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PART 2 QUALITY REQUIREMENTS TO BE OBSERVED BY THE APPLICANT/HOLDER - PDF
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1 CERTIFICATION REGULATIONS NF MARK FOR ALCOHOL TESTERS PART 2 QUALITY REQUIREMENTS TO BE OBSERVED BY THE APPLICANT/HOLDER CONTENTS 2.1. Requirements concerning products 2.2. Requirements concerning the quality management system 2.3. Requirements concerning marking 2.4. Applicant's/holder's commitments Rev. 11 March 2015
2 2.1. REQUIREMENTS CONCERNING PRODUCTS REFERENCE STANDARDS - NF X (October 2014) Chemical alcohol testers - Evaluation of alcohol impregnation through analysis of exhaled air Specifications and test methods. The certificates in force as per standard NF X : 2013 remain valid until 30 September NF X (April 2007) - Electronic alcohol testers category 2 Evaluation of alcohol impregnation through analysis of exhaled air Specifications and test methods. - NF EN (April 2011) Alcohol testers other than disposable devices Requirements and test methods. - NF EN (December 2012) Alcohol testers for the general public Requirements and test methods REGULATORY CONTEXT - Order of 27 April 2012 amending the order of 14 October 2008 relative to the certification of alcohol impregnation screening units through exhaled air (or exhaled air alcohol testers) used by law enforcement authorities and to the approval of laboratories authorised to perform tests, inspection and checking of these appliances. - Decree no of 1 September 2008 on electronic alcohol testers - Decree no of 28 February 2012 covering obligatory possession of an alcohol tester by the driver of a motor vehicle ALCOHOL TESTER CATEGORIES N.B.: In accordance with the provisions of the order of 14 October 2008, only chemical alcohol testers and electronic alcohol testers NF EN can be used by law enforcement authorities. a) Chemical alcohol testers: Definition: These are disposable instruments designed for collective and/or individual screening of breath alcohol: Specifications of standard NFX (Octobre 2014): Acceptance criteria on appliances from the same production batch (cf. definition of a batch, part 1, Para. 1.2): The batch must be compliant. Long drift tests: 200 samples are kept for 6 months by the laboratory. Once this period has passed, tests are performed at C1 and C2 concentrations. The results must conform to the requirements of the standard for these concentrations. b) electronic alcohol testers NF EN Alcohol testers other than disposable devices: Portable electronic alcohol testers NF EN 15964: Definition: These repetitive-use instruments are designed for collective and/or individual screening of breath alcohol. They are fitted with cordless electricity supply. Specifications of standard NF EN (April 2011): Part 2 page 2 -
3 Acceptance criteria on 10 units from the same manufacturing batch: - precision on 10 appliances: the 10 units must comply with Para of the standard; - Other characteristics: Paras , 7.6.6, 7.6.7, 7.7 and 7.8 of standard: tests on 1 unit: the unit must be conforming. - other metrological characteristics in Para. 7 of the standard: tests on 2 units: the 2 units must be compliant Stationary electronic alcohol testers NF EN 15964: Definition: These instruments are designed for collective and/or individual screening of breath alcohol. They must resemble a terminal and be integral with a holder that does not enable them to be moved during use. Specifications of standard NF EN (April 2011): Acceptance criteria on 4 units from the same manufacturing batch: - precision on 4 appliances: the 4 units must comply with Para of the standard; - Other characteristics: Paras , 7.6.6, 7.6.7, 7.7 and 7.8 of standard: tests on 1 unit: the unit must be conforming. - other metrological characteristics in Para. 7 of the standard: tests on 2 units: the 2 units must be compliant. c) electronic alcohol testers NF EN Alcohol testers for the general public Requirements and test methods: Portable electronic alcohol testers NF EN 16280: Definition: These repetitive-use instruments are designed for collective and/or individual screening of breath alcohol. They are fitted with cordless electricity supply Specifications of standard NFX (April 2007): Acceptance criteria on 10 units from the same manufacturing batch: - Type and drift test cycle: Paras. 5.3, 5.4 and 5.8 of standard: tests on 10 units: the 10 units must be compliant. - other metrological characteristics in Para. 5 of the standard: tests on 2 units: the 2 units must be compliant. Specifications of standard NF EN (December 2012): Acceptance criteria on 10 units from the same manufacturing batch: - precision on 10 appliances: the 10 units must comply with Para of the standard; - Other characteristics: tests on 2 units: the 2 units must be compliant Stationary electronic alcohol testers NF EN 16280: Definition: These instruments are designed for collective and/or individual screening of breath alcohol. They must resemble a terminal and be integral with a holder that does not enable them to be moved during use. Specifications of standard NFX (April 2007): Acceptance criteria on 4 units from the same manufacturing batch: - Type and drift test cycle: Paras. 5.3, 5.4 and 5.8 of standard: tests on 4 units: the 4 units must be compliant. - other metrological characteristics in Para. 5 of the standard: tests on 2 units: the 2 units must be compliant. Part 2 page 3 -
