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Audit

An audit is an evidence gathering process. Audit evidence is used to evaluate how well audit criteria are being met. Audits must be objective, impartial, and independent, and the audit process must be both systematic and documented. There are three types of audits: first-party, second-party, and third-party audits. First-party audits are internal audits. Second and third party audits are e ternal audits. !rgani"ations use first party (internal) audits to audit themselves for internal purposes. #owever, you don$t have to do them yourself. %ou can as& an e ternal organi"ation to carry out an internal audit on behalf of your organi"ation. %ou can also use first party audits to declare that your organi"ation complies with the 'S! ())* standard +a self-declaration,. Second party audits are e ternal audits. They$re usually done by customers or by others on their behalf. #owever, they can also be done by any e ternal party that has an interest in your organi"ation. Third party audits are e ternal audits as well. #owever, they$re performed by independent +disinterested, e ternal organi"ations. Third party audits are used to determine whether or not an organi"ation complies with the 'S! ())* standard. Third party auditors are referred to as registrars or certification bodies.

Audit criteria
Audit criteria include policies, procedures, and re-uirements. Audit evidence is used to determine how well such audit criteria are being met. Audit evidence is used to determine how well policies are being implemented, how well procedures are being applied, and how well re-uirements are being met.

Auditee
An auditee is an organi"ation that is being audited. Organizations include companies, corporations, enterprises, firms, charities, associations, and institutions +or some combination of these,. Organizations can be either incorporated or unincorporated and can be privately or publicly owned.

Audit evidence

Audit evidence includes records, factual statements, and other verifiable information that is related to the audit criteria being used. Audit criteria include policies, procedures, and re-uirements. Audit evidence can be either -ualitative or -uantitative. Objective evidence is data that shows or proves that something e ists or is true.

Audit findings
Audit findings result from a process that evaluates audit evidence and compares it against audit criteria. Audit findings can show that audit criteria are being met +conformity, or that they are not being met +nonconformity,. They can also identify improvement opportunities. Audit findings are used to assess the effectiveness of the -uality management system and to identify opportunities for improvement. Audit evidence includes records, factual statements, and other verifiable information that is related to the audit criteria being used. Audit criteria include policies, procedures, and re-uirements.

Auditor
'n the conte t of this -uality management standard, an auditor is a person who collects evidence in order to evaluate how well -uality management systems meet re-uirements. Auditors are e pected to determine whether -uality management systems comply with standards and other planned arrangements. They must also be able to determine whether -uality management systems are properly implemented and maintained. And they must be able to do all of this while being independent, objective, impartial, and competent.

Audit plan
An audit plan specifies how you intend to conduct a particular audit. 't describes the activities you intend to carry out and the arrangements you intend to ma&e. An audit is an evidence gathering process. Audit evidence is used to evaluate how well audit criteria are being met.

analy"ing data. and so on. you can say that it conforms to that re-uirement. the processes and activities that will be included. legal re-uirements. and boundary of a particular audit.oncession A concession is a special approval that is granted to release a nonconforming product for use or delivery. Characteristics can be inherent or assigned. performing management reviews. The scope of an audit is generally defined by specifying the physical location of the audit. 0hen your organi"ation meets a re-uirement..onformity 'n the conte t of this standard. customer re-uirements. An inherent characteristic e ists in something or is a permanent feature of something. the organi"ational units that will be e amined. to conform means to meet or comply with re-uirements. . product re-uirements. . e tent. setting objectives. There are -uality re-uirements. for e ample. and implementing corrective and preventive actions. or implied. /e-uirements can be e plicitly specified +li&e the 'S! ())* re-uirements. Concessions are usually limited by time and -uantity and tend to specify that nonconforming characteristics may not violate specified limits. management re-uirements. A specified requirement is one that has been stated +in a document. .ontinual improvement Continual improvement is a set of activities that an organi"ation periodically carries out in order to enhance its ability to meet re-uirements. while an assigned characteristic is a feature that is attributed or attached to something. There are many types of re-uirements.. and the time period that will be covered.haracteristic A characteristic is a distinctive feature or property of something.Audit scope The scope of an audit is a statement that specifies the focus. Continual improvements can be achieved by carrying out audits +and using audit findings and conclusions. . .

