INTERNATIONAL STANDARDS REGISTRAIONS 1 SCOPE

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INTERNATIONAL STANDARDS REGISTRAIONSISO 9001-2015 STANDARD (Property of International Standards Registrations)ContentsISO 9001-20151234567SCOPE .1NOMATIVE REFERENCES.1TERMS AND DEFINACTIONS . 1CONTEXT OF THE ORGNIZATION .14.1 UNDERSTANDING THE ORGNIZATION AND ITS CONTEXT .14.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTRESTED PARTIES 24.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM .24.4 QUALITY MENAGEMENT SYSTEMS AND ITS PROCESSES . .2LEADERSHIP 35.1 LEADERSHIP AND COMMITMENT . 35.1.1 GENERAL .35.1.2 CUSTOMER FOCUS 35.2 POLICY . 45.2.1 ESTLABLISHING THE QUALITY POLICY .45.2.2COMMUNICATING THE QUALITY POLICY .45.3 ORGANIZATIONAL ROLES , RESPONSIBILITIES AND AUTHORITIES .4PLANNING . 46.1 ACTION TO ADDRESS RISKS AND OPPORTUNITIES .46.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM .56.3 PLANNNING OF CHANGES .5SUPPORT 67.1 RESOURCES .67.1.1 GENERAL .67.1.2 PEOPLE 67.1.3 INFRASTRUCTURE .67.1.4 ENVOIRMENT FOR THE OPERATION OF PROCESSES .67.1.5 MONITORING AND MEASURING RESOURCES .77.1.6 ORGNIZATIONAL KNOWLEDGE .77.2 COMPETENCE .87.3 AWARENESS 8www.isoregistrations.com

7.4 COMMUNICATION . .87.5 DOCUMENTED INFORMATION .97.5.1 GENERAL . .97.5.2 CREATING AND UPDATING .97.5.3 CONTROL OF DOCUMENTED INNFORMATION .98OPERATIONN . .98.1 OPERATIONAL PLANNING AND CONTROL .98.2 REQUIRMENTS FOR PRODUCTS AND SERVICES . .108.2.1 CUSTOMER COMMUNICATION .108.2.2 DETERMINING THE REQUIRMENTS FOR PRODUCTS AND SERVICES 108.2.3 REVIEW OF THE REQUERMENTS FOR PRODUCT AND SERVICES 108.2.4 CHANGES TO REQUERMENTS FOR PRODUCTS AND SERVICES .118.3 DESIGN AND DEVALOPMENT OF PRODUCTS AND SERVICES . . 118.3.1 GENERAL . .118.3.2 DESIGN AND DEVELOPMENT PLANNING .118.3.3 DESIGN AND DEVELOPMENT INPUTS . .118.3.4 DESIGN AND DEVELOPMENT CONTROLS . .128.3.5 DESIGN AND DEVELOPMENT OUTPUTS .128.3.6 DESIGN AND DEVELOPMENT CHANGES . .128.4 CONTROLOF EXTERNALLY PROVIDED PROCESSES PRODUCTS AND SERVICES .138.4.1 GENRAL .138.4.2 TYPE AND EXTENT OF CONTROL 138.4.3 INFORMATION FOR EXTERNAL PROVIDERS .138.5 PRODUCTION AND SERVICE PROVISION .148.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION .148.5.2 IDENTIFICATION AND TRACEABILITY .148.5.3 PROPERTY BELONGING TO CUSTOMERS OR EXTRNAL PROVIDERS .15www.isoregistrations.com

8.5.4 PRESERVATION .158.5.5 POST-DELEVERY ACTIVITES .158.5.6 CONTROL OF CHANGES .158.6 RELEASE OF PRODUCTION AND SERVICES . .158.7 CONTROL OF NONCONFOMING OUTPUTS . . 169 PERFORMANCE EVALUTION 169.1 MONITORING , MEASUREMENT,ANALYSIS AND EVALUATION .169.1.1 GENERAL .169.1.2 CUSTOMER SATISFACTION .179.1.3 ANALYSIS AND EVALUATION .179.2 INTERNAL AUDIT .179.3 MANAGEMENT REVIEW .189.3.1 GENREAL .189.3.2 MANAGEMENT REVIEW INPUTS . . 189.3.3 MANAGMENT REVIEW OUTPUTS . 1810 IMPROVEMENT 1910.1 GENERAL .1910.2 NONCONFORMITY AND CORRECTIVE ACTION .1910.3 CONTINUAL IMPROVEMENT 19ANNEX A (INFORMATIVE) CLERIFICATION OF NEW STRUCTURE, TERMINOLOGY AND CONCEPT .21ANNEX B (INFORMATIVE) OTHER INTERNATIONAL STANDARDS ON QUALITY MANAGEMENT ANDQUALITY MANAGEMENT SYSTEMS DVELOPED BY ISO/TC176 .25BIBLIOGRAHY 28www.isoregistrations.com

