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ISO 9001:2008 Quality management systems

ISO 9000 is a series of standards, developed and published by the International Organization for Standardization (ISO), that define, establish, and maintain an effective quality assurance system for manufacturing and service industries. Outline contents for ISO 9001 are as follows: Page iv !ore"ord Pages v to vii Section # Intro Pages $ to $% Requirements Section $ Scope Section & Normative Reference Section ' Terms and definitions (specific to ISO (##$, not specified in ISO (###) Section % Quality Management System Section ) Management Responsibility -hese are the ) Section * Resource Management requirements Section + Product Realization Section , Measurement, analysis and improvement Pages $) to && -ables of .orrespondence bet"een ISO (##$ and other standards Page &' ibliograp!y / 0efore the certification body can issue or rene" a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections % to ,. Sections $ to ' are not directly audited against, but because they provide conte1t and definitions for the rest of the standard, their contents must be ta2en into account. Section % Section ) Section * Section + Section , Quality Management System Management Responsibility Resource Management Product Realization Measurement, analysis and improvement

/ -he standard specifies that the organization shall issue and maintain the follo"ing six documented procedures $. .ontrol of 3ocuments (%.&.') &. .ontrol of 4ecords (%.&.%) '. Internal 5udits (,.&.&) %. .ontrol of 6onconforming Product 7 Service (,.') ). .orrective 5ction (,.).&) *. Preventive 5ction (,.).')

/ -he standard also requires

8uality manual, Statement of quality policy 8uality ob9ectives

/ In addition to these procedures, ISO (##$ &##, requires the organization to document any other procedures required for its effective operation. -he standard also requires the organization to issue and communicate a documented quality policy, a 8uality :anual ("hich may or may not include the documented procedures) and numerous records, as specified throughout the standard.

Possible question
General Requirements / -o design and implement the 8:S, the organization has to 3etermine processes needed for the quality management system and their application throughout the organization (Process Identification) 3etermine the sequence and interaction of these processes (Process Sequence and Interaction) 3etermine criteria and methods for effective operation and control of the processes (Process :anagement) ;nsure the availability of the resources and supporting information (Process 4esources) :onitor, measure "here applicable, and analyze these processes (Process :onitoring) Implement actions to achieve planned results and continual improvement of these processes (Process Improvement)

Documentation Required / -he quality management system documentation shall include 3ocumented 8uality Policy and quality ob9ectives 8uality :anual 3ocumented procedures and records 3ocuments, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes -he scope of the quality management system 3etails of and 9ustification for any e1clusions -he documented procedures or reference to them 5 description of the interaction bet"een the processes

Qualit !anual includes

3ocuments describe requirement or actions to be ta2en 4ecords provide evidence of the conformity to requirement

"!ana#ement representati$e% is the person "ho has delegated authority from top management to ;nsuring that processes needed for the quality management system are established, implemented and maintained 4eporting to top management on the performance of the quality rnanagement system and any need for improvement ;nsuring the a"areness of customer requirements is actively promoted throughout the organization .oordinate communication "ith e1ternal parties on matters relating to the quality management system Resources <uman 4esources / Infrastructure / =or2 ;nvironment Desi#n $erification should demonstrate that design output meets the design input. Desi#n $alidation is intended to confirm that regardless of "hether or not the design outputs meets the specification of the design input, does the resulting product fulfill the customer>s needs in the real "orld? &reser$ation of product / -he organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. 5s applicable, preservation shall include $) Identification &) <andling ') Pac2aging %) Storage )) Protection 'ontrol of !onitorin# and !easurin# (quipment -his is all about control and calibration of the test and measuring equipment "hich is used to prove that product conforms to specifications. =here necessary to ensure valid results, measuring equipment shall .alibrate and7or verify the measuring equipment at specified intervals or prior to use .alibrate the equipment to national or international standards (or record other basis) 5d9ust or re/ad9ust as necessary Identify the measuring equipment in order to determine its calibration status Safeguard them from improper ad9ustments Protect them from damage and deterioration

