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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.

Audit scope
The scope of an audit is a statement that specifies the focus, e tent, and boundary of a particular audit. The scope of an audit is generally defined by specifying the physical location of the audit, the organi"ational units that will be e amined, the processes and activities that will be included, and the time period that will be covered.

.haracteristic
A characteristic is a distinctive feature or property of something. Characteristics can be inherent or assigned. An inherent characteristic e ists in something or is a permanent feature of something, while an assigned characteristic is a feature that is attributed or attached to something.

.oncession
A concession is a special approval that is granted to release a nonconforming product for use or delivery. Concessions are usually limited by time and -uantity and tend to specify that nonconforming characteristics may not violate specified limits.

.onformity
'n the conte t of this standard, to conform means to meet or comply with re-uirements. There are many types of re-uirements. There are -uality re-uirements, customer re-uirements, product re-uirements, management re-uirements, legal re-uirements, and so on. /e-uirements can be e plicitly specified +li&e the 'S! ())* re-uirements, or implied. A specified requirement is one that has been stated +in a document, for e ample,. 0hen your organi"ation meets a re-uirement, you can say that it conforms to that re-uirement.

.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. Continual improvements can be achieved by carrying out audits +and using audit findings and conclusions,, performing management reviews, analy"ing data, setting objectives, and implementing corrective and preventive actions.

.orrection
A correction is any action that is ta&en to eliminate a nonconformity. #owever, corrections do not address causes. 0hen applied to products, corrections can include rewor&ing products, reprocessing them, regrading them, assigning them to a different use, or simply destroying them.

.orrective action
Corrective actions are steps that are ta&en to remove the causes of an e isting nonconformity or undesirable situation. The corrective action process is designed to prevent the recurrence of nonconformities or undesirable situations. 't tries to ma&e sure that e isting nonconformities and situations don$t happen again. 't tries to prevent recurrence by eliminating causes. Corrective actions address actual problems. 1ecause of this, the corrective action process can be thought of as a problem solving process.

.ustomer
A customer is anyone who receives products or services from a supplier organi"ation. Customers can be people or organi"ations and can be either e ternal or internal to the supplier organi"ation. For e ample, a factory may supply products or services to another factory +customer, within the same organi"ation. According to 'S! ())), e amples of customers include clients, consumers, end-users, purchasers, retailers, and beneficiaries.

.ustomer satisfaction
Customer satisfaction is a perception. 't is also a -uestion of degree. 't can vary from high satisfaction to low satisfaction. 'f customers believe that you2ve met their re-uirements, they e perience high satisfaction. 'f they believe that you2ve not met their re-uirements, they e perience low satisfaction. Since satisfaction is a perception, customers may not be satisfied even though you$ve met all contractual re-uirements. 3ust because you haven$t received any complaints doesn$t mean that customers are satisfied. There are many ways to monitor and measure customer satisfaction. %ou can use customer satisfaction and opinion surveys4 you can collect product -uality data +post delivery,, trac& warranty claims, e amine dealer reports, study customer

compliments and criticisms, and analy"e lost business opportunities.

5esign and development


esign and development is a process +or a set of processes,. This process uses resources to transform re-uirements +inputs, into characteristics or specifications +outputs, for products, processes, and systems. %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, separate processes. %ou may also use the terms design and development interchangeably if they mean the same thing in your organi"ation.

5esign and development review


esign and development revie! is a set of activities whose purpose is to evaluate the suitability, ade-uacy, effectiveness, and sometimes the efficiency of a set of characteristics or specifications. esign and development revie! can be used to evaluate product, process, and system characteristics or specifications. 'n this conte t, an effective set of characteristics or specifications is one that has the potential to achieve planned results or reali"e planned activities.

5esign and development validation


esign and development validation is a process. This process uses objective evidence to confirm that products meet the re-uirements which define their intended use or application. 0henever specified re-uirements have been met, a validated status is achieved. The process of validation can be carried out under realistic use conditions or within a simulated use environment.

5esign and development verification


esign and development verification is a process. 't uses objective evidence to confirm that design and development outputs meet design and development input re-uirements. 0henever specified input re-uirements have been met, a verified status is achieved.

