Rules for the certification of Quality Management Systems Certification schemes for the automotive sector Effective from 10th December 2015 RINA Società per azioni Via Corsica, 12-16128 Genova - Italy Tel.: +39 01053851 - Fax: +39 0105351000 www.rina.org Technical rules
CONTENTS CHAPTER 1 GENERAL... 3 CHAPTER 2 REFERENCE STANDARD / CERTIFICATION REQUIREMENTS... 5 CHAPTER 3 INITIAL CERTIFICATION... 7 CHAPTER 4 MAINTAINING VALIDITY OF THE CERTIFICATE.....8 CHAPTER 5 RECERTIFICATION.....8 CHAPTER 11 SUSPENSION, REINSTATEMENT AND WITHDRAWAL OF CERTIFICATION......9 CHAPTER 13 CONTRACTUAL CONDITIONS... 10 CHAPTER 14 TRANSITION....10
CHAPTER 1 GENERAL 1.1 These Rules define the additional and/or substitutive procedures applied by RINA for the certification of Automotive Management Systems in relation to what is already defined in the 1.2 - General Rules for the Certification of Management Systems For any issues not covered in this document, reference should be made to - General contract conditions governing system, product and staff - Rules for Achieving and Maintaining IATF Recognition 4th Edition for ISO/TS 16949 RINA issues this certificate to organisations whose Quality Management System has been recognised as fully conforming to the following standards: ISO/TS 16949:2009 AVSQ-MIA QS9000/TE SUPPLEMENT In particular, RINA issues the following certificates: ISOTS16949:2009 in the sphere of CISQ AUTOMOTIVE, a federation of Certification Bodies recognised by IATF (International Automotive Task Force) for certification activities according to ISO/TS 16949. For Italy, IATF delegates management of the ISO/TS 16949 Certification Scheme to ANFIA (National Association of Car Manufacturers). AVSQ-MIA in the sphere of ACCREDIA accreditation QS9000/TE SUPPLEMENT out of accreditation The above certificates can be issued both independently and as supplements to ISO 9001:2008 certificates. 1.3 The certification service is available to all organisations working in the automotive sector and does not depend on whether they belong to an association or group but just on the type of activity they perform. The choice of the model of Quality System, from among those indicated in the previous paragraph, is generally made by the organisation depending on the type of products/services it supplies for the automotive sector: - ISO/TS 16949:2009 Production materials Production components or spare parts Heat treatments, galvanic treatments, Painting or other surface treatments Other specific customer products 3
- AVSQ-MIA and QS9000/TE SUPPLEMENT Organisations working in the automotive sector which supply equipment, machinery, plants and production/processing and measuring instruments The "automotive sector" comprises the manufacture of cars, lorries (light, medium and heavy), buses and motorcycles. The "automotive sector" does not comprise industrial, agricultural and earth-moving vehicles. In particular, the ISO/TS 16949:2009 technical specification can also be applied directly to car manufacturers. For ISO/TS 16949:2009 certification, where not expressly indicated in this document, reference must be made to the following rules: IATF - Rules for Achieving and Maintaining IATF Recognition 4th Edition for ISO/TS 16949 RINA will apply the fees established on the basis of its current tariffs for the certification service and guarantees fairness and uniformity of application. RINA is entitled to refuse requests for certification by organisations that have been the subject, or whose production or activities have been the subject, of restriction, suspension or proscription by a public authority. 1.6 The body guaranteeing the certificates issued by RINA (Accreditation Body - ANFIA) may require its observers to take part in the audits performed by RINA in order to ascertain whether the auditing methods applied by RINA comply with the relative standards. The participation of these observers is agreed in advance between RINA and the organisation. If the organisation refuses to accept the above, RINA will implement the certificate withdrawal process. 4
CHAPTER 2 REFERENCE STANDARD / CERTIFICATION REQUIREMENTS 2.1 To obtain RINA certification, a Quality System, as far as applicable in relation to the type of product or service in question, must satisfy, both initially and in the long run, the requirements of the reference scheme and those indicated in the following points of the present chapter, as well as: any additional elements required by the Accreditation Bodies any specific requirements requested by the Customer During its accreditation activities, in fact, RINA must abide by certain reference documents issued by the accreditation bodies. These documents can be obtained from RINA or directly from the accreditation bodies (consulting their Internet sites, for example). 2.2 In particular, in order to obtain Quality System certification, the organisation must: 2.2.1 Have established a Quality System and kept it active in total compliance with the requirements of the reference certification scheme. A Quality System is considered as being fully operative when: it has been applied for at least twelve months for certification according to ISO/TS 16949:2009 (for at least 3 months for certification according to AVSQ- MIA, QS9000/TE SUPPLEMENT), the internal audit system has been fully implemented and its effectiveness can be demonstrated, at least one management review of the system has been carried out and documented, the objectives and processes required to obtain results in agreement with customer requirements and company policy have been defined, these processes have been developed. monitoring activities and measurements of the processes and products with respect to the policy, the product objectives and requirements have been performed and registered, actions have been implemented to promote continual process improvement and guarantee constancy in production methods and in the quality of the products or services supplied. 2.2.2 Have prepared a manual: defining the goal/scope of the Quality Management System, describing the main processes and their interactions and containing or referring to the relative documented procedures. The description of the processes and their interactions must be extended to all those developed by the organisation (also to outsourced processes required to 5