INTRODUCTION0.1 GENERALThe adoption of a quality management is a strategic decision for an organization thatcan help to improve its overall performance and provide a sound basic for sustainabledevelopment initiatives.The potential benefits to an organization of implementing a quality managementsystem based on this international standard are:a) the ability to consistently provide products and services that meet customer andapplicable statutory and regulatory requirements;b) facilitating opportunities to enhance customer satisfaction;c) addressing risk and opportunities associated with its context and objectives;d) the ability to demonstrate conformity to specified quality management systemrequirements.This International Standards can be used by internal and external parties.It is not the intent of this International Standards to imply the need for:– uniformity in the structure of different quality management systems;– alignment of documentation to the clause structure of this Internationalstandards;– the use of the specific terminology of this International Standards with theorganization.The quality management systems requirements specified in this International Standards arecomplementary to requirements for products and services.This International Standards employs the process approach, which incorporates the Plan-DoCheck-Act (PDCA) cycle and risk- based thinking.The process approach enables an organization to plan its processes and their interactions.The PDCA cycle enables an organization to ensure that its processes are adequately resourcedand managed, and that opportunities for improvement are determined and acted on.Risk – based thinking enables an organization to determine the factors that could cause itsprocesses and its quality management system to deviate from the planned results, to put inwww.isoregistrations.com

place preventive controls to minimize negative effects and to make maximum use ofopportunities as they arise (see clause A4).Consistently meeting requirements and future needs and expectation poses a challenge fororganization in an increasingly dynamic and complex environment. To achieve this objective,the organization might find it necessary to adopt various forms of improvement in addition tocorrection and continual improvement, such as breakthrough change, innovation and reorganization.In this International standards, the following verbal forms are used:–– “shall” indicates a requirement;––“should” indicates a recommendation;––“may” indicates a permission;––“can” indicates a possibility or a capability.Information marked as ”NOTE” is for guidance in understanding or clarifying the associatedrequirement.0.2 QUALITY MANAGEMENT PRINCIPLESThis International Standards is based on the quality management principles in ISO 9000.The descriptionsInclude a statement of each principle, a rationale of why the principle and examination of typical actionto improve the organization’s performance when applying the principle.The quality management principles are:–– customers focus––leadership;––engagement of people;––process approach;––improvement;––evidence-based decision marking;––relationship management .www.isoregistrations.com

0.3 PROCESS APPROACH0.3.1 GENERALThe International Standards promotes the adoption of a process approach when developing,implementing and improving the effectiveness of quality management system, to enhancecustomer satisfaction by meeting customer requirements. Specific requirements consideressential to the adoption of a process approach are included in 4.4Understanding and meaning interrelated process as a system contributes to the organization’seffectiveness and efficiency in achieving its intended result. This approach enables theorganization’s to control the interrelationship and interdependencies among the processes ofthe system, so that the overall performance of the organization can be enhanced.The process approach involves the systematic definition and management of process, and theirinteraction, so as to achieve the intended result in accordance with the quality policy andstrategic direction of the organization. Management of the process and the system as a wholecan be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinkingsee (0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.The application of the process approach in a quality management system enables:a)b)c)d)understanding and consistency in meeting requirements;the consideration of processes in terms of added value;The achievement of effective process performance;Improvement of processes based on evaluation of data and information.Figure -1 gives a schematic representation of any process and show the interaction of itselements. The monitoring and measuring check points, which are necessary for control, arespecific to each process and will vary depending on the related risks.www.isoregistrations.com

0.3.2 PLAN-DO-CHECK-ACT CYCLEThe PDCA cycle can be applied to all processes and to the quality management system as awhole figure-2 illustrates how clauses 4 to 10 can be grouped relation to the PDCA cycle.www.isoregistrations.com

NOTE - Number in brackets refer to the clauses in this International standards.Figure 2-representation of the structure of this International Standards in the PDCA cycle.The PDCA cycle can be briefly described as follows:www.isoregistrations.com