6ffectiveness

"ffectiveness refers to the degree to which a planned effect is achieved. 7lanned activities are effective if these activities are reali"ed. Similarly, planned results are effective if these results are actually achieved. For e ample, an effective process is one that reali"es planned activities and achieves planned results. Similarly, 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, and resources used +inputs,. "fficiency can be enhanced by achieving more with the same or fewer resources. The efficiency of a process or system can be enhanced by achieving more or getting better results +outputs, with the same or fewer resources +inputs,.

'nfrastructure
The term infrastructure refers to the entire system of facilities, e-uipment, and services that an organi"ation needs in order to function. According to 'S! ())*, 7art 8.9, the term infrastructure includes buildings and wor&spaces +including related utilities,, process e-uipment +both hardware and software,, support services +such as transportation and communications,, and information systems.

'nspection
#nspections use observation, measurement, testing and judgment to evaluate conformity. #nspection results are compared with specified re-uirements in order to establish whether conformity has been achieved. $roduct inspections compare product characteristics with product re-uirements in order to evaluate conformity.

'nterested party
An interested party is a person or group that has a sta&e in the success or performance of another organi"ation. #nterested parties may be directly affected by the organi"ation or actively concerned about its performance. #nterested parties can come from inside or outside of the organi"ation. 6 amples of interested parties can include customers, suppliers, owners, partners, employees, unions, ban&ers, or members of the general public.

'nternal audit
#nternal audits are referred to as first-party audits. !rgani"ations use internal (first party) 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 use first party audits to declare that your organi"ation complies with the 'S! ())* standard. This is called a self-declaration.

:anagement
The term management refers to all the activities that are used to coordinate, direct, and control an organi"ation. 'n this conte t, the term management does not refer to people. 't refers to activities. 'S! ())) uses the term top management to refer to people.

:anagement review
The overall purpose of a management revie! is to evaluate the suitability, ade-uacy, and effectiveness of an organi"ation2s -uality management system, and to loo& for improvement opportunities. %anagement revie!s are also used to identify and assess opportunities to change an organi"ation$s -uality policy and -uality objectives, to address resource needs, and to loo& for opportunities to improve its products.

: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. Some of these include -uality management systems, environmental management systems, emergency management systems, food safety management systems, occupational health and safety management systems, information security management systems, and business continuity management systems.

:easuring e-uipment
'n the conte t of this standard, measuring equipment includes all the things that are needed to carry out a measurement process. Accordingly, measuring equipment includes measuring instruments

and apparatuses as well as all the associated software, standards, and reference materials.

;onconforming product
0hen one or more characteristics of a product fail to meet specified re-uirements, it is referred to as a nonconforming product. 0hen a product deviates from specified product re-uirements, it fails to conform. &onconformity products must be identified and controlled to prevent unintended use or delivery. A product is the output of a process. $roducts can be tangible or intangible. 'S! ())) lists four generic product categories: services, software, hardware, and processed materials.

;onconformity
&onconformity refers to a failure to comply with re-uirements. A re-uirement is a need, e pectation, or obligation. 't can be stated or implied by an organi"ation, its customers, or other interested parties. There are many types of requirements. Some of these include -uality re-uirements, customer re-uirements, management re-uirements, product re-uirements, and legal re-uirements. 0henever your organi"ation fails to meet one of these re-uirements, a nonconformity occurs. 'S! ())* lists quality management system requirements . 0hen your organi"ation deviates from these re-uirements, a nonconformity occurs.

!bjective evidence
!bjective evidence is data that shows or proves that something e ists or is true. !bjective evidence can be collected by performing observations, measurements, tests, or by using any other suitable method.

!utsourced process
An outsourced process is any process that is part of your organi"ation$s -uality management system +<:S, but is performed by a party that is e ternal to your organi"ation.

According to 'S! ())*, you must identify and control your outsourced processes , and you must ensure that each outsourced process is effective. %ou also need to figure out how to control the interaction between internal and outsourced processes. A process is a set of activities that are interrelated or that interact with one another. 7rocesses use resources to transform inputs into outputs.
According to 'S!=T. *>8=S. ?=;@?8/, Athe terms subcontract and outsource are interchangeable and have the same meaningB.

