en 45000 series

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EUROPEAN COMMISSIONDIRECTORATE-GENERAL IIIINDUSTRYLegislation and standardization; telematics networksQuality Policy, certification and conformity marking

Brussels, 25 March 1998III/B/4/AJ D(98)

CERTIF 98/4 EN

THE EN 45000 STANDARDS, ACCREDITATION ANDNOTIFICATION OF NOTIFIED BODIES

1. Background

From the discussions in the Senior Officials Group on Standardisation (SOGS) it hasbecome apparent that there exists a need of clarifying the role of the EN 45000 series ofstandards and the use of accreditation in the notification process for notified bodies.Basically this involves two interrelated tasks. The first task is to identify which of thestandards in the EN 45000 series best relates to the modules of the Global Approach.Secondly, one has to identify whether the EN 45000 standards fully reflect the needs ofthe directives, in terms of e.g. criteria on technical competence, in order for them to givepresumption of conformity. When doing this it is necessary to identify the role ofaccreditation in the assessment and surveillance process.

The relationship between the EN 45000 standards and the modules is discussed indocument Certif 97/51. The remainder of this document attempts to address whether thecriteria in the standards need to be amplified and/or complemented in order to fully takeinto account the requirements on notified bodies. This is basically done in terms ofidentifying the different aspects that would need to be studied further and who should beresponsible for different actions. It should also be noted that this document should be seenin the framework of Certif 97/12, which gives the basic setting for the operation of thenotified bodies system.

2. The EN 45000 standards and requirements on notified bodies

The European Co-operation for Accreditation (EA) has within a Reference Group ontechnical assessment of bodies seeking notifications, inter alia, made a comparison

1 The EN 45000 Series of Standards and the Conformity Assessment Procedures of the Global Approach.

2 Code of Conduct for the functioning of the system of Notified Bodies.

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between requirements on notified bodies and the criteria in EN 45004, 45011 and 45012.This has provided a good basis for determining which criteria in the standards wouldpossibly need to be amplified and/or supplemented for the purpose of the directives.

Generally speaking, the criteria in standards EN 45004, 45011 and 45012 can be said tocover the technical requirements on notified bodies. However, the EA study indicates thatthere is a possible need of amplifying/complementing certain parts of the standards. Evenif not included in the EA comparisons, the same could be said of EN 45001, with theexception that this standard does not cover the functions related to evaluation anddecision of conformity (cf. clauses 9, 10 and 12 in EN 45011 and clause 13 in EN 45004).

Based on the EA comparisons the following areas have been identified as possibly needingfurther guidance:

- Independence, impartiality and integrity: clarification and guidance on theseparation of notified body activities with other, e.g. consultancy, marketsurveillance (e.g. identify under which conditions a notified body could assist inmarket surveillance activities), other conformity assessment services.

- Documentation of processes: It might need to be clarified that the notified bodymust clearly document the procedures necessary to carry out the conformityassessment procedures laid down in the directives and for which it is notified for.This can for example mean outlining the evaluation criteria for the products,assigning responsibility for the performance of tests, examinations, decisions onconformity etc., conditions and procedures for granting, maintaining, extending,suspending and withdrawing certificates.

- Qualification of personnel: Guidance on the training and qualification of personnelfor example in relation to knowledge of the product, its design and constructionand the potential risks encountered through its use. This would be needed both ingeneral terms and for assessment against generally stated health and safetyobjectives and general performance requirements, i.e. professional judgement. Forthe quality system modules guidance would be needed on the qualification ofauditors in relation to their ability to judge whether the manufacturer can identifythe appropriate product requirements and carry out the relevant tests andinspections.

- Subcontracting: Guidance on how to take onboard the conditions onsubcontracting as set out in the Guide to the New and Global Approach.

- Testing activities: Guidance on conditions to carry out testing required by themodules.

- Co-ordination activities: Guidance on the need of participating in or beinginformed of activities in the co-ordination groups of notified bodies and relatedstandardisation activity. The notified body groups develop common understandingand practice concerning the technical application of the conformity assessmentprocedures. This has a direct bearing on the technical capability of a notified body.

The necessary clarification and guidance should be elaborated under the understandingthat:

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- Accreditation is a recognition of conformity with requirement in the relevantstandards. Since guidance is necessary for the use of the standards in relation tonotified bodies, accreditation must be seen as an assessment technique used toassess bodies seeking notification.

- The minimum criteria in the annexes of the directives have different wordings. Thisdoes not mean that there is a difference with regard to the objectives ofestablishing the independence, impartiality, integrity, technical competence etc. ofthe notified body, unless a different wording can be explicitly related to the needsof the directive in question.