customers may not be satisfied even though you$ve met all contractual re-uirements. 'f they believe that you2ve not met their re-uirements.orrective action Corrective actions are steps that are ta&en to remove the causes of an e isting nonconformity or undesirable situation. 3ust because you haven$t received any complaints doesn$t mean that customers are satisfied. The corrective action process is designed to prevent the recurrence of nonconformities or undesirable situations. For e ample. 1ecause of this. and beneficiaries.. reprocessing them. purchasers. study customer . 't tries to ma&e sure that e isting nonconformities and situations don$t happen again. . 't can vary from high satisfaction to low satisfaction. retailers. Corrective actions address actual problems. they e perience high satisfaction. There are many ways to monitor and measure customer satisfaction.ustomer satisfaction Customer satisfaction is a perception. end-users. within the same organi"ation. e amine dealer reports. According to 'S! ())). assigning them to a different use. . they e perience low satisfaction. Customers can be people or organi"ations and can be either e ternal or internal to the supplier organi"ation. corrections do not address causes. or simply destroying them. 'f customers believe that you2ve met their re-uirements.orrection A correction is any action that is ta&en to eliminate a nonconformity. 't is also a -uestion of degree. 't tries to prevent recurrence by eliminating causes. e amples of customers include clients. #owever. corrections can include rewor&ing products. 0hen applied to products. the corrective action process can be thought of as a problem solving process. a factory may supply products or services to another factory +customer.ustomer A customer is anyone who receives products or services from a supplier organi"ation. trac& warranty claims. . Since satisfaction is a perception. regrading them. %ou can use customer satisfaction and opinion surveys4 you can collect product -uality data +post delivery.. consumers.

5esign and development verification esign and development verification is a process. 0henever specified input re-uirements have been met. for products. 5esign and development esign and development is a process +or a set of processes. 'n this conte t. This process uses objective evidence to confirm that products meet the re-uirements which define their intended use or application. 't uses objective evidence to confirm that design and development outputs meet design and development input re-uirements. esign and development revie! can be used to evaluate product. 5esign and development review esign and development revie! is a set of activities whose purpose is to evaluate the suitability. 6ffectiveness . and systems. effectiveness. an effective set of characteristics or specifications is one that has the potential to achieve planned results or reali"e planned activities. processes. a verified status is achieved.. a validated status is achieved. The process of validation can be carried out under realistic use conditions or within a simulated use environment. and analy"e lost business opportunities. and sometimes the efficiency of a set of characteristics or specifications. ade-uacy. process. 0henever specified re-uirements have been met. and system characteristics or specifications. %ou may treat design and development as different stages of a single integrated design and development process or you may treat design and development as two +or more. into characteristics or specifications +outputs. %ou may also use the terms design and development interchangeably if they mean the same thing in your organi"ation. separate processes. 5esign and development validation esign and development validation is a process.compliments and criticisms. This process uses resources to transform re-uirements +inputs.

'nspection #nspections use observation. owners. and services that an organi"ation needs in order to function.9. unions. 7lanned activities are effective if these activities are reali"ed."ffectiveness refers to the degree to which a planned effect is achieved. The efficiency of a process or system can be enhanced by achieving more or getting better results +outputs. 7art 8. the term infrastructure includes buildings and wor&spaces +including related utilities.. testing and judgment to evaluate conformity. planned results are effective if these results are actually achieved. #nspection results are compared with specified re-uirements in order to establish whether conformity has been achieved. e-uipment. 'nterested party An interested party is a person or group that has a sta&e in the success or performance of another organi"ation. . and resources used +inputs. suppliers. employees.. partners. According to 'S! ())*. process e-uipment +both hardware and software. ban&ers. "fficiency can be enhanced by achieving more with the same or fewer resources. For e ample. an effective set of characteristics or specifications is one that has the potential to reali"e planned activities and achieve planned results 6fficiency "fficiency is a relationship between results achieved +outputs. measurement. Similarly. $roduct inspections compare product characteristics with product re-uirements in order to evaluate conformity. 'nfrastructure The term infrastructure refers to the entire system of facilities. with the same or fewer resources +inputs. #nterested parties may be directly affected by the organi"ation or actively concerned about its performance.. or members of the general public. #nterested parties can come from inside or outside of the organi"ation. an effective process is one that reali"es planned activities and achieves planned results. Similarly.. 6 amples of interested parties can include customers. support services +such as transportation and communications. and information systems..

!rgani"ations use internal (first party) audits to audit themselves for internal purposes. occupational health and safety management systems. %ou can as& an e ternal organi"ation to carry out an internal audit on behalf of your organi"ation. :anagement review The overall purpose of a management revie! is to evaluate the suitability. Some of these include -uality management systems. measuring equipment includes measuring instruments . and to loo& for improvement opportunities. food safety management systems. %anagement revie!s are also used to identify and assess opportunities to change an organi"ation$s -uality policy and -uality objectives. and business continuity management systems. direct. :easuring e-uipment 'n the conte t of this standard.'nternal audit #nternal audits are referred to as first-party audits. #owever. :anagement system A management system is a set of interrelated or interacting elements that organi"ations use to implement policy and achieve objectives. There are many types of management systems. 'n this conte t. ade-uacy. environmental management systems. %ou can use first party audits to declare that your organi"ation complies with the 'S! ())* standard. emergency management systems. to address resource needs. :anagement The term management refers to all the activities that are used to coordinate. and to loo& for opportunities to improve its products. the term management does not refer to people. and effectiveness of an organi"ation2s -uality management system. This is called a self-declaration. information security management systems. Accordingly. 't refers to activities. you don$t have to do them yourself. 'S! ())) uses the term top management to refer to people. measuring equipment includes all the things that are needed to carry out a measurement process. and control an organi"ation.

