ISO 9001:2015 Overview And Comparison - ICAO
Improving performance,reducing riskISO 9001:2015Overview and ComparisonIntroductionThe purpose of this handout is to share LRQA insight into the newly revisedinternational Quality Management System (QMS) Standard ISO 9001:2015,which was published on September 15, 2015.Organizations certified to ISO 9001:2008 will have three years followingpublication of ISO 9001:2015 to transition to the revised standard. As aresult, LRQA recognizes that there will be ongoing demand for knowledgeof ISO 9001:2008 at least until September 2018.
ISO 9001:2015 OverviewBackgroundAll Management System Standards (MSSs) are subject to regular review.The last significant revision to ISO 9001 was in 2000. ISO 9001:2008 clarifiedpoints and enhanced compatibility with ISO 14001 (EMS). More recently,ISO 9001 has been subject to a comprehensive rewrite to ensure that its aimsand purpose appropriately support the changing needs of today’s world andreflect the increasingly complex environments in which organizations operate.Many organizations use and arecertificated to multiple managementsystem standards. This had led toorganizations seeking to combine orintegrate their management systems inan effective and efficient manner. Thereality is that the continued proliferationof ISO MSSs has resulted in manyapparently common requirements thatare subtly or substantially different. Thishas caused confusion and inconsistentunderstanding and implementation.Essentially, Annex SL defines how allfuture new and revised MSS will bestructured. The first standard to adoptthis structure was the Business ContinuityManagement standard (ISO 22301).Similarly, the new version of ISO 9001has been prepared using the“High-Level Structure” (i.e. clausesequence, common text andterminology provided in Annex SL).In order to deliver consistent andcompatible management systemstandards in the future, the ISO TechnicalManagement Board has produced acommon framework for all MSSs.This common framework is referred toas “Annex SL1”.The development and approval ofISO MSSs follows an established processand sequence; Committee Draft (CD),Draft International Standard (DIS),Final Draft (FDIS) followed by publicationof the Standard.The significance of changes usuallydiminishes as development progresses.Once the FDIS is released the nature ofany further change is normally minor.In May 2014, the new version of ISO 9001had reached the DIS stage.ISO/DIS 9001:2014 was approved by thetechnical committee and released forpublic review and comment. The FDISversion was published in July 2015.The FDIS version was then adopted as thefinal published standard ISO 9001:2015 onSeptember 15, 2015.There will be a three year transitionperiod for existing ISO 9001:2008accredited certifications, giving a deadlineof September 2018 for organizations tomigrate their QMS to ISO 9001:2015 fortheir certification to remain valid.1 Specifically:Annex SL of ISO/IEC Directives, Part 1,Consolidated ISO Supplement, aft designspec. andWD0Approveddesign spec.and WD1CD forcommentand ballotISO/DIS9001:2014publishedfor comment(3 18ISO 9001:2015publishedThree yeartransitionperiodPlease note that these timescales are subject to changeThe changes and what they meanWhen comparing the current standardto ISO 9001:2008, the changes seemextensive. We know ISO 9001:2008 toISO 9001:2015 adopts the High LevelStructure of Annex SL, and thatthe main areas of change are:02 Context of the organization Leadership Process approach Risk-based thinkingOver the following pages, LRQA looks atthe main differences and how they mayrequire change within a QMS.
