Comparison Matrix ISO 9001:2015 vs ISO 9001:2008 - ?· Comparison Matrix ISO 9001:2015 vs ISO 9001:2008…

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<ul><li><p>Comparison MatrixISO 9001:2015 vs ISO 9001:2008</p><p>Description:</p><p>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.</p><p>Purpose / Usage:</p><p>The purpose of the document is to highlight the changes between the new and old standard. Use this document to better understand the differences; and to help implement any necessary changes in your Quality Management System. Take your existing QMS, and map where the old standard applies and develop a plan, if necessary, to modify any processes, procedures or definitions with the goal of conformance prior to your next audit.</p><p>Intended Audience:</p><p>This document is intended for the ISO 9001 QMS Stakeholders in an organization, the Internal Auditors, and the Quality Manger(s).</p><p>Copyright: </p><p>All rights reserved by American System Registrar. This document may be distributed to any person as is without modification. We encourage its use to any and all parties interested in conforming to ISO standards with a goal of maintaining their certification status or seeking their first certification audit.</p><p>About ASR:</p><p>American System Registrar is an accredited Certification Body for ISO 9001, ISO 14001, ISO 13485, AS9100, AS9120, and ISO/TS 16949. We provide 3rd party audits with the goal of adding value to your organization, not just a certification. ASR is client centered and affordable for every size organization. Click here to read more about us.</p><p>Version: 3 (6/18/2017)</p><p>Please distribute unmodified to Colleagues - Copyright by: American System Registrar</p><p>http://asrworldwide.com/http://asrworldwide.com/about-asr-the-quality-registrar/who-we-are.htmlhttp://asrworldwide.com/about-asr-the-quality-registrar/asr-accreditations.htmlhttp://asrworldwide.com/http://asrworldwide.com/http://asrworldwide.com/</p></li><li><p> Comparison Matrix ISO 9001:2015 vs ISO 9001:2008 </p><p>ISO 9001:2015 clause ISO 9001:2008 clause Comments 4 Context of the organization</p><p>4.1 Understanding the organization and its context</p><p>The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.The organization shall monitor and reviewinformation about these external andinternal issues.NOTE 1 Issues can include positive andnegative factors or conditions for consideration.</p><p>NOTE 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.</p><p>NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.</p><p>No equivalent clause Generally organizations address this by developing a vision statement and a missionstatement; these are developed into a long term strategic direction and a strategic plan. These further lead to shorter 3 to 5 year business development plans, which are supported by annual goals and objectives. For small to medium size organizations, these may be unstated and undocumented and be in the mind of the owner or may not exist at all.</p><p>The issues can relate to:Legal (FDA, FAA, DOT, EPA, OHSA)Market &amp; competitionTechnology developmentCultural &amp; social directionsEconomic development International Trade</p><p>4.2 Understanding the needs and expectations of interested parties</p><p>Due to their effect or potential effect onthe organizations ability to consistentlyprovide products and services that meetcustomer and applicable statutory andregulatory requirements, the organizationshall determine:</p><p>a) the interested parties that are relevantto the quality management system;</p><p>b) the requirements of these interestedparties that are relevant to the quality</p><p>No equivalent clause Organizations interested parties include:Owner(s) individuals, investment companies, corporate ownership, stockholders EmployeesRegulators CustomersCompetitorsTrade AssociationsState and local business communityOwners Suppliers</p><p>Please distribute unmodified to Colleagues - Copyright by: American System Registrar</p><p>http://asrworldwide.com/http://asrworldwide.com/</p></li><li><p>management system.The organization shall monitor and review information about these interested parties and their relevant requirements.</p><p>Neighbors</p><p>4.3 Determining the scope of the quality management system</p><p>The organization shall determine the boundaries and applicability of the quality management system to establish its scope.When determining this scope, theorganization shall consider:</p><p>a) the external and internal issues referredto in 4.1;</p><p>b) the requirements of relevant interestedparties referred to in 4.2;</p><p>c) the products and services of theorganization.</p><p>The organization shall apply all the requirements of this International Standardif they are applicable within the determined scope of its quality management system.The scope of the organizations qualitymanagement system shall be availableand be maintained as documentedinformation. The scope shall state thetypes of products and services covered,and provide justification for anyrequirement 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 organizations ability orresponsibility to ensure the conformity of itsproducts and services and the</p><p>4.2.2 Quality manualThe organization shall establish and maintain a quality manual that includesa) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),</p><p>Scope requirements are more explicit </p><p>Required ContentTypes of products &amp; servicesApplication of all requirements from ISO 9001 that are applicable if they have activities/processes they are to be includedBoundaries of the QMSJustification for any exclusions</p><p>Scope determined by considering external &amp;internal issues, requirements of interested parties &amp; products &amp; services </p><p>Please distribute unmodified to Colleagues - Copyright by: American System Registrar</p><p>http://asrworldwide.com/http://asrworldwide.com/</p></li><li><p>enhancement of customer satisfaction. 4.4 Quality management system4.4.1 The organization shall establish, implement,</p><p>maintain and continually improve a qualitymanagement system, including the processesneeded and their interactions, in accordancewith the requirements of this InternationalStandard.