ISO Revisions Moving From ISO/TS 16949:2009 To IATF 16949:2016

Transcription

ISO RevMoving fromISO/TS 16949:2009to IATF 16949:2016Transition Guide

IATF 16949:2016 - Automotive Quality Management System - Transition GuideAn effective Quality Management System is vital for organizations in theautomotive industry. It helps them continually improve, meet customerrequirements, and ensure customer satisfaction.This guide has been designed to help you meet therequirements of the new automotive standard for QualityManagement Systems (QMS) IATF 16949:2016, which hasreplaced ISO/TS 16949:2009. IATF 16949:2016 is to beimplemented as a supplement to, and in conjunction withISO 9001:2015 rather than being a standalone QMSstandard. It specifies the requirements for establishing,implementing, maintaining and continually improving aQMS for any organization, in the automotive industryregardless of size.ISO 9001 was updated in 2015 to address the changesin the way we do business and maintain its relevance intoday’s world.The new standard will help you to: Integrate with other management systems Provide an integrated approach to organizationalmanagement Reflect the increasingly complex internationalenvironment in which organizations operate in thisindustrySo why is it changing? Ensure the new standard reflects the needs of allpotential user groupsThe International Automotive Task Force (IATF) whooperate this standard have decided to base it onISO 9001:2015 with some additional enhancements. Thismeans that organizations in the automotive industryseeking IATF 16969 certification must also comply withISO 9001:2015. Enhance an organization’s ability to satisfy itscustomers and continually improve2NB. This transition guide is designed to be read in conjunction withIATF 16949:2016 and ISO 9001:2015. It does not contain thecomplete content of the standards and should not be regarded as aprimary source of reference in place of the published standards ofreference in place of the published standard itself.

bsigroup.comWhat’s in the new standard and whatare the benefits for organizations?ISO 9001 is the world’s most recognized management system standard and is used by over amillion organizations across the world. The new version has been written to maintain itsrelevance in today’s marketplace and to continue to offer organizations improved performanceand business benefits. IATF 16949:2016 builds on this to develop a robust QMS that facilitatescontinual improvement, emphasizes defect prevention, and helps reduce variation and waste inthe supply chain, consideration of product safety and embedded software have also beenincluded.The new standard will help you to: Introduce an integrated approach with other managementsystem standards Bring quality and continual improvement into the heart of theorganization Increase involvement of the leadership team Mitigate risk and improve opportunity management with a greaterapplication of risk-based thinkingOne of the major changes in IATF 16949:2016 is that it brings qualitymanagement and continual improvement into the heart of anorganization. This means that the new standard is an opportunity fororganizations to align their strategic direction with their qualitymanagement system. The starting point of the new version ofthe standard is to identify internal and external parties and issueswhich affect the QMS. This means that it can be used to help enhanceand monitor the performance of an organization, based on a higherlevel strategic view.Our customers tell us they get multiple benefits as a result ofimplementing and adopting a system that meets the requirements ofISO/TS 16949. The new IATF 16949 standard will continue to do thisand provide additional value.The new IATF 16949 standard will: Facilitate continual improvement: Regular assessment will ensureyou continually use, monitor and improve your processes Increase market opportunities so you can demonstrate tocustomers excellent levels of safety, reliability and traceabilitythroughout the supply chain Increase efficiency that will save you time, money and resources Ensure compliance with a system supported by regulatoryauthorities that helps to mitigate your risks Motivate, engage and involve staff with more efficient internalprocesses and a greater emphasis on awareness Help you trade as certification to this standard is mandatory forsuppliers to most of the original equipment manufacturers in theautomotive industryUseful standards for your transitionISO 9001 is part of a family of quality management related standards. You may find thissection useful for further reference in addition to ISO 9001:1ISO 9000, Quality management systems Fundamentals and vocabulary5 ISO 31000, Risk management Principles and guidelines2ISO 9004, Managing for the sustained success of an organization- A quality management approach6 ISO 10004, Quality management Customer satisfaction - Guidelines for monitoring and measuring3ISO 10001, Quality management - Customer satisfaction Guidelines for codes of conduct for organizations7 ISO 10014, Quality management Guidelines for realizing financial and economic benefits4ISO 10002, Quality management - Customer satisfaction Guidelines for complaints handling in organizations8 ISO 19011, Guidelines for auditing management systems3