@ittle ;1planation
ISO does not certif organizations itself. 6umerous certification bodies e1ist, "hich audit organizations and, upon success, issue ISO (##$ compliance certificates. 5n organization applying for ISO (##$ certification is audited based on an e1tensive sample of its sites, functions, products, services and processes. -he auditor presents a list of problems (defined as AnonconformitiesA, AobservationsA, or Aopportunities for improvementA) to management. If there are no ma9or nonconformities, the certification body "ill issue a certificate. =here ma9or nonconformities are identified, the organization "ill present an improvement plan to the certification body (e.g., corrective action reports sho"ing ho" the problems "ill be resolved)B once the certification body is satisfied that the organization has carried out sufficient corrective action, it "ill issue a certificate. )wo t pes of auditin# are required to become registered to the standard auditing by an e1ternal certification body (e1ternal audit) and audits by internal staff trained for this process (internal audits). -he aim is a continual process of revie" and assessment to verify that the system is "or2ing as it is supposed toB to find out "here it can improveB and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their 9udgments.

8uality policy
In quality management a quality policy is a document 9ointly developed by management and quality e1perts to e"press t!e quality ob#ectives of t!e organization, t!e acceptable level of quality and t!e duties of specific departments to ensure quality. 8uality policy management is a long term strategic issue and often has a $# year scope.

-he quality policy must be endorsed by top management and it must be "idely distributed through out the organization.

Section ).' of the ISO (##$ standard requires a "ritten, "ell defined quality policy that is communicated and understood "ithin an organization. Section ).' also sets out some of the requirements for quality policies.

*)op !ana#ement* means the people "ho have e1ecutive authority to direct and control the organization.

Inde1 of 4equirement
S(')IO+ , - Q./0I)1 !/+/G(!(+) S1S)(! %.$ Ceneral 4equirements %.$.$ 8uality System Processes %.& 3ocumentation 4equired S(')IO+ 2 - !/+/G(!(+) R(S&O+SI3I0I)1 ).$ :anagement .ommitment ).& .ustomer !ocus ).' 8uality Policy ).% Planning ).) 4esponsibility, 5uthority and .ommunication ).* :anagement 4evie" S(')IO+ 4 - R(SO.R'( !/+/G(!(+) *.$ Provision of 4esources *.& <uman 4esources *.' Infrastructure *.% =or2 ;nvironment S(')IO+ 5 - &ROD.') R(/0I6/)IO+ +.$ Planning of Product 4ealization +.& .ustomer/related Processes +.' 3esign and 3evelopment +.% Purchasing +.) Production Provision +.* .ontrol of :onitoring and :easuring ;quipment S(')IO+ 7 - !(/S.R(!(+)8 /+/01SIS /+D I!&RO9(!(+) ,.$ Ceneral ,.& :onitoring and :easurement ,.' .ontrol of 6onconforming Product ,.% 5nalysis of 3ata ,.) Improvement

S(')IO+ , - Q./0I)1 !/+/G(!(+) S1S)(!

%.$ General Requirements -o design and implement the 8:S, the organization has to 3etermine processes needed for the quality management system and their application throughout the organization (Process Identification) 3etermine the sequence and interaction of these processes (Process Sequence and Interaction) 3etermine criteria and methods for effective operation and control of the processes (Process :anagement) ;nsure the availability of the resources and supporting information (Process 4esources) :onitor, measure "here applicable, and analyze these processes (Process :onitoring) Implement actions to achieve planned results and continual improvement of these processes (Process Improvement)

6ote $ &rocesses needed for the quality management system include the processes for management activities, provision of resources, product realization, and measurement, analysis, and improvement 6ote & /n outsourced process is a process the organization needs for its quality management system, and "hich the organization chooses to have performed by an e1ternal party (e.g. management system consultancy, <ealth D Safety support etc). 6ote ' (nsurin# control o$er outsourced processes. -his includes vendor evaluation and selection, product verification and subcontractor monitoring 7 feedbac2. Outsourced processes does not absolve your organization of the responsibility to conform to all customer, statutory, and regulatory requirements. %.$.$ 8uality System Processes -he quality management system is designed as a system of interrelated processes. 5ll main activities of the system are defined as 8uality System Processes (8SPs) and are grouped into the follo"ing four categories. Product 4ealization Processes (P4P) :easurement, 5nalysis and Improvement Processes (:IP) :anagement 4esponsibility Processes (:4P) 4esource :anagement Processes (4:P)

