NF Certification Reference System:

Transcription

1 CERTIFICATION NF Certification Reference System: THERMOPLASTIC MATERIAL DRAIN OR SEWER SYSTEM OPERATING WITHOUT PRESSURE Identification No.: 442 Revision No.: Revision rev02 Effective date: 01/03/2017 The English version is provided for information. In case of doubt or dispute, the French version only is valid. CENTRE SCIENTIFIQUE ET TECHNIQUE DU BATIMENT CERTIFYING BODY MANDATED BY AFNOR CERTIFICATION 84 avenue Jean Jaurès Champs-sur-Marne Marne-la-Vallée Cedex 2 Tel.: +33 (0) Fax: +33 (0) MARNE-LA-VALLÉE / PARIS / GRENOBLE / NANTES / SOPHIA-ANTIPOLIS

2 TABLE OF CONTENTS Partie 1 Application Scope Certification added value Applying for certification / Certification contract Applicant s commitment... 8 Publication Partie 2 The certification programme Regulations The standards and complementary specifications Declaration of modifications Quality management provisions: audit reference system Option 1: Quality MANAGEMENT Option 2: Quality control Marking General provisions Conditions for terminating marking or for removing the mark in the case of suspension, withdrawal or abandonment Fraud and falsification Partie 3 Certification Process General Certification application handling process Audits Sampling Inspections in retail sites Tests Partie 4 The stakeholders The certifying body Audit bodies Test bodies Specific Committee Partie 5 Glossary PAGE 2

3 This certification reference system has been submitted for validation by the CSTB Technical Department. It was approved by the AFNOR Certification Managing Director on 01/03/2017 for acceptance into the NF certification system. It cancels and replaces all previous versions. As a certifying body accredited by the COFRAC under number , scope of accreditation available at CSTB undertakes to draft certification reference systems that guarantee an appropriate level of requirements for the quality of products, their suitability for use and their durability. This certification reference system may therefore be revised, in whole or in part, by CSTB, after the interested parties have been consulted in accordance with the requirements of standard NF X The revision of the certification reference system is approved by the AFNOR Certification Managing Director. MODIFICATION HISTORY Creation of the NF mark: 18/02/2011 Modified section The whole document Revision no. Date brought into application Modification made 0 18/02/2011 First issue of the certification reference system The whole document The whole document 01 30/08/ /03/2017 Revision of the certification reference system: revision of all technical documents, integration of a subcontracting procedure for manufactured components, updates to standards and test operating procedures Revision of the certification reference system: revision of all technical documents, integration of simplified sampling for a range of the same group manufactured on several sites and removal of TD8. Modification of the document s structure. PAGE 3

4 Partie 1 Application 1.1 Scope This certification reference system currently concerns piping systems (pipes, fittings, manholes, inspection chambers, ancillary fittings, etc.) for thermoplastic material drain or sewer systems operating without pressure, divided into 6 groups of products. : Structured-wall piping with smooth external surface group (Type A), Structured-wall piping with profiled external and smooth internal surface group (Type B), Ancillary fittings and inspection chambers group, Manholes and inspection chambers in vehicular and pedestrian areas and deeply buried systems group, Solid-wall PVC-U piping systems group, PP piping systems group, Table 1 explains the categories of products covered by each group. All rights to use the NF mark are granted to a manufacturer based on conformity to one or more standards and, if applicable, the complementary specifications for a product or range of products from a designated manufacturer and manufacturing unit. TECHNICAL DOCUMENTS Structured-wall piping with smooth external surface (Type A) Structured-wall piping with profiled external and smooth internal surface (Type B) Ancillary fittings and inspection chambers Manholes and inspection chambers in vehicular and pedestrian areas and deeply buried systems Solid-wall PVC-U piping PP piping Table 1: Categories of products covered per Technical Document CATEGORIES - Pipes for seal ring assembly - Shaped fittings for seal ring assembly - Pipes for seal ring assembly - Injected fittings for seal ring assembly - Shaped fittings for seal ring assembly - Rotomoulded fittings for seal ring assembly - Ancillary fittings - Connection chambers (closed to traffic) - Inspection chambers (closed to traffic) - Manholes - Connection chambers - Inspection chambers - Pipes for solvent welding assembly - Pipes for seal ring assembly - Fittings for seal ring assembly - Pipes for seal ring assembly - Fittings for seal ring assembly PAGE 4

