requires a better delimitation of the products covered by this Directive with respect to those covered by Directive 95/16/EC of the European Parliament and of the Council of 29 June 1995 on the approximation of the laws of the Member States relating to liftsf10. A redefinition of the scope of the latter Directive is thus deemed necessary. Directive 95/16/EC should therefore be amended accordingly.

(28)

Since the objective of this Directive, namely, to lay down the essential health and safety requirements in relation to design and manufacture in order to improve the safety of machinery placed on the market, cannot be sufficiently achieved by the Member States and can be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(29)

In accordance with point 34 of the Interinstitutional Agreement on better law-makingf11, Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(30)

The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commissionf12,

HAS ADOPTED THIS DIRECTIVE:

Annotations to the whole text

Footnotes

f1

OJ C 154 E, 29.5.2001, p. 164.

f2

OJ C 311, 7.11.2001, p. 1.

f3

Opinion of the European Parliament of 4 July 2002 (OJ C 271 E, 12.11.2003, p. 491), Council Common Position of 18 July 2005 (OJ C 251 E, 11.10.2005, p. 1) and Position of the European Parliament of 15 December 2005 (not yet published in the Official Journal). Council Decision of 25 April 2006.

f4

OJ L 207, 23.7.1998, p. 1. Directive as amended by Directive 98/79/EC (OJ L 331, 7.12.1998, p. 1).

f5

Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery (OJ L 183, 29.6.1989, p. 9).

f6

OJ L 256, 13.9.1991, p. 51.

f7

OJ L 393, 30.12.1989, p. 13. Directive as last amended by Directive 2001/45/EC of the European Parliament and of the Council (OJ L 195, 19.7.2001, p. 46).

f8

OJ L 171, 9.7.2003, p. 1. Directive as last amended by Commission Directive 2005/67/EC (OJ L 273, 19.10.2005, p. 17).

f9

OJ L 220, 30.8.1993, p. 23.

f10

OJ L 213, 7.9.1995, p. 1. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

f11

OJ C 321, 31.12.2003, p. 1.

f12

OJ L 184, 17.7.1999, p. 23.