management re-uirements. a nonconformity occurs. or by using any other suitable method.onconforming product 0hen one or more characteristics of a product fail to meet specified re-uirements. and legal re-uirements. .onconformity &onconformity refers to a failure to comply with re-uirements. 'S! ())) lists four generic product categories: services. $roducts can be tangible or intangible. . There are many types of requirements. 't can be stated or implied by an organi"ation. Some of these include -uality re-uirements. it is referred to as a nonconforming product. A product is the output of a process. and processed materials. customer re-uirements. &onconformity products must be identified and controlled to prevent unintended use or delivery. product re-uirements. but is performed by a party that is e ternal to your organi"ation. or other interested parties. it fails to conform. !bjective evidence can be collected by performing observations. its customers. or obligation. 'S! ())* lists quality management system requirements . A re-uirement is a need.and apparatuses as well as all the associated software. a nonconformity occurs. !utsourced process An outsourced process is any process that is part of your organi"ation$s -uality management system +<:S. measurements. 0hen a product deviates from specified product re-uirements. standards. tests. e pectation. 0hen your organi"ation deviates from these re-uirements. and reference materials. !bjective evidence !bjective evidence is data that shows or proves that something e ists or is true. hardware. software. . 0henever your organi"ation fails to meet one of these re-uirements.

@?8/. the preventive action process can be thought of as a ris& analysis process. 'n general. $reventive actions address potential problems. The preventive action process is designed to prevent the occurrence of nonconformities or situations that do not yet e ist. 't tries to prevent occurrence by eliminating causes. preventive actions prevent occurrence. *>8=S. 7rocesses use resources to transform inputs into outputs. ocumented procedures can be very general or very detailed. Athe terms subcontract and outsource are interchangeable and have the same meaningB. 1oth types of actions are intended to prevent nonconformities. or anywhere in between. According to 'S! ())). procedures may or may not be documented. ?=. 7reventive action $reventive actions are steps that are ta&en to remove the causes of potential nonconformities or potential situations that are undesirable. According to 'S!=T. 0hile a general procedure could ta&e the form of a simple flow diagram. a detailed procedure could be a one page form or it could be several pages of te t. 0hile corrective actions prevent recurrence. ones that haven2t yet occurred. 'S! ())* e pects you to document your procedures. you must identify and control your outsourced processes . in most cases. A detailed procedure defines and controls the wor& that should . %ou also need to figure out how to control the interaction between internal and outsourced processes. 7rocedure A procedure is a way of carrying out a process or activity. and you must ensure that each outsourced process is effective.According to 'S! ())*. #owever. A process is a set of activities that are interrelated or that interact with one another.

A process'based quality management system uses a process approach to manage and control how its -uality policy is implemented and how its -uality objectives are achieved.be done. which inputs should be used. 'S! ())) does not formally define this important term so we2ve given it a try. the interaction between these processes. 7rocess A process is a set of activities that are interrelated or that interact with one another. who should do it. and e plains how it should be done. 0hen managers use a process approach. Organizational processes should be planned and carried out under controlled conditions. $rocesses are interconnected because the output from one process becomes the input for another process.. These process interactions create a single integrated process'based (%S.?. The concept of a Aprocess'based quality management systemB is briefly mentioned in the introduction to 'S! ())* +section ). 7rocess-based -uality management system +<:S. An effective process is one that reali"es planned activities and achieves planned results. 'n addition. Since the output of one process becomes the input of another process. it e plains what authority and what responsibility has been allocated. . processes are AgluedB together by means of such input output relationships. 7rocess approach The process approach is a management strategy. processes interact and are interrelated by means of such input-output relationships. #owever. and what outputs should be generated. 6ach process uses resources to transform inputs into outputs. and under what circumstances. and the inputs and outputs that tie these processes together. it means that they manage the processes that ma&e up their organi"ation. $rocesses use resources to transform inputs into outputs. 'n effect. A process-based <:S is a networ& of interrelated and interconnected processes.

