Information for transition of ISO/TS 16949:2009 to IATF 16949 Adam Biegaj MSc. – Eng. - MBA Product Compliance Management Automotive
TÜV SÜD Management Service GmbH
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Timeframe for Transition
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Calculation and Audit Team
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Possible main changes in new IATF 16949
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Summary
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Information for Transition of ISO/TS 16949:2009 • In August 2016 ISO, the International Organization for Standardization confirmed that ISO/TS 16949:2009 becomes new Automotive Standard IATF 16949:2016 in conjunction with ISO 9001:2015 • IATF 16949:2016 defines the fundamental quality system requirements for automotive organizations and represents a strong customer orientation with incorporation of common automotive customer-specific requirements • In addition new Rules for certification to IATF 16949:2016 are scheduled to be released in November 2016 (Source: http://www.iatfglobaloversight.org/)
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Timeframe for Transition • 15th September 2018 all “old” certificates will lose there validity based on ISO 9001:2008 validity
• Publication of new IATF 16949 is planned for October 2016 • Complete transition phase is only max. 23 months time (Source: http://www.iatfglobaloversight.org/)
Publication of the new IATF 16949 (October 2016 )
2017
Today (Sept. 2016)
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2018
Transition phase for certification
End of transition (14th September 2018)
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Timeframe for transition • After publication in October 2016 organizations need to analyze and if necessary establish changes into their Management System
• Effective implementation must be verified and documented from the organization before starting external audits (e.g. with internal audits, action plans, management review, etc.) • Trainings for the Organisations’ internal auditors should be finished • All CB´s auditors have to pass non-proctored examinations after conducting online trainings from Dec. 2016 - Jan. 2017 latest until 30. June 2017 (Source: http://www.iatfglobaloversight.org/)
Publication of the new IATF 16949 (October 2016 )
2017
Today (Sept. 2016)
Possible trainings start for 1st, 2nd, 3rd party auditors
2018
Transition phase for certification
End of transition (14th September 2018)
(Dec.2016 - January 2017)
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Timeframe for transition • First transition audits may be conducted from February / March 2017, if the organization and 3rd party auditors are ready for it. • Last possible audit date should be in May 2018 due to NC management, certification decision process and creation of the new certificates (Source: http://www.iatfglobaloversight.org/)
Publication of Rules for IATF 16949 (November 2016)
Publication of the new IATF 16949
Estimated execution of first audits
(October 2016 )
(Sept. 2016)
Last possible date for transition audit
(1. October 2017)
(February 2017)
2017
Today
Last possible day auditing according to ISO/TS 16949
Start Auditors’ trainings
Possible start of first audits
(May 2018)
2018
Transition phase for certification (February 2017 till May 2018)
End of transition (14th September 2018)
(February 2017)
(Dec.2016 January 2017)
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Possible timing for transition audits • The transition audit shall be completed instead of a normal cycle audit: o In case of a planned Surveillance Audit: Audit must be conducted -3 / +1 month of due date In case of failure to meet this requirement, de-certification process is initiated o In case of a planned Recertification Audit: Audit must be conducted -3 / +0 month of due date In case of failure to meet this requirement transition audit must be performed as complete new initial certification. • Due date is the last audit day from last certification or re-certification audit. (Source: http://www.iatfglobaloversight.org/)
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Content
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Timeframe for Transition
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Calculation and Audit Team
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Possible main changes in new IATF 16949
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Summary
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Calculation of Audit days for transition • Each transition audit has to be calculated with repeat audit days • In addition min. 0.5 audit days shall be added for o Documentation review prior to transition audit o Documentation review shall include min. a review of client’s Quality Management system documentation incl. evidence about conformity to IATF 16949 o In case of remote supporting functions additional information required – if not audited before Production Sites o Documentation review can be conducted off-site or on-site o If required Documentation is not submitted to auditor for off-site review then 0.5 days should be added on-site for review prior to transition audit • New certificate will be issued latest on 14th September 2018 with a three year validity minus 1 day (Source: http://www.iatfglobaloversight.org/)
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Audit team requirements for Transition Audit • As transition audit must comply with Repeat Audit requirements with following exceptions: o There can be more than one auditor from previous audit cycle used as carry-over auditor plus minimum one new auditor for this cycle o In following surveillance audit auditor(s), which have not audited previous cycle must be used o If only 1 auditor is appointed for transition audit, auditor can audit maximum 7 audit days instead of 5 without using 2nd auditor What does that mean for audit team? 1. New auditor must be used for cycle starting with transition audit 2. Existing audit team can do transition audit, but not conducting following surveillance audits
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Transfer Audits from other Certification Body
• Organizations are not allowed to perform transition to IATF 16949 at the same time as changing the Certification Body (Transfer Audit). • First a transfer audit must be completed according to transfer audit rules and only in following audit a transition audit is possible. • This means that transfer to any CB must be completed before end of August 2017 that the NEW CB can perform transition to IATF 16949 with -3 months in May 2018. Otherwise initial certification audit has to be performed with change of Certification Body • Other possibility is to transfer only ISO 9001:2015 and then do upgrade to IATF 16949 with upgrade rules
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Content
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Actual official information
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Calculation and Audit Team
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Possible main changes in new IATF 16949
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Summary
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Possible main changes in new IATF 16949 This section talks about possible changes in new IATF 16949 based on TÜV SÜD knowledge from IATF CB Conference in April 2016 and Gap Assessments conducted in cooperation with 2 of our clients and VDA-QMC / SMMT.