ISO 9001:2015 OverviewStructure of the standard in line with Annex SLThe first significant change inISO 9001:2015 is that there are nowten sections instead of the existingeight in ISO 9001:2008.If your QMS manual is written aroundand references the clauses of the currentISO 9001 then, if you decide to keepyour quality manual, the numbers willneed to be updated to match the newclause numbering. However, the structureand terminology of Annex SL andISO 9001:2015 do not need to bereflected in the documentation of anorganization’s QMS.The following describes the High LevelStructure of Annex SL in more mative referencesTerms and definitionsContext of the ormance evaluationImprovementAnnex SL states the following:“ An effective managementsystem is usually based onmanaging the organization’sprocesses using a Plan-DoCheck-Act approachin order to achieve theintended outcomes.”So it is no surprise that the PDCA cycleis also very much evident in the waythat the revised ISO 9001 standard isstructured. Figure 1 of ISO 9001:2008– Model of a process-based qualitymanagement system in the currentstandard is retained in an updatedform showing the links to clauses ofISO 9001:2015.Some of the above ten headings arefamiliar (Scope, Normative References,Terms and Definitions and Planning)but some are new (in particular,Context of the organization andLeadership). Furthermore, when someof the ten headings are expandedout for ISO 9001:2015, some of thefamiliar terms for the current ISO 9001re-appear, all be it at times with someminor changes of wording, for exampleInternal Audit, Management Reviewand Design.So, for these topics, the existingprocesses within your current QMSmay well already address the newrequirements since they have largelyonly been re-arranged to fit in withthe Annex SL structure. Other familiarterms of the current ISO 9001 alsoreappear with subtle changes and/orenhancements; for example outsourcingand purchasing in the current standardreappear under control of externallyprovided products and services.At the back of this handout we haveincluded a useful correlation matrixbetween the clauses of ISO 9001:2008and ISO/FDIS 9001:2015.03
ISO 9001:2015 OverviewContext of the organizationSection 4 dedicates itself to the“organizational context”.This section is divided intofour sub clauses:4.1. Understanding the organizationand its context.4.2. Understanding the needs andexpectations of interested parties.4.3. Determining the scope of thequality management system.4.4. Quality management system andits processes.The latter two of these findcounterparts in the General section4.1 of ISO 9001:2008 but the former twoare new requirements and they requirean organization to think about the issuesthat can affect it as well as the partiesthat have an interest in it includinghow to garner these parties’ relevantrequirements.04Understanding the organizationand its contextUnderstanding the needs andexpectations of interested partiesISO 9001:2015 uses the term “contextof the organization”. This expandsthe concept of the organizationalenvironment referenced in ISO 9001:2008to include not only the businessenvironment, but also internal factors,such as organizational culture, andexternal factors, such as socio-economicconditions under which it operates.ISO 9001:2015 requires organizations togo through a process initially to identifythese groups and then to identifytheir needs and expectations that arerelevant to the organization’s qualitymanagement system.ISO 9001:2015 requires organizationsto identify, monitor and review internaland external issues that are relevant toits purpose and strategic direction, andthat have the ability to impact the QMS’sintended results.Relevant interested parties are groupsor individuals who have the ability toimpact (or potentially impact or beimpacted by) the organization’s ability tosupply consistently products and servicesthat meet customer and applicablestatutory and regulatory requirements.Customers, shareholders, board membersand competitors would all fit into thisclassification.
ISO 9001:2015 OverviewLeadershipProcess approachSection 5 dedicates itself to “Leadership”.Where ISO 9001:2008 promotes theadoption of a process approachISO 9001:2015 requires the organizationto establish a process-based qualitymanagement system.This section is divided intothree sub clauses:5.1. Leadership and commitment.5.2. Policy.5.3. Organizational roles, responsibilitiesand authorities.ISO 9001:2015 replaces “Managementresponsibility” with “Leadership”, andrepositions a number of ISO 9001:2008requirements as leadership activities.This clause calls for the organization’stop management to demonstrate theirinvolvement and engagement with thequality management system thoughdirect participation in, for example: Taking accountability for theeffectiveness of the qualitymanagement system. Promoting the use of the processapproach. Supporting