| Version: |
2 (March 2010) |
Source:
|
Resolution BT 16/2004 (approving BT N 7106 and confirming
resolution BT 68/2000) |
| Target group: |
Technical Committee (TC), Working Group (WG) |
1. Purposes
2. Definitions
3. Background
4. Philosophy behind the concept
5. Practical information
6. Guidelines for the Technical Committees
7. Supporting tools
1. Purpose
Many questions were asked by European Standard writers in CEN Technical Committees (TC) or Working Groups (WG) on the correct application of the CEN policy in this matter, as expressed in resolution
BT 58/1998. This document is meant to give guidance in this matter. It does explicit the topic, but it does not add to nor modify the established policy.
2. Definitions
Definitions are extracted from EN 45020:2006 'Standardization and related activities - General vocabulary (ISO/IEC 17000:2004)'. They can also be found in the BOSS glossary (see below).
2.1 Basic definitions
See glossary for the following definitions:
- Conformity assessment
- Conformity evaluation
- Product standard
- Testing standard
2.2 Related definitions
See glossary for the following definitions:
- Certification
- Conformity assessment scheme
- Conformity surveillance
- Conformity testing
- Inspection conformity
- Third party
- Type testing
3. Background
3.1 As far as the content of product standards in relation to conformity assessment is concerned, the CEN policy consists in the use of ISO/IEC Guide 7:1994, as confirmed by Resolution CA 25/1996, 'Document CERT.BOARD N 14 - Revised' (Annex 1) and Resolution BT 1/1996. This policy was also confirmed for ECISS by Resolution COCOR 5/1998 (Annex 2). BT reconfirmed and clarified this policy once more in Resolution BT 58/1998.
3.2 Experience shows that in several cases standard drafters are interpreting the scope of this policy as limited to the 'compulsory third party certification'. However, the policy described in ISO/IEC Guide 7 is much broader than this. The essential Clause 4.7 of this document is to be found in Annex 3.
4. Philosophy behind the concept
4.1 The philosophy of writing 'Product Standards' is that such a standard shall contain normative requirements on the product, and not on any party involved in the manufacturing, testing or distribution of the product. For the validation of the product requirements, test methods are given either in the product standards or in separate testing standards. There again no requirements can be incorporated as to who should perform the tests. In summary, it can be said that product standards and the related test standards shall describe WHAT and HOW, but not WHO.
4.2 A lot of misconception exists on the notions CONFORMITY EVALUATION and CONFORMITY ASSESSMENT. For the sake of evaluation of conformity of a product to a product standard, the standard shall define which methods of validation (tests or calculation) are used for each of the specified characteristics of the product. Additionally, the test method(s) must describe clearly how the test is to be performed (selection and preparation of samples, use of testing instruments or test rigs, data to be recorded, etc.) and which are the acceptance criteria i.e. the limits to be used for accepting or rejecting the result.
Conformity assessment of a single product or a group of products may also include assurance of conformity (supplier's declaration, certification), registration, accreditation and approval (as well as their combinations). However, this does not mean at all that the product standard shall include the description of these activities, because by doing so, it would go beyond the definition of a product standard.
4.3 Basic principle for a product standard: it is the PRODUCT that is to be evaluated, NOT the PRODUCTION LINE. This means that the evaluation method can be used by ANY involved party on ANY individual product, including prototypes, samples from the production line, products supplied, etc. Clauses specifying that a certain number of prototypes, or a certain number of production types must be tested have no place in a product standard, because these are NOT requirements on an individual product, but on a production line or a manufacturing system.
Such requirements belong to a manufacturing quality system. It is through a quality system that a manufacturer can obtain assurance that the products coming from a production line conform to what he claims as characteristics of the product that is considered to be in conformity with a certain standard. However, the description of such a quality system does not belong to a product standard.
4.4 The previous paragraphs deal with product standards. However, there can be different types of standards dealing with aspects of a manufacturing process, or with delivery conditions. Delivery condition standards usually include criteria for accepting or rejecting a batch of products, and within this context they may specify sampling procedures, programmes of tests to be carried out, packing, documentation, etc.
Such requirements may be normative provided that they are presented in a separate standard, that the title and scope of such a standard indicate the content clearly, and that the related product standard(s) do not include normative references to it. It should indeed be possible to prove compliance with a product standard without having to prove compliance with the manufacturing process criteria.
4.5 For conformity evaluation, the product standard and the related testing standard(s) cannot be seen separately. It is therefore self-evident that clauses that are not allowed in a product standard cannot appear in the testing standard(s) to which the product standard refers normatively.
5. Practical application
5.1 Based on the principle, the following typical types of normative requirements are not allowed in a product standard or a related testing standard:
- a requirement on a third party certification system (see ISO/IEC Guide 7, Clause 4.7 a and b on certification and allocation of responsibilities); or
- a requirement on a factory quality control system (see Clause 4.7 d); or
- a requirement on prototype or production type testing (see Clause 4.7 c and d on manufacturing process quality systems).
NOTE Because of some specific particularities of the Construction Products Directive (CPD) and its related Mandates, the Technical Board (BT) has, by resolution BT 57/1999, approved a derogation related to factory production control. This derogation was later confirmed by resolution BT 71/1999. For the CPD field, there is a specific guideline (CMF N 076 Rev.6) which was presented in Annex to document BT N 6169.