7reventive action
$reventive actions are steps that are ta&en to remove the causes of potential nonconformities or potential situations that are undesirable. 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. 0hile corrective actions prevent recurrence, preventive actions prevent occurrence. 1oth types of actions are intended to prevent nonconformities. $reventive actions address potential problems, ones that haven2t yet occurred. 'n general, the preventive action process can be thought of as a ris& analysis process.

7rocedure
A procedure is a way of carrying out a process or activity. According to 'S! ())), procedures may or may not be documented. #owever, in most cases, 'S! ())* e pects you to document your procedures. ocumented procedures can be very general or very detailed, or anywhere in between. 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. A detailed procedure defines and controls the wor& that should

be done, and e plains how it should be done, who should do it, and under what circumstances. 'n addition, it e plains what authority and what responsibility has been allocated, which inputs should be used, and what outputs should be generated.

7rocess
A process is a set of activities that are interrelated or that interact with one another. $rocesses use resources to transform inputs into outputs. $rocesses are interconnected because the output from one process becomes the input for another process. 'n effect, processes are AgluedB together by means of such input output relationships. Organizational processes should be planned and carried out under controlled conditions. An effective process is one that reali"es planned activities and achieves planned results.

7rocess approach
The process approach is a management strategy. 0hen managers use a process approach, it means that they manage the processes that ma&e up their organi"ation, the interaction between these processes, and the inputs and outputs that tie these processes together.

7rocess-based -uality management system +<:S,


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. A process-based <:S is a networ& of interrelated and interconnected processes. 6ach process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. 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 ).?,. #owever, 'S! ())) does not formally define this important term so we2ve given it a try.

7roduct
A product is the output of a process. $roducts can be tangible or intangible. 'S! ())) lists four generic product categories : services, software, hardware, and processed materials. :any products combine several of these categories. For e ample, an automobile +a product, combines hardware +e.g. tires,, software +e.g. engine control algorithms,, and processed materials +e.g. lubricants,. Service is always the result of an interaction between a service supplier and a customer and can ta&e many forms. Service can be provided to support an organi"ation$s own products +e.g. warranty service or the serving of meals,. .onversely, service can be provided for a product supplied by a customer +e.g. a repair service or a delivery service,. Service can also involve the provision of an intangible thing to a customer +e.g. entertainment, transportation, or advice,. 0hile soft!are is intangible, and includes things li&e approaches and procedures, hard!are and processed materials are tangible and are often referred to as goods.

7roduct inspection
$roduct inspection is an activity that compares product characteristics with product re-uirements in order to evaluate conformity. :ore precisely, 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. $roduct inspections use observation, measurement, testing and judgment to evaluate conformity.

7roduct reali"ation
A product starts out as an idea. The idea is realized or actuali"ed by following a set of product reali"ation processes. $roduct realization refers to all the processes that are used to bring products into being.

<uality
The quality of something can be determined by comparing a set of inherent characteristics with a set of re-uirements. 'f those inherent characteristics meet all re-uirements, high or e cellent -uality is achieved. 'f those characteristics do

not meet all re-uirements, a low or poor level of -uality is achieved. (uality is, therefore, a -uestion of degree. As a result, the central -uality -uestion is: #ow well does this set of inherent characteristics comply with this set of re-uirementsC 'n short, 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. According to this definition, quality is a relative concept. 1y lin&ing -uality to re-uirements, 'S! ())) argues that the quality of something cannot be established in a vacuum. (uality is always relative to a set of re-uirements.

<uality assurance +<A,


(uality assurance is a set of activities intended to establish confidence that -uality re-uirements will be met. <A is one part of -uality management.

<uality characteristic
A quality characteristic is tied to a re-uirement and is an inherent feature or property of a product, process, or system. A requirement is a need, e pectation, or obligation. 't can be stated or implied by an organi"ation, its customers, or other interested parties. An inherent feature or property e ists in something or is a permanent characteristic of something.

<uality control
(uality control is a set of activities intended to ensure that -uality re-uirements are actually being met. (uality control is one part of -uality management.

<uality improvement
(uality improvement refers to anything that enhances an organi"ation2s ability to meet -uality re-uirements. (uality improvement is one part of -uality management.