5 The NF mark strives to inspect the safety characteristics for people and goods, the suitability for use and the durability of the products, as well as any complementary characteristics to enable them to stand out on the market. 1.2 Certification added value Certification is recognition from a third party that the characteristics are compliant, demonstrating the added value of the products covered by this reference system. The certified characteristics of the thermoplastic material drain or sewer system operating without pressure application are defined in technical documents no. 2 to 7. The CSTB is responsible for assessing the certified characteristics, with the following control measures: Admission Continued monitoring Production audit carried out by a qualified technical auditor: - Verification that the production inspections and records have been carried out: raw materials, manufacturing, finished products, - Verification of the quality management provisions: metrology, packaging, storage, traceability, product marking, processing of nonconformities and customer complaints, - Supervision of certified characteristics tests carried out by the applicant, where applicable. Tests carried out by a laboratory recognised by the certifying body (independent and competent): - Samples are taken by the certifying body on the site of the applicant/holder. Yes Yes Yes Frequency: 2 annual audit(s) (*) Yes Frequency: 1 annual test campaign (*) The applicable follow-up audit regime during monitoring of certified products is the twice-yearly regime (2 audits per year) during the 3 years immediately following admission, then the yearly regime (1 audit per year). In the case of the yearly regime: The CSTB will ensure that the interval between two visits is not less than 9 months and does not exceed 15 months, Heightened review inspection Any critical deviation, whether or not it is accompanied by a sanction, may justify a return to the twice-yearly regime, at the initiative of CSTB, possibly after the Specific Committee gives its recommendation, for a defined period of time, with or without additional heightened inspections. PAGE 5

6 1.3 Applying for certification / Certification contract Any legal entity: manufacturing products within the scope defined above and that can comply with the technical requirements described in Part 2 of this document, or distributing products within the scope defined above for which the manufacturer complies with the technical requirements described in Part 2 of this document, can apply to receive a right to use the NF mark Thermoplastic material drain or sewer system operating without pressure. Such a request is referred to as an "application"; the entity making the request is known as the "applicant". The applicant submits its application to the certifying body. It is accompanied by all the useful information concerning the given products, the production conditions and quality control to ensure compliance of the processes with this certification reference system. An application form and the list of information to be supplied to support an application are appended to this certification reference system. During a period of 10 working days, beginning on the date of receipt by the certifying body of its application for certification, the applicant has the right to withdraw from its commitments, for any reason whatsoever, by sending a registered letter with acknowledgement of receipt to the certifying body. The Certification contract is composed of the completed and signed application letter, possibly accompanied by the estimate; it is governed by all the documents referenced by this application letter (NF mark general rules, certification reference system, complementary technical requirements, etc.). The Contract is entered into for an unlimited term. The holder may terminate NF certification, with no further legal formality, for all or some of its certifications for any reason whatsoever, in particular when activity has ceased. Such termination takes effect only after the expiration of a period of 15 days beginning on the date of receipt by CSTB of the registered letter with return receipt, remitted by the holder, communicating the termination of the NF certification, with no further legal formality, for one of the reasons defined above. Beginning on the date when the termination takes effect, the holder undertakes to no longer use, in any way whatsoever, nor reproduce, on any medium whatsoever, the NF mark for the products, the certification of which has halted. The certifying body reserves the right to halt an NF certification. The certifying body then specifies the transitional procedures and conditions before the definitive halting of the certification concerned. The contract is governed by French law. If there is any problem with interpretation, execution or validity of the Contract, the Parties agree to solve their differences out of court unless there is an emergency that justifies calling in a competent jurisdiction acting in summary proceedings. PAGE 6

7 If the Parties are unable to resolve their disagreement within three (3) months from the date it occurred, the dispute will be brought by the most diligent Party before the competent French courts. Note 1: Particular case of an admission request in a country subject to special vigilance: After observing a number of tensions throughout the world, the French Ministry of Foreign Affairs defined alert areas for each country under the following conditions: green areas for normal vigilance; yellow areas for increased vigilance; orange areas inadvisable unless for imperative reasons; red areas highly inadvisable. In accordance with the recommendations of the French Government, with a view to ensuring the safety of CSTB personnel and its subcontractors (hereafter referred to as the Auditors ), any admission applications for certification made by entities whose sites to be assessed within the framework of certification are situated on the territory of a country classified in orange- or red-alert areas shall not be taken into consideration by CSTB. As regards certification applications made by entities whose sites to be assessed within the framework of certification, during the admission or follow-up stages, are situated on the territory of a country classified in a yellow-alert area, Auditors are allowed to travel provided the audited entity makes arrangements locally and entirely at its own expenses for the transport and accommodation of Auditors so that their safety may be ensured. Within 10 days prior to any travel, the applicant/holder shall provide CSTB with the Auditors travel and accommodation conditions required to ensure their safety. The CSTB may make observations and justify additional requests; it reserves the right to cancel any business trip if the conditions submitted do not provide sufficient guarantees for safety. Note 3: Specific case of a new application in the context of a withdrawal or suspension of a certificate following a penalty If CSTB announces the withdrawal of a certificate following a penalty, the holder loses its right to use the NF mark. It becomes a former holder. Former holders may not submit a new certification application for a product, service or person that is identical to the product, service or person at the source of the decision to withdraw the certificate, unless they provide CSTB with evidence deemed satisfactory demonstrating that curative and corrective actions have been implemented since the withdrawal decision, bringing the product, service or person into strict and sustainable compliance with all the Certification requirements. Similarly, if CSTB announces the suspension of a certificate following a penalty, the holder loses the right to use the NF mark until CSTB lifts this suspension. By lifting the suspension, it is assumed that the holder has supplied CSTB with evidence deemed satisfactory demonstrating that curative and corrective actions have been brought in following the suspension decision, bringing the product, service or person into strict and sustainable compliance with all the Certification requirements PAGE 7