%.& 3ocumentation 4equired -he quality management system documentation shall include 3ocumented 8uality Policy and quality ob9ectives 8uality :anual 3ocumented procedures and records

3ocuments, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes

6ote $ -he term Adocumented procedureA means that the procedure is established, documented, implemented and maintained. 6ote & )he extent of the qualit mana#ement s stem documentation can differ from one organization to another due to Size of organization and type of activities, .omple1ity of processes and their interactions, and .ompetence of personnel. 6ote ' -he documentation can be in any form or type of medium. -hey can be paper, electronic, film, video, audio, etcetera. 8uality :anual includes -he scope of the quality management system 3etails of and 9ustification for any e1clusions -he documented procedures or reference to them 5 description of the interaction bet"een the processes

"'ontrol of Documents% ;stablish a documented procedure to 5pprove documents for adequacy prior to issue 4evie", update as necessary, and re/approve documents Identify the changes and current document revision status :a2e relevant documents available at points of use ;nsure the documents remain legible and readily identifiable Identify e1ternal documents and control their distribution Prevent obsolete documents from unintended use 5pply suitable identification if obsolete documents are retained

"'ontrol of Records% ;stablish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system. Eeep records legible, readily identifiable, and retrievable. -here are si1 2ey issues "hich the records management program needs to address / So, .ontrol of 4ecords defines specifically records $. Identification

&. Storage '. Protection %. 4etrieval ). 4etention *. 3isposition 3ocuments describe requirement or actions to be ta2en 4ecords provide evidence of the conformity to requirement S(')IO+ 2 - !/+/G(!(+) R(S&O+SI3I0I)1 ).$ :anagement .ommitment -op management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by .ommunicating to the organization the importance of meeting customer as "ell as statutory and regulatory requirements ;stablishing the quality policy and quality ob9ectives .onducting management revie"s ;nsuring the availability of resources. ).& .ustomer !ocus -op management shall ensure that customer requirements are determined and are met "ith the aim of enhancing customer satisfaction. ).' 8uality Policy -op management shall ensure that the quality policy 5ppropriate to the purpose of the organization !ocused on meeting requirements and continual improvement Fsed as a frame"or2 for quality ob9ectives .ommunicated and understood at appropriate levels 4evie"ed for continuing suitability 6ote $ -he policy needs to be communicated and understood throughout the organization. It is usually an e1pected that every member of staff "ill have an understanding of the quality policy and ho" to apply it in their day to day "or2. 6ote & -he quality policy is also communicated to customers, consumers and other interested parties. !or this purpose, it is displayed in the reception area and posted on the company>s internet site. ).% Planning

Planning falls into t"o categoriesB plannin# to fulfill the qualit o:;ecti$es, and plannin# to fulfill product requirements and the inte#rit of the mana#ement s stem. Qualit o:;ecti$es -op management shall ensure that quality ob9ectives are established at relevant functions and levels "ithin the organization. -he quality ob9ectives shall be measurable and consistent "ith the quality policy. Qualit mana#ement s stem plannin# -op management shall ensure that the planning of the quality management system a) :eet the requirements given in %.$, as "ell as the quality ob9ectives, and b) :aintain the integrity of the quality management system "hen changes are planned and implemented. ).) 4esponsibility, 5uthority and .ommunication $%!ose #ob is t!at&$ is not a question "hich should ever need to be as2ed in a "ell structured and clearly documented management system. -op management shall ensure that responsibilities and authorities are defined and communicated "ithin the organization. "!ana#ement representati$e% is the person "ho has delegated authority from top management to ;nsuring that processes needed for the quality management system are established, implemented and maintained 4eporting to top management on the performance of the quality rnanagement system and any need for improvement ;nsuring the a"areness of customer requirements is actively promoted throughout the organization .oordinate communication "ith e1ternal parties on matters relating to the quality management system "Internal communication% ;nsure the appropriate communication processes are established and carried out "ithin the organization regarding the effectiveness of the system. -o have means for communicating organizational and customer requirements to staff. :ethods of communicating the effectiveness of the 8:S include "ee2ly department leadperson meetings and daily (management) production meetings, management revie"s, circulation of minutes of management revie" meetings, internal audit closing meetings, and other routine business communication. ).* :anagement 4evie" 4evie" the quality management system at planned intervals to ;nsure a suitable, adequate, and effective system 5ssess possible opportunities for improvement ;valuate the need for any changes to the system