–– Plain : establish the objectives of the system and its processes, and the resources neededto deliver result in accordance with customers’ requirement and the orgnizatio’s policies, andidentify and address risk and opportunities;–– Do: implement what was planned;–– Check: monitor and (where application) measure processes and the resulting products andservices against policies, objectives, requirements and planned activities, and report the result;–– Act: take action to improve performance, as necessary.0.3.3 risk-based thinkingRisk-based thinking (see clause-4) is essential for achieving an effective quality managementsystem. The concept of risk- based thinking has been implicit in previous edition of thisInternational Standards including, for example, carrying out preventive action to eliminatepotential nonconformities, analyzing any nonconformities that do occur, and taking action toprevent recurrence that is appropriate for the effects of the nonconformity.To conform to the requirements of this International Standards, an organization needs to planand implement action to address risk and opportunities. Addressing both risk and opportunitiesestablishes a basis for increasing the effectiveness of the quality management system,achieving improved result and preventing negative effects.Opportunities can arise as a result of a situation favourable to achieving an intended result, forexample, a set of circumstances that allow the organization to attract customers, develop newproducts and services, reduce waste or improve productivity. Action to address opportunitiescan also include consideration of associated risks. Risk is the effect or uncertainty and any suchuncertainty can have positive or negative effects. A positive devlation arising from a risk canprovide an opportunity, but not all positive effects of risk result in opportunities.0.4 Relationship with other management system standardsRisk-based thinking (see Clause A.4) is essential for achieving an effective qualitymanagement system. The concept of risk-based thinking has been impliciteditions of this International Standards including, for examples. Carrying outpreventive action to prevent recurrence that is appropriate for the effects of thenonconformity.To conform to the requirements of this International Standards, an organizationneeds to plan and implement action to address risk and opportunities. Addressingwww.isoregistrations.com

both risk and opportunities establishes a basic for increasing the effectives of thequality management system, achieving improved result and preventing negativeeffects.Opportunities can arise as a result of a situation favorable to achieving anintended result for examples, a set of circumstances that allow the organizationto attract customers, develop new products and services, reduce waste orimprove productivity. Action to address opportunities can also includeconsideration of associated risks. Risk is the effect of uncertainty and any suchuncertainty can have positive or negative effects. A positive devlation arsing froma risk can provide an opportunity, but not all positive effects of risk result inopportunities.0.4 Relationship with other management system standardsThis International Standards applies the framework developed by ISO to improve alignmentamong its International standards for management systems (see Clause A.1).This International Standards enables an organization to use the process approach, coupled withthe PDCA cycle and risk-based thinking, to align or integrate its quality management systemwith the requirements of other management system standards.This International Standards relates to ISO 9000and ISO 9004 as follows:–– ISO 9000 Quality managements systems –– Fundamentals and vocabulary providesessential background for the proper understanding and implementation of this InternationalStandards;–– ISO 9004 Managing for the sustained success of an organization ––A quality managementapproach provides guidance for organization that chose to progress beyond the requirementsof this International Standards.QUALITY MANAGMENTS SYSTEMS –REQUIRMENTS1. Scopewww.isoregistrations.com

This International Standards specifies requirements for a quality management System whenan organization:a) needs to demonstrate its ability to consistently provide products and services that meetcustomer and applicable statutory and regulatory requirements, andb) aims to enhance customer satisfaction through the effective application of the system,including processes for improvement of the system and the assurance of conformity tocustomer and applicable statutory and regulatory requirements.ALL the requirements of this International Standards are generic and are Intended to beapplicable to any organization, regardless of its type or size, or the products and services itprovides.NOTE 1 In this International Standards, the terms “product” or “service” only apply toproducts and services intended, for or required by. A customer.NOTE 2 statutory and regulatory requirements can be expressed as legal requirements.2 Normative ReferencesThe following documents, in whole or in part, are normatively referenced in thisdocuments and are indispensable for its application. For dated references, only theedition cited applies. For undated references, the latest edition of The referenceddocument (including any amendments) applies.ISO 9000:2005, Quality management systems –– Fundamentals and vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000:2015apply.4 context of the organization4.1 Understanding the organization and its contextThe organization shall determine external and internal issues that are relevant to itspurpose and its strategic direction and that affect its ability to achieve the intendedresults(s) of its quality management system.The organization shall monitor and review information about these external and internalissue.www.isoregistrations.com