<uality management
(uality management includes all the activities that organi"ations use to direct, control, and coordinate -uality. These activities include formulating a -uality policy and setting -uality objectives. They also include -uality planning, -uality control, -uality assurance, and -uality improvement.

<uality management system +<:S,


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. A process'based (%S uses a process approach to manage and control how its -uality policy is implemented and -uality objectives are achieved. A process'based (%S is a networ& of many interrelated and interconnected processes +elements,. 6ach process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. These process interactions create a single process'based (%S.

<uality manual
A quality manual documents an organi"ation2s -uality management system +<:S,. 't can be a paper manual or an electronic manual. According to 'S! ())*, your -uality manual should:

5efine the scope of your <:S. 6 plain reductions in the scope of your <:S.

3ustify all e clusions +reductions in scope,.

5escribe how your <:S processes interact. 5ocument your -uality procedures or refer to them.

<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 planning is

one part of -uality management.

<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, perform a process, reali"e a product, or manage a contract. (uality plans also specify who will do what and when.

<uality policy
An organi"ation$s quality policy defines top management$s commitment to -uality. A quality policy statement should describe an organi"ation$s general -uality orientation and clarify its basic intentions. (uality policies should be used to generate -uality objectives and should serve as a general framewor& for action. (uality policies can be based on the 'S! ())) <uality :anagement 7rinciples and should be consistent with the organi"ation$s other policies.

<uality objectives
A quality objective is a -uality oriented goal. A quality objective is something you aim for or try to achieve. (uality objectives are generally based on or derived from your organi"ation$s -uality policy and must be consistent with it. 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. )ecords provide evidence that activities have been performed or results have been achieved. They always document the past. )ecords can, for e ample, be used to show that traceability re-uirements are being met, that verification is being performed, and that preventive and corrective actions are being carried out.

/e-uirement

A requirement is a need, e pectation, or obligation. 't can be stated or implied by an organi"ation, its customers, or other interested parties. A specified requirement is one that has been stated +in a document for e ample,, whereas an implied requirement is a need, e pectation, or obligation that is common practice or customary. There are many types of requirements. Some of these include -uality re-uirements, customer re-uirements, management re-uirements, product re-uirements, and legal re-uirements.

/eview
A revie! is an activity. 'ts purpose is to figure out how well the thing being reviewed is capable of achieving established objectives. )evie!s as& the following -uestion: is the subject of the review a suitable, ade-uate, effective, and efficient way of achieving your organi"ation$s objectivesC There are many &inds of revie!s. Some of these include management reviews, design and development reviews, customer re-uirement reviews, and nonconformity reviews. /elative to the previous types of revie!s, the focus of each review is as follows: -uality management systems, design characteristics and specifications, customer re-uirements, and nonconformities, respectively.

Service
According to 'S! ())), a service is a type of product. Service is always the result of an activity or interaction between a service supplier and a customer and can ta&e many forms. Service can be provided to support an organi"ation$s own products +e.g. warranty service or the serving of meals,. .onversely, service can be provided for a product supplied by a customer +e.g. a repair service or a delivery service,. Service can also involve the provision of an intangible thing to a customer +e.g. entertainment, transportation, or advice,.

Special process
A special process is any production or service delivery process that generates outputs that cannot be measured, monitored, or

verified until it2s too late. 't2s often too late because deficiencies may not be obvious until after the resulting products have been used or services have been delivered. 'n order to prevent output deficiencies, these special processes must be validated in order to prove that they can generate planned results.

Standard
A standard is a document. 't is a set of rules that control how people develop and manage materials, products, services, technologies, processes, and systems. #SO*s standards are agreements . 'S! refers to them as agreements because its members must agree on content and give formal approval before they are published. #SO standards are developed by technical committees. :embers of these committees come from many countries. Therefore, 'S! standards tend to have very broad support.

Supplier
A supplier is a person or an organi"ation that provides products. Suppliers can be either internal or e ternal to the organi"ation. #nternal suppliers provide products to people within their own organi"ation while e+ternal suppliers provide products to other organi"ations. 6 amples of suppliers include organi"ations and people who produce, distribute, or sell products, provide services, or publish information.