- Notified bodies are involved in the process of establishing the conformity ofproducts according to the requirements of the directives, whether themanufacturer has applied harmonised standards or not. Therefore, there should beno possibility of distinguishing different types of notified bodies. Having said this,it must be clear that a notified body can only operate within the limits of itstechnical competence in terms of the products and modules it is notified for.

- Notified bodies must be assessed in the specific product area in which theyoperate. The assessment and surveillance process must ensure that this capability isassured and maintained.

Concerning EN 45001, although similar clarification and guidance would be necessary,requirements and criteria for operating functions relating to evaluation and decision onconformity would also have to be established.

At the last SOGS meeting the urgency on finding solutions to the above-mentioned issueswas recognised. In order to progress the necessary work the Commission services haveproposed a work programme (Annex 1), which outlines for each activity the work thatwould need to be done and the responsible parties. The result from the different activitiesshould thereafter be taken on board an overall guidance document on notified bodies (seebelow).

3. The Assessment and Surveillance Process

Even if the criteria for the operation of notified bodies is clearly laid down and reflects thestate of the art, it is the assessment and surveillance process that will determine if thesecriteria are fulfilled and maintained. The assessment process must determine if the bodyhas adequately trained technical staff with knowledge and experience of the relevanttechnology, suitable facilities and equipment, policies and procedures to ensure integrityand impartiality, correct understanding of the directive, documented procedures to carryout the conformity assessment procedures of the directive etc.

The criteria on accreditation bodies and the accreditation process are laid down in thestandards EN 45003 and EN 45010. These standards should therefore be the basis for theassessment and surveillance of the technical competence, independence, impartiality andintegrity of bodies seeking notification. It would be useful to examine whether thesestandards need to be supplemented and/or amplified with regard to the technicalassessment and surveillance of notified bodies, in particular in light of the guidanceelaborated along the lines described above. Furthermore, the assessment and surveillance

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process must not only ensure that a notified body has the capability to operate accordingto the relevant criteria but that is also does so in practice. The need of guidance regardingthe assessment and surveillance process is also taken on board in the draft workprogramme at Annex 1.

4. Need of overall guidance on the technical assessment and notification ofnotified bodies

The EA Reference Group report recommends that all harmonised requirements on notifiedbodies and any guidance on their implementation should be brought together in a self-contained document. The need for consolidating all relevant information on notifiedbodies was also apparent from the discussions in SOGS, and in particular in relation todocuments such as Certif 97/1, 97/43 and 97/5. A proposal for the contents of such anoverall guidance document on the technical assessment and notification of notified bodiesis at Annex 2.

5. Conclusions

This note has identified the need and urgency of establishing guidance on the use of theEN 45000 standards for the technical assessment of notified bodies. A work programme isproposed on how to progress the necessary work. It should be pointed out that this workshould be seen a transitional solution until a final answer can be found within arestructured set of EN 45000 standards along a functional approach.

Taking into account that existing requirements, criteria, guidance, procedures etc. fornotified bodies are spread out in a number of documents, it would be beneficial for thecoherence of the notified body system to consolidate all this information. I hope we candiscuss these important matters and arrive at an agreement on how to progress at the nextSOGS meeting on 30 and 31 March 1998.

3 Accreditation and the Community’s Policy in the Field of Conformity Assessment.

Draft work programme for elaborating guidance to the EN 45000 standards in relation to the requirements on notified bodies Annex 1

1. Independence, Impartiality and IntegrityGeneral description of issues to be addressed Work to be done

Stages Responsibilities Result Deadline

1. Setting of general objectives. Notifying authorities, Commission Clear indication from nationalauthorities on general objectives to beattained with regard to separation ofactivities.

2. Concrete guidance inapplying the requirements ofthe standards.

EA in consultation with interestedparties, e.g. CEN, CLC, ETSI,Notified Body Groups, Europeanorganisations of conformity assessmentbodies.

EA guidance document to EN 45000standards or if appropriate into EN.

Clarification and guidance on the separation ofnotified body activities with other activities,e.g. consultancy, market surveillance (e.g.identify under which conditions a notified bodycould assist in market surveillance activities),other conformity assessment services.

3. Consolidation. Notifying authorities, Commission Bring together with other guidance onnotified bodies.

2. Documentation of ProcessesGeneral description of issues to be addressed Work to be done

Stages Responsibilities Result Deadline1.Concrete guidance inapplying the criteria of the EN45000 standards.

EA in consultation with interestedparties, e.g. CEN, CLC, ETSI, NotifiedBody Groups, European organisationsof conformity assessment bodies.

EA guidance document to EN 45000standards.