4 Specifications of standard NF EN (December 2012): Acceptance criteria on 4 units from the same manufacturing batch: - precision on 4 appliances: the 4 units must comply with Para of the standard; - Other characteristics: tests on 2 units: the 2 units must be compliant SPECIAL PROVISIONS FOR ELECTRONIC ALCOHOL TESTERS The upper limit of the display authorised is 0.24 mg/l. The unit must not provide any display at the legal limit of 0.25mg/l and above it and must indicate an excess of the limit by a red diode or a message. Moreover, regarding the inspection of Para of standard NF EN and of Para. 6.1 of standard NF EN 16280, only the alcohol tester function is validated for the NF mark. It is therefore necessary to state this notion clearly in the manual. For NF EN alcohol testers: - the manufacturer must specify the maximum number of measurements - a counter specifying the number of breaths remaining must be visible SPECIFIC PROVISIONS FOR HARSHER TEMPERATURES THAN THOSE RECOMMENDED BY STANDARDS Besides the tests recommended by standards, the metrological characteristics can be checked under harsher conditions than those recommended by standards (e.g., at a temperature of 10 C besides the temperature of 10 C and 40 C recommended by standards). Any claim by a manufacturer regarding these different conditions must be previously validated through tests conducted by the LNE TEMPORARY PROVISIONS FOR CHEMICAL ALCOHOL TESTERS FOLLOWING THE PUBLICATION OF STANDARD NF X OF OCTOBER 2014 Chemical alcohol testers must conform to the standards in force. That said, because of the October 2014 version of standard NF X , a transitional period has been decided on for the NF-Alcohol testers mark. This transitional period is defined until 30 September During this period, NF-certified chemical alcohol testers conforming to the 2013 or 2014 version of standard NF X may be produced. As from 1 October 2015, the NF certificates will be updated, and all products conforming to the 2013 version of standard NF X will have their certificates withdrawn and may no longer be produced with the NF mark. At this date, only chemical alcohol testers produced as per the requirements of the October 2014 version of standard NF X will be NF-certified. Part 2 page 4 -
5 2.2. REQUIREMENTS CONCERNING THE QUALITY MANAGEMENT SYSTEM GENERAL REQUIREMENTS The manufacturer s quality system must, in respect of the products concerned by the application of this mark, conform to the chapters mentioned below of standard ISO 9001: quality management systems requirements. 4. Quality management system 4.1. General requirements 4.2. General documentation requirements 5. Management responsibility 5.1. Management commitment 5.3. Quality policy 5.4. Planning Responsibility and authority Management Representative 5.6. Management review 6.1. Provision of resources 6.2. Human resources 6.3. Infrastructure 6.4. Work environment 7. Product realisation 7.1. Quality planning 7.2. Customer-related processes 7.3. Design and development 7.4. Purchasing 7.5. Production and service provision Control of service preparation and production Validation of processes for production and service provision Identification and traceability Preservation of the product 7.6. Control of monitoring and measuring equipment 8. Measurement, analysis and improvement 8.1. General 8.2. Monitoring and measurement Internal audit Monitoring and measurement of processes Product monitoring and measurement 8.3. Control of nonconforming product 8.4. Data analysis Corrective action Preventive action None of the explicit requirements referring to notions of "continual improvement" are taken into account. Part 2 page 5 -
6 SPECIFIC QUALITY REQUIREMENTS Planning of product realisation - Para. 7.1 of standard ISO 9001 During planning of production realisation, the manufacturer must take into account points a b -c and d of Para. 7.1 of the standard. Verification of product purchased - Para of standard ISO 9001 The manufacturer must check the quality of raw materials used in the manufacture of products for which he holds the right to use the NF Mark. For example, defined and regular inspections on reception or certificate of conformity with suppliers' technical specifications or general specifications. Records must be made of inspections carried out indicating the acceptance criteria and decisions taken in the event of nonconformity. Identification and traceability - Para of standard ISO 9001 The manufacturer must prepare instructions for identifying the product with marking that conforms to the requirements of Para below. Traceability is a requirement of the NF mark. Consequently, the measures defined in standard ISO 9001 concerning unique identification of the product must be taken into account. Such identification shall make it possible to ensure traceability and to find the product history (records of manufacturing, components used and associated inspections). The traceability of batches produced and marketed must also enable top-down traceability (records of customers/distributors associated with each batch or series marketed). Preservation of the product - Para of standard ISO 9001 Storage The manufacturer shall use designated storage areas or premises to avoid the damaging or the deterioration of the product when it waits for use or delivery. To detect any deterioration, the status of the stocked product shall be evaluated at appropriate and defined intervals. Packaging The manufacturer must control the packaging, conditioning and marking processes, insofar as necessary to ensure compliance with specified requirements. Control of monitoring and measuring equipment - Para. 7.6 of standard ISO 9001 Requirements a, b, c, d and e of the standard must be taken into account for inspection and test equipment likely to have an influence on tests carried out for NF mark purposes. Inspection, measurement and test equipment must be used in such a way that measurement uncertainty is known and compatible with the required capability for measuring purposes. Product monitoring and measurement - Para of standard ISO 9001 During planning of product realisation, the manufacturer must take into account points c and d of Para of the standard. Part 2 page 6 -