8 1.4 Applicant s commitment Before making its request, the applicant shall make sure that it meets the conditions set down in this certification reference system concerning its product and the sites concerned. It is the applicant s responsibility to make sure that the regulations applicable to its product are fulfilled. It shall commit to respecting those same conditions during the whole duration of use of the NF mark. The applicant undertakes: 1. to accept and comply with the conditions fixed and defined in the certification reference system specific to the field of products concerned and, in particular, to: - present the products for certification in compliance with the existing regulations concerned, - implement the modifications required by the changes in the certification reference system communicated by the certifying body, - use the NF mark under the conditions set down in the certification reference system and only for the certified products, - follow up on the decisions made by the certifying body as part of certification (in particular, specify and implement corrective actions in response to any disparity detected or apply a sanction decision). 2. to pay the certification fees (management, audit and tests, if need be) in conformity with the price list in force; 3. to not submit any counterfeited products for certification; 4. to take the necessary measures: - to conduct the audit, including the supply of elements to be examined such as documentation and records, access to the relevant equipment, locations, production areas, staff and subcontractors of the client concerned, - for the participation or non-participation of third-party observers during the audit, where appropriate, - for the participation or non-participation of third-party observers during the audit (COFRAC auditor, CSTB certified auditor or CSTB staff); the presence of this observer is systematically communicated to the applicant by CSTB prior to the audit. The applicant may decline an observer on the basis of justifying a potential conflict of interest. 5. to examine and record all complaints: - to make these records available to the certifying body and the auditors, upon request, - to take any appropriate action related to those complaints or defects observed in the products affecting their conformity to the certification requirements, - to document action taken. 6. to meet the conditions for use of the NF Mark as defined in paragraphs 4.1 and 4.2 of the NF s general rules; PAGE 8

9 7. to efficiently apply the production control system established in order to meet the requirements of the certification reference system; 8. to immediately inform the certifying body of any modification to the basic file submitted during the application for the right to use the NF mark under the conditions set down in this certification reference system (in particular any modification to the product(s) related to the application); 9. to inform the certifying body of any definitive or temporary halt in production concerning the certificate under the conditions set down by the certification reference system; 10. to make statements and provide communication on certification consistent with the scope of certification; 11. to not use the certification of its projects in a way that could harm the certification body, the NF Mark or the certified products, particularly: - to not use the NF mark in a way that is improper or non-compliant with the certification reference system in force; - to not use the certifying body s logo. 12. upon suspension, withdrawal or termination of certification, to discontinue its use of all advertising materials that contain any reference thereto, to take action as required by the certification reference system and to take any other required measures; 13. to communicate to the certifying body, at its request, all the advertising printed materials and catalogues referring to the NF mark; 14. if copies of the certification documents are provided to others, to reproduce them in their entirety or as specified in the certification reference system; 15. when making reference to the certification of its products in communication materials, whether physical or electronic, such as documents, brochures or ads, to comply with the requirements set down in the general rules of the NF mark in addition to the requirements defined in the certification reference system; 16. for all the associated personnel of the certifying body or for its qualified subcontractors, to make sure that all the safety provisions concerning the working conditions, sites or equipment are in compliance with the regulations in force at the locations concerned. Note: Specific case of production subcontracting by an applicant: The applicant may subcontract part of the manufacture of its products covered by this certification reference system. In this case, it commits to respecting the requirements defined in paragraph of this certification reference system Failure to comply with all of these commitments may lead to examination of the applicant s application being interrupted or suspended. PAGE 9

10 Publication The certifying body reserves the right to publish the certificates to provide the best possible information to users. The certified characteristics, the list of holders of the NF mark and/or the NF certificates are made public via the certifying body's website. PAGE 10