other relevantmanagement roles to demonstratetheir leadership as it applies to theirareas of responsibility.Thus, the top management assumean active role in the QMS by takingaccountability for its success themselves(and not leaving it to the ManagementRepresentative – which, by the way,is no longer explicitly called for in thenew version). The leaders must alsointegrate the QMS into the organization’sprocesses; so the process approach is moreto the fore in the new standard. Promoting improvement.ISO 9001:2015 Clause 4.4 states explicitrequirements that need to be met in thedesign, operation and maintenance of aprocess-based management system. Forexample, determination of inputs requiredand outputs expected, resources needed,and assignment of responsibilities andauthorities.Much of what is given in clause 4.4 ofISO 9001:2015 can be found inISO 9001:2008. However what waspreviously promoted is now a requirement,with requirements around processesappearing throughout ISO 9001:2015.For example, ISO 9001:2015 also statesthat organizations need to determineperformance indicators that allow forthe effective operation and control ofprocesses, identify risks and opportunitiesfor processes, and plan to address these.Risk-based thinkingThe concept of risk-based thinkingis described in the Introduction ofISO 9001:2015.Now risk is considered and includedthroughout the standard and the termpreventive action has disappeared.Risk is about what could happen andwhat the effect of this happening mightbe. Risk also considers how likely it is tohappen.ISO 9001:2015 requires the use of riskbased thinking to achieve conformityin the products and services providedby an organization, and thereby improvecustomer satisfaction, in the followingway:Risk is commonly understood to benegative. In risk-based thinking, whendealing with uncertainty, opportunitycan also be found. The opportunity couldbe related to reducing the likelihood ofsomething going wrong or improvingconformity and customer satisfaction.One of the key changes in ISO 9001:2015is to establish a systematic approach torisk, rather than treating it as a singlecomponent of a QMS; as is the case withISO 9001:2008 where preventive action isa standalone clause. Clause 4 (Context) the organization isrequired to determine the risks whichmay affect this (i.e. conformity in theproducts and services provided by anorganization). Clause 6 (Planning) the organizationis required to determine the risksand opportunities that need to beaddressed and plan actions to addressthem. Clause 8 (Operation) the organizationis required to implement processes toaddress risks and opportunities. Clause 9 (Performance evaluation) theorganization is required to monitor,measure, analyze and evaluate therisks and opportunities. Clause 10 (Improvement) theorganization is required to improve byresponding to changes in risk. Clause 5 (Leadership) top managementis required to commit to ensuring therisks and opportunities that can affectconformity of products and servicesand the ability to enhance customersatisfaction are determined andaddressed.05
ISO 9001:2015 OverviewOther changesMost of the requirements of ISO 9001:2008 are carried forward to ISO 9001:2015.To improve consistency of interpretation and understanding, and aid translation,many requirements remain unchanged. Also the restructuring of the standardoften means existing requirements have new clause numbers. The term ‘product’ is replaced by‘products and services’. ‘Quality objectives’ is expanded to‘Quality objectives and planning toachieve them’ with more emphasison planning how objectives will beachieved and making these planningrequirements explicit rather thanimplicit. The phrase ‘externally providedprocesses, products and services’replaces ‘Purchasing’. References to a documented qualitymanual, documented procedures andto quality records are removed.Instead, throughout ISO/FDIS 9001:2015there are specific references to“Documented Information”.This is information that theorganization is required to keep,control and maintain. There is no longer a requirementto appoint a ‘Managementrepresentative’.There are other changes where aspectsof a management system are moreclearly described because the Annex SLformat has a clause to address it.Such as: Competence Awareness Scope CommunicationThis ensures that there is commonalitywith other management systemstandards and so you will be able to seethe same headings in ISO 14001:2015and ISO 45001 (the replacement forOHSAS 18001 when it is published) andgroup what you do for them together inyour management system.Lastly, there is clause 10 aboutImprovement. ISO 9001:2015 recognizesthat incremental (continuous)improvement is not the onlyimprovement profile. Improvementcan also arise as a result of periodicbreakthroughs, reactive change or asa result of reorganization.Changes to the model of a process–based quality management systemThe new version of the standard brings with it an updated versionof the model, including the relevant clause numbers.Quality Management System (4)Organizationand itscontent (4)PlanSupportandOperation(7, ship(5)Planning(6)ActNeeds andexpectations ofrelevantinterestedparties (4)06PerformanceEvaluation(9)CheckProductsand servicesImprovement(10)(Reproduced fromISO 9001:2015)