2.3 manufacture/provide a determined product/service that are determining as regards the capacity of the product/service to satisfy the applicable requirements). This can be done in various ways: Descriptions Flow charts or logograms Tables or matrices Other taking into consideration the requirements of the standard and giving a description, not necessarily detailed, of the resources and procedures used to ensure compliance with these requirements, specifying any exclusions of production lines or requirements of the reference standard, illustrating for the latter the reasons why these exclusions do not affect the quality of the product/service supplied, In particular, ISO/TS 16949:2009 only allows exclusion of the requirements relative to chapter 7.3 of the Standard, exclusively as regards product design and development, as long as they do not affect the capacity of the organisation to provide products/services responding to customer and applicable legislative requirements. Point 7.3 is always applicable to the design of the production process. containing a suitable description of the company organisation. The requirements indicated in point 2.2 are verified by RINA by means of a two-stage initial audit: Stage 1 audit (PHASE 1) - RINA conducts an initial suitability audit at the organisation's site Stage 2 audit (PHASE 2) - RINA performs an on-site audit. The special features of the initial audit are described in the next chapter. 6
CHAPTER 3 INITIAL CERTIFICATION 3.5 In addition to what is stated in section 3.5 of the General Rules for the Certification of Management Systems, the certification process is suspended if major or minor2 non conformities are found. If at least one or more major and/or minor non-conformities are found, a supplementary audit must be performed within three months in order to check that the proposed corrective action has been applied correctly and effectively; if this audit is successful the certification process is renewed. Depending on the seriousness and number of findings, RINA may decide to perform a supplementary audit at organisation's site or conduct a documents review of the corrective action taken by the organisation. If the supplementary audit for checking the proposed corrective action is not performed within three months from the stage 2 audit, RINA reserves the right to terminate the certification procedure and charge the time and money spent up until that moment. In such a case, if the Organisation wishes to proceed with RINA certification, it must submit a new application and repeat the certification procedure. 1 If it is impossible to access the Internet, the organisation may fill in a paper form and send it to the pertinent RINA Office. 2 Major and/or minor non-conformities are: Major non-conformity a) the total non-consideration of one or more requirements of the Reference standard A certain number of minor non-conformities concerning a single requirement may point to the total inadequacy of the system and therefore generate one major non-conformity. b) A situation that may determine the delivery of a non-conforming product or one that does not comply with current law. c) the non-observance of one or more requirements of these rules. d) A situation that is likely to cause a failure in the management system or reduce its ability to assure controlled processes or products/services Minor non-conformity Failure to observe the reference standard that, according to the auditor's judgement and experience, is not such as to: a) make the Quality Management System fail; b) reduce its ability to assure controlled processes or products; c) lead to the delivery of non-conforming product. It may be: a) a shortcoming concerning Quality Management System documents; b) a single slight failure observed regarding a requirement of the company Quality Management System. 7
CHAPTER 4 MAINTAINING VALIDITY OF THE CERTIFICATE 4.6 In addition to what is stated in section 4.6 of the General Rules for the Certification of Management Systems, If any non-conformities are found during the surveillance audits, RINA evaluates the management of these non-conformities as follows: if major non-conformities are found, the organisation is subjected to a supplementary audit within the deadline established by RINA, depending on the importance of the non-conformities, but always within three months from the surveillance audit; if minor non-conformities are found, the organisation may be subjected to a supplementary audit at the auditor s discretion and within the deadline established by RINA. The organisation must always send RINA written evidence to show it has effectively implemented the proposed corrective action and within 60 days from notification of the non-conformities. Depending on the seriousness and number of findings, RINA may decide to perform a supplementary audit at the organisation's site or conduct a documents review of the corrective action taken by the organisation. If the non-conformities are not eliminated within the established times or if they do not assure the supplied products/services satisfy customer requirements and applicable law, RINA may suspend certification until these non-conformities have been eliminated and, in any case, as specified in point 11.1. All costs relative to any supplementary audits deriving from shortcomings in the Quality System will be charged to the organisation. CHAPTER 5 RECERTIFICATION 5.4 In addition to what is stated