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. 't refers to the people who coordinate, direct, and control organi"ations. The term management refers to all the activities that are used to coordinate, direct, and control an organi"ation. The term management does not refer to people. 't refers to activities.

Traceability
Traceability is the ability to identify and trace the history, distribution, location, and application of products, parts, and materials. A traceability system records and follows the trail as

products, parts, and materials come from suppliers and are processed and ultimately distributed as end products.

Dalidation
,alidation is a process. 't uses objective evidence to confirm that the re-uirements which define an intended use or application have been met. 0henever all re-uirements have been met, a validated status is achieved. 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, the term validation is used in at least two different situations: design and development and production and service provision. esign and development validations use objective evidence to confirm that products meet the re-uirements which define their intended use or application. $roduction and service provision processes must be validated whenever process outputs cannot be measured, monitored, or verified until after the product is in use or the service has been delivered +by then it$s too late to do anything about output deficiencies and defects,. 'n this case, validations use objective evidence to confirm that production and service provision processes are capable of producing planned results.

Derification
,erification is a process. 't uses objective evidence to confirm that specified re-uirements have been met. 0henever specified re-uirements have been met, a verified status is achieved. 'n the conte t of this standard, the term verification is used in at least two different situations: design and development and purchasing. esign and development verifications use objective evidence to confirm that design and development outputs meet specified input re-uirements. Similarly, objective evidence must be used to verify or confirm that purchased products meet specified purchasing re-uirements. There are many ways to verify that re-uirements have been met. For e ample, you could do tests, perform demonstrations, carry out alternative calculations, compare a new design specification with a proven design specification, or you could inspect

documents before you issue them.

0or& environment
The term !or- environment refers to wor&ing conditions. 't refers to all of the conditions and factors that influence wor&. 'n general, these include physical, social, psychological, and environmental conditions and factors. .or- environment includes lighting, temperature, and noise factors, as well as the whole range of ergonomic influences. 't also includes things li&e supervisory practices as well as reward and recognition programs. All of these things influence wor&.

'S! ())* ?))E <FAG'T% :A;AH6:6;T /6<F'/6:6;TS


I. H6;6/AG /6<F'/6:6;TS I.* 56D6G!7 %!F/ <FAG'T% :A;AH6:6;T S%ST6: +<:S,

6stablish your organi"ation2s <:S. ocument your organi"ation2s <:S. #mplement your organi"ation2s <:S. %aintain your organi"ation2s <:S. #mprove your organi"ation2s <:S.

I.?. 5!.F:6;T %!F/ <FAG'T% :A;AH6:6;T S%ST6: +<:S,

I.?.* :A;AH6 <FAG'T% :A;AH6:6;T S%ST6: 5!.F:6;TS

5evelop documents for your organi"ation2s <:S. :a&e sure that your organi"ation2s <:S documents respect and reflect what you do and how you do it.

I.?.? 7/67A/6 <FAG'T% :A;AH6:6;T S%ST6: :A;FAG "stablish a -uality manual for your organi"ation. %aintain your organi"ation2s -uality manual.

I.?.9 .!;T/!G <FAG'T% :A;AH6:6;T S%ST6: 5!.F:6;TS .ontrol your organi"ation2s <:S documents. .ontrol documents that are used as <:S records.

I.?.I 6STA1G'S# <FAG'T% :A;AH6:6;T S%ST6: /6.!/5S 6stablish your organi"ation2s <:S records. 6stablish a procedure to control your <:S records.

'S! ())* ?))E <FAG'T% :A;AH6:6;T /6<F'/6:6;TS


@. :A;AH6:6;T /6<F'/6:6;TS @.* S#!0 %!F/ .!::'T:6;T T! <FAG'T%

Support the development of your organi"ation2s <:S. Support the implementation of your organi"ation2s <:S. Support efforts to continually improve the effectiveness of your organi"ation2s <:S.

@.? F!.FS !; %!F/ .FST!:6/S

6nhance customer satisfaction by ensuring that customer re-uirements are being identified. 6nhance customer satisfaction by ensuring that customer re-uirements are being met.