ISO 9001:2015 OverviewConclusionThe most significant changes that ISO 9001:2015 will introduce come from adopting Annex SL.Organizations will need to review fullytheir current QMS to ensure all the newand enhanced requirements ofISO 9001:2015 are met. For anyorganization the degree of changenecessary will be dependent upon thematurity and effectiveness of the currentmanagement system, organizationalstructure and practices.It will be September 2018 before certifiedorganizations must complete transitionto the new standard, however accreditedcertification bodies are advising thattheir clients start to make appropriatepreparations as soon as practical and notdelay until the last moment.ISO 9001:2015 will build upon thecurrent standard; it will not take qualitymanagement in a new and completelydifferent direction. The course you areattending now will give you essentialknowledge and skills and help lay thefoundation for your further developmentand transition to ISO 9001:2015.In preparation for the changes, LRQAcan perform a Gap Analysis on yourcurrent system to determine howmuch work you need to do to bring itinto line with the new standard.We will also offer transition courseswhich will bring your auditors up tospeed with the new requirements andthe types of evidence that you will belooking for to verify conformance.We will also be offering a numberof highly useful training courses tobring you, your management andyour auditors up to speed on thenew standard in readiness for asmooth transition to being certifiedto ISO 9001:2015.These will be:We are offering: ISO 9001:2015 –What’s it all about?A one day appreciation course. Preparing for ISO 9001:2015A two day implementation coursefor management system managers. ISO 9001:2015 for internal auditorsA one day course for internalauditors. ISO 9001:2015 Lead Auditortransition trainingA two day course for those whohave successfully completed QMSAuditor/Lead Auditor training basedon ISO 9001:2008 or ISO 9001:2000,and want to upgrade to the newstandard; including those auditorsseeking re-registration with IRCA oranother auditor certification body.In the meantime we will continue tokeep clients and delegates informedand ensure our courses remain currentand relevant.07
ISO 9001:2008 to ISO 9001:2015Comparison MatrixISO 9001:2008ISO 9001:20154Quality management system4.4Quality management system and its processes4.1General requirements4.4Quality management system and its processes4.2Documentation requirements7.5Documented information4.2.1 General7.5.1 General4.2.2 Quality manualNo longer a requirement4.2.3 Control of documents7.5.2 Creating and updating7.5.3 Control of documented Information4.2.4 Control of records7.5.2 Creating and updating7.5.3 Control of documented Information5Management responsibility55.1Management commitmentLeadership and commitment5.15.1.1 General5.2Customer focus5.1.2 Customer focus5.3Quality policy5.2Policy5.4Planning6Planning5.4.1 Quality objectives6.2Quality objectives and planning to achieve them5.4.2 Quality management system planning66.16.3PlanningActions to address risks and opportunitiesPlanning of changes5Leadership5.5.1 Responsibility and authority5.3Organizational roles, responsibilities and authorities5.5.2 Management representativeNo longer a requirement5.5.3 Internal communication7.4Communication5.69.3Management review5.5Responsibility, authority and communicationManagement reviewLeadership5.6.1 General9.3.1 Management review5.6.2 Review input9.3.2 Management review inputs5.6.3 Review output9.3.3 Management review outputs6Resource management7.16.1Provision of resources7.1.1 General6.2Human resourcesTitle removed7.1.2 People7.2CompetenceResources6.2.1 General7.2Competence6.2.2 Competence, training and e7.1.3 Infrastructure6.4Work environment7.1.4 Environment for the operation of processes7Product realization8Operation7.1Planning of product realization8.1Operational planning and control7.2Customer-related processes8.2Requirements for products and services7.2.1 Determination of requirements related to theproduct8.2.2 Determining the requirements related to the products andservices7.2.2 Review of requirements related to the product8.2.3 Review of requirements related to the productsand services7.2.3 Customer communication7.4Communication8.2.1 Customer communication08