</p><p>The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:</p><p>a) determine the inputs required and theoutputs expected from theseprocesses;</p><p>b) determine the sequence and interactionof these processes;</p><p>c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;</p><p>d) determine the resources needed forthese processes and ensure theiravailability;</p><p>e) assign the responsibilities andauthorities for these processes;</p><p>f) address the risks and opportunities asdetermined in accordance with therequirements of 6.1;</p><p>g) evaluate these processes and implement any changes needed to ensure that these processes achievetheir intended results;</p><p>h) improve the processes and the quality management system.4.4.2 To the extent necessary, theorganization shall:</p><p>4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.The organization shalla)determine the processes needed for the </p><p>quality management system and their application throughout the organization (see 1.2),b) determine the sequence and interactionof these processes,c)determine criteria and methods needed to ensure that both the operation and control of these processes are effective,d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,e)monitor, measure where applicable, and analyse these processes, andf) implement actions necessary to achieve planned results and continual improvement of these processes.</p><p>These processes shall be managed by the organization in accordance with the requirements of this International Standard.Where an organization chooses to outsourceany process that affects product conformity torequirements, the organization shall ensurecontrol over such processes. The type andextent of control to be applied to theseoutsourced processes shall be defined withinthe quality management system.</p><p>NOTE 1 Processes needed for the quality management system referred to above include </p><p>Process Approach additions/changesAssign responsibilities &amp; authorities for the processesAddress risks and opportunities with link to 6.1 </p><p>Discussion of outsourced processes moved to a reference in clause 8.1 which refers to control described in clause 8.4 basically the purchasing requirements</p><p>Please distribute unmodified to Colleagues - Copyright by: American System Registrar</p><p>http://asrworldwide.com/http://asrworldwide.com/</p></li><li><p>a) maintain documented information to support the operation of its processes;</p><p>b) retain documented information to haveconfidence that the processes are being carried out as planned.</p><p>processes for management activities, provision ofresources, product realization, measurement, analysis and improvement.</p><p>NOTE 2 An outsourced process is a process that the organization needs for its quality managementsystem and which the organization chooses to have performed by an external party.</p><p>NOTE 3 Ensuring 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 as</p><p>a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements,</p><p>b) the degree to which the control for the process is shared,</p><p>c) the capability of achieving the necessary control through the application of 7.4.</p><p>5 Leadership5.1 Leadership and commitment5.1.1 GeneralTop management shall demonstrate leadership and commitment with respect to the quality management system by:</p><p>a) taking accountability for the effectiveness of the quality management system;</p><p>b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;</p><p>c) ensuring the integration of the quality management system requirements into the organizations business processes;</p><p>d) promoting the use of the process </p><p>5.1Management commitmentTop management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness bya) communicating to the organization the </p><p>importance of meeting customer as well as statutory and regulatory requirements,b) establishing the quality policy,c) ensuring that quality objectives are </p><p>established,d) conducting management reviews, ande) ensuring the availability of resources.</p><p>Top Management new/now explicit commitments:Accountability for effectivenessEnsuring QMS achieves intended resultsCompatible with Strategic Direction of organizationIntegration with business processes (interpreted in context of nature of organization for profit; not for profit; private, public)</p><p>Please distribute unmodified to Colleagues - Copyright by: American System Registrar</p><p>http://asrworldwide.com/http://asrworldwide.com/</p></li><li><p>approach and risk-based thinking;e) ensuring that the resources needed for</p><p>the quality management system are available;</p><p>f) communicating the importance of effective quality management and of conforming to the quality management system requirements;</p><p>g) ensuring that the quality management system achieves its intended results;</p><p>h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;</p><p>i) promoting improvement;j) supporting other relevant </p><p>management roles to demonstrate their leadership as it applies to theirareas of responsibility.</p><p>NOTE Reference to business in thisInternational Standard can be interpretedbroadly to mean those activities that are core tothe purposes of the organizations existence,whether the organization is public, private, forprofit or not for profit.</p><p>5.1.2 Customer FocusTop management shall demonstrate leadership and commitment with respect to customer focus byensuring that:</p><p>a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;</p><p>b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are </p><p>5.2 Customer focusTop management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).</p><p>Customer focus tie to risk as affecting products &amp; services</p><p>Customer focus tie to regulatory requirements as well as customer requirements </p><p>Please distribute unmodified to Colleagues - Copyright by: American System Registrar</p><p>http://asrworldwide.com/http://asrworldwide.com/</p></li><li><p>determined and addressed;c) the focus on enhancing customer </p><p>satisfaction is maintained.</p><p>5.2 Policy5.2.1 Developing the quality policyTop management shall establish, implement and maintain a quality policy that:a) is appropriate to the purpose and </p><p>context of the organization and supportsits strategic direction;</p><p>b) provides a framework for setting quality objectives;</p><p>c) includes a commitment to satisfy applicable requirements;</p><p>d) includes a commitment to continual improvement of the quality management system.</p><p>5.2.2 Communicating the quality policyThe quality policy shall:a) be available and be maintained as </p><p>documented information;b) be communicated, understood and </p><p>applied within the organization;c) be available to relevant interested </p><p>parties, as appropriate.</p><p>5.3 Quality policy</p><p>Top management shall ensure that the quality policya)is appropriate to the purpose of the </p><p>organization,b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,c) provides a framework for establishing and reviewing quality objectives,d) is communicated and understood within the organization, ande) is reviewed for continuing suitability.</p><p>Policy tie...</p></li></ul>

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