So following content of the presentation can be withdrawn, reduced or expanded with final version of IATF 16949 as many feedbacks from CB conference, Oversight Offices and connected organizations (OEMs, Tier 1, etc.) have been submitted to IATF for review.
(Source for all coming pages: IATF Gap Assessment Information May 2016)
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Possible main changes in new IATF 16949 Rework of the terms and definition to have better clarification and definition • Clear definition and difference between outsourced process and remote location • Inclusion of definition for Customer Specific Requirements (CSR) to define that CSR are “supplemental requirements to this Automotive QMS standard” and not “technical” requirements
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Possible main changes in new IATF 16949 Implementation of the context of the organisation as performance targets for the QM system • Review of interested parties* and their requirements shall be considered in setting annual performance targets in the organization • Supporting functions (on-site or remote) must be clearly defined in the scope of the QM System • Outsourced processes shall be included in QM System
*Interested parties can be identified from legal, technological, competitive, cultural, social or economic environments
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Possible main changes in new IATF 16949 A product safety part as required out of the CSR of VW
• Documented process for the management of product safety • Special training for personnel involved in this process • Identification of statutory and regulatory product-safety requirements • Identification and control of product-safety characteristics • Special approvals from organization’s customers can be necessary • Transfer of product-safety requirements to sub-tier suppliers
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Possible main changes in new IATF 16949 Risk analysis and contingency plans
• Risks and preventive actions must be addressed for each process of the organization (e.g. as part of process analysis or process descriptions) • Continual risk analysis should include a minimum of potential and actual recalls, field complaints, scraps and reworks
• For manufacturing processes and infrastructure contingency plans shall be defined with periodical tests for effectiveness, reviews and updates • Contingency plans shall include notification to customers, re-start of production and production stop procedure, also in case the procedure was not followed
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Possible main changes in new IATF 16949 Overhauling of the requirements for suppliers and so for the supply chain • Detailed supplier selection process criteria, what criteria must be considered for selection of new suppliers incl. risks and qualify history of performance • Specific requirements for suppliers of software with software quality insurance system like SPICE • Supplier QM System to comply with IATF 16949 or periodic second-party audits are required • More focus on supplier development by close monitoring of supplier performance, audit findings • Definition of second party audit process
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Possible main changes in new IATF 16949 Internal audits
• Requirements for using specific tools for process and product audits in case of no customer requirement exist (e.g VDA 6.3, AIAG CQI-x, VDA 6.5 for product audits, etc.) • Internal auditor qualification included customer specific requirements from different OEMs and request to have more evidences of knowledge and training like for core tools, customer requirements, etc. • Maintenance of internal auditors’ qualification shall be defined e.g. with evaluating of audit results, execution of minimum number of audits per year, auditor development
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Possible main changes in new IATF 16949 Management Review • More and more detailed Inputs to Management review are required, e.g. Addressing of risks Process effectiveness and efficiency Product conformance Warranty conformance Review of Customer scorecards Potential field failures through FMEA analysis • Management review output shall include action plan, where customer requirements are not met
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Possible main changes in new IATF 16949 Warranty management and field failure test analysis requirements are more formalized • Organization shall have a warranty management process according to existing standards like NTF (no trouble found), AIAG CQI-14 – Automotive Warranty Management Guideline • Analysis with root cause analysis report and formal problem solving process shall be performed on all customer complaints, field failures and any returned parts
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Possible main changes in new IATF 16949 Additional requirements for auditing “embedded software” in products • Requirements for products with embedded software will be included in many chapters of IATF 16949 beginning with the scope of IATF 16949 including those products • Requirements included for Product and Process design • Requirements broken down to suppliers of the organization • Consideration of interactions of embedded software with the product in case of customer complaints
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Content
TÜV SÜD Management Service GmbH
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Timeframe for Transition
2
Calculation and Audit Team
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Possible main changes in new IATF 16949
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Summary
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Summary • Very tough timeframe for Organizations to analyse and implement IATF 16949 changes in their QM System and to perform 3rd party transition audit
• Very tough timeframe and auditor resource problem for Certification Bodies • Cooperation about timing needed between Organizations and Certification Body to plan as early as possible the transition audit date considering especially Remote Locations • Partly difficult changes in IATF 16949 for implementation in a short timeframe like supplier management, product safety requirements, risk analysis and for contingency plan....
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Possible main changes in new IATF 16949
Questions? Website for IATF 16949 information: www.tuev-sued.de/ms/iatf-16949
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Thank you for your attention! Adam Biegaj MSc. – Eng. - MBA Product Compliance Management Automotive Email:
[email protected]
TÜV SÜD Management Service GmbH