11 Partie 2 The certification programme The certification programme for the thermoplastic material drain or sewer system operating without pressure application contains this certification reference system, which references: the NF mark General Rules, which set the organisation and conditions for the use of the mark; the standards and the complementary specifications defined in Technical Document No. 1; the additional technical requirements: Technical Documents No. 2 to 7 This certification reference system is in line with the framework of the certification of products and services, other than food-related, as provided for in the Consumer Code (articles R and R and L to L ). It specifies the conditions for applying the General Rules of the NF mark to products defined in Part Regulations The granting of the right to use the NF mark can in no way substitute CSTB's responsibility for the legal responsibility on the company holding the NF mark usage right. As regards the regulatory requirements covered by this certification reference system, the applicant/holder shall submit to the certifying body during the certification audits the documentary evidence defined in the regulations and attesting to the compliance of its product with the regulatory requirements. Note: if the documentary evidence is not handled or available on the site where the audit is being conducted, this evidence shall be submitted to the certifying body, using any appropriate means, before the certifying body completes its assessment. The applicant/holder is held responsible to the certifying body for any inaccurate, deceptive and/or non-compliant documentary evidence with regard to the definition of documentary evidence as laid down in the regulations. The certifying body s tasks do not lie in proving conformity of a product with the regulatory requirements listed in this document. Those tasks are strictly incumbent upon the bodies approved by the authorities in charge of applying each of the regulations concerned. PAGE 11

12 2.2 The standards and complementary specifications For the references that indicate a date of implementation or an index, only the version cited is applicable. For references that do not indicate a date of implementation or index, the most recent version of the reference document applies (including any amendments) PRODUCT STANDARDS The products about which these rules are concerned, must meet the requirements set down in the standards cited in the technical documents defined in paragraph List of standards cited by product group: Structured-wall piping with smooth external surface group (Type A): NF EN (September 2007) Plastics piping systems for non-pressure underground drainage and sewerage - Structured-wall piping systems of unplasticised poly(vinyl chloride) (PVC-U), polypropylene (PP) and polyethylene (PE) - Part 1: General requirements and performance characteristics. NF EN (September 2007) Plastics piping systems for non-pressure underground drainage and sewerage - Structured-wall piping systems of unplasticised poly(vinyl chloride) (PVC-U), polypropylene (PP) and polyethylene (PE) - Part 2: Specifications for pipes and fittings with smooth internal and external surface and the system, Type A. NF EN ISO 3126 (September 2005) Plastics piping systems Plastics components Determination of dimensions. Structured-wall piping with profiled external and smooth internal surface group (Type B): NF EN (September 2007) Plastics piping systems for non-pressure underground drainage and sewerage - Structured-wall piping systems of unplasticised poly(vinyl chloride) (PVC-U), polypropylene (PP) and polyethylene (PE) - Part 1: General requirements and performance characteristics. NF EN (March 2009) Plastics piping systems for non-pressure underground drainage and sewerage - Structured-wall piping systems of unplasticised poly(vinyl chloride) (PVC-U), polypropylene (PP) and polyethylene (PE) - Part 3: Specifications for pipes and fittings with smooth internal and profiled external surface and the system, Type B. Ancillary fittings and inspection chambers group: NF EN (April 2011) Plastics piping systems for non-pressure underground drainage and sewerage - Unplasticised poly(vinyl chloride) (PVC- U), polypropylene (PP) and polyethylene (PE) - Part 1: Specifications for ancillary fittings including inspection chambers. PAGE 12

13 Manholes and inspection chambers in vehicular and pedestrian areas and deeply buried systems group: NF EN (March 2009) Plastics piping systems for non-pressure underground drainage and sewerage - Unplasticised poly(vinyl chloride) (PVC- U), polypropylene (PP) and polyethylene (PE) - Part 2: Specifications relating to manholes and inspection chambers in vehicular and pedestrian areas and deeply buried systems. Solid-wall PVC-U piping systems group: NF EN (April 2009) Plastics piping systems for non-pressure underground drainage and sewerage - Part 1: Specifications for pipes, fittings and the system. PP piping systems group: NF EN (May 2009) Plastics piping systems for non-pressure underground drainage and sewerage - Polypropylene (PP) - Part 1: Specifications for pipes, fittings and the system The standards are supplemented by complementary specifications (defined in paragraph below) COMPLEMENTARY SPECIFICATIONS In addition to the requirements set down in the previous paragraphs, the products shall meet the complementary specifications defined in the following technical documents (these technical documents have the same revision index as the certification reference system: No. 2: - Technical Document 1: Specifications applicable to all groups. - Technical Document 2: Structured-wall piping with smooth external surface group (Type A). - Technical Document 3: Structured-wall piping with profiled external and smooth internal surface group (Type B). - Technical Document 4: Ancillary fittings and inspection chambers group. - Technical Document 5: Manholes and inspection chambers in vehicular and pedestrian areas and deeply buried systems group. - Technical Document 6: Solid-wall PVC-U piping systems group. - Technical Document 7: PP piping systems group. 2.3 Declaration of modifications This paragraph specifies the information that the holder of the right to use the NF mark must provide to CSTB and the procedures it must follow in the event of any modifications to: the holder; PAGE 13