@.9 SF77!/T %!F/ <FAG'T% 7!G'.%

6nsure that your organi"ation2s -uality

policy serves its overall purpose. 6nsure that your -uality policy ma&es it clear that re-uirements must be met. 6nsure that your -uality policy ma&es a commitment to continually improve the effectiveness of your <:S. 6nsure that your -uality policy supports your organi"ation2s -uality objectives. 6nsure that your -uality policy is communicated and discussed throughout your organi"ation. 6nsure that your -uality policy is periodically reviewed to ma&e sure that it is still suitable.

@.I .A//% !FT %!F/ <:S 7GA;;';H

@.I.* 6STA1G'S# <FAG'T% !136.T'D6S Support the establishment of -uality objectives. 6stablish -uality objectives for your organi"ation. :a&e sure that your -uality objectives are effective.

@.I.? 7GA; <FAG'T% :A;AH6:6;T S%ST6: +<:S, 7lan the establishment of your <:S. 7lan the documentation of your <:S. 7lan the implementation of your <:S. 7lan the maintenance of your <:S. 7lan the continual improvement of your <:S.

@.@ AGG!.AT6 <:S /6S7!;S'1'G'T% A;5 AFT#!/'T%

@.@.* 56F';6 /6S7!;S'1'G'T'6S A;5 AFT#!/'T'6S 6nsure that <:S responsibilities and authorities are defined. 6nsure that <:S responsibilities and authorities are communicated throughout your organi"ation.

@.@.? ./6AT6 :A;AH6:6;T /67/6S6;TAT'D6 /!G6 Appoint a member of your organi"ation2s management to oversee your <:S.

Hive your management representative authority over and responsibility for your organi"ation2s <:S.

@.@.9 SF77!/T ';T6/;AG .!::F;'.AT'!; 6nsure that appropriate communication processes are established within your organi"ation. 6nsure that internal communication occurs throughout your organi"ation.

@.8 76/F!/: <:S :A;AH6:6;T /6D'60S

@.8.* /6D'60 <FAG'T% :A;AH6:6;T S%ST6: +<:S, .arry out management reviews of your organi"ation2s <:S at planned intervals. 6valuate improvement opportunities. Assess the need to ma&e changes. :aintain a record of your management reviews.

@.8.? 6JA:';6 :A;AH6:6;T /6D'60 ';7FTS 6 amine information about your <:S +inputs,.

@.8.9 H6;6/AT6 :A;AH6:6;T /6D'60 !FT7FTS Henerate management review decisions and actions +outputs, to improve your organi"ation. Henerate management review decisions and actions +outputs, to change your general -uality orientation. Henerate management review decisions and actions +outputs, to address resource needs.

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8. /6S!F/.6 /6<F'/6:6;TS 8.* 7/!D'56 /6<F'/65 <:S /6S!F/.6S

#dentify the resources that your <:S needs. $rovide the resources that your <:S needs.

8.? 7/!D'56 .!:76T6;T <:S 76/S!;;6G

8.?.* 6;SF/6 T#6 .!:76T6;.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.

8.?.? :66T .!:76T6;.6 /6<F'/6:6;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. 7rovide training, or ta&e other suitable steps, to meet your organi"ation2s <:S competence re-uirements. 6valuate the effectiveness of your organi"ation2s <:S training and awareness activities. :aintain suitable records which show that personnel within your <:S are competent.

8.9 7/!D'56 ;6.6SSA/% ';F/AST/F.TF/6

#dentify the infrastructure that your organi"ation needs in order to ensure that product re-uirements are met. $rovide the infrastructure that your organi"ation needs in order to ensure that product re-uirements are met. %aintain the infrastructure that your organi"ation needs in order to ensure that product re-uirements are met.

8.I 7/!D'56 SF'TA1G6 0!/K 6;D'/!;:6;T

#dentify the wor& environment that your organi"ation needs in order to ensure that product re-uirements are met. %anage the wor& environment that your organi"ation needs in order to ensure that product re-uirements are met.

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>. /6AG'LAT'!; /6<F'/6:6;TS >.* .!;T/!G 7/!5F.T /6AG'LAT'!; 7GA;;';H

6stablish a product reali"ation planning process.

