How to manage the transition successfully AUTOMOTIVE MANAGEMENT SYSTEM TRANSITION FROM ISO/TS 16949 TO IATF 16949 TECHNICAL GUIDE EDITION OCT 2017 Move Forward with Confidence
IATF HAS PUBLISHED THE NEW STANDARD FOR AUTOMOTIVE QUALITY MANAGEMENT SYSTEM, IATF 16949 IN OCTOBER 2016. THE FIRST EDITION OF IATF 16949 REPLACES ISO/TS 16949:2009 STANDARD. The new standard is released keeping in mind the automotive industry actors need to adapt continuously to dynamic environment which requests efficiency and adaptability. This technical guide written by Bureau Veritas automotive experts will help you to prepare and realize a successful transition. IATF 16949:2016 & ISO 9001:2015 Main changes IATF New Requirements What Impact to Expect on Your Management System? What is the Transition Process? How can Bureau Veritas Support you in Your Transition? 3 4 7
3 IATF TRANSITION FROM ISO/TS 16949 TO IATF 16949 IATF 16949:2016 & ISO 9001:2015 MAIN CHANGES IATF 16949 will follow ISO 9001:2015 document structure with the following clauses organization: 10 clauses instead of on previous versions 1 to 3 : Generic and introductory clauses information s Introductory clauses 1 2 3 SCOPE NORMATIVE REFERENCES TERMS AND DEFINITIONS 4 to 10: s replaces previous ones. These will allow to follow the PDCA cycle in coherence with Automotive process management IATF 16949 standard does not contain any text from ISO 9001:2015, that s why it is compulsory to get both standard document as soon as possible. Organization will have to satisfy both standards during the transition audit IATF 16949:2016 only contains Automotive additional requirements Basic clauses, common to all management systems standards 4 5 6 7 9 CONTEXT OF THE ORGANIZATION LEADERSHIP PLANNING SUPPORT OPERATION PERFORMANCE EVALUATION 10 IMPROVEMENT IATF 16949:2016 & ISO 9001:2015 oriented on same high-level structure and continuous improvement approach ISO 9001 : 2015 has developed its clauses structure based on the PDCA approach. This methodology is well known in the automotive industry and coherent with the increasing of continuous improvement requirement and expectations. IATF complemented ISO approach with most recent requirements from Automotive market and supply chain stakeholders. Note: The new high level structure has been clearly defined in this revision of the standard, for management to drive the organization towards having a robust management system fulfilling customer expectations as a whole. s ISO 9001:2015 & IATF 16949 New Requirements PLAN 4 5 Context of organization Leadership 6 7 Planning Support Risk Base Thinking Integration of Customer Specific Requirements DO Operations First & Second Party Auditors competencies Product Safety Manufacturing Feasibility CHECK 9 Performance Evaluation Monitor & measure the results Warranty Management Development of Product with Embedded Software ACT 10 Improvement Take actions and improve the results The organizations are free to interpret the model as it sees fit to their management systems. It s not specifically requested to organize their MS along the same line than clauses. The Organization, the Quality Management System (QMS) documentation and processes need to be focused on the business needs and customer expectations.
IATF TRANSITION FROM ISO/TS 16949 TO IATF 16949 4 IATF NEW REQUIREMENTS RISK BASED THINKING Organizations are nowadays continuously asked to adapt to various unexpected changes. Based on ISO 9001:2015, IATF 16949 standard focus on the adaptability and anticipation of risks in Automotive actors processes. It s now a pro-active approach that is requested. Organizations will have to analyze all the potential risks that the entire supply chain could face and define the necessary action plans and processes adaptation, that will be necessary in order to ensure the product and process reliability, while keeping in mind client requirements satisfaction. Risk Based Thinking Approach Market safer and more stable Identifying and mitigating risks Mitigate risks before manufacturing the product and process installation Manage the manufacturing process in front of changes (expected and unexpected) Multidisciplinary approach Full product lifecycle checked from development phase until product / process approval Assessing the manufacturing feasibility Evaluate design changes after product approval Control and react to the changes Adjust the internal audit according to changes frequency Complete Supply chain prevented from risks Conducting Contingency planning reviews Identifying & supporting processes owners Ensuring Customer targets and Quality objectives Implementing corporate responsibility initiatives Organizations need to prevent all risks of change and adapt all processes accordingly PRODUCT SAFETY Product Safety is a new requirement in IATF 16949. The purpose is to reinforce product safety and reliability throughout its lifetime, starting from the development phase, through the end of its use by the customer. In all instances, the product needs to keep its integrity, reliability and performance and what the purpose of its design. Product Safety Approach with documented process Product should performed for its designed without causing harm or damages Product Design and Manufacturing Process Robustness Control plan approvals (P) FMEA Training organization / client & related * processes against product safety requirements Supply chain robustness against product safety requirements * (Product) Failure Modes and Effects Analysis Organizations must have processes to ensure product safety throughout the entire product life cycle