14 the manufacturing unit; the quality organisation of the manufacturing plant; the product; modification concerning the use of externally recycled or reclaimed materials. Failure to respect this obligation as observed by CSTB may lead to a suspension or withdrawal of the right to use the NF mark. In the cases not provided for earlier, CSTB determines whether the modifications call the certification into question and whether it is necessary to carry out an additional inspection. Depending on the results of the examination, CSTB communicates the appropriate decision MODIFICATION CONCERNING THE HOLDER The holder shall communicate in writing to CSTB any legal modification of its company or any modification to the company name. In case of merger, liquidation or absorption of the holder, all rights to use the mark, which it may have, automatically stop. A new admission application may be submitted and its examination may be simplified depending upon the modifications made MODIFICATION CONCERNING THE MANUFACTURING UNIT - Case of a production transfer: Any transfer (total or partial) of the manufacturing unit of a certified product to another production site entails an immediate halt of NF marking by the holder on the products concerned. The holder shall declare this transfer in writing to CSTB, which will organise an audit of the new production unit and, as the case may be, have tests carried out. The inspection visit can be simplified or even eliminated when the new production unit is already well known to CSTB. The assessment and renewal decision procedures for certification are the same as those for admission as described in Part 3 of this certification reference system. - Case of a modified production process: The holder shall prove that the modification of the production process does not have an impact on the performances of the product s certified features (Cf : V15); they inform CSTB of this. PAGE 14

15 2.3.3 MODIFICATION CONCERNING THE PRODUCTION UNIT S QUALITY ORGANISATION The holder must notify CSTB about any change to its quality organisation that could have an influence on production compliance with the requirements of this certification reference system (modifications concerning its facilities, quality plans, etc.). In particular, it shall declare any modification in the certification of its quality management system. Any temporary halt in the internal quality assurance operation for a certified product entails an immediate halt in the NF marking of this product by the holder, which must inform CSTB of this. The CSTB then communicates to the holder a decision to suspend the right to use the NF mark for a specific duration following which, if the right of use cannot be re-established, this holder s right to use the NF mark will be withdrawn MODIFICATION CONCERNING THE CERTIFIED PRODUCT Any modification of the certified product in relation to the application dossier, the accepted model and rules set out in these rules that could have an effect on the conformity of the product with the requirements of this certification reference system, shall be declared in writing to CSTB. Depending on the modification declared, CSTB determines whether this is a certification extension application TEMPORARY OR DEFINITIVE HALT IN PRODUCTION Any definitive or temporary halt in the manufacture of the certified product (or range or products) or any abandonment of a right to use the NF mark shall be declared in writing to CSTB, specifying the time necessary to sell off the inventory of the NF-labelled products. Upon expiration of the time frame indicated by the holder, the suspension or withdrawal of the right to use the NF Mark is communicated by CSTB. Any temporary halt in the manufacture of the certified product (or range of products) must be the subject of a suspension of the right to use the NF mark for a maximum period of 6 months, renewable once, if applicable. The total duration of the suspension of the right to use the NF mark for these products must not exceed a duration equivalent to the length of time between 2 audits (maximum of 15 months) and, after consultation with the Specific Committee, will lead to a suspension or withdrawal of the right to use the mark for these products. The lifting of the suspension may only be announced following one or more assessments MODIFICATION CONCERNING THE DISTRIBUTION SYSTEM The distributor who s right to use the NF mark has been maintained shall commit to informing CSTB of any modifications in its supplies that would result in the right to use the NF mark no longer being maintained. The distributor's right to use the NF mark can only be validated after a new examination in accordance with Part 3 of this certification reference system. PAGE 15

16 2.3.7 MODIFICATION CONCERNING THE USE OF EXTERNALLY RECYCLED OR RECLAIMED MATERIALS The holder of the right of use must commit to informing CSTB when it decides to use externally recycled or reclaimed materials. The right to use the mark cannot be maintained unless the holder s procedure is compliant with the requirements defined in Technical Document No. 3 Table 1 and Appendix 1 Externally recycled or reclaimed materials specifications. This modification must be the subject of an extension application for the right of use, which will be processed during follow-up, extension or admission audits in the context of the NF 442 mark and will be the subject of a notification after consultation with the Specific Committee. PAGE 16