NOTE 1 Issue can include positive and negative factors condition for consideration.NOTE 2 Understanding the external context can be facilitated by considering issues arisingfrom legal, technological, competitive, market, social and economic environments, whetherinternational, national, regional or local.NOTE 3 Understanding the internal context can be facilitated by considering issues relatedto values, culture, knowledge and performance of the organization.4.2 Understanding theinterested partiesneedsandexpectationsofDue to their effect or potential effect on the organization’s ability to consistently provideproducts and services that customer and applicable statutory and regulatory requirements,the organization shall determine:a) the interested parties that are relevant to the quality management system;b) the requirements of these interested parties that are relevant to the qualitymanagement system.The organization shall monitor and review information about these interested parties andtheir relevant requirements.4.3 Determining the scope of the quality managementsystemThe organization shall determine the boundaries and applicability of the qualitymanagement system to establish its scope.When determining this scope, the organization shall consider:a) the external and internal issues referred to in 4.1;b) the requirements of relevant interested parties referred to in 4.2c) the products and services of the organization.The organization shall apply all the requirements of this International Standards if they areapplicable within the determined scope of its quality management system.The scope of the organization’s quality management system shall be available and bemaintained as documented information. The scope shall state the types of products andservices covered, and provide justification for any requirement of this Internationalwww.isoregistrations.com

Standards that the organization determines is not applicable to the scope of its qualitymanagement system.Conformity to this International Standards may be claimed if the requirements determinedas not being applicable do not affect the organization’s ability or responsibility to ensure theconformity of its products and services and the enhancement of customer satisfaction.4.4 Quality management system and its processes4.4.1The organization shall establish, implement, maintain and continually improve aquality management system, including the process needed and their interactions, in aaccordance with the requirements of this International Standards.The organization shall determine the process needed for the quality management systemand their application throughout the organization, and shall:a) determine the inputs required and the outputs expected from these processes.b) determine the sequence and interaction of these processes;c) determine and apply the criteria and methods (including monitoring measurements andrelated performance indicators) needed to ensure the effective operation and control ofthese processes;d) determine the resources needed for these processes and ensure their availability;e) assign the responsibilities and authorities for these processes;f) address the risks and opportunities as determined in accordance with the requirementsof 6.1 ;g) evaluate these processes and implement any changes needed to ensure that theseprocesses achieve their intended results;h) improve the processes and the quality management system.4.4.2 To the extent necessary, the organization shall:a) maintain documented information to support the operation of its processes;b) retain documented information to have confidence that the processes are being carriedout as planned.5 Leadership5.1 Leadership and commitmentwww.isoregistrations.com

5.1.1GeneralTop management shall demonstrate leadership and commitment with respect to the qualitymanagement system by:a) taking accountability for the effectiveness of the quality management system;b) ensuring that the quality policy and quality objectives are established for the qualitymanagement system and are compatible with the context and strategic direction of theorganization;c) ensuring the integration of the quality management system requirement into theorganization’s business processes;d) promoting the use of the process approach and risk-based thinking;e) ensuring that the resources needed for the quality management system are available;f) communicating the importance of effective quality management and of conforming tothe quality management system requirement;g) ensuring that the quality management system achieves its intended result;h) engaging, directing and supporting person to contribute to the effectiveness of thequality management system;i) promoting improvement;j) supporting other relevant management roles to demonstrate their leadership as itapplies to their areas of responsibleity.NOTE: Reference to “business” in this International Standards can be interpreted to meanthose activities that are core to the purposes of the organization’s existence, whether theorganization is public, private, for profit or not for profit.5.1.2Customer focusThe management shall demonstrate leadership and commitment with respect to customerfocus by ensuring that :a) customer and application statutory and regulatory requirements are determined,understood and consistently met;b) the risks and opportunities that can affect conformity of products and services and theability to enhance customer satisfaction are determined and addressed;c) the focus on enhancing customer satisfaction is maintained.5.2 Policywww.isoregistrations.com

5.2.1 Establishing the quality policyTop management shall establish, implement and maintain a quality policy that:a) is appropriate to the purpose and context of the organization and supports its strategicdirection;b) provides a framework for setting quality objectives;c) includes a commitment to satisfy application requirements;a) includes a commitment to continual improvement of the quality management system.5.2.2 Communicating the quality policyThe quality policy shall:a) be available and be maintained as documented information;b) be communicated, understood and applied within the organization;c) be available to relevant interested parties, as appropriate.5.3 Organization roles, responsibilities and authoritiesTop management shall ensure that the responsibilities and authorities for relevant roles areassigned, communicated and understood within the organization.Top management shall assign the responsibility and authority for:a) ensuring that the quality management system conforms to the requirement of thisInternational Standards;b) ensuring that the processes are delivering their intended outputs;c) reporting on the performance of the quality management system and on opportunitiesfor improvement (see 10.1) , in particular to top management;d) ensuring the promotion of customer focus throughout the organization;e) ensuring that the integrity of the quality management system is maintained whenchanges to the quality management system are implemented.5 Planning6.1 Action to address risks and opportunities6.1.1 When planning for the quality management system, the organization shall considerthe issues referred to in 4.1 and the requirement referred to in 4.2 and determine the risksand opportunities that need to be addressed to:www.isoregistrations.com