an automobile +a product. Service can also involve the provision of an intangible thing to a customer +e.7roduct A product is the output of a process.g. and includes things li&e approaches and procedures. service can be provided for a product supplied by a customer +e. Service can be provided to support an organi"ation$s own products +e. or advice. :ore precisely. 'f those inherent characteristics meet all re-uirements. lubricants. software. warranty service or the serving of meals.. entertainment. and processed materials +e. a product inspection compares one or more characteristics of a product with specified re-uirements in order to determine if the product meets these re-uirements. high or e cellent -uality is achieved.g. The idea is realized or actuali"ed by following a set of product reali"ation processes. 'f those characteristics do . 7roduct reali"ation A product starts out as an idea. 0hile soft!are is intangible.g... and processed materials.g. <uality The quality of something can be determined by comparing a set of inherent characteristics with a set of re-uirements.g.. $roducts can be tangible or intangible. software +e. $roduct realization refers to all the processes that are used to bring products into being. testing and judgment to evaluate conformity. 7roduct inspection $roduct inspection is an activity that compares product characteristics with product re-uirements in order to evaluate conformity. transportation. :any products combine several of these categories. . $roduct inspections use observation.g. tires. a repair service or a delivery service. measurement. Service is always the result of an interaction between a service supplier and a customer and can ta&e many forms.onversely. engine control algorithms. hardware. combines hardware +e. For e ample. 'S! ())) lists four generic product categories : services.. hard!are and processed materials are tangible and are often referred to as goods..

a -uestion of degree. <A is one part of -uality management. (uality is always relative to a set of re-uirements. According to this definition. therefore. (uality assurance is a set of activities intended to establish confidence that -uality re-uirements will be met. (uality control is one part of -uality management. . A requirement is a need. An inherent feature or property e ists in something or is a permanent characteristic of something. As a result. <uality assurance +<A. 1y lin&ing -uality to re-uirements. the quality of something depends on a set of inherent characteristics and a set of re-uirements and how well the former complies with the latter. <uality control (uality control is a set of activities intended to ensure that -uality re-uirements are actually being met.not meet all re-uirements. process. its customers. <uality characteristic A quality characteristic is tied to a re-uirement and is an inherent feature or property of a product. or obligation. (uality improvement is one part of -uality management. e pectation. or system. a low or poor level of -uality is achieved. the central -uality -uestion is: #ow well does this set of inherent characteristics comply with this set of re-uirementsC 'n short. (uality is. quality is a relative concept. <uality improvement (uality improvement refers to anything that enhances an organi"ation2s ability to meet -uality re-uirements. or other interested parties. 't can be stated or implied by an organi"ation. 'S! ())) argues that the quality of something cannot be established in a vacuum.

<uality manual A quality manual documents an organi"ation2s -uality management system +<:S.. These process interactions create a single process'based (%S. 't can be a paper manual or an electronic manual. • 3ustify all e clusions +reductions in scope. <uality planning (uality planning involves setting -uality objectives and then specifying the operational processes and resources that will be needed to achieve those objectives. <uality management system +<:S.. processes interact and are interrelated by means of such input-output relationships. Since the output of one process becomes the input of another process.<uality management (uality management includes all the activities that organi"ations use to direct. and coordinate -uality. • • 5escribe how your <:S processes interact. 5ocument your -uality procedures or refer to them.. -uality assurance. These activities include formulating a -uality policy and setting -uality objectives. -uality control. A process'based (%S uses a process approach to manage and control how its -uality policy is implemented and -uality objectives are achieved. • 6 plain reductions in the scope of your <:S. According to 'S! ())*. (uality planning is . They also include -uality planning. A process'based (%S is a networ& of many interrelated and interconnected processes +elements. 6ach process uses resources to transform inputs into outputs. control. and -uality improvement. A quality management system is a set of interrelated or interacting elements that organi"ations use to direct and control how -uality policies are implemented and -uality objectives are achieved. your -uality manual should: • 5efine the scope of your <:S.

(uality policies should be used to generate -uality objectives and should serve as a general framewor& for action. They are usually formulated at all relevant levels within the organi"ation and for all relevant functions. /ecord A record is a type of document. A quality policy statement should describe an organi"ation$s general -uality orientation and clarify its basic intentions. A quality objective is something you aim for or try to achieve. <uality plan A quality plan is a document that is used to specify the procedures and resources that will be needed to carry out a project. <uality policy An organi"ation$s quality policy defines top management$s commitment to -uality. )ecords can. for e ample. reali"e a product. that verification is being performed. (uality plans also specify who will do what and when. They always document the past. be used to show that traceability re-uirements are being met. (uality objectives are generally based on or derived from your organi"ation$s -uality policy and must be consistent with it. (uality policies can be based on the 'S! ())) <uality :anagement 7rinciples and should be consistent with the organi"ation$s other policies. or manage a contract. /e-uirement . <uality objectives A quality objective is a -uality oriented goal. )ecords provide evidence that activities have been performed or results have been achieved. and that preventive and corrective actions are being carried out.one part of -uality management. perform a process.