Fse your product reali"ation planning process to plan the reali"ation of your organi"ation2s products. 7repare planning outputs that are suitable and consistent with your organi"ation2s methods. 5evelop the processes that you will need to use in order to reali"e products.

>.? .!;T/!G .FST!:6/-/6GAT65 7/!.6SS6S

>.?.* '56;T'F% %!F/ F;'<F6 7/!5F.T /6<F'/6:6;TS 'dentify the re-uirements that your customers want you to comply with. 'dentify the re-uirements that are dictated by your product2s intended use or purpose. 'dentify the re-uirements that are imposed on your products by e ternal agencies. 'dentify any additional re-uirements that are important to your organi"ation and must be met.

>.?.? /6D'60 .FST!:6/S2 7/!5F.T /6<F'/6:6;TS /eview your customers2 product re-uirements. :aintain a record of your product re-uirement reviews. .ontrol changes in customers2 product re-uirements.

>.?.9 .!::F;'.AT6 0'T# %!F/ .FST!:6/S "stablish customer communication arrangements. #mplement customer communication arrangements.

>.9 .!;T/!G 7/!5F.T 56S'H; A;5 56D6G!7:6;T

>.9.* 7GA; 7/!5F.T 56S'H; A;5 56D6G!7:6;T 7lan the design and development of your products. .ontrol the design and development of your products. Fpdate your planning outputs whenever product design and development progress ma&es this necessary.

>.9.? '56;T'F% 56S'H; A;5 56D6G!7:6;T ';7FTS

5efine product design and development inputs. :aintain a record of design and development inputs. /eview your product design and development inputs.

>.9.9 H6;6/AT6 56S'H; A;5 56D6G!7:6;T !FT7FTS 7roduce product design and development outputs. Approve product design and development outputs before they are formally released. Derify that product design and development outputs meet design and development input re-uirements.

>.9.I .A//% !FT 56S'H; A;5 56D6G!7:6;T /6D'60S 7erform systematic design and development reviews throughout the design and development process. :aintain a record of design and development reviews.

>.9.@ 76/F!/: 56S'H; A;5 56D6G!7:6;T D6/'F'.AT'!;S .arry out design and development verifications. :aintain a record of design and development verifications.

>.9.8 .!;5F.T 56S'H; A;5 56D6G!7:6;T DAG'5AT'!;S 7erform design and development validations. :aintain a record of design and development validations.

>.9.> :A;AH6 56S'H; A;5 56D6G!7:6;T .#A;H6S #dentify changes in design and development. )ecord changes in design and development. )evie! changes in design and development. ,erify changes in design and development. ,alidate changes in design and development. Approve changes in design and development before you implement these changes.

>.I .!;T/!G 7F/.#AS';H A;5 7F/.#AS65 7/!5F.TS

>.I.* 6STA1G'S# .!;T/!G !F %!F/ 7F/.#AS';H 7/!.6SS

6stablish criteria that you can use to control suppliers. 6valuate your suppliers2 ability to supply products that meet your organi"ation2s re-uirements. Select suppliers that are capable of supplying products that meet your organi"ation2s specified re-uirements. :a&e sure that purchased products meet specified purchase re-uirements.

>.I.? S76.'F% %!F/ 7F/.#AS';H /6<F'/6:6;TS 5escribe your purchasing re-uirements. 6nsure that purchasing re-uirements are ade-uately specified before you discuss them with suppliers.

>.I.9 D6/'F% %!F/ 7F/.#AS65 7/!5F.TS "stablish product verification or inspection methods in order to ensure that purchased products meet purchase re-uirements. #mplement product verification or inspection methods in order to ensure that purchased products meet purchase re-uirements.

>.@ .!;T/!G 7/!5F.T'!; A;5 S6/D'.6 7/!D'S'!;

>.@.* 6STA1G'S# .!;T/!G !F 7/!5F.T'!; A;5 S6/D'.6 .arry out production under controlled conditions. .arry out service provision under controlled conditions.

>.@.? DAG'5AT6 7/!5F.T'!; A;5 S6/D'.6 7/!D'S'!; Dalidate production and service provision processes whenever process outputs cannot be measured, monitored, 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 ,. 6stablish arrangements to control special processes.

