TABLE OF CONTENTS 1 2 3 4 5 6 7 8 9 INTRODUCTION WHAT TYPE OF SITES CAN OR CANNOT BE CERTIFIED? WHAT PARTS OF THE PLANT CAN BE EXCLUDED AND WHAT IS THE IMPACT ON THE AUDIT DURATION? THE AUDIT PREPARATION THE ON-SITE AUDIT DURATION THE TIMING BETWEEN AUDITS THE MANAGEMENT AND TIMELINE OF NON-CONFORMITIES THE DECERTIFICATION PROCESS: SUSPENSION OF THE CERTIFICATION THE CONTRACT TERMS AND CONDITIONS WHERE WILL THE AUDITOR FOCUS DURING THE AUDIT? TO SUM-UP: MAIN CHANGES FOR THE 4 TH EDITION RULES 3 4 5 5 6 6 7 8 8 9 10
INTRODUCTION On October 1 st, 2013, the IATF published the 4 th edition rules of ISO/TS 16949: the international rules for automotive quality management. These new rules will come into force April 1 st, 2014. This new version has been published with the aim to further enhance the quality in the automotive industry and to increase the value of the ISO/TS certification and audit process for all stakeholders. HOW ARE YOU IMPACTED AS AN AUTOMOTIVE ISO/TS CERTIFIED COMPANY? In the following pages, we have summarized the key changes that impact organizations like yours. This document does not intend to present all changes introduced by the 4 th edition of the rules, only a selection of those that may impact the largest population of certified organizations. p.3
1 WHAT TYPE OF SITES CAN OR CANNOT BE CERTIFIED? CLARIFICATION: Fabless sites are not eligible for certification. The new rules clearly define a Fabless site and clearly specify that a Fabless site is not eligible for certification. A Fabless manufacturing site is the design and distribution of production parts where the fabrication or fab of the production part is outsourced to a specialized manufacturer. Fabless companies separate the design from the manufacturing to concentrate on research, design, development and testing. CHANGE: Manufacturing Site Extensions (also known as manufacturing satellites) do not exist anymore, and must be treated as Manufacturing Sites. Starting April 1 st 2014 and to be implemented on a one-year timeline until April 1 st 2015: A main Manufacturing Site will continue with the current cycle but with a new calculation of days according to a separate headcount of only the Manufacturing Site (all site extensions removed). Certificates for the Manufacturing Site will be revised with removal of site extensions from the certificate appendix. The current site extensions will become new Manufacturing Sites as either stand-alone or within a corporate scheme with the main Manufacturing Site. A previous site extension will start with an initial audit scheduled according to audit cycle rules, however, no Stage 1 is required and the duration of Stage 2 can be reduced to the equivalent duration of a recertification audit. A new certificate for a previous site extension shall be issued after a positive certification decision following the initial audit. p.4
2 WHAT PARTS OF THE PLANT CAN BE EXCLUDED AND WHAT IS THE IMPACT ON THE AUDIT DURATION? CHANGE: Under strict conditions, part of a site can now be excluded from the audit. On a site where all manufacturing processes related to the automotive production are performed in a dedicated portion of the site (the processes are physically separated from the non-automotive production), and all employees working on the automotive processes are completely dedicated to the automotive processes, then it may be possible to raise a request to exclude the non-automotive manufacturing processes from the audit. Acceptance, if granted, can lead to a reduction of the audit duration. The Certification Body will relay the request to the Oversight Body (IATF), which is the only entity empowered to approve such a request. If the approval is granted, the Certification Body is then requested to verify the situation on-site during the regular audits. Note: This portion of site possibility existed previously and was removed by IATF due to repeated abuse. This option has been reinstated in the 4th edition of the rules, but it is likely that IATF will be strict in the decision and follow-up of the application. If your organization wants to apply for this option, please consider that detailed supporting documentation will be requested and that the timeframe to achieve a decision will generally take several weeks. 3 THE AUDIT PREPARATION CHANGE: The audit preparation is extended: more documents are to be provided by the certified client, to be reviewed and used by the lead auditor to prepare the audit plan. The new rules require the certified clients or the organization seeking certification, prior to any on-site audit, to provide a list of documents and information for the preparation of the audit plan. These include records such as (but not only) QMS including evidence of conformity to ISO/TS 16949 requirements and showing the linkages or interfaces to any remote support functions and/or outsourcing processes. p.5