a repair service or a delivery service. whereas an implied requirement is a need. Service According to 'S! ())). its customers. 'ts purpose is to figure out how well the thing being reviewed is capable of achieving established objectives.. service can be provided for a product supplied by a customer +e. Service can also involve the provision of an intangible thing to a customer +e.A requirement is a need. monitored. Service is always the result of an activity or interaction between a service supplier and a customer and can ta&e many forms. effective.g. /elative to the previous types of revie!s. respectively. entertainment. e pectation. or other interested parties. customer re-uirements.g. Service can be provided to support an organi"ation$s own products +e. design and development reviews. 't can be stated or implied by an organi"ation. the focus of each review is as follows: -uality management systems. Special process A special process is any production or service delivery process that generates outputs that cannot be measured.onversely. customer re-uirement reviews. or .. Some of these include -uality re-uirements. and nonconformities. warranty service or the serving of meals. design characteristics and specifications. e pectation. or obligation that is common practice or customary. A specified requirement is one that has been stated +in a document for e ample. and efficient way of achieving your organi"ation$s objectivesC There are many &inds of revie!s. Some of these include management reviews. or advice. and legal re-uirements. product re-uirements. . ade-uate. /eview A revie! is an activity. a service is a type of product.. )evie!s as& the following -uestion: is the subject of the review a suitable. customer re-uirements. or obligation. management re-uirements.g. There are many types of requirements. and nonconformity reviews.. transportation.

distribution. and application of products. and control an organi"ation. and control organi"ations. products. or sell products. or publish information. :embers of these committees come from many countries. Top management 0hen 'S! ())* uses the term top management it is referring to a person or a group of people at the highest level within an organi"ation. #SO standards are developed by technical committees. technologies. A traceability system records and follows the trail as . and systems. Therefore. provide services. 't refers to activities. direct. Standard A standard is a document. The term management does not refer to people. distribute. 6 amples of suppliers include organi"ations and people who produce. The term management refers to all the activities that are used to coordinate. Traceability Traceability is the ability to identify and trace the history. Supplier A supplier is a person or an organi"ation that provides products. services. these special processes must be validated in order to prove that they can generate planned results. and materials. 'n order to prevent output deficiencies. #SO*s standards are agreements . #nternal suppliers provide products to people within their own organi"ation while e+ternal suppliers provide products to other organi"ations. 't2s often too late because deficiencies may not be obvious until after the resulting products have been used or services have been delivered. processes. Suppliers can be either internal or e ternal to the organi"ation. 'S! standards tend to have very broad support. location. direct.verified until it2s too late. 'S! refers to them as agreements because its members must agree on content and give formal approval before they are published. parts. 't is a set of rules that control how people develop and manage materials. 't refers to the people who coordinate.

esign and development verifications use objective evidence to confirm that design and development outputs meet specified input re-uirements.products. you could do tests.erification is a process. 'n the conte t of this standard. a verified status is achieved. 0henever specified re-uirements have been met. 'n this case. perform demonstrations. compare a new design specification with a proven design specification. Dalidation . The process of validation can be carried out under realistic use conditions or within a simulated use environment.. 'n the conte t of this standard. For e ample. There are many ways to verify that re-uirements have been met. 0henever all re-uirements have been met. a validated status is achieved. Derification .alidation is a process. or you could inspect . 't uses objective evidence to confirm that specified re-uirements have been met. carry out alternative calculations. $roduction and service provision processes must be validated whenever process outputs cannot be measured. objective evidence must be used to verify or confirm that purchased products meet specified purchasing re-uirements. or verified until after the product is in use or the service has been delivered +by then it$s too late to do anything about output deficiencies and defects. and materials come from suppliers and are processed and ultimately distributed as end products. parts. the term validation is used in at least two different situations: design and development and production and service provision. 't uses objective evidence to confirm that the re-uirements which define an intended use or application have been met. Similarly. the term verification is used in at least two different situations: design and development and purchasing. monitored. esign and development validations use objective evidence to confirm that products meet the re-uirements which define their intended use or application. validations use objective evidence to confirm that production and service provision processes are capable of producing planned results.

* :A.TS I. • • • • • 6stablish your organi"ation2s <:S. . 't also includes things li&e supervisory practices as well as reward and recognition programs. %aintain your organi"ation2s <:S. 'S! ())* ?))E <FAG'T% :A. H6.T /6<F'/6:6.F:6. ocument your organi"ation2s <:S. #mplement your organi"ation2s <:S.F:6. social. 5!.environment includes lighting. psychological. I. #mprove your organi"ation2s <:S.AH6:6. 'n general. these include physical.TS . I.AH6:6. and environmental conditions and factors.?.T S%ST6: 5!.documents before you issue them.AH6:6.AH6:6.T S%ST6: +<:S. and noise factors.?. 0or& environment The term !or.T %!F/ <FAG'T% :A. All of these things influence wor&.or. as well as the whole range of ergonomic influences. 't refers to all of the conditions and factors that influence wor&.environment refers to wor&ing conditions.AH6 <FAG'T% :A. temperature.TS I.T S%ST6: +<:S.* 56D6G!7 %!F/ <FAG'T% :A.6/AG /6<F'/6:6.

