ISO 9001:2015 Transition Guide

Improving performance,reducing riskISO 9001:2015Transition GuideAn LRQA perspective

IntroductionThe publication of the Draft International Standard (DIS) ofthe International Quality Management System (QMS) Standard(ISO/DIS 9001:2014) signified the first time all current and futureusers can access and review the proposed changes to ISO 9001.As a result, organizations are able to start planning fortheir transition to the new standard when it is published(currently forecast by ISO to be September 2015).The draft standard contains both new elements and existingelements that are changing and this document sets out toprovide interested parties with insight into the potentialimpact of the changes on organizations.

What’s new?The International Organization for Standardization(ISO) normally reviews standards every five years toensure that they are relevant to changing marketdemands. The publication of ISO/FDIS 9001:2015will mark the next to final stage in revisions processtowards publication of ISO 9001:2015.What’s new?The proposed new elements can beseparated into two types:1) those inserted as part of the widerAnnex SL introduction to all ISOManagement System Standards (MSS)and2) those specifically introduced as partof the revision process for ISO 9001.Common terminology and structureAnnex SL (the new high level structureand common text for all new andrevised ISO standards) is the singlebiggest change to the proposed newdraft standard document. At firstglance, Annex SL appears to make thestandard writers lives ‘much easier’ butin reality, as organizations begin tounderstand and appreciate the valueof different management systems allspeaking a common language, it willbe organizations - and in turn theconsumer - who stand to be the truebeneficiaries.This structure will drive MSS integration,thereby delivering increasedorganizational benefits and efficiencieswhile providing a more complete viewof an organization – often spanningmultiple sites, geographies andinvolving multiple suppliers.New terms and definitionsThe proposed new version containsmany definitions; they have beenincluded to help the reader understandall the terms used. An understanding ofthe definitions is vital in order to fullygrasp the new standards requirements.A decision will be made later as towhich definitions remain in ISO 9001and which are included in ISO 9000,which gives the fundamental conceptsand vocabulary for quality MSS.One term that is used extensivelythroughout is ‘determine’.Determination is defined inISO 9001:2015 as: “Activity tofind out one or more characteristicsand their characteristic values”.Within the management systemsenvironment, organizations will have toconsider how they can provide evidencethat a process of determination hastaken place and that an output fromthat process exists.Annex A has been introduced and isinformative in nature. This Annexprovides clarification for the newStructure, Terminology and Conceptscontained within the proposed newstandard.ContextContext of the organization is newand requires an organization todetermine the internal and externalissues and requirements that canimpact on the planning of the qualitysystem. Context becomes an importantconsideration and helps to ensure thatthe management system is designedand suitably adapted for a specificorganization.Risk based approachThe incorporation of Annex SL intoISO 9001:2015 drives a risk basedapproach to thinking and acting.The requirements under a risk basedapproach affect quality planningand incorporate much of what waspreviously titled preventive action.Now an organization will need todetermine the risks and opportunitiesthat need to be addressed to giveassurance that the QMS can achieveits intended results.This greater focus on risk will meanthat an organization will need todemonstrate how this requirementis met. The extent and formality ofthe approach needed in a particularorganization will – of course – beinfluenced by its context.While the structure and terminologyhas changed, there is no requirementfor an organization to use these termsor to follow the numbering or structurewithin their management system.03

Scope and applicabilityThe manner in which inclusion andexclusion of requirements forthe proposed new draft standard isaddressed is different from previousversions. Now organizations willhave to determine the scope of themanagement system and maintain thisas documented information. The scopewill need to be determined from theboundaries of the organization, itscontext, its interested parties and itsproducts and services.Where requirements can be applied,it is expected that they will be unlessthere is a clear reason that they arenot applicable.Documented informationThe terms ‘documented procedure’and ‘record’ have been replaced with‘documented information’.04The nature and type of documentedinformation that an organizationneeds to maintain or retain isdependent on the context and itsoperating environment. The waydocumented information is definedin ISO 9001:2015 provides more scopefor an organization to determinewhat is appropriate for its uniqueset of circumstances, rather than justfollowing a prescriptive format.Organizational knowledgeAn organization will now need toconsider what knowledge it needs toachieve conformity of products andservices along with how it will develop,maintain and retain such knowledge.While this is a new requirement,many organizations will already havea system to manage the informationand knowledge required to performsuccessfully, which can be incorporatedinto their QMS.Control of externally providedproducts and servicesPurchasing has become ‘control ofexternally provided products andservices’ to make it clear that therequirements apply to both physicalproducts and consumed servicesrelated to the end product of theorganization. While not specificallya new requirement, there has alwaysbeen some confusion around whethercertain categories of externally providedproducts and services should beincluded within the scope of the QMS.Now it is clear that however provided,an organization will need to apply a riskbased approach and determine the typeand extent of controls necessary.