in section 5.4 of the General Rules for the Certification of Management Systems, if at least one or more major and/or minor non-conformities are found, within a maximum of three months and in any case before the date of expiry of the certificate of conformity, a supplementary audit must be performed in order to ascertain the correct and effective application of the proposed corrective action. Depending on the seriousness and number of findings, RINA may decide to perform a supplementary audit at the organisation's site or conduct a documents review of the corrective action taken by the organisation. The established times within which the organisation must perform the supplementary audit are communicated to the organisation in the recertification audit report. All costs relative to any supplementary audits deriving from shortcomings in the Quality System will be charged to the organisation. 8
CHAPTER 11 SUSPENSION, REINSTATEMENT AND WITHDRAWAL OF CERTIFICATION 11.1 The validity of the certificate of conformity may be suspended as indicated in GENERAL CONTRACT CONDITIONS GOVERNING SYSTEM, PRODUCT AND STAFF CERTIFICATION and in the following specific cases: if the organisation does not allow surveillance or recertification audits to be performed at the requested frequencies; if major and/or minor non-conformities are found in the Quality System which have not been corrected within the time limits established by RINA notification of customer claims to the organisation (CHRYSLER - Needs Improvement Status, FORD - Q1 Revocation status, GM and FIAT New Business Hold, CSL I and/or CSL II or other notifications received from car makers). if the organisation does not observe the deadlines established for the communication of corrective actions, following non-conformities indicated on the audit report; if the organisation has made far-reaching changes to its Site/s or moves to another site without informing RINA of such changes if the organisation has made significant modifications to its QS which have not been accepted by RINA; if the organisation has undergone important re-structuring and has not reported this to RINA; if it refuses or obstructs the participation in audits of the observers of an accreditation body (ANFIA); for evidence that the Quality Management System does not guarantee the respect of the laws and regulations applicable to the activity and/or the site/s; if justified and serious claims received by RINA are confirmed. The organisation may also make a justified request to suspend certification, normally for not more than six months (four months for the suspension of ISO/TS 16949:2002 certificates) and in no case after the date of expiry of the certificate. This suspension will be notified to the organisation in writing, stating the conditions for reinstating certification and the date by which the new conditions are to be complied with. Suspension of the validity of the certificate is made public by RINA directly on the website www.rina.org. For ISO/TS 16949:2002 certification, the suspension of the certificate of conformity is notified to IATF. 11.2 Reinstatement of certification is subject to verification that the shortcomings which led to the suspension itself have been eliminated. This is achieved by means of an analytical audit checking the compliance of the Quality Management System with all the requirements of the reference standard. It is notified to the organisation in writing and made public by RINA on its website www.rina.org. 9
11.3 Failure to fulfil the conditions as per point 10.2 above by the established date will lead to revocation of the Certificate of Conformity Revocation of the certificate of conformity may be decided as indicated in GENERAL CONTRACT CONDITIONS GOVERNING SYSTEM, PRODUCT AND STAFF CERTIFICATION and in the following specific cases: when there are reasons such as those indicated in point 11.1 for suspension, which are held to be particularly serious; if the organisation stops the activities or services covered by the certified Quality Management System for over six months as a rule; if the organisation does not accept the new economic conditions established by RINA due to a modification in the contract; for the case of multi-site organisations, if the headquarters or one of the sites does not comply with the criteria required to maintain certification; if the organisation, following notification by customers (CHRYSLER - Needs Improvement Status, FORD - Q1 Revocation status, GM-FIAT New Business Hold, CSLI and/or CSLII or other notifications received from car makers), does not show the notifications have been dealt with within the deadline of the period of suspension for any other reason that RINA deems to be serious. Withdrawal of the Certificate of Conformity is notified in writing to the Organisation and made public by RINA. Any organisation which, following revocation of its Certificate, wishes to be re-certified, must submit a new application and follow the entire procedure all over again. CHAPTER 13 CONTRACTUAL CONDITIONS For contract conditions, the contents of the current edition of the RINA document "General Contract Conditions for System, Product and Staff Certification" apply. CHAPTER 14 TRANSITION In accordance with IATF 2015-007 comunique of 12 October 2015, for the Organization that have successfully passed the certification / recertification audit and the certificate will be issued/re-issued after 15 September 2015, the certificate in conformance with ISO / TS 16949: 2009 will have the expiry date locked at 14 September 2018, date corresponding to the end of the transition period provided by IAF (International Accreditation Forum) for the certification in accordance with ISO 9001:2015. 10
Publication: RC/C.92 English edition RINA Società per azioni Via Corsica, 12-16128 Genova - Italy Tel.: +39 01053851 - Fax: +39 0105351000 www.rina.org Technical rules