I.TS @.AH6:6. :a&e sure that your organi"ation2s <:S documents respect and reflect what you do and how you do it. @. I.?.* S#!0 %!F/ .? 7/67A/6 <FAG'T% :A.!.?.% • 6nsure that your organi"ation2s -uality .AH6:6.TS • • .T /6<F'/6:6.T S%ST6: /6.T S%ST6: 5!. %!F/ .9 SF77!/T %!F/ <FAG'T% 7!G'. 6nhance customer satisfaction by ensuring that customer re-uirements are being met.AH6:6.AH6:6.ontrol documents that are used as <:S records.ontrol your organi"ation2s <:S documents. Support efforts to continually improve the effectiveness of your organi"ation2s <:S. 6stablish a procedure to control your <:S records.T /6<F'/6:6. 'S! ())* ?))E <FAG'T% :A.9 .TS @.T T! <FAG'T% • • • Support the development of your organi"ation2s <:S.FST!:6/S • • 6nhance customer satisfaction by ensuring that customer re-uirements are being identified.FAG • • "stablish a -uality manual for your organi"ation. I. @.T S%ST6: :A.F:6. :A. Support the implementation of your organi"ation2s <:S. %aintain your organi"ation2s -uality manual.? F!.!/5S • • 6stablish your organi"ation2s <:S records.• • 5evelop documents for your organi"ation2s <:S.!::'T:6.I 6STA1G'S# <FAG'T% :A.?.AH6:6.FS !.T/!G <FAG'T% :A. .

/6AT6 :A. @..? . 6nsure that <:S responsibilities and authorities are communicated throughout your organi"ation. 6nsure that your -uality policy ma&es a commitment to continually improve the effectiveness of your <:S.TAT'D6 /!G6 • Appoint a member of your organi"ation2s management to oversee your <:S.@ AGG!.AT6 <:S /6S7!.* 56F'.H @. @.@.I. 6nsure that your -uality policy is communicated and discussed throughout your organi"ation.6 /6S7!.S'1'G'T'6S A.* 6STA1G'S# <FAG'T% !136. :a&e sure that your -uality objectives are effective. 6nsure that your -uality policy supports your organi"ation2s -uality objectives.T /67/6S6.A//% !FT %!F/ <:S 7GA.I. 7lan the documentation of your <:S.AH6:6.I .T S%ST6: +<:S. @. 6stablish -uality objectives for your organi"ation. 7lan the implementation of your <:S.T'D6S • • • Support the establishment of -uality objectives.5 AFT#!/'T'6S • • 6nsure that <:S responsibilities and authorities are defined. @. <FAG'T% :A. 7lan the continual improvement of your <:S.S'1'G'T% A. 7lan the maintenance of your <:S. . • • • • • 7lan the establishment of your <:S.'. 6nsure that your -uality policy is periodically reviewed to ma&e sure that it is still suitable.AH6:6.5 AFT#!/'T% @.? 7GA.policy serves its overall purpose. • • • • • 6nsure that your -uality policy ma&es it clear that re-uirements must be met.@.

Assess the need to ma&e changes.• Hive your management representative authority over and responsibility for your organi"ation2s <:S. • • 6nsure that appropriate communication processes are established within your organi"ation.'.!::F.T <:S 76/S!.T /6<F'/6:6. to address resource needs.AT'!.9 SF77!/T '.T6/. 8. to improve your organi"ation. @.6 :A.AH6:6.AG .? 6JA:'. @.T S%ST6: +<:S.@..6 /6<F'/6:6.8.!:76T6.? 7/!D'56 . Henerate management review decisions and actions +outputs.AH6:6. Henerate management review decisions and actions +outputs. to change your general -uality orientation. @.TS 8.AH6:6..TS 8.8. 6valuate improvement opportunities.AH6:6.AH6:6. 6nsure that internal communication occurs throughout your organi"ation.arry out management reviews of your organi"ation2s <:S at planned intervals.* /6D'60 <FAG'T% :A. /6S!F/.7FTS • 6 amine information about your <:S +inputs.8.6G . :aintain a record of your management reviews. 'S! ())* ?))E <FAG'T% :A.6/AT6 :A.6S • • #dentify the resources that your <:S needs. • • • • .T /6D'60 '.8 76/F!/: <:S :A.T /6D'60 !FT7FTS • • • Henerate management review decisions and actions +outputs.9 H6. @.* 7/!D'56 /6<F'/65 <:S /6S!F/. $rovide the resources that your <:S needs.T /6D'60S @.