>.@.9 '56;T'F% A;5 T/A.K %!F/ 7/!5F.TS 6stablish the uni-ue identity of your organi"ation2s products +if appropriate,. 'dentify the monitoring and measurement status of your organi"ation2s products.

>.@.I 7/!T6.T 7/!76/T% SF77G'65 1% .FST!:6/S #dentify property supplied to you by customers.

,erify property supplied to you by customers. $rotect property supplied to you by customers. Safeguard property supplied to you by customers.

>.@.@ 7/6S6/D6 %!F/ 7/!5F.TS A;5 .!:7!;6;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/

>.8 .!;T/!G :!;'T!/';H A;5 :6ASF/';H 6<F'7:6;T

'dentify your organi"ation2s monitoring and measuring needs and re-uirements. Select e-uipment that can meet your organi"ation2s monitoring and measuring needs and re-uirements. 6stablish monitoring and measuring processes. .alibrate your monitoring and measuring e-uipment whenever necessary to ensure that results are valid. 7rotect your monitoring and measuring e-uipment. .onfirm that monitoring and measuring software is capable of doing the job you want it to do. 6valuate the validity of previous measurements whenever you discover that your measuring or monitoring e-uipment is out-of-calibration.

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E. /6:65'AG /6<F'/6:6;TS E.* 6STA1G'S# :!;'T!/';H A;5 :6ASF/6:6;T 7/!.6SS6S

#dentify the monitoring, measurement, and analytical processes that your organi"ation needs to have in order to be able to demonstrate conformity and ma&e improvements. $lan how monitoring, measurement, and analytical processes will be used to demonstrate conformity

and ma&e improvements. #mplement your organi"ation2s monitoring, measurement, and analytical processes.

E.? .A//% !FT :!;'T!/';H A;5 :6ASF/6:6;T A.T'D'T'6S

E.?.* :!;'T!/ A;5 :6ASF/6 .FST!:6/ SAT'SFA.T'!; 6stablish methods that you can use to monitor and measure customer satisfaction +perceptions,. :onitor and measure customer satisfaction.

E.?.? 7GA; A;5 76/F!/: /6HFGA/ ';T6/;AG AF5'TS 6stablish an internal audit procedure. .arry out internal audits of your <:S. Ta&e action to address audit results.

E.?.9 :!;'T!/ A;5 :6ASF/6 %!F/ <:S 7/!.6SS6S Select suitable methods to monitor and measure the processes that ma&e up your organi"ation2s <:S. :onitor and measure your <:S processes. Ta&e appropriate action whenever your <:S processes fail to achieve planned results.

E.?.I :!;'T!/ A;5 :6ASF/6 7/!5F.T .#A/A.T6/'ST'.S %onitor your organi"ation2s product characteristics. %easure your organi"ation2s product characteristics.

E.9 '56;T'F% A;5 .!;T/!G ;!;.!;F!/:';H 7/!5F.TS

"stablish a nonconforming products procedure. ocument your nonconforming products procedure. #mplement your nonconforming products procedure. %aintain your nonconforming products procedure.

E.I .!GG6.T A;5 A;AG%L6 <FAG'T% :A;AH6:6;T 5ATA

Figure out what &ind of data you need to collect about your organi"ation2s <:S. .ollect data about your organi"ation2s <:S. 7rovide information by analy"ing your <:S data.

E.@ :AK6 ':7/!D6:6;TS A;5 TAK6 /6:65'AG A.T'!;S

E.@.* ':7/!D6 T#6 6FF6.T'D6;6SS !F %!F/ <:S .ontinually improve the effectiveness of your <:S. Fse information to improve the effectiveness of your <:S.

E.@.? .!//6.T ;!;.!;F!/:'T'6S T! 7/6D6;T /6.F//6;.6 "stablish a corrective action procedure. ocument your corrective action procedure. #mplement your corrective action procedure. %aintain your corrective action procedure.

E.@.9 7/6D6;T T#6 !..F//6;.6 !F ;!;.!;F!/:'T'6S "stablish a preventive action procedure. ocument your preventive action procedure. #mplement your preventive action procedure. %aintain your preventive action procedure.