Clarification needed that the notified bodymust clearly document the proceduresnecessary to carry out the conformityassessment procedures laid down in thedirectives and for which it is notified for. Thiscan for example mean outlining the evaluationcriteria for the products, assigningresponsibility for the performance of tests,examinations, decisions on conformity etc.,conditions and procedures for granting,maintaining, extending, suspending andwithdrawing certificates.

3. Qualification of PersonnelGeneral description of issues to be addressed Work to be done

Stages Responsibilities Result Deadline1. Setting of general objectivesand levels.

Notifying authorities, Commission Clear indication of general levels oftraining, education and experience.

2. Concrete guidance onapplying the criteria in the EN45000 standards


EA guidance document to EN 45000standards or if appropriate into EN.

Guidance on the training and qualification ofpersonnel for example in relation to knowledgeof the product, its design and construction andthe potential risks encountered through its use.This would be needed both in general termsand for assessment against generally statedhealth and safety objectives and generalperformance requirements, i.e. professionaljudgement. For the quality system modulesguidance would be needed on the qualificationof auditors in relation to their ability to judgewhether the manufacturer can identify theappropriate product requirements and carry outthe relevant tests and inspections.

3. Consolidation Notifying authorities, Commission Bring together with other guidance onnotified bodies.

4. SubcontractingGeneral description of issues to be addressed Work to be done

Stages Responsibilities Result Deadline1. Concrete guidance onapplying the criteria in the EN45000 standards.



2. Consolidation. Notifying authorities, Commission Bring together with other guidance onnotified bodies

Guidance on conditions for subcontractingspecific for notified bodies, e.g. as set out in theGuide to the New and Global Approach.

5. TestingGeneral description of issues to be addressed Work to be done

Stages Responsibilities Result Deadline1. Concrete guidance onapplying the criteria in the EN45000 standards.

EA in consultation with interestedparties, e.g. CEN, CLC, ETSI, NotifiedBody Groups, European organisationsof conformity assessment bodies



Guidance on conditions to carry out testingrequired by the modules.

6. Co-ordination ActivitiesGeneral description of issues to be addressed Work to be done

Stages Responsibilities Result Deadline1. Setting of general rules andconditions.

Notifying authorities, Commission Basic rules on participation/informed onactivities in Notified Body Groups andstandards work and how the results ofthis work should be taken on board.

2. Concrete guidance inapplying criteria in the EN45000 standards.


EA guidance document to the EN 45000standards.

Guidance on the need of participating in orbeing informed of activities in the co-ordination groups of notified bodies and relatedstandardisation activity. The notified bodygroups develop common understanding andpractice concerning the technical application ofthe conformity assessment procedures. Thishas a direct bearing on the technical capabilityof a notified body.


7. EN 45001General description of issues to be addressed Work to be done

Stages Responsibilities Result Deadline1. Setting of criteria EA, CEN, CLC and ETSI in

consultation with interested parties,e.g. notifying authorities, NotifiedBody Groups, European organisationsof conformity assessment bodies.

EA guidance document to EN 45001 ortechnical report to EN 45001 or ifappropriate into EN.

2. Consolidation Notifying authorities, Commission Bring together with other guidance onnotified bodies

Need of elaborating criteria related to theevaluation of test results and decisions ongranting, maintaining, extending, suspendingand withdrawing certificates.

8. The Assessment and Surveillance ProcessGeneral description of issues to be addressed Work to be done

Stages Responsibilities Result Deadline1. Examination of needs andsetting of general objectives

Notifying authorities, Commission Setting of general objectives and ruleswith regard to the technical assessmentand surveillance of notified bodies.

2. Concrete guidance onapplying criteria in EN 45003and EN 45010.


EA guidance document or if appropriateinto EN.

Possible need of guidance on the assessmentand surveillance process for notified bodies inorder to ensure that they have the adequatecapabilities and operate accordingly.


Annex 2

DRAFT

Guidance on the Technical Assessment and Notification of Notified Bodies withinthe context of Technical Harmonisation Directives

0. Background

1. Technical Assessment of Notified Bodies

1.1 Technical Requirements on Notified Bodies

1.1.1 The criteria in the New Approach directives

1.1.2 The EN 45000 series of standards

1.1.3 Relationship between the EN 45000 Standards and the Modules ofthe Global Approach

1.1.3.1 Specific solutions for individual directives

1.1.4 Additional and/or supplementary requirements to the EN 45000standards

1.1.4.1 Directive specific requirements

1.2 Criteria for the Assessment Process

1.2.1 Directive specific requirements

1.3 The Surveillance Process

2. Notification

2.1 General rights and obligations of Notified Bodies

2.2 Code of Good Practice

2.3 The Notification Procedure

2.4 Co-operation between Notified Bodies

en 45000 series

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