6 !F 0!/K6/S • 6nsure the competence of anyone within your <:S who could directly or indirectly affect your ability to meet product re-uirements.I 7/!D'56 SF'TA1G6 0!/K 6. $rovide the infrastructure that your organi"ation needs in order to ensure that product re-uirements are met.6SSA/% '.:6. 8.!.?.!:76T6. /6AG'LAT'!. 7GA. %aintain the infrastructure that your organi"ation needs in order to ensure that product re-uirements are met.6 /6<F'/6:6.TF/6 • • • #dentify the infrastructure that your organi"ation needs in order to ensure that product re-uirements are met. 7rovide training.H • 6stablish a product reali"ation planning process. /6<F'/6:6. 'S! ())* ?))E <FAG'T% :A.* 6.* . .AH6:6.!:76T6..T/!G 7/!5F.TS >. 8. %anage the wor& environment that your organi"ation needs in order to ensure that product re-uirements are met. • • • 8.8.9 7/!D'56 .'.F/AST/F.. or ta&e other suitable steps. to meet your organi"ation2s <:S competence re-uirements.SF/6 T#6 .T • • #dentify the wor& environment that your organi"ation needs in order to ensure that product re-uirements are met.? :66T ..6.TS • 'dentify the competence re-uirements of personnel within your <:S who perform wor& that could directly or indirectly affect your organi"ation2s ability to meet product re-uirements.?. 6valuate the effectiveness of your organi"ation2s <:S training and awareness activities.T /6AG'LAT'!.TS >. :aintain suitable records which show that personnel within your <:S are competent.T /6<F'/6:6.D'/!.

7repare planning outputs that are suitable and consistent with your organi"ation2s methods. >.7FTS .5 56D6G!7:6. 5evelop the processes that you will need to use in order to reali"e products.9.6SS6S >.9. 'dentify the re-uirements that are dictated by your product2s intended use or purpose.T /6<F'/6:6.FST!:6/-/6GAT65 7/!.!::F. . 'dentify any additional re-uirements that are important to your organi"ation and must be met.T >.T /6<F'/6:6. >. Fpdate your planning outputs whenever product design and development progress ma&es this necessary.?.T/!G .ontrol the design and development of your products.9 .'<F6 7/!5F. A.* 7GA.'.5 56D6G!7:6.T'F% 56S'H.T'F% %!F/ F.? /6D'60 .!.!.FST!:6/S • • "stablish customer communication arrangements. >.TS • • • • 'dentify the re-uirements that your customers want you to comply with. :aintain a record of your product re-uirement reviews. #mplement customer communication arrangements. A. >.• • • Fse your product reali"ation planning process to plan the reali"ation of your organi"ation2s products.T/!G 7/!5F.FST!:6/S2 7/!5F.T 56S'H. >.?. . 7/!5F.T 56S'H.T '.? .5 56D6G!7:6.T • • • 7lan the design and development of your products.TS • • • /eview your customers2 product re-uirements.* '56.? '56. 'dentify the re-uirements that are imposed on your products by e ternal agencies. A.AT6 0'T# %!F/ .9 .?.ontrol changes in customers2 product re-uirements.

9.S • • 7erform design and development validations.!.* 6STA1G'S# .9 H6.5 7F/.T/!G !F %!F/ 7F/.T /6D'60S • • 7erform systematic design and development reviews throughout the design and development process.S • • .5 56D6G!7:6.#A.6/AT6 56S'H.T DAG'5AT'!. Derify that product design and development outputs meet design and development input re-uirements.H 7/!.AH6 56S'H. /eview your product design and development inputs.5 56D6G!7:6. >.alidate changes in design and development.TS >. .!.8 .I .#AS'.5 56D6G!7:6. A.T D6/'F'. >.9.arry out design and development verifications. )evie! changes in design and development. Approve changes in design and development before you implement these changes.@ 76/F!/: 56S'H.I . :aintain a record of design and development validations.9.I.H A.T !FT7FTS • • • 7roduce product design and development outputs.5 56D6G!7:6.#AS65 7/!5F.A//% !FT 56S'H. :aintain a record of design and development inputs.T/!G 7F/.5F. A.#AS'.T .erify changes in design and development. )ecord changes in design and development.T 56S'H. A. :aintain a record of design and development verifications.AT'!.!. >. >.> :A. . >.6SS .• • • 5efine product design and development inputs. >.5 56D6G!7:6. A. :aintain a record of design and development reviews. A.9. Approve product design and development outputs before they are formally released.H6S • • • • • • #dentify changes in design and development.9.

6 • • .@.arry out service provision under controlled conditions.* 6STA1G'S# .5 S6/D'.5 S6/D'.5 T/A. • >. >.. monitored. >.TS • • 6stablish the uni-ue identity of your organi"ation2s products +if appropriate. • Dalidate production and service provision processes whenever process outputs cannot be measured.H /6<F'/6:6.? DAG'5AT6 7/!5F.T'!.T/!G !F 7/!5F.6 7/!D'S'!. 6valuate your suppliers2 ability to supply products that meet your organi"ation2s re-uirements.#AS65 7/!5F.T 7/!76/T% SF77G'65 1% .I.!. >.#AS'.9 D6/'F% %!F/ 7F/.I 7/!T6. Select suppliers that are capable of supplying products that meet your organi"ation2s specified re-uirements.6 7/!D'S'!.. .T'!.T/!G 7/!5F.FST!:6/S • #dentify property supplied to you by customers. 6stablish arrangements to control special processes. :a&e sure that purchased products meet specified purchase re-uirements.T'!.TS • • 5escribe your purchasing re-uirements. . >.@.I. 6nsure that purchasing re-uirements are ade-uately specified before you discuss them with suppliers. A.@.@.arry out production under controlled conditions.5 S6/D'. or verified until after the product is in use or the service has been delivered +such a process is often referred to as a special process . 'dentify the monitoring and measurement status of your organi"ation2s products.@ . >.!.? S76.K %!F/ 7/!5F. #mplement product verification or inspection methods in order to ensure that purchased products meet purchase re-uirements.9 '56.'F% %!F/ 7F/.TS • • "stablish product verification or inspection methods in order to ensure that purchased products meet purchase re-uirements.T'F% A.• • • • 6stablish criteria that you can use to control suppliers. >. A. A.