17 2.4 Quality management provisions: audit reference system PURPOSE Applicants/holders and their distributors holding a right of use are each responsible for the right to use the NF mark for the relevant product. The applicant/holder shall implement all necessary means to guarantee that the product complies with this certification reference system at all times. In addition, it must ensure the control of its external service providers using all methods to assess all the component elements of a product or external service(s) for which it is the applicant or holder of the right to use the certification mark. This paragraph sets the minimum provisions that the applicant/holder shall implement in terms of quality management to ensure that the products are manufactured respecting the certification reference system at all times. The quality system depends in part on the establishment by the applicant/holder of a set of organisational measures ensuring conformity of the delivered products with the standards and complementary specifications, if applicable. These provisions are described in paragraphs 2.5 and 2.6 below: The quality requirements are defined according to 2 options, left to the choice of the applicant or holder: 2.5 Option 1: Quality MANAGEMENT The Quality management option relies on certification of the compliance of the holder s system with the ISO 9001 quality management model. The applicant/holder shall have implemented its own methods, the existence and effectiveness of which have been assessed based on the requirements of standard NF EN ISO 9001: NF EN ISO 9001 revision 2008 (applicable until September 15, 2018) and NF EN ISO 9001 revision 2015 (applicable as of September 15, 2015). The audits are carried out according to Table 2 as follows. This table indicates the specific requirements in standard NF EN ISO 9001, which must be verified in the context of the certification. If the manufacturing unit is not NF EN ISO 9001-certified, the applicant/holder must justify the introduction of a range of organisational provisions and a production control system to control conformity with the standards and complementary specifications for the delivered products that meet at least the requirements in this certification reference system. As part of an audit, all requirements identified on the shaded lines in Table 2 below must be audited, as well as the register of client complaints; these reductions lead to a shorter audit period but not fewer audits. All other requirements in terms of quality management shall be audited over a 3-year period. A customer complaint register shall be kept and shall mention how the complaints are being dealt with. The holder s register shall comprise the following: PAGE 17

18 - a record of all complaints and appeals; - a record of follow-up actions taken; - a record of the corrective measures adopted when the complaints revealed a manufacturing anomaly. As part of this option, CSTB may take certification issued by a certification body for systems into account, provided that: - the ISO 9001 certificate includes within its scope and domain the sites and activities covered by the certification mark; and - the ISO 9001 certificate is issued by a certifying body accredited by the COFRAC or by a member of the EA (European cooperation for Accreditation) or by a member of the IAF (International Accreditation Forum) - see signatories on the COFRAC website and - the last ISO 9001 audit report from the body is forwarded to CSTB, prior to the body s audit or examined during the body s audit. The choice of one or the other of these options involves: The applicant or holder putting in place a system consistent with the option chosen. Various third-party quality assurance procedures. In all cases, this reduction can be called into question if the conditions according to which the reduction was accepted are no longer respected. Possible simplification: If the manufacturing unit has a certified quality management system that conforms to standard NF EN ISO 9001, the audits may be simplified. Only the requirements identified on a shaded line in Table 2 are to be audited. This simplification is possible as long as: the ISO 9001 certificate includes within its scope and domain the sites and activities covered by the certification mark; and the ISO 9001 certificate is issued by a certifying body accredited by the COFRAC or by a member of the EA (European cooperation for Accreditation) or by a member of the IAF (International Accreditation Forum) - see signatories on the COFRAC website and the last ISO 9001 audit report from the body is forwarded to CSTB, prior to the body s audit or examined during the body s audit. 2.6 Option 2: Quality control The Quality control option relies in part on the establishment by the holder of a set of organisational measures ensuring conformity of delivered products with standards and complementary specifications, in the absence of certification of conformity of the quality assurance system by an accredited certifying body. These provisions are described in Paragraphs and The applicant/holder shall justify that a set of organisation measures and a production control system have actually been set up to control conformity with standards and PAGE 18

19 complementary specifications for delivered products satisfying at least the requirements in this certification reference system MINIMUM REQUIREMENTS FOR QUALITY MANAGEMENT Table 2 (Applicable requirements) ISO 9001: 2008 ISO 9001: 2015 REQUIREMENTS MINIMUM EVIDENCE EXPECTED APPLICABLE 5. Leadership * Organization chart / Organizational roles, responsibilities and authorities * Description of responsibilities and authorities (examples: organization chart, job sheets, etc.) For individuals in charge of inspection or having a direct impact on the critical points in terms of product creation and production * Person appointed to be responsible for organizing and efficiently implementing the production system All the items except: * ISO 9001 V15: 5.3 c,d 7. Support Environment for the operation of processes Evidence of maintenance of the work environment. Examples: storage of a product and its components to protect them from bad weather, suitable ambient conditions, etc. For processes related to production of products/services * List of the inspection, measuring and test equipment used on the product/service production site and/or in the laboratory, * Identification of the equipment used to determine its validity, Monitoring and measuring resources * Planning for the verification or calibration of the equipment having an impact on the validity of the results (in particular the equipment used to perform tests on certified characteristics), For processes related to production of products/services * Evidence of the verification and/or calibration operations (ex: equipment data sheet, verification or calibration report, etc.), * Evidence of connection to national or international standards (where possible), * Validation of software used to monitor and measure the specified requirements, where appropriate. PAGE 19