These documents are analyzed by the audit team to determine the critical areas to be prioritized during the audit. In cases where the client fails to deliver all of the required information prior to the issuance of the audit plan, the rules specify that: the Certification Body must include additional time prior to the start of the opening meeting to collect and review the missing information, or the Certification Body shall initiate the decertification process (risk of suspension/withdrawal of the certificate). 4 THE ON-SITE AUDIT DURATION CHANGE: Before each audit, an additional on-site time is added to review the latest data and update the audit plan accordingly. The new rules require including in the usual audit plan a minimum of one additional hour onsite prior to the opening meeting for the verification of the changes to the current customer and internal performance data, including a review of the current online customer reports and customer scorecards. The new rules specify again how the Certification Body shall act upon new information: adjustments may be made to the audit plan, which could lead to an increase of the duration in order to comply with the requirements. This extra hour is in addition to the 8-hour audit day. 5 THE TIMING BETWEEN AUDITS CHANGE: Recertification audit window timeframe is slightly modified. The closing meeting of the recertification audit must now take place 3 years (-3 months, +0 days) from the closing meeting date of the previous certification audit (Stage 2 or Recertification audit). p.6
6 THE MANAGEMENT AND TIMELINE OF NON-CONFORMITIES CHANGE: Non-conformity management: response time is reduced to 60 days. The client shall now respond and submit within a maximum of 60 days all documentation needed to be reviewed in order to close a non-conformity (the evidence of the implemented correction, the root cause analysis and its results, the evidence of the implementation of the systemic corrective actions, etc.). The Certification Body shall proceed with the review of the response from the client and any outstanding issue shall be resolved within 90 days from the closing meeting. If no resolution is achieved, the rules require the Certification Body to withdraw the certificate. CHANGE: When answering a non-conformity, the client must provide new additional information. The client must now additionally provide within the 60-day period: Evidence that the systemic corrective action includes consideration of the impact on their similar processes and products. Verification of the effectiveness of the implemented corrective actions. CHANGE: Only limited exceptional reasons can justify a non-conformity not being closed within 90 days. In such cases an on-site special audit is required. It may occur that, in exceptional cases, a corrective action cannot be implemented within 90 days (i.e. new piece of equipment machinery, testing is required and the lead time for installation is more than 90 days, etc.). In this case, the 4 th edition of the rules requires the Certification Body to perform an additional special on-site audit to verify the effectiveness of the implemented corrective actions. This audit should be performed as soon as possible and before the following audit in the cycle. CLARIFICATION: An on-site follow-up audit is mandatory in the case of a major non-conformity. The 3 rd edition of the rules specifies that a major non-conformity should require an on-site verification. The 4 th edition clarifies the situation and makes the on-site follow-up audit mandatory in the case of a major non-conformity. p.7
7 THE DECERTIFICATION PROCESS: SUSPENSION OF THE CERTIFICATION CHANGE: In the case a surveillance audit is not conducted on time, the certificate will be suspended. As soon as the surveillance cycle is no longer respected, the decertification process must be initiated by the Certification Body. The rules for the 4 th edition clearly specify that if the cycle deadline is surpassed by more than 20 days, the certificate will be suspended, even if, in the interim, the late audit has been performed. If the late surveillance audit is not performed within 90 days of the cycle deadline, then the certificate must be withdrawn. CHANGE: In the case of a major non-conformity, the certificate will be suspended. As soon as a major non-conformity is raised during a closing meeting of a surveillance or recertification audit, the decertification process must be initiated by the Certification Body and the certificate will be suspended within 20 days (the Certification Body is required to suspend the certificate in all cases). 8 THE CONTRACT TERMS AND CONDITIONS CHANGE: Additional contractual elements are required between the client and the Certification Body with a possible impact on the existing contractual Terms and Conditions. The 4 th edition of the rules mentions specific requirements that must be included in the contract binding the certified client and its Certification Body. The contracts must be reviewed to ensure the requirements are included in a compliant way. For instance, one of the requirements mandates that the contract mention that a consultant to the client cannot attend the audit. If the current contract is not compliant with the 4 th edition rules, it will need to be updated and signed again. Since there is still some uncertainty about IATF s deadline for certified organizations to achieve compliance to the 4th edition (either before the next audit or before application of the new edition), we strongly recommend that you have your contract updated and signed before April 1 st, 2014. Certification Bodies will also now be obligated to keep certification records such as receipts from travel expenses, regardless of who made payments. p.8