ISO 9001:2008 to ISO 9001:2015Comparison MatrixISO 9001:2008ISO 9001:20157.38.3Design and developmentDesign and development of products and services7.3.1 Design and development planning8.3Design and development of products and services8.3.1 General8.3.2 Design and development planning7.3.2 Design and development inputs8.3.3 Design and development Inputs7.3.3 Design and development outputs8.3.5 Design and development outputs7.3.4 Design and development review8.3.4 Design and development controls7.3.5 Design and development verification8.3.4 Design and development controls7.3.6 Design and development validation8.3.4 Design and development controls7.3.7 Control of design and development changes8.3.6 Design and development changes7.48.4PurchasingControl of externally provided processes, productsand services7.4.1 Purchasing process8.4.1 General8.4.2 Type and extent of control7.4.2 Purchasing information8.4.3 Information for external providers7.4.3 Verification of purchased product8.6Release of products and services7.58.5Production and service provisionProduction and service provision7.5.1 Control of production and service provision8.5.1 Control of production and service provision8.5.5 Post-delivery activities7.5.2 Validation of processes forproduction and service provision8.5.1 Control of production and service provision7.5.3 Identification and traceability8.5.2 Identification and traceability7.5.4 Customer property8.5.3 Property belonging to customers or external providers7.5.5 Preservation of product8.5.4 Preservation7.6Control of monitoring and measuringequipment7.1.5 Monitoring and measuring resources8.0Measurement, analysis and improvement9.18.1General9.1.1 General8.2Monitoring and measurement9.1Monitoring, measurement, analysis and evaluationMonitoring, measurement, analysis and evaluation8.2.1 Customer satisfaction9.1.2 Customer satisfaction8.2.2 Internal audit9.28.2.3 Monitoring and measurement of processes9.1.1 General8.2.4 Monitoring and measurement of product8.6Release of products and services8.3Control of nonconforming product8.7Control of nonconforming outputs8.4Analysis of data9.1.3 Analysis and evaluation8.5Improvement10Improvement8.5.1 Continual improvement10.110.3GeneralContinual Improvement8.5.2 Corrective action10.2Nonconformity and corrective action8.5.3 Preventive actionClause removedInternal audit09
ISO 9001:2015 to ISO 9001:2008Comparison Matrix10ISO 9001:2015ISO 9001:20084Context of the organization1.0Scope4.1Understanding the organization and its context1.1General4.2Understanding the needs and expectations of interestedparties1.1General4.3Determining the scope of the quality management system1.2Application4.2.2a Quality manual4.4Quality management system and its processes4.1General requirements4.2.2c Quality manual5Leadership5Management responsibility5.1Leadership and commitment5.1Management commitment5.1.1 General5.1Management commitment5.1.2 Customer focus5.2Customer focus5.2Policy5.3Quality policy5.3Organizational roles, responsibilitiesand authorities5.5.1 Responsibility and authority5.5.2 Management representative6Planning5.4.2 Quality management system planning6.1Actions to address risks and opportunities5.4.2 Quality management system planning8.5.3 Preventive action6.2Quality objectives and planning to achieve them5.4.1 Quality objectives6.3Planning of changes5.4.2 Quality management system planning7Support6Resource management7.1Resources6Resource management7.1.1 General6.1Provision of resources7.1.2 People6.1Provision of resources7.1.3 Infrastructure6.3Infrastructure7.1.4 Environment for the operation of processes6.4Work environment7.1.5 Monitoring and measuring resources7.6Control of monitoring and measuring equipment7.1.6 Organizational knowledgeNew requirement7.2Competence6.2.1 General6.2.2 Competence, training and awareness7.3Awareness6.2.2 Competence, training and awareness7.4Communication5.5.3 Internal communication7.2.3 Customer communication7.5Documented information4.2Documentation requirements7.5.1 General4.2.1 General7.5.2 Creating and updating4.2.3 Control of documents4.2.4 Control of records7.5.3 Control of documented Information4.2.3 Control of documents4.2.4 Control of records8Operation7Product realization8.1Operational planning and control7.1Planning of product realization8.2Requirements for products and services7.2Customer-related processes8.2.1 Customer communication7.2.3 Customer communication8.2.2 Determining requirements related to products and services7.2.1 Determination of requirements relatedto the product