20 Competence Documented information Control of externally provided processes, products and services * Compliance with test methods and inspection provisions. * Actions planned to acquire the necessary skills (training, tutoring, etc.), where appropriate. * List of the internal and external documented information. Examples: Procedures, operating methods, test methods, inspection instructions, quality records * Evidence of control of internal and external documents Example: Availability of the applicable version of the test method, the reference system, the inspection provisions, etc. 8. Operation * List of the service providers * Contract/order defining the requirements of the applicant/holder of the certification * Evidence of the verification of raw materials, components (1), services purchased * Evidence of the verification of subcontracting conditions: transport, handling, tests (2), etc. For individuals in charge of inspection or having a direct impact on the critical points in terms of product creation and production For the processes related to completion of the products All the items except: * ISO 9001 v08: , Note: Quality manuals are no longer required. For raw materials, purchased components and external services affecting the quality of the product/service > External providers: * supplier of raw materials, components, services integrated into the product/service * subcontractor of external services (ex: tests, handling, transport, etc.) (*) Specific case of applicants/holders subcontracting part of their production The CSTB audits the subcontractors (as provided for in the certification reference system) All the items except: * ISO 9001 v08: * ISO 9001 v15: ISO 9001: 2008 ISO 9001: 2015 REQUIREMENTS MINIMUM EVIDENCE EXPECTED APPLICABLE * Information defining the characteristics of products and services. Examples: product plan / description of the service, etc / Control of production and service provision * Information defining the activities to be carried out and the results to be obtained. Examples: operating method(s), working instruction(s), test method(s), certification reference system (expected performance) * Monitoring and measurement activities Examples: Monitoring plan, inspection procedures and instruction(s), test method(s), etc. * Conservation of documented PAGE 20

21 information proving the conformity of products/services with the acceptance criteria (Same as ISO 9001 v08 and 8.6.ISO 9001 v14) Identification and traceability Preservation Control of changes (in production / service provision) Release of products and services * Identification/Marking of the product in accordance with the requirements in the Certification reference system, *Marking of commercial documents in compliance with this certification reference system. Verification that the product is preserved throughout the production line (identification, handling, storage, packaging, transport, etc.) * Evidence of the control of the modifications in the manufacturing process / service provision, in particular, the impact of modifications on the product s performance (3): - reviewing the modifications, - person authorising modifications and all necessary related actions. * Provisions for the control of products; records of the results of inspections and conformity with the acceptance criteria (4) * Name of the individuals responsible for releasing the finished products / services For identification and traceability PAGE 21

22 ISO 9001: 2008 ISO 9001: 2015 REQUIREMENTS MINIMUM EVIDENCE EXPECTED APPLICABLE Control of nonconforming outputs *Provisions for processing nonconformities, including customer complaints and implementation of these provisions (5) * No dispensation granted as regards the performance of a certified characteristic 9. Performance evaluation Management review Management review report 10. Improvement Nonconformity and corrective action * Implementation of corrective actions to deal with nonconformities pertaining to a certified product, including customer complaints (6) * Effectiveness of the actions taken. *: No acceptance by exemption may be considered for a product with NF marking. As part of follow-up, the auditor decides the points to be audited basing him/herself on previous audit reports and on any modifications made to the system since the last audit REQUIREMENTS SPECIFIC TO THE PRODUCTS The applicant/holder shall possess the necessary ways and means for the inspection and testing defined by the standards and complementary specifications mentioned in Paragraph 2.2 of this certification reference system and in the technical documents relative to each product group. The applicant/holder commits to carrying out reliable and regular verification of its production. The inspection operations are organised in three phases as follows: - operations concerning product components; - checks carried out during production; - checks and tests carried out on finished products. (1) Inspection of product components Applicants are required to carry out an inspection of all components used in the manufacture of their certified products upon receipt and in all cases prior to use. PAGE 22