a) give assurance that the quality management system can achieve its intended result (s):b) enhance desirable effects;c) achieve improvement,6.1.2 The organization shall plan:a) action to address these risks and opportunities;b) how to:1) integrate and implement the action into its quality management system processes(see 4.4)2) evaluate the effectiveness of these actions.Action taken to address risks and opportunities shall be proportionate to the potentialimpact on the conformity of products and services.NOTE 1 Option to address risks ca include avoiding risk, taking risk in order to pursue anopportunity, eliminating the risk source, changing the likelihood or consequences, sharingthe risk, or retaining risk by informed decision.NOTE 2 Opportunities can lead to the adoption of new practices, launching new products,opening new markets, addressing new customers, building partnerships, using newtechnology and other desirable and viable possibilities to address the organization’s or itscustomer’s needs.6.2 Quality objectives and planning to achieve them6.2.1 The organization shall establish quality objectives at relevant function, levels andprocesses need for the quality management system.The quality objectives shall:a)b)c)d)be consistent with the quality policy;be measurable;take into account applicable requirements;be relevant to conformity of products and services and to enhancement of customersatisfaction;e) be monitored;f) be communicated;www.isoregistrations.com

g) be updated as appropriate.The organization shall maintain documented information on the quality objectives.6.2.2 When planning how to achieve its quality objectives, the organization shall determine:a) what will be done;b) what resources will be required;c) when it will be responsible;d) when it will be completed;e) how the result will be evaluated.6.3 Planning of changesWhen the organization determines the need for changes to the quality management system,the changes shall be carried out in a planned manner (see 4.4)The organization shall consider:a)b)c)d)the purpose of the changes and their potential consequences;the integrity of the quality management system;the availability of resources;the allocation or reallocation of responsibilities.7 Support7.1 Resources7.1.1 GeneralThe organization shall determine and provide the resources needed for the establishment,implementation, maintenance and continual improvement of the quality management system.The organization shall consider:a) the capabilities of, and constraints on existing internal resources;b) what needs to be obtained from external providers;7.1.2 Peoplewww.isoregistrations.com

The organization shall determine and person necessary for the effective implementation of itsquality management system and for the operation and control of its processes.7.1.3 InfrastructureThe organization shall determine, provide and maintain the infrastructure necessary for theoperation of its process and to achieve conformity of products and services.NOTEInfrastructure can include:a) building and associated utilities;b) equipment, including hardware and software;c) transportation resources;d) information and communication technology.7.1.4 Environment for the operation of processesThe organization shall determine, provide and maintain the environment necessary for theoperation of its processes and to achieve conformity of products and services.NOTE A suitable environment can be a combination of human and physical factors, such as:a) social (e.g. non-discriminatory, calm, non-confrontational);b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);These factors can differ substantially depending on the on the products and services provided7.1.5Monitoring and measuring resources7.1.5.1 GeneralThe organization shall determine and provide the resources needed to ensure valid and reliableresult when monitoring or measuring is used to verify the conformity of products and servicesto requirements.The organization shall ensure that the resources providing:a) are suitable for specific type of monitoring and measurement activities being undertaken;b) are maintained to ensure their continuing fitness for their purpose.www.isoregistrations.com

The organization shall retain appropriate documented information evidence of fitness forpurpose of the monitoring and measurement resources.7.1.5.2 Measurement traceabilityWhen measurement traceability is a requirement, or is considered by the organization to be anessential part of providing confidence in the validity of measurement results, measuringequipment shall be:a) calibrated or verified, or both, at specified intervals, or prior to use, againstmeasurement standards traceable to international or national measurement standards;when no such standards exist, the basis used for calibration or verification shall beretained as documented information;b) identified in order to determine their status;c) safeguarded from adjustments, damage or deterioration that would invalidate thecalibration status and subsequent measurement results.The organization shall determine if the validity of previous measurement results has beenadversely affected when measuring equipment is found to be unfit for its intended purpose,and shall take appropriate action as necessary.7.1.6 Organization knowledgeThe organization shall determine the knowledge for the operation of its processes and toachieve conformity of products and services.This knowledge shall be maintained and be made available to the extent necessary.When addressing changing needs and trends, the organization shall consider its currentknowledge and determine how to acquire or access any necessary additional knowledgeand required updates.NOTE 1 Organizati

ISO 9001-2015 1 SCOPE . –– ISO 9004 Managing for the sustained success of an organization ––A quality management ap

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