7 For the purposes of the NF mark, the inspection plan set up must be defined on the basis of a sampling plan drawn up in line with standard ISO 2859 and must always include at least the tests and inspections referred to below: Incoming inspection and testing The manufacturer must ensure that the incoming product is nor used or incorporated (except in case of emergency situations which must be defined) until its conformity with specified requirements has been proven (inspection or other provisions). In-process inspection and testing The manufacturer shall: inspect the product and conduct tests as required by the inspection plan, keep the product until the required inspections and tests are finished or until the necessary reports have been received and checked. Inspection and final tests Note: For internal inspection, the manufacturer must be equipped with a test facility that should be able to generate test gas containing known concentrations of alcohol at a temperature of 34 C and relative humidity over 90% and should provide testing of alcohol concentrations specified in standards NF X , NF X , NF EN and NF EN The main characteristics of this facility to be controlled by the manufacturer are defined in the standards (for the record, the Dubowski system is documented in Annex G of the OIML R 126, 1998 edition). The manufacturer must establish and keep a qualification file for the alcohol tester test bench. The manufacturer must be able to demonstrate that the sampling plan used is adapted to the size of the manufacturing batches. Control of nonconforming products - Para of standard ISO 9001 The manufacturer must deal with a nonconforming NF-marked product in one of the following ways: - by taking measures to eliminate the nonconformity, - by authorising its use, release or acceptance with a waiver: in this case, prior agreement must be obtained from the LNE - by taking measures to prevent its use (scrapping for example). - by setting up all necessary measures to warn his customers and call in the units. If he becomes aware of having delivered faulty products that could be harmful to the users, the manufacturer must set up all necessary measures to warn his customers and call in the products. Corrective actions - Para of standard ISO 9001 Records indicating complaints made against certified products and their processing must be produced and conserved. Part 2 page 7 -
8 ADDITIONAL SPECIFICATIONS FOR CALIBRATION OR REPAIRS OF ELECTRONIC ALCOHOL TESTERS For this, the manufacturer must define in its quality system: - the provisions for calibration, on-site maintenance or repairs: training, accreditation, instructions, procedures - who is competent to carry out said operations and to keep the necessary records up-todate, - the resources and equipment necessary, - ensure the follow-up and application of said provisions, In the event of subcontracting, these provisions must be subject to a contract between the manufacturer and subcontractor, in which the latter undertakes to conduct the aforementioned operations according to the instructions stipulated by the manufacturer and agree to the performance of audits by the LNE. The manufacturer must inform the LNE of these provisions. NF marking on an alcohol tester remains valid only if the calibration is carried out by the manufacturer or by an organisation declared by the manufacturer to the LNE and audited by the LNE. The manufacturer must inform its customers of the subcontracting organisations that may carry out the calibrations and/or repairs. Part 2 page 8 -
9 2.3. REQUIREMENTS CONCERNING MARKING Marking is an integral part of the certification of a product. Beyond the identification of a certified product and its traceability, the marking of a product with the NF logo ensures better protection of the users and enables holders to be protected against unauthorised use and forgery. Without prejudice of the sanctions laid down in the General Rules of the NF mark, any incorrect announcement of the certified features and any fraudulent use of the NF logo exposes the holder to lawsuits for frauds and/or misleading advertising. Copying of and marking with the logos of AFNOR, AFNOR Certification, and the LNE is strictly forbidden without prior authorisation from these bodies. The holder undertakes to respect the graphics charter of the NF mark. The NF certified product must bear a designation and identification distinct from non-nf certified products. The holder must only use the NF logo to distinguish certified products, without risk of any possible confusion with other products, particularly with non-nf certified products. The holder is recommended to submit all of the documents relating to the NF mark to the LNE beforehand. REMINDER: Article R of the French Consumer Code stipulates that: "When reference is made to certification in advertising, labelling or presentation of any product or service or in associated commercial documents of any kind, the following information must always be brought to the consumer's or user's attention: the name or corporate name of the certifying body or the collective certification mark, the denomination of the certification reference standard used, The modalities according to which the certification reference standard can be consulted or obtained PRODUCT AND PACKAGING MARKING Every certified product should be visibly and permanently marked with the NF logo in accordance with the requirements of the graphics charter, and in compliance with the specific standards and regulations in force. The additional indications relating to the NF mark are the affixing of the NF logo and the information mentioned below: Part 2 page 9 -