.6. $rotect property supplied to you by customers. and analytical processes will be used to demonstrate conformity • .TS A.• • • .onfirm that monitoring and measuring software is capable of doing the job you want it to do.T • • • • • • • 'dentify your organi"ation2s monitoring and measuring needs and re-uirements. /6:65'AG /6<F'/6:6.T 7/!.AH6:6.erify property supplied to you by customers. measurement.@.@ 7/6S6/D6 %!F/ 7/!5F. >. Safeguard property supplied to you by customers. measurement. 6stablish monitoring and measuring processes.5 .T /6<F'/6:6.!. and analytical processes that your organi"ation needs to have in order to be able to demonstrate conformity and ma&e improvements.5 :6ASF/'.TS E.H A.T/!G :!.alibrate your monitoring and measuring e-uipment whenever necessary to ensure that results are valid.6SS6S • #dentify the monitoring. 6valuate the validity of previous measurements whenever you discover that your measuring or monitoring e-uipment is out-of-calibration.H A. .'T!/'.TS E. Select e-uipment that can meet your organi"ation2s monitoring and measuring needs and re-uirements.TS • :a&e sure that your products and components continue to conform to re-uirements !hile they are being processed internally/ :a&e sure that your products and components continue to conform to re-uirements !hile they are being delivered to the intended destination/ • >. $lan how monitoring.H 6<F'7:6. 'S! ())* ?))E <FAG'T% :A.8 . 7rotect your monitoring and measuring e-uipment.5 :6ASF/6:6.* 6STA1G'S# :!.!:7!.'T!/'.

5 :6ASF/6 %!F/ <:S 7/!.. Ta&e action to address audit results. • • 6stablish methods that you can use to monitor and measure customer satisfaction +perceptions.T 5ATA . E.AH6:6.?.AG%L6 <FAG'T% :A.T'F% A.? .'T!/ A.5 A. %aintain your nonconforming products procedure.5 76/F!/: /6HFGA/ '.H A.!.H 7/!5F. .5 .5 :6ASF/6:6. E.5 :6ASF/6 .I . E. ocument your nonconforming products procedure.T .9 :!.FST!:6/ SAT'SFA.T6/'ST'.?.'T!/ A.!.T/!G .T A. E. #mplement your nonconforming products procedure.TS • • • • "stablish a nonconforming products procedure.!GG6. :onitor and measure your <:S processes.T A.T'!. and analytical processes.?.? 7GA.T'D'T'6S E. • #mplement your organi"ation2s monitoring. Ta&e appropriate action whenever your <:S processes fail to achieve planned results..'T!/'.!.S • • %onitor your organi"ation2s product characteristics. :onitor and measure customer satisfaction.?.* :!.AG AF5'TS • • • 6stablish an internal audit procedure.T6/. E.I :!.arry out internal audits of your <:S.6SS6S • • • Select suitable methods to monitor and measure the processes that ma&e up your organi"ation2s <:S.9 '56.and ma&e improvements.A//% !FT :!.F!/:'. %easure your organi"ation2s product characteristics. A.'T!/ A.5 :6ASF/6 7/!5F.#A/A. measurement. E.

ocument your preventive action procedure.!.!.S E.6 !F . #mplement your preventive action procedure.T T#6 !.T'D6. 7rovide information by analy"ing your <:S data.• • • Figure out what &ind of data you need to collect about your organi"ation2s <:S..ollect data about your organi"ation2s <:S. .F!/:'T'6S T! 7/6D6.F!/:'T'6S • • • • "stablish a preventive action procedure.9 7/6D6.!.F//6.@.@ :AK6 ':7/!D6:6.? . %aintain your corrective action procedure.@.6SS !F %!F/ <:S • • .6 • • • • "stablish a corrective action procedure.ontinually improve the effectiveness of your <:S. E.F//6. .T /6.TS A. E. Fse information to improve the effectiveness of your <:S.!..T .@.5 TAK6 /6:65'AG A. %aintain your preventive action procedure.* ':7/!D6 T#6 6FF6.!//6.... ocument your corrective action procedure.T'!. E. #mplement your corrective action procedure.