Comparison Matrix ISO 9001:2015 Vs ISO 9001:2008

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Comparison MatrixISO 9001:2015 vs ISO 9001:2008Description:This document is provided by American System Registrar. It shows relevant clauses, side-by-side, of ISO 9001:2008 standard andthe 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 understandthe differences; and to help implement any necessary changes in your Quality Management System. Take your existing QMS, andmap where the old standard applies and develop a plan, if necessary, to modify any processes, procedures or definitions with the goalof conformance prior to your next audit.Intended Audience:This document is intended for the ISO 9001 QMS Stakeholders in an organization, the Internal Auditors, and the Quality Manger(s).Copyright:All rights reserved by American System Registrar. This document may be distributed to any person “as is” withoutmodification. We encourage its use to any and all parties interested in conforming to ISO standards with a goal ofmaintaining their certification status or seeking their first certification audit.About ASR:American System Registrar is an accredited Certification Body for ISO 9001, ISO 14001, ISO 13485, AS9100, AS9120, and ISO/TS16949. We provide 3rd party audits with the goal of adding value to your organization, not just a certification. ASR is client centeredand affordable for every size organization. Click here to read more about us.Version: 2 (5/25/2016)Provided by: American System Registrar

Comparison Matrix ISO 9001:2015 vs ISO 9001:2008ISO 9001:2015 clause4 Context of the organization4.1 Understanding the organization and itscontextThe organization shall determine externaland internal issues that are relevant to itspurpose and its strategic direction and thataffect its ability to achieve the intendedresult(s) of its quality management system.The organization shall monitor and reviewinformation about these external andinternal issues.ISO 9001:2008 clauseNo equivalent clauseNOTE 1Issues can include positive andnegative factors or conditions for consideration.CommentsGenerally organizations address this bydeveloping a vision statement and a missionstatement; these are developed into a longterm strategic direction and a strategic plan.These further lead to shorter 3 to 5 yearbusiness development plans, which aresupported by annual goals and objectives.For small to medium size organizations,these may be unstated and undocumentedand be in the mind of the owner or may notexist at all.The issues can relate to:Legal (FDA, FAA, DOT, EPA, OHSA)Market & competitionTechnology developmentCultural & social directionsEconomic developmentInternational TradeNOTE 2 Understanding the external contextcan be facilitated by considering issues arisingfrom legal, technological, competitive, market,cultural, social and economic environments,whether international, national, regional orlocal.NOTE 3Understanding the internal contextcan be facilitated by considering issues relatedto values, culture, knowledge andperformance of the organization.4.2 Understanding the needs andexpectations of interested partiesDue to their effect or potential effect onthe organization’s ability to consistentlyprovide products and services that meetcustomer and applicable statutory andregulatory requirements, the organizationshall determine:a) the interested parties that are relevantto the quality management system;b) the requirements of these interestedparties that are relevant to the qualityProvided by: American System RegistrarNo equivalent clauseOrganization’s interested parties include:Owner(s) – individuals, investmentcompanies, corporateownership, sTrade AssociationsState and local business communityOwnersSuppliers

management system.The organization shall monitor and reviewinformation about these interested partiesand their relevant requirements.4.3 Determining the scope of the qualitymanagement systemThe organization shall determine theboundaries and applicability of the qualitymanagement system to establish itsscope.Whendeterminingthisscope,theorganization shall consider:a) the external and internal issues referredto in 4.1;b) the requirements of relevant interestedparties referred to in 4.2;c) the products and services of theorganization.The organization shall apply all therequirements of this International Standardif they are applicable within thedetermined scope of its qualitymanagement system.The scope of the organization’s qualitymanagement system shall be availableand be maintained as documentedinformation. The scope shall state thetypes of products and services covered,andprovidejustificationforanyrequirement of this International Standardthat the organization determines is notapplicable to the scope of its qualitymanagement system.Conformity to this International Standardmay only be claimed if the requirementsdetermined as not being applicable do notaffect the organization’s ability orresponsibility to ensure the conformity of itsproductsandservicesandtheProvided by: American System RegistrarNeighbors4.2.2 Quality manualThe organization shall establish andmaintain a quality manual that includesa) the scope of the quality managementsystem, including details of andjustification for any exclusions (see1.2),Scope requirements are more explicitRequired ContentTypes of products & servicesApplication of all requirements from ISO9001 that are applicable – if they haveactivities/processes they are to be includedBoundaries of the QMSJustification for any exclusionsScope determined by considering external &internal issues, requirements of interestedparties & products & services