9 WHERE WILL THE AUDITOR FOCUS DURING THE AUDIT? Many changes of the rules do not apply to the certified client but rather to the Certification Bodies. These changes give insight regarding the IATF s current and most prominent topics. These topics include customer-specific requirement management and the new rules outline strict guidance for auditors on what data to assess during the audit. This document has been elaborated with great care: from a gap analysis of the rules evolution performed by experienced experts, to a 3-day seminar held by IATF and finally by direct discussions with IATF members and IATF oversight organizations. However, it is only a partial summary and cannot replace your own full review of the 4 th edition of the rules or ensure to provide the relevant correct answers to all specific situations. Note also that at the time of the release of this document, some clarifications and interpretations are still being awaited from IATF that may specify or amend the content provided hereafter. We encourage you to look for updates of this document on our website at www.bureauveritas.com/scs and to reach out to your main contact at. To purchase the full version in your local language of the IATF 4 th Edition Rules, Rules for Achieving IATF Recognition 4 th Edition, October 1, 2013, please visit the IATF website: www.iatfglobaloversight.org/publications.aspx MORE QUESTIONS? JOIN US FOR OUR WEBINAR! To provide more insight, we will hold webinars on January 14 th, 2014 on the 4 th edition of the rules and on the transition period. These webinars are free, public and are open to everyone. We encourage you to invite your relevant contacts involved in ISO/TS: your quality team members, your quality contacts within your suppliers and anyone else who may be impacted. Find more details and to register online, visit: http://isots16949.bureauveritas.com/webinar/ p.9
TO SUM-UP: MAIN CHANGES FOR THE 4TH EDITION RULES. Are you ready for the 4 th Edition? Below is a handy checklist of the major changes to ISO/TS 16949. Fabless sites are not eligible for certification. Sites sem produção não são elegíveis. Manufacturing Site Extensions (also known as manufacturing satellites) do not exist anymore, and must be treated as Manufacturing Sites. Extensão dos sites de produção (também conhecidos como satélite de produção) deixam de existir e devem ser tratados como Unidades de Produção. Under strict conditions, part of a site can now be excluded from the audit. Sob condições restritas, um site pode agora ser excluído do processo de auditoria. The audit preparation is extended: more documents are to be provided by the certified client, to be reviewed and used by the lead auditor to prepare the audit plan. A preparação da auditoria é alargada: o cliente certificado deve fornecer mais documentos, para serem analisados e utilizados pelo auditor coordenador para preparar o plano de auditoria. Before each audit, an additional on-site time is added to review the latest data and update the audit plan accordingly. Antes de cada auditoria é adicionado tempo de auditoria "on site" de forma a rever as últimas informações e actualizar o plano de auditoria em conformidade. Recertification audit window timeframe is slightly modified. O agendamento da auditoria de recertificação é ligeiramente alterado. Non-conformity management: response time is reduced to 60 days. Gestão das não-conformidades: tempo de resposta reduzido para 60 dias. When answering a non-conformity, the client must provide new additional information. Ao responder a uma não-conformidade, o cliente deve fornecer informações adicionais. Only limited exceptional reasons can justify a non-conformity not being closed within 90 days. In such cases an on-site special audit is required. Apenas razões excepcionais podem justificar o facto das não-conformidades não terem sido encerradas no prazo de 90 dias. Nestes casos é necessária uma auditoria extra no local. An on-site follow-up audit is mandatory in the case of a major non-conformity. Uma auditoria de seguimento no local é obrigatória no caso de uma não-conformidade grave. In the case a surveillance audit is not conducted on time, the certificate will be suspended. Caso uma auditoria de acompanhamento não tenha sido realizada a tempo, o certificado será suspenso. In the case of a major non-conformity, the certificate will be suspended. Caso se verifique uma não conformidade grave, o certificado será suspenso. Additional contractual elements are required between the client and the Certification Body with a possible impact on the existing contractual Terms and Conditions. Elementos contratuais adicionais serão necessários entre o cliente e o organismo de certificação com possíveis impactos no actual contrato. p.10
ISO/TS 16949 Rules 4 th Edition: Credits : Graphic design : www.distillateurgrahik.com Photos : Cover Jenny Wymore - SunKissed Photography / Cover algre-fotolia.com / Cover loraks - fotolia.com / p.3 Kovalenko Inna / p.5 artstudio_pro - Nataliya Hora/ p.6 LVDESIGN-fotolia.com / p.4-p.7-p.9 Monty Rakusen 67-71 Boulevard du Château 92571 Neuilly-sur-Seine Cedex - France Tel.: +33 (0) 1 55 24 70 00 certification.contact@bureauveritas.com www.bureauveritas.com/scs