.onsider the need for changes to the quality policy and ob9ectives Inputs for management revie" must include information on !ollo"/up actions from earlier revie"s 4esults of audits .ustomer feedbac2 Process performance and product conformity Status of preventive and corrective actions that have been ta2en 5ny changes that could affect the quality system 4ecommendations for improvement(of system, process or product) Outputs from the management revie" must include any decisions and actions related to Improvement of the effectiveness of the system Improvement of the effectiveness of processes Improvement of product "ith respect to customer requirements 4esource need Maintain records of t!e management revie's( S(')IO+ 4 - R(SO.R'( !/+/G(!(+) *.$ Provision of 4esources 3etermine and provide the resources necessary to Implement and maintain the quality management system .ontinually improve the effectiveness of the system ;nhance customer satisfaction by meeting customer requirements <uman Resources - Infrastructure - =or> (n$ironment ;nsure people performing "or2 affecting conformity to product requirements are competent based on the appropriate education, training, s2ills, and e1perience. -he organization must 3etermine the competency needs for personnel Provide training (or ta2e other actions) to achieve the necessary competence ;valuate the effectiveness of the actions ta2en Inform employees of the relevance and importance of their activities

;nsure they 2no" their contribution to achieving quality ob9ectives :aintain education, training, s2ill, and e1perience records 3etermine, provide, and maintain the necessary infrastructure to achieve product conformity. Infrastructure includes, as applicable 0uildings, "or2space, and associated utilities Process equipment (both hard"are and soft"are) Supporting services (such as transport, communication, or information systems) 3etermine and manage the "or2 environment needed to achieve product conformity. -he term Gwor> en$ironmentH relates to those conditions under "hich "or2 is performed, including physical, environmental, and other factors such as noise, temperature, humidity, lighting, or "eather. -he management of the "or2 environment should cover such issues as 5ssuring legal compliance "ith health and safety requirements, Identifying and controlling any special environmental requirements, ;nsuring that house2eeping is reasonable for the type of "or2 being performed. S(')IO+ 5 - &ROD.') R(/0I6/)IO+ -his term is the generic heading for all the activities "hich cover everything from initial customer contact to post/delivery maintenance, "hen required. In summary clause seven of the standard addresses the follo"ing issues )(* Planning of product realization -his covers all the things "hich used to be called quality planning, and addresses ho" the organization ma2es appropriate arrangements for meeting customer requirements. )(+ ,ustomer-related processes -hese are bro2en into three areasB identification of product requirements, the revie" of requirements and managing customer communications. )(. /esign and development 6e1t comes design. Section +.' is divided into seven sub/sections. )(0 Purc!asing !ollo"ing on from the design and7or development requirements come those devoted to the sub9ect of procurement activity. )(1 Production and service provision -his covers process controls and validation, product identification and traceability, customer property and product preservation