enhancement of customer satisfaction.4.4 Quality management system4.4.1 The organization shall establish, implement,maintain and continually improve a qualitymanagement system, including the processesneeded and their interactions, in accordancewith the requirements of this InternationalStandard.4.1General requirementsThe organization shall establish, document,implement and maintain a qualitymanagement system and continuallyimprove its effectiveness in accordance withthe requirements of this InternationalStandard.The organization shalla)determine the processes needed for thequality management system and theirapplication throughout the organization(see 1.2),b) determine the sequence and interactionof these processes,c) determine criteria and methods neededto ensure that both the operation andcontrol of these processes are effective,d) ensure the availability of resourcesand information necessary to supportthe operation and monitoring of theseprocesses,e)monitor, measure where applicable, andanalyse these processes, andThe organization shall determine theprocesses needed for the qualitymanagement system and their applicationthroughout the organization, and shall:a) determine the inputs required and theoutputsexpectedfromtheseprocesses;b) determine the sequence and interactionof these processes;c) determine and apply the criteria andmethods (including monitoring,measurements and relatedperformance indicators) needed toensure the effective operation andcontrol of these processes;d) determine the resources needed forthese processes and ensure theirf) implement actions necessary to achieveavailability;planned results and continuale) assigntheresponsibilitiesandimprovement of these processes.authorities for these processes;These processes shall be managed byf) address the risks and opportunities as the organization in accordance with thedetermined in accordance with the requirements of this International Standard.requirements of 6.1;Where an organization chooses to outsourceg) evaluate these processes andany process that affects product conformity torequirements, the organization shall ensureimplement any changes needed tocontrol over such processes. The type andensure that these processes achieveextent of control to be applied to thesetheir intended results;outsourced processes shall be defined withinh) improve the processes and the qualitythe quality management system.management system.4.4.2 To the extent necessary, the NOTE 1 Processes needed for the qualitymanagement system referred to above includeorganization shall:Provided by: American System RegistrarProcess Approach additions/changesAssign responsibilities & authorities for theprocessesAddress risks and opportunities with link to6.1Discussion of outsourced processes movedto a reference in clause 8.1 which refers tocontrol described in clause 8.4 basically thepurchasing requirements

a) maintain documented information tosupport the operation of itsprocesses;b) retain documented information to haveconfidence that the processes arebeing carried out as planned.processes for management activities, provision ofresources, product realization, measurement,analysis and improvement.NOTE 2 An “outsourced process” is a process thatthe organization needs for its quality managementsystem and which the organization chooses tohave performed by an external party.NOTE 3Ensuring control over outsourcedprocesses does not absolve the organization ofthe responsibility of conformity to all customer,statutory and regulatory requirements. The typeand extent of control to be applied to theoutsourced process can be influenced by factorssuch asa) the potential impact of the outsourced process onthe organization's capability to provide productthat conforms to requirements,b) the degree to which the control for the process isshared,c) the capability of achieving the necessary controlthrough the application of 7.4.5 Leadership5.1 Leadership and commitment5.1.1 GeneralTop management shall demonstrateleadership and commitment with respect tothe quality management system by:a) taking accountability for theeffectiveness of the qualitymanagement system;b) ensuring that the quality policy andquality objectives are establishedfor the quality management systemand are compatible with the contextand strategic direction of theorganization;c) ensuring the integration of the qualitymanagement system requirementsinto the organization’s businessprocesses;d) promoting the use of the processProvided by: American System Registrar5.1 Management commitmentTop management shall provide evidence ofits commitment to the development andimplementation of the quality managementsystem and continually improving itseffectiveness bya) communicating to the organization theimportance of meeting customer as wellas statutory and regulatoryrequirements,b) establishing the quality policy,c) ensuring that quality objectives areestablished,d) conducting management reviews, ande) ensuring the availability of resources.Top Management – new/now explicitcommitments:Accountability for effectivenessEnsuring QMS achieves intended resultsCompatible with Strategic Direction oforganizationIntegration with business processes(interpreted in context of nature oforganization – for profit; not for profit;private, public)

approach and risk-based thinking;e) ensuring that the resources needed forthe quality management system areavailable;f) communicating the importance ofeffective quality management andof conforming to the qualitymanagement system requirements;g) ensuring that the quality managementsystem achieves its intendedresults;h) engaging, directing and supportingpersons to contribute to theeffectiveness of the qualitymanagement system;i) promoting improvement;j) supporting other relevantmanagement roles to demonstratetheir leadership as it applies to theirareas of responsibility.NOTE Reference to “business” in thisInternational Standard can be interpretedbroadly to mean those activities that are core tothe purposes of the organization’s existence,whether the organization is public, private, forprofit or not for profit.5.1.2 Customer FocusTop management shall demonstrateleadership and commitment with respectto customer focus byensuring that:a) customer and applicable statutoryand regulatory requirements aredetermined, understood andconsistently met;b) the risks and opportunities that canaffect conformity of products andservices and the ability to enhancecustomer satisfaction areProvided by: American System Registrar5.2 Customer focusCustomer focus tie to risk as affectingproducts & servicesTop management shall ensure thatcustomer requirements are determined andare met with the aim of enhancingcustomer satisfaction (see 7.2.1 and 8.2.1).Customer focus tie to regulatoryrequirements as well as customerrequirements

determined and addressed;c) the focus on enhancing customersatisfaction is maintained.5.2 Policy5.2.1Developing the quality policyTop management shall establish, implementand maintain a quality policy that:a) is appropriate to the purpose andcontext of the organization and supportsits strategic direction;b) provides a framework for setting qualityobjectives;c) includes a commitment to satisfyapplicable requirements;d) includes a commitment to continualimprovement of the qualitymanagement system.5.2.2 Communicating the quality policyThe quality policy shall:a) be available and be maintained asdocumented information;b) be communicated, understood andapplied within the organization;c) be available to relevant interestedparties, as appropriate.5.3 Organizational roles, responsibilities andauthoritiesTop management shall ensure that theresponsibilities and authorities for relevantroles are assigned, communicated andunderstood within the organization.Top management shall assign theresponsibility and authority for:a) ensuring that the quality managementsystem conforms to the requirementsof this International Standard;b) ensuring that the processes aredelivering their intended outputs;c) reporting on the performance of theProvided by: American System Registrar5.3 Quality policyTop management shall ensure that the qualitypolicya)is appropriate to the purpose of theorganization,b)includes a commitment to comply withrequirements and continually

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