Contents

  1. 1Scope
  2. 2Definitions
  3. 3Specific Directives
  4. 4Market surveillance
  5. 5Placing on the market and putting into service
  6. 6Freedom of movement
  7. 7Presumption of conformity and harmonised standards
  8. 8Specific measures
  9. 9Specific measures to deal with potentially hazardous machinery
  10. 10Procedure for disputing a harmonised standard
  11. 11Safeguard clause
  12. 12Procedures for assessing the conformity of machinery
  13. 13Procedure for partly completed machinery
  14. 14Notified bodies
  15. 15Installation and use of machinery
  16. 16CE marking
  17. 17Non-conformity of marking
  18. 18Confidentiality
  19. 19Cooperation between Member States
  20. 20Legal remedies
  21. 21Dissemination of information
  22. 21aExercise of the delegation
  23. 22Committee
  24. 23Penalties
  25. 24Amendment of Directive 95/16/EC Repealed
  26. 25Repeal
  27. 26Transposition
  28. 27Derogation
  29. 28Entry into force
  30. 29Addressees
  31. Annex I: Essential health and safety requirements relating to the the design and construction of machinery
  32. GENERAL PRINCIPLES
  33. 1The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.
  34. 2Division 2
  35. 3Division 3
  36. 4Division 4
  37. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
  38. GENERAL REMARKS
  39. 1.1.1Definitions
  40. 1.1.2Principles of safety integration
  41. 1.1.3Materials and products
  42. 1.1.4Lighting
  43. 1.1.5Design of machinery to facilitate its handling
  44. 1.1.6Ergonomics
  45. 1.1.7Operating positions
  46. 1.1.8Seating
  47. CONTROL SYSTEMS
  48. 1.2.1Safety and reliability of control systems
  49. 1.2.2Control devices
  50. 1.2.3Starting
  51. Stopping
  52. 1.2.4.1Normal stop
  53. 1.2.4.2Operational stop
  54. 1.2.4.3Emergency stop
  55. 1.2.4.4Assembly of machinery
  56. 1.2.5Selection of control or operating modes
  57. 1.2.6Failure of the power supply
  58. PROTECTION AGAINST MECHANICAL HAZARDS
  59. 1.3.1Risk of loss of stability
  60. 1.3.2Risk of break-up during operation
  61. 1.3.3Risks due to falling or ejected objects
  62. 1.3.4Risks due to surfaces, edges or angles
  63. 1.3.5Risks related to combined machinery
  64. 1.3.6Risks related to variations in operating conditions
  65. 1.3.7Risks related to moving parts
  66. 1.3.8Choice of protection against risks arising from moving parts
  67. 1.3.8.1Moving transmission parts
  68. 1.3.8.2Moving parts involved in the process
  69. 1.3.9Risks of uncontrolled movements
  70. REQUIRED CHARACTERISTICS OF GUARDS AND PROTECTIVE DEVICES
  71. 1.4.1General requirements
  72. Special requirements for guards
  73. 1.4.2.1Fixed guards
  74. 1.4.2.2Interlocking movable guards
  75. 1.4.2.3Adjustable guards restricting access
  76. 1.4.3Special requirements for protective devices
  77. RISKS DUE TO OTHER HAZARDS
  78. 1.5.1Electricity supply
  79. 1.5.2Static electricity
  80. 1.5.3Energy supply other than electricity
  81. 1.5.4Errors of fitting
  82. 1.5.5Extreme temperatures
  83. 1.5.6Fire
  84. 1.5.7Explosion
  85. 1.5.8Noise
  86. 1.5.9Vibrations
  87. 1.5.10Radiation
  88. 1.5.11External radiation
  89. 1.5.12Laser radiation
  90. 1.5.13Emissions of hazardous materials and substances
  91. 1.5.14Risk of being trapped in a machine
  92. 1.5.15Risk of slipping, tripping or falling
  93. 1.5.16Lightning
  94. MAINTENANCE
  95. 1.6.1Machinery maintenance
  96. 1.6.2Access to operating positions and servicing points
  97. 1.6.3Isolation of energy sources
  98. 1.6.4Operator intervention
  99. 1.6.5Cleaning of internal parts
  100. INFORMATION
  101. 1.7.1Information and warnings on the machinery
  102. 1.7.1.1Information and information devices
  103. 1.7.1.2Warning devices
  104. 1.7.2Warning of residual risks
  105. 1.7.3Marking of machinery
  106. 1.7.4Instructions
  107. 1.7.4.1General principles for the drafting of instructions
  108. 1.7.4.2Contents of the instructions
  109. 1.7.4.3Sales literature
  110. 2SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY
  111. FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS OR PHARMACEUTICAL PRODUCTS
  112. 2.1.1General
  113. 2.1.2Instructions
  114. PORTABLE HAND-HELD AND/OR HAND-GUIDED MACHINERY