)(2 ,ontrol of monitoring and measuring devices )(2 addresses t!e issues of t!e control of calibration and use of test and inspection equipment and ot!er measurement devices( +.$ Planning of Product 4ealization Planning for product realization is product quality planning. 5ny document used by an organization to identify specific customer requirements can be called a quality plan, even if the information is restricted to quantity and delivery date. 3etermine through the planning 8uality ob9ectives and product requirements 6eed for processes, documents, and resources Ierification, validation, monitoring, measurement, inspection, and test activities .riteria for product acceptance 4ecords as evidence the processes and resulting product meet requirements 6ote $ 5 document specifying the processes of the quality management system (including the product realization processes), and the resources to be applied to a specific product, pro9ect or contract, can be referred to as a qualit plan? 6ote & -he organization can also apply the requirements given in +.' to the development of product realization processes. +.& .ustomer/related Processes -hese are bro2en into three areas of activity, "hich are $) -he identification of product requirements &) 4evie"ing those requirements ') :anaging customer communications Determination of requirements related to the product -he organization shall deternnine 4equirements specified by the customer, including the requirements for delivery and post/ delivery activities 4equirements not stated by the customer but necessary for specified or intended use, "here 2no"n Statutory and regulatory requirements applicable to the product 5ny additional requirennents considered necessary by the organization 6ote Post/delivery activities include, for e1ample, actions under "arranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

Re$iew of Requirements Related to the &roduct 4evie" the product requirements before committing to supply the product to the customer in order to ;nsure product requirements are defined 4esolve any requirements differing from those previously e1pressed ;nsure its ability to meet the requirements 'ustomer 'ommunication 3etermine and implement effective arrangements for communicating "ith customers on Product information Inquiries, contracts, or order handling (including amendments) .ustomer feedbac2 (including customer complaints) +.' 3esign and 3evelopment 3esign and development activities are described in seven discrete "ords(planning / inputs / outputs / revie" / verification / validation / .ontrol of changes). 5t each stage of process the inputs and outputs must be documented and the records maintained. -he emphasis is on defining "hat it is that the activity is trying to achieve and then recording "hat has been achieved. (3esign and 3evelopment Planning) -his planning must determine the Stages of design and development 5ppropriate revie", verification, and validation activities for each stage 5ssignment of responsibility and authority for design and development activities (3esign and 3evelopment Inputs) 3etermine product requirement inputs and maintain records. -he inputs must include !unctional and performance requirements 5pplicable statutory and regulatory requirements 5pplicable information derived from similar designs Other requirements essential for design and development such as / customer requirements for pac2aging, disposal after use, recycling of materials, process requirements, storage and maintenance requirements, interchangeability, upgradeability, etcetera.

(3esign and 3evelopment Outputs) 3ocument the outputs of the design and development process in a form suitable for verification against the inputs to the process. -he outputs must 0e approved before their release :eet design and development input requirements Provide information for purchasing, production, and service .ontain or reference product acceptance criteria 3efine essential characteristics for safe and proper use 6ote Information for production and service can include details for product preservation. (3esign and 3evelopment 4evie") -here are three fi1ed agenda items required by the standard ;valuation of the ability of the design to meet the requirements, and Identification of any problems, and finally 5ppropriate action to follo"/up and resolve any issues identified during the revie". (3esign and development verification) Ierification shall be performed in accordance "ith planned arrangements (see +.'.$) to ensure that the design and development outputs have met the design and development input requirements. 4ecords of the results of the verification and any necessary actions shall be maintained (see %.&.%). (3esign and 3evelopment Ialidation) Perform validation in accordance "ith planned arrangements (see +.'.$) to confirm the resulting product is capable of meeting the requirements for its specified application or intended use. Ierification should demonstrate that design output meets the design input. 3esign validation is intended to confirm that regardless of "hether or not the design outputs meets the specification of the design input, does the resulting product fulfill the customer>s needs in the real "orld? (.ontrol of design and development changes) 3esign and development changes shall be identified and records maintained. -he changes shall be revie"ed, verified and validated, as appropriate, and approved before implementation. +.% Purchasing -his section creates the requirements for the control of procurement operations. It is divided into three areas of activity selection, evaluation and control of suppliers, the creation and development of purchasing information, and the verification of purchased product.

(Purchasing Process) ;nsure that purchased product conforms to its specified purchase requirements