IATF 16949:2016 - Automotive Quality Management System - Transition GuideComparing IATF 16949:2016 withISO/TS 16949:2009The new standard is based on Annex SL – the newhigh level structure. This is a common frameworkfor all ISO management systems. This helps tokeep consistency, align different managementsystem standards, offer matching sub-clausesagainst the top level structure and apply commonlanguage across all standards. It will be easier fororganizations to incorporate their QMS into corebusiness processes and get more involvementfrom senior management.The Plan-Do-Check-Act (PDCA) cycle can beapplied to all processes and to the qualitymanagement system as a whole. The diagramhere (Figure 1) illustrates how Clauses 4 to 10 canbe grouped in relation to PDCA.l it yQuaOrganization andits context (4)Management System(Figure 1Support& )DoNeeds and expectationsof relevant interestedparties (4)Results ofthe rsatisfactionCheckProductsand servicesImprovement(10)New/updated conceptCommentContext of the organizationConsider the combination of internal and external factors and conditions that can have aneffect on an organization’s approach to its products, services, investments and interested parties.IssuesIssues can be internal or external, positive or negative and include conditions that eitheraffect or are affected by the organization.Interested partiesCan be a person or organization that can affect, be affected by, or perceive themselves to be affectedby a decision or activity. Examples include suppliers, customers or competitors.LeadershipRequirements specific to top management who are defined as a person or group of peoplewho directs and controls an organization at the highest level.Risk associated with threatsand opportunitiesRefined planning process replaces preventive action and is defined as the effect ofuncertainty on an expected result.CommunicationThere are explicit and more detailed requirements for both internal and external communications.Documented informationReplaces documents and records. There are 2 types: maintained (i.e. procedures and workinstructions) and retained (i.e. records).Performance evaluationThe measurement of quality performance and the effectiveness of the QMS, covering themethods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results.Nonconformity and correctiveactionMore detailed evaluation of both the nonconformities themselves and corrective actionsrequired. Human factors have been added as an element of root cause analysis.Management reviewMore detailed requirements relating to inputs and outputs of the review.Product safetyRequirement to address the items defined within this new requirement in a documented anddedicated process for the management of product-safety related products and manufacturingprocesses.Embedded softwareDetailed requirements for products with embedded software. Organizations must also implement andmaintain a system for software quality assurance of these products.Corporate responsibilityRequirement to have corporate responsibility policies including an anti-bribery policy, an employeecode of conduct, and an ethics escalation (whistle-blowing) policy.Supplier managementAdditional requirements regarding the organization’s supplier selection process have been added.Internal auditsInternal audit frequency requirements have been modified.4

bsigroup.comThe key requirements of IATF 16949:2016Clause 1: ScopeClause 1 details the scope of the standard and there is asupplementary note to cover products with embedded software.Clause 2: Normative referencesISO 9000, Quality Management System - Fundamental andvocabulary is referenced and provides valuable guidance.Clause 3: Terms and definitionsTerms and definitions are contained in ISO 9000:2015 - QualityManagement - Fundamentals and vocabulary. The new standardcontains additional terms and definitions relevant for the automotiveindustry including “accessory parts”, “challenge part”, “manufacturingservices”, “outsourced processes”, “production shutdown”, “specialstatus”, and “total productive maintenance”.Clause 4: Context of the organizationThis is a new clause that establishes the context of the QMS and howthe business strategy supports it. The ‘context of the organization’ isthe clause that underpins the rest of the new standard. It gives anorganization the opportunity to identify and understand the factorsand parties in their environment that support the qualitymanagement system.Firstly, the organization will need to determine external and internalissues that are relevant to its purpose, i.e. what are the relevantissues, both inside and out, that have an impact on what theorganization does, or that would affect its ability to achieve theintended outcome(s) of its management system.It should be noted that the term “issue” covers not only problemswhich could be the subject of preventive actions, but also importanttopics for the management system to address, such as any marketassurance and governance goals the organization might set.Secondly an organization will also need to identify the “interestedparties” that are relevant to their QMS. These groups could includeshareholders, employees, customers, suppliers, statutory andregulatory bodies and even pressure groups. Each organization willidentify their own unique set of “interested parties” and over timethese may change in line with the strategic direction of theorganization.Next the scope of the QMS must be determined. This could includethe whole of the organization or specific identified functions. Anysupporting outsourced functions or processes will also need to beconsidered in the organization’s scope if they are relevant to theQMS.You are required to establish, implement, maintain and continuallyimprove the QMS in accordance with the requirements of thestandard. This requires the adoption of a process approach andalthough every organization will be different, documentedinformation such as process diagrams or written procedures couldbe used to support this.Product Safety is a new section in the standard. It has enhancedrequirements designed to address current and emerging issuesthat the automotive industry is facing. The standard now lists thedocumented processes for the management of productsafety-related products and manufacturing processes that anorganization is required to have.5

IATF 16949:2016 - Automotive Quality Management System - Transition GuideClause 5: LeadershipClause 6: PlanningThis clause places requirements on “top management” which is theperson or group of people who directs and controls the organizationat the highest level. The ISO requirements have been supplemented byrequiring organizations to adopt a corporate responsibilityrequirement. This reflects increasing market and governmentalexpectations for improved integrity in social and environmentalmatters. There is an increased emphasis on people “owning” the QMSrather than one individual. The new standard requires topmanagement to identify “process” owners who must be competentand understand their roles in relation to the QMS.Planning has always been a familiar element in the automotivestandards, but now there is an increased focus on ensuring that it isconsidered with Clause 4.1 ‘Context of the organization’ and Clause4.2 ‘Interested parties’.Top management now have greater involvement and responsibilityin the management system and must ensure that the requirementsof it are integrated into the organization’s processes and that thepolicy and objectives are compatible with the strategic direction ofthe organization. The quality policy should be a living document, atthe heart of the organization. To ensure this, top management areaccountable and have a responsibility to ensure the QMS is madeavailable, communicated, maintained and understood by all parties.There is also a greater focus on top management to enhancecustomer satisfaction by identifying and addressing risks andopportunities that could affect it. They need to demonstrateconsistent customer focus by showing how they meet customerrequirements, regulatory and statutory requirements, and also howthe organization maintains enhanced customer satisfaction.In the same context, they need to have a grasp of the organization’sinternal strengths and weaknesses and how these could have animpact on delivery and conformity of products or services. This willstrengthen the concept of business process management. Inaddition, top management need to demonstrate an understanding ofthe key risks associated with each process and the approach takento manage, reduc

ISO/TS 16949:2009. An effective Quality Management System is vital for organizations in the automotive industry. It helps them continually improve, meet customer . requirements, and ensure customer satisfaction. 2 IATF 16949:2016 - Automotive Quality Management System - Transition Guide This guide has been designed to help you meet the requirements of the new automotive standard for Quality .