  115. 2.2.1General
  116. 2.2.1.1Instructions
  117. Portable fixing and other impact machinery
  118. 2.2.2.1General
  119. 2.2.2.2Instructions
  120. 2.3MACHINERY FOR WORKING WOOD AND MATERIAL WITH SIMILAR PHYSICAL CHARACTERISTICS
  121. MACHINERY FOR PESTICIDE APPLICATION
  122. 2.4.1Definition
  123. 2.4.2General
  124. 2.4.3Controls and monitoring
  125. 2.4.4Filling and emptying
  126. Application of pesticides
  127. 2.4.5.1Application rate
  128. 2.4.5.2Distribution, deposition and drift of pesticide
  129. 2.4.5.3Tests
  130. 2.4.5.4Losses during stoppage
  131. Maintenance
  132. 2.4.6.1Cleaning
  133. 2.4.6.2Servicing
  134. 2.4.7Inspections
  135. 2.4.8Marking of nozzles, strainers and filters
  136. 2.4.9Indication of pesticide in use
  137. 2.4.10Instructions
  138. 3SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET HAZARDS DUE TO THE MOBILITY OF MACHINERY
  139. GENERAL
  140. 3.1.1Definitions
  141. WORK POSITIONS
  142. 3.2.1Driving position
  143. 3.2.2Seating
  144. 3.2.3Positions for other persons
  145. 3.3CONTROL SYSTEMS
  146. 3.3.1Control devices
  147. 3.3.2Starting/moving
  148. 3.3.3Travelling function
  149. 3.3.4Movement of pedestrian-controlled machinery
  150. 3.3.5Control circuit failure
  151. PROTECTION AGAINST MECHANICAL HAZARDS
  152. 3.4.1Uncontrolled movements
  153. 3.4.2Moving transmission parts
  154. 3.4.3Roll-over and tip-over
  155. 3.4.4Falling objects
  156. 3.4.5Means of access
  157. 3.4.6Towing devices
  158. 3.4.7Transmission of power between self-propelled machinery (or tractor) and recipient machinery
  159. PROTECTION AGAINST OTHER HAZARDS
  160. 3.5.1Batteries
  161. 3.5.2Fire
  162. 3.5.3Emissions of hazardous substances
  163. INFORMATION AND INDICATIONS
  164. 3.6.1Signs, signals and warnings
  165. 3.6.2Marking
  166. Instructions
  167. 3.6.3.1Vibrations
  168. 3.6.3.2Multiple uses
  169. 4SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET HAZARDS DUE TO LIFTING OPERATIONS
  170. GENERAL
  171. 4.1.1Definitions
  172. Protection against mechanical hazards
  173. 4.1.2.1Risks due to lack of stability
  174. 4.1.2.2Machinery running on guide rails and rail tracks
  175. 4.1.2.3Mechanical strength
  176. 4.1.2.4Pulleys, drums, wheels, ropes and chains
  177. 4.1.2.5Lifting accessories and their components
  178. 4.1.2.6Control of movements
  179. 4.1.2.7Movements of loads during handling
  180. Machinery serving fixed landings
  181. 4.1.2.8.1Movements of the carrier
  182. 4.1.2.8.2Access to the carrier
  183. 4.1.2.8.3Risks due to contact with the moving carrier
  184. 4.1.2.8.4Risk due to the load falling off the carrier
  185. 4.1.2.8.5Landings
  186. 4.1.3Fitness for purpose
  187. REQUIREMENTS FOR MACHINERY WHOSE POWER SOURCE IS OTHER THAN MANUAL EFFORT
  188. 4.2.1Control of movements
  189. 4.2.2Loading control
  190. 4.2.3Installations guided by ropes
  191. INFORMATION AND MARKINGS
  192. 4.3.1Chains, ropes and webbing
  193. 4.3.2Lifting accessories
  194. 4.3.3Lifting machinery
  195. INSTRUCTIONS
  196. 4.4.1Lifting accessories
  197. 4.4.2Lifting machinery
  198. 5SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY INTENDED FOR UNDERGROUND WORK
  199. 5.1RISKS DUE TO LACK OF STABILITY
  200. 5.2MOVEMENT
  201. 5.3CONTROL DEVICES
  202. 5.4STOPPING
  203. 5.5FIRE
  204. 5.6EXHAUST EMISSIONS
  205. 6SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY PRESENTING PARTICULAR HAZARDS DUE TO THE LIFTING OF PERSONS
  206. GENERAL
  207. 6.1.1Mechanical strength
  208. 6.1.2Loading control for machinery moved by power other than human strength
  209. 6.2CONTROL DEVICES
  210. RISKS TO PERSONS IN OR ON THE CARRIER
  211. 6.3.1Risks due to movements of the carrier
  212. 6.3.2Risk of persons falling from the carrier
  213. 6.3.3Risk due to objects falling on the carrier
  214. MACHINERY SERVING FIXED LANDINGS
  215. 6.4.1Risks to persons in or on the carrier
  216. 6.4.2Controls at landings
  217. 6.4.3Access to the carrier
  218. 6.5MARKINGS
  219. Annex II: Declarations
  220. CONTENT
  221. AEC DECLARATION OF CONFORMITY OF THE MACHINERY
  222. BDECLARATION OF INCORPORATION OF PARTLY COMPLETED MACHINERY
  223. 2CUSTODY