10 CHEMICAL or ELECTRONIC ALCOHOL TESTER 0/0 Identification number of the manufacturer / manufacturing site The NF mark must be accompanied by the following indelible information: 1. an identification number of the manufacturer / manufacturing site (number appearing on the certificate) as presented below. 2. the commercial reference of the alcohol tester appearing on the NF certificate. 3. a code providing traceability of the product (production batch number for chemical alcohol testers, and a unique serial number for electronic alcohol testers (cf. definition of a batch in part 1, Para. 1.2)), this coding must be formalised in the manufacturer s quality documents, and: a. for chemical alcohol testers: codification that needs to appear on the packaging or the product. Each chemical alcohol tester must be packaged individually. The codification ensuring the product s traceability may therefore be marked on the individual packaging only. b. for electronic alcohol testers: codification that needs to appear on the packaging and the product The dimensions of this marking and means used are left to the manufacturer's discretion provided the information is legible and smear proof. For chemical alcohol testers destined for the general public, packaging units are limited to a maximum of 10 alcohol testers. For chemical alcohol testers designed for the police, a package insert for 50 units is acceptable; and packaging units are limited to maximum 150 alcohol testers. N.B.: - For chemical alcohol testers: indication 1 will be marked in an envelope frame (see example above). The marking of indications 2 and 3 may be outside the envelope frame. - For electronic alcohol testers: indication 1 will be marked in an envelope frame (see example above). The marking of indications 2 and 3 and the type of alcohol tester (electronic NF EN or NF EN 16280) may be outside the envelope frame. The English version of the NF logo with the wording certified by the LNE is available from the LNE. Part 2 page 10 -
11 Specific requirements for electronic alcohol testers NF EN and NF EN In addition to the requirements defined in paragraph concerning electronic alcohol testers, the manufacturer must mark the following legibly on the appliance: the maximum period of use between two calibrations: - 1 year maximum for NF EN electronic alcohol testers - the maximum number of breaths for NF EN alcohol testers Specific requirements for chemical alcohol testers The following information must feature on the outer packaging of chemical alcohol testers: - threshold C for which the alcohol tester is marketed; - if the limiting pouch may be reused the possible number of times it may be reused. Temporary provisions following the publication of standard NF X revised in October 2014 : The standard version (June 2013 or October 2014), according to which the alcohol tester has been produced, must be clearly stated on the product and packaging Specific requirements for all types of alcohol tester An alcohol tester may present a different legal threshold from the French legal thresholds (0.10 and 0.25), in which case it is necessary to specify which countries are concerned on the product and packaging marking. Moreover, a postal address in Europe, for the products marketing manager, must feature on the outer packaging INSTRUCTIONS FOR USE The instructions for use must comply with the requirements of applicable standards. Moreover, in addition to the NF marking defined in paragraph 2.3.1, the minimum additional information that must be brought to users' attention under the terms of Article R115-2 of the French Consumer Code concerning certification of industrial products and services, must appear in the instructions for use provided on delivery of the products. This information is: - the name and address of the certification body LNE 1, rue Gaston Boissier Paris - Website: - the main certified characteristics: o Fitness for use o Metrological properties Part 2 page 11 -