23 This inspection, the content of which may vary according to the applicant s internal inspection structure and the guarantees of regularity provided by the suppliers, generally includes: - incoming checks enabling the delivery to be accepted; - quality assurance operations, making it possible to assess the compliance and/or the regularity of the product s components when compared with the expected characteristics. The method for taking the samples necessary for the inspection shall be described in detail in the applicant s quality plan and shall not be left to the operator s discretion only. This inspection may be simplified if the applicant contractually imposes a comprehensive check before delivery by its supplier(s) and if it possesses, for each batch delivered, the resulting analysis sheets; or if the supplier is certified according to standard NF EN ISO 9001 for the products concerned; or if the products are certified. (2) Subcontracting tests The applicant may outsource the completion of tests to an external laboratory, on the condition that a contract is put in place. Subcontracting is only possible if the following conditions are met: - Subcontracting the tests does not result in a disruption to the production process (due to wait time for results, for example); - The conditions for subcontracting tests must be formalised in the holder's quality plans or in the contract and must, moreover, define the testing frequency, the requested wait times for results, the notification of results in writing, the procedure in the case of non-compliant results and the type of equipment used; - The subcontractors' laboratory where the test is carried out is accredited according to standard NF EN ISO/CEI 17025, otherwise the party requesting the test (the holder of the NF mark) ensures that the equipment used is compliant (calibration, test configuration, etc.). The holder shall record the results of the previous inspections. Should the admissible number of not-entirely-satisfactory products be exceeded, the holder must: - carry out enhanced inspections the following month, - implement the necessary corrective actions and include them on the quality assurance records. (3) Approach to the assessment of the additional requirement in standard ISO 9001 version 2015 compared to Standard ISO 9001 version 2008 Within the framework of the Product Certification audit, the only additional requirement referred to concerns the requirements of in Table 1: Control of changes in production / service provision. PAGE 23

24 If the applicant/holder does not comply with this requirement, the auditor shall communicate: a suggested improvement (if the assessment occurred prior to 15/09/18) a deviation (if the assessment occurred after to 15/09/18). (4) Inspection during production and on finished products The applicant/holder shall possess the necessary ways and means for the inspections and tests defined by the standards, reference documents and complementary specifications mentioned in Paragraph 2.2 of this reference system. The applicant/holder commits to carrying out reliable and regular verification of its production. During production In-production inspection must be organised by the applicant/holder. This concerns the product in its intermediate states in the main steps of manufacturing and the review inspection of the set points of the production equipment (fabrication machines, tooling). Verification instructions shall be formalised and made available to the operators. The inspection results shall be recorded upon each inspection. The applicant shall check the characteristics of the finished products before their delivery. It is responsible for organising this inspection. The inspections and tests on products manufactured by the applicant are usually carried out according to the standards and complementary specifications mentioned in the technical documents of this certification reference system. They respect the testing methods specified in the technical documents of these rules. Measuring the various characteristics verified is done according to the operating procedures defined in the reference standards referred to in Paragraph 2.2 of this certification reference system and in the technical documents relative to each group and product group. The inspections on finished products are carried out by the holder itself at the production site. Type testing for an application for the right to use the NF mark Type testing for an admission application Type testing for an extension application NOTE: A type test is a test carried out once on a new product or upon each major modification to a product, such as a change in formulation. On finished products Applicants/holders are required to verify the characteristics of the finished products before delivery and are responsible for organising this inspection. The inspections and tests of finished products manufactured by the applicant/holder are carried out according to the standards and additional specifications mentioned in this certification reference system. The various inspected characteristics are measured using the operating procedures specified in the reference standards mentioned in Paragraph 2.2 of this certification reference system. PAGE 24

25 The inspections of finished products are carried out by the applicants/holders themselves in their own manufacturing unit. Applicants/holders shall take random samples at the end of the production line and carry out the inspections and tests on these samples. The samples taken must be representative of the dimensions of the products covered by this certification reference system. The method for collecting the samples required for testing must be clearly specified in the holder's quality plan and must not be left to the sole discretion of the operator. The method for collecting the samples required for testing must be clearly specified in the applicant's/holder's quality plan and must not be left to the sole discretion of the operator. Utilising the results The test results shall be utilised by the operator or the supervisor to whom he/she remits them so as to verify, at a minimum, the compliance or non-compliance with the internal specifications and with the specifications in this reference system. Applicants/holders shall record the results of the previous inspections. Should the results of the usual inspections prove to be insufficient, the latter shall be heightened and the causes of failure shall be detected in order to remedy this by supplementing the manufacturing inspections, where appropriate. If the results of the standard inspections are inconclusive, the inspections are heightened in order to detect the causes of the failure and to remedy this by completing manufacturing inspections, when necessary. (5) Provisions for processing non-conformities These notably include: an analysis for identifying the cause of the anomaly, an analysis to determine the impact of the anomaly on production since the previous inspection, management ensuring that the implementation of the corrective actions is effective, in the unlikely event that non-compliant products are delivered to a customer, the latter shall be notified immediately so that appropriate measures can be taken. (6) Customer complaints The customer complaint record is audited; to do this, holders shall keep: a record of all the complaints and appeals pertaining to products covered by this certification reference system; a record of the corrective measures adopted when the complaints have revealed a production anomaly. The holder shall be able to show the auditor extracts from these records relating to complaints that involve products covered by this certification reference system. 2.7 Marking General provisions Marking is an integral part of the certification of a product. PAGE 25