What’s changing?In addition to several new focus areas,ISO 9001:2015 introduces a numberof changes to existing requirements.These changes often clarify the intentof a particular clause or make implicitrequirements more explicit. These maynot require an organization to changeits management system in any way.However, it would be worthwhile foran organization to review whether thenew wording of the standard aligns withtheir current organizational practices.LeadershipThe requirements relating to therelationship between the role topmanagement plays in creating andsupporting an effective QMS havebeen enhanced. There are now moreareas where top management needsto demonstrate their involvement andengagement with the QMS, such as: Ensuring integration of QMSrequirements into the organizations’business processes Promoting awareness of the processapproach Assuring the QMS achieves itsintended results Supporting other relevantmanagement roles to demonstratetheir leadershipPlanning of changesAnother requirement that has beenexpanded and clarified is that ofplanning of changes. Where the needfor change is identified there is nowa much clearer requirement for suchchanges to be carried out in a plannedand systematic manner. Again, anorganization will need to review itsown approach to managing changes tosee if any revision of its QMS is necessary.Analysis and evaluationThe proposed new draft standardtext has expanded and enhancedthe previous requirements to clarifywhat is expected. The performance,monitoring and review definitionsare all relevant here. Analysis andevaluation of appropriate datacovering conformity of productsand services, customer satisfaction,conformity to the management system,process performance, external providerperformance and so on, are all areaswhere an organization will need toreview its current approach anddetermine if any change is necessary.The output of the Analysis andEvaluation is now a defined input intothe Management Review process.Management reviewBecause of the incorporation ofAnnex SL and the revision to otherareas within the proposed new draftstandard, the scope of information tobe considered at management reviewmay also need to be extended. Thereis now an explicit requirement formanagement review to consider:Management representativeISO 9001:2015 no longer requiresa specific role of a managementrepresentative but defines roleswhere top management needs toassign appropriate responsibility andauthority. If this can be achievedthrough assignment to one person,then it may be that no change isnecessary. If, however, the rangeof roles is broader than that of oneperson, then an organization willneed to show how they have beenassigned to appropriate personnel.Quality manualThe requirement for a specificdocument called a quality manualhas been replaced with a clause titledQuality Management System andits Processes. Organizations are nowrequired to determine the processesneeded for the QMS – their inputs,outputs, sequence and interaction– then maintain documentedinformation to the extent necessaryto support the understanding andoperation of those processes. how changes in its context affect theQMS and its strategic direction and the effectiveness of actions taken toaddress risks and opportunities.05

How canLRQA help?LRQA, through our extensive range ofpublic and on-site training courses, ourclient specific gap analysis tools and ourinformative and educational online services,offers organizations a tailored path tosuccessful transition to ISO 9001:2015.06The degree of change necessary willdepend on how an organizationhas developed and uses its existingmanagement system. Considerationneeds to be given to a] whether itsISO 9001:2008 is limited to strictlymeeting the requirements as specifiedin the standard or b] whether it hassystems and processes in place that,while not specifically required inISO 9001:2008, are viewed asmanagement best practice.Our ISO 9001 new standard transitionservices have been designed so thatthey are about your organization andyour management system. We arecommitted to providing robust insightinto your systems that help you makean effective and efficient transition toISO 9001:2015.Gap analysisOur range of gap analysis servicesassess your existing QMS against therequirements of the proposed newstandard in order to help you developyour transition plan.