12 - for NF EN electronic alcohol testers, each alcohol tester must have instructions of use that specify: o the unique use of the end fitting o that the maximum alcohol level is reached within minimum 20 minutes. Any measurement previously performed shall automatically provide a alcohol level lower than the real level. - for NF EN and NF EN electronic alcohol testers, the user s instructions must state that only the alcohol tester function is covered by the NF mark. - for chemical alcohol testers (temporary provisions following the publication of standard NF X revised in October 2014), the standard version (June 2013 or October 2014), according to which the alcohol tester has been produced, must clearly feature in the user s instructions. Any translation of the user s instructions into a language other than French is the manufacturer s responsibility. Nevertheless, regarding the NF mark, the manufacturer is asked to confirm to the LNE that: o if the user s instructions are multilingual, the French version is the same as the version validated when NF mark certification was granted; o the manufacturer undertakes to ensure that any user s instructions translated into another language enable usage under the same conditions as those of the French version and strictly comprise the same user s instructions as the French version DOCUMENTATION References to the NF Mark in documents (order confirmations, invoices, delivery slips, advertising leaflets, catalogues, etc.) must be clear enough to avoid any risk of confusion between certified products and others. The NF Mark must be reproduced on documents and advertising in compliance with the requirements defined in Para The English version "certified by LNE" is available from the LNE. Prior to publication, it is recommended that the holder submit any sales document bearing the Mark, including modifications of said documents, to the LNE. The holder must send, on request from the LNE, any document in which reference is made, directly or indirectly, to the NF mark. 2.4 APPLICANT'S/HOLDER'S COMMITMENTS The applicant/holder endeavours generally to give the LNE the means to proceed in the operations necessary to the good process of the evaluation and the monitoring of his file and in particular to : constantly meet the requirements defined by these certification rules, and to implement the necessary changes in the timeframes set by the LNE in the event that the certification rules change, give the representatives authorised by the LNE the information and working documents necessary to the good progress of the evaluation; Part 2 page 12 -
13 only give information which the applicant/holder ensures is true and accurate; designate a manager as the LNE s special contact person; introduce to LNE s authorised representatives the personnel assigned to the different missions; give its personnel all the instructions required so that it collaborates with the LNE s authorised representatives and accepts to participate in whatever interview; provide authorised LNE representatives with means of access and transportation within the sites and buildings being audited, including sites of sub-contractors if necessary; inform authorised LNE representatives of the provisions and health safety instructions applicable to the sites and buildings being audited and its personnel and put at their disposal whatever relevant equipment; pay the LNE the amounts due for evaluation, in accordance with the financial conditions defined and accepted by the applicant/holder. authorise the presence of an observer who is required to respect confidentiality. This observer may be imposed upon the LNE by standards or agreements of which it is a signatory. The applicant/holder is systematically informed of the presence of this observer by the LNE prior to the audit. take the necessary measures if non-conformities are noted, within the timeframe stipulated by the LNE, return to the audit manager the duly filled out non-conformity sheets, within 3 weeks from the last day of the audit. implement the actions required to enable the certificate to be granted within 11 months of the initial audit. Once this deadline has passed, a new initial audit will have to take place before certification, Send to the mark laboratory the samples taken in the conditions defined in parts 3 and 4. It is also incumbent on the certificate holder to: affix the NF mark on only the products covered by the certificates issued by the LNE and which conform with the applicable requirements; reserve the commercial name of the product for only the products covered by the certificates issued by the LNE and which conform with the applicable requirements; inform the LNE beforehand of any modification to the product and any information likely to affect compliance with the requirements of these rules, the assessment methods being defined in part 4, provide the LNE with any data or information necessary to draw up and maintain the certificate; keep a record of all complaints of which holder has been aware concerning the compliance of (a) product(s) with certification requirements and to provide the LNE with these recordings upon request, and Part 2 page 13 -
14 o take any appropriate action regarding these complaints and imperfections noted in the products which impact upon their compliance with the certification requirements, o document the actions taken. stop making any reference to the certification of the products concerned and to stop using all of the means of communication making reference thereto in the event of suspension, reduction, withdrawal or refusal of renewal of the certificate, authorise follow-up authorisations to be carried out during the period of validity of the certificate, based on the frequency specified in part 4, in addition to any other duly justified supplementary evaluation. make declarations on the certifications in line with the scope of the certificate, not use the certification granted by the LNE in a way which could damage the LNE, nor make a statement on the certification of its products which the LNE could consider as misleading or non-authorised; reproduce the certificates in their entirety, including appendices in the event of provision to a third party. Part 2 page 14 -
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