  224. Annex IIICE marking
  225. Annex IV: Categories of machinery to which one of the procedures referred to in Article 12(3) and (4) must be applied
  226. 1Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
  227. 2Division 2
  228. 3Division 3
  229. 4Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
  230. 5Division 5
  231. 6Division 6
  232. 7Division 7
  233. 8Division 8
  234. 9Division 9
  235. 10Division 10
  236. 11Division 11
  237. 12Machinery for underground working of the following types:
  238. 13Division 13
  239. 14Division 14
  240. 15Division 15
  241. 16Division 16
  242. 17Division 17
  243. 18Division 18
  244. 19Division 19
  245. 20Division 20
  246. 21Division 21
  247. 22Division 22
  248. 23Division 23
  249. Annex V: Indicative list of the safety components referred to in Article 2(c)
  250. 1Division 1
  251. 2Division 2
  252. 3Division 3
  253. 4Division 4
  254. 5Division 5
  255. 6Division 6
  256. 7Division 7
  257. 8Division 8
  258. 9Division 9
  259. 10Division 10
  260. 11Division 11
  261. 12Division 12
  262. 13Division 13
  263. 14Division 14
  264. 15Division 15
  265. 16Division 16
  266. 17Components for machinery designed for lifting and/or lowering persons between different landings and included in the following list:
  267. Annex VIAssembly instructions for partly completed machinery
  268. Annex VII
  269. ATechnical file for machinery
  270. 1The technical file shall comprise the following:
  271. 2The technical file referred to in point 1 must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.
  272. 3Division 3
  273. BRelevant technical documentation for partly completed machinery
  274. Annex VIII: Assessment of conformity with internal checks on the manufacture of machinery
  275. 1Division 1
  276. 2Division 2
  277. 3Division 3
  278. Annex IXEC type-examination
  279. 1Division 1
  280. 2For each type, the application for an EC type-examination shall be submitted by the manufacturer or his authorised representative to a notified body of his choice.
  281. 3The notified body shall:
  282. 4If the type satisfies the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer and his authorised representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject.
  283. 5Division 5
  284. 6Division 6
  285. 7Division 7
  286. 8Division 8
  287. 9Division 9
  288. 9.1Division 9.1
  289. 9.2Division 9.2
  290. 9.3The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years.
  291. 9.4Division 9.4
  292. Annex XFull quality assurance
  293. 1Division 1
  294. 2Division 2
  295. 2.1The manufacturer or his authorised representative shall lodge an application for assessment of his quality system to a notified body of his choice.
  296. 2.2The quality system must ensure conformity of the machinery with the provisions of this Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions. The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans, manuals and records.
  297. 2.3The notified body shall assess the quality system to determine whether it satisfies the requirements of point 2.2.
  298. 2.4The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure that it remains appropriate and effective.
  299. 3Division 3
  300. 3.1Division 3.1
  301. 3.2The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as:
  302. 3.3Division 3.3
  303. 3.4Moreover, the notified body may pay the manufacturer unannounced visits. The need for these additional visits and their frequency will be determined on the basis of a visit monitoring system managed by the notified body. In particular, the following factors will be taken into account in the visits monitoring system:
  304. 4The manufacturer or his authorised representative shall keep available for the national authorities, for a period of ten years from the last date of manufacture:
  305. Annex XI: Minimum criteria to be taken into account by Member States for the notification of bodies
  306. 1Division 1
  307. 2Division 2
  308. 3Division 3
  309. 4The staff responsible for inspection shall have:
  310. 5Division 5
  311. 6Division 6
  312. 7Division 7
  313. 8Division 8
  314. 9Division 9
  315. Annex XIICorrelation table