ISO 9001:2015 to ISO 9001:2008Comparison MatrixISO 9001:2015ISO 9001:20088.2.3 Review of requirements related to the products and services7.2.2 Review of requirements related to the product8.2.4 Changes to requirements for products and services7.2.2 Review of requirements related to the product8.37.3Design and development8.3.1 General7.3Design and development8.3.2 Design and development planning7.3.1 Design and development planning8.3.3 Design and development inputs7.3.2 Design and development inputs8.3.4 Design and development controls7.3.4 Design and development review7.3.5 Design and development verification7.3.6 Design and development validation8.3.5 Design and development outputs7.3.3 Design and development outputs8.3.6 Design and development changes7.3.7 Control of design and development changes8.47.4.1 Purchasing processDesign and development of products and servicesControl of externally provided processes,products and services8.4.1 General7.4.1 Purchasing process8.4.2 Type and extent of control7.4.1 Purchasing process7.4.3 Verification of purchased product8.4.3 Information for external providers7.4.2 Purchasing information8.57.5Production and service provisionProduction and service provision8.5.1 Control of production and service provision7.5.1 Control of production and service provision7.5.2 Validation of processes for production andservice provision8.5.2 Identification and traceability7.5.3 Identification and traceability8.5.3 Property belonging to customers or external providers7.5.4 Customer property8.5.4 Preservation7.5.5 Preservation of product8.5.5 Post-delivery activities7.5.1 Control of production and service provision8.5.6 Control of changes7.3.7 Control of design and development changes8.6Release of products and services8.2.4 Monitoring and measurement of processes7.4.3 Verification of purchased product8.7Control of nonconforming outputs8.39Performance evaluationNew requirement9.1Monitoring, measurement, analysis and evaluation8Measurement, analysis and improvement9.1.1 General8.1General9.1.2 Customer satisfaction8.2.1 Customer satisfaction9.1.3 Analysis and evaluation8.49.2Internal audit8.2.2 Internal audit9.3Management review5.6Management review10Improvement8.5ImprovementControl of nonconforming productAnalysis of data10.1 General8.5.1 Continual improvement10.2 Nonconformity and corrective action8.3Control of nonconforming product8.5.2 Corrective action10.3 Continual Improvement8.5.1 Continual improvement11
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ISO 9001:2015 Overview ISO 9001:2015 Overview Risk-based thinking The concept of risk-based thinking is described in the Introduction of ISO 9001:2015. Risk is about what could happen and what the effect of this happening might be. Risk also considers how likely it is to happen. Risk is commonly understood to be negative. In risk-based thinking .
ISO 9001:2015 QMS and ISO 14001:2015 EMS and ISO 45001:2018 Internal audit 6. Principals of Quality Management System-ISO 9001:2015 7. ISO 9001 and 14001 and ISO 45001:2018 EQHSMS audit records 8. Table of Documented information Summary against ISO 9001:2015 and ISO 14001:2015 require
ISO 9001.2015 & ISO 14001.2015 Gap Analysis Checklists* ISO 9001.2015 & ISO 14001.2015 Internal Audit Checklists* ISO 9001 & ISO 14001 Employee Newsletters *Sample Included. ISO 9001:2015 QUALITY MANAGEMENT SYSTEM ***** ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEM ***** QMS - EMS MANUAL Your Company Name
ISO 9001:2015 QMS and ISO 14001:2015 EMS and OHSAS 18001 Internal audit 6. Principals of Quality Management System-ISO 9001:2015 7. ISO 9001 and 14001 and OHSAS 18001 EQHSMS audit records 8. Tables Table - 1 Documented information Summary against ISO 9001:2015 and ISO 14001:2015 requirements 9. Chemical Chart
ISO 9001:2015 vs ISO 9001:2008 Description: This document is provided by American System Registrar. It shows relevant clauses, side-by-side, of ISO 9001:2008 standard and the ISO 9001:2015 standard. Purpose / Usage: The purpose of the document is to highlight the changes between the new and old standard. Use this document to better understand
Final Draft International Standard (FDIS) of ISO 9001 and vice versa. This guide provides the following: 1. An overview of the changes, deletions, new or enhanced ISO 9001 requirements 2. A mapping between Quality Management System (QMS) requirements in ISO 9001:2008 and ISO FDIS 9001:2015 where the requirement is essentially the same 3.
ISO 9001 requirements 2. A mapping between Quality Management System (QMS) requirements in ISO 9001:2008 and ISO 9001:2015 where the requirement is essentially the same 3. "Documented Information" has been adopted. Consequently, the The reverse mapping Table 1 will help if you are considering a transition project from ISO 9001:2008 to the .
ISO 9001:2015 Checklist with 9001:2008 Comparisons Ref. Questions from 9001:2015 . verified during the audit. This is a great list to take with you when each process is visited, audited. ISO 9001:2015 Checklist with 9001:2008 Comparisons Ref. Questions from 9001:2015
ISO 9001 requirements 2. A mapping between Quality Management System (QMS) requirements in ISO 9001:2008 and ISO 9001:2015 where the requirement is essentially the same 3. "Documented Information" has been adopted. Consequently, the The reverse mapping Table 1 will help if you are considering a transition project from ISO 9001:2008 to the .