Resolution BT 71/1999 as it was approved did not only apply to the Construction field but to all European Product Standards. However, BT has later confirmed in resolution BT 67/2000 that resolution BT 71/1999 only applies automatically to product standards under the CPD, and that all derogation requests should each time be addressed to BT:
- a requirement on a qualification scheme of personnel competence (see Clause 4.7 b on the allocation of responsibilities);
- a requirement on a suppliers' certificate (see Clause 4.7 a).
5.2 If a TC is of the opinion that a certification system, a quality system, a qualification scheme or a type testing scheme should be set up for the product(s) covered by the product standard, this can be stated as a recommendation in an informative element of the standard, possibly with additional recommendations on the way such a system should operate. Certification schemes are not the task of a TC. However, if there is a need for them, the CEN Certification Board may be addressed.
5.3 Conclusion
Product standards, whether harmonised or non-harmonised shall give all the necessary information allowing the evaluation of conformity of the product to the specified requirements. Any other requirement, not pertaining to the product itself, but to the manufacturer or to any other party shall not be in the normative part of product standards.
Elements such as factory production control, type-testing, third party certification may be given as recommendations in an informative annex (see also note in Clause 5.1).
In the context of mandates related to certain EU Directives, requirements for the attestation of conformity related to harmonised parts of product standards can be either implicitly or explicitly mentioned in the declaration of the type of attestation that is mentioned in the compulsory informative Annex Z. This may typically be the case for items such as 'factory production control' or 'third party certification' (see note in Clause 5.1).
6. Guidelines for the Technical Committees
6.1 The TCs shall not use in the normative part of the (F)prENs compulsory requirements (verbal form 'shall' or similar) allocating responsibilities on parties making use of the standard. The TC secretaries should check their draft (F)prENs on the presence of such clauses, and remove them prior to sending them to the CEN-CENELEC Management Centre (CCMC) for Enquiry or Formal Vote.
Typical examples of terms or expressions to be avoided are:
- approved body, approved test house, approved by, etc.
- attestation of conformity
- authorised body, authorised test house, etc.
- certification, certified, etc.
- EN ISO 9000, 9001, 9002, etc. (or EN 29000, etc. - old numbering)
- external supervision
- inspection body
- notified body
- production control (except with BT derogation – see note in Clause 5.1)
- prototype testing, first-type testing, type testing, etc. (except with BT derogation – see note in Clause 5.1)
- quality assurance, quality control, quality system, etc.
- surveillance
- third party
6.2 In the past, several European Standards were published containing clauses which should not have been included, had the policy been clearly established and checked. Furthermore, several draft standards arrive at CCMC for one or other procedure (Enquiry, Formal Vote) also containing such clauses, mainly due to a lack of clear understanding of the policy. Therefore, all TCs should be instructed to check the content of their published standards for the presence of such clauses (see list above) and if some are discovered, a revision should be started as soon as possible.
6.3 As explained in Clause 5.2, a TC may be of the opinion that a certain concept of 'quality system', 'factory production control system', 'type-testing scheme', 'qualification scheme' or 'certification system' may be either the best way, or may specify minimal conditions to obtain or prove conformity of a product range to a standard.
NOTE For 'factory production control', see resolution BT 71/1999 and resolution
BT 67/2000.
The TC opinion may be presented in an 'Informative Annex' to the standards. An example of such an annex follows (please note that the letter A is only an example and that optional possibilities are in square brackets).
Annex [A]
(informative)
Conformity assessment
A.1 This European Standard contains the conditions for the evaluation of conformity of any single product to the standard. However, in order to make an assessment of conformity of a full range of products coming off a production line, more elements may be needed such as a factory production control system or quality system, a type-testing scheme, a qualification scheme and/or a certification scheme. These systems are independent from the strict evaluation of conformity of a single product, and may be required either by legislation or regulations, or by contractual agreements.
A.2 Unless there is a [factory production control system] [quality system] [type-testing scheme] [qualification scheme] [certification scheme] in place, CEN/TC xxx is of the opinion that the following clauses represent [the best way] [minimal conditions] to assess the conformity of a range of products to this standard.
(To be followed by a description of the system or scheme recommended by the TC.)
7. Supporting tools
7.1 Reference documents
- Resolution CA 25/1996: Certification Clauses in ENs;
- Resolution BT 1/1996: Certification Clauses in European Standards
- Resolution BT 57/1999: Effects or resolution BT 58/1998 on the Construction Sector
- Resolution BT 71/1999: Factory production control in product standards
- Resolution BT 16/2004: Product standards and conformity assessment
- EN 45020:2006: Standardization and related Activities: General Vocabulary (ISO/IEC Guide 2:2004)
- ISO/IEC Guide 7:1994: Guidelines for drafting of standards suitable for use for conformity assessment
7.2 Annexes
- Annex 1: Document on Product Standards and Conformity Assessment
(CERT.BOARD N 14 - Revised)
- Annex 2: Resolution COCOR 5/1998: Certification clauses in European Standards
- Annex 3: EXTRACT (Clause 4.7) from ISO/IEC Guide 7/1974