5 IATF TRANSITION FROM ISO/TS 16949 TO IATF 16949 MANUFACTURING FEASIBILITY On the same way than organization shall integrate risk management in their process, manufacturing capabilities are keys to satisfy clients requirements and targets. This approach will have to be conducted regarding both, expected and unexpected sources of change. Manufacturing Feasability Capabilities to demonstrate that performance and timing targets specified by customer are satisfied Organization must asssess their capacity to satisfy customer target in both delivery timing and product performances. DEVELOPMENT OF PARTS WITH EMBEDDED SOFTWARE IATF 16949 standard had to reflect the challenges proposed by a new driven by wire world. More and more devices and equipment are connected to the numerical world. Suppliers need to ensure the robustness of their equipment in term of reliability, performance all along the supply chain and lifetime of products. Development Embedded Software Product / Manufacturing Process & Supply Chain robustness Product Validation for embedded software products Sourcing from Origin management in front of CR Risk Management of sourcing & material change WARRANTY MANAGEMENT IATF 16949 standard integrate the necessity to comply with the increase of warranty management importance. This item needs to be integrated in organizations approach and be anticipated much before complains arrive. Capability to provide warranty for the product when requested Warranty Management Process Address and integrate applicable Customer Special Requirements Warranty party analysis procedure to address NTF (No Trouble Found) situation and how to validate them Decision Making process to be shared and agreed with the customer when applicable
IATF TRANSITION FROM ISO/TS 16949 TO IATF 16949 6 NEW REQUIREMENT: OTHER IATF SPECIFICITIES IATF 16949 precised specific items on audits competencies management and relationship between the parties CR & CSR IATF 16949 clarifies also Customer and Customer Specific Requirements in the Standard. 1st & 2nd Party Auditor Auditors competencies Documented process compiling auditor competency Organization, through documentation, must be able to demonstrate the competencies of their trainers. Competencies of 2nd Party Auditor shall be also demonstrated 2nd Party Auditors shall meet CSR for auditor qualification Automotive approach including risk based thinking Core tools management capabilities CSR knowledge & CSR satisfaction checking capabilities Software assessment methodologies when applicable WHAT IS THE TRANSITION PROCESS? Content & Timeline Transition Audit (TA) will have to be realized at the next audit planned ISO/TS audit will be planned whatever next audit is RA, SA 1 or 2 IATF 16949 Transition Audit can t be separated in 2 or more audit sessions. A new 3 years cycle will start and replace the current one from last day of TA Current ISO/TS 16949 end of Certificate is 14/09/201 in any case After TA, End of Certificate will be TA + 3 years (based on existing rules of calculation, with last day of TA considered as reference) NEW ISO 9001:2015 published LOW IMPACT IATF 16949:2016 published Rule N 5 IATF 16949 published MEDIUM IMPACT Jan 1 st 2017 Oct 1 st 2017 Bureau Veritas Certification expected transition period May 14 th 201 No valid ISO/TS certificates Sept 23 rd 2015 Oct 1 st 2016 Nov 1 st 2016 MEDIUM IMPACT 1 st Transition Audit possible according to IATF HIGH IMPACT April 1 st 2017 100% audit - IATF 16949:2016 Critical Period: 120 days before end of ISO/TS Certificates Sep 14 th 201 IATF 16949 transition complete
7 IATF TRANSITION FROM ISO/TS 16949 TO IATF 16949 GET THE NEW CERTIFICATION IATF 16949:2016 INTEGRATE PARTS OF OTHER MANAGEMENT SYSTEMS & UPDATE DOCUMENTATION MONITOR THE NEW PROCESSES, PRODUCE & ANALYSE NEW KPIs. ACT ACCORDINGLY TRAIN YOUR CORE TEAM (QUALITY MANAGERS, INTERNAL AUDITORS, MANAGERS) ADAPT YOUR MANAGEMENT PROCESSES TO MAKE THEM COMPLIANT HOW CAN BUREAU VERITAS SUPPORT YOU IN YOUR TRANSITION? NEW E-LEARNING COURSES SELF ASSESSMENT TOOL Are available on Bureau Veritas lead platform Get trained to the transition at your own pace and without engaging in travel expenses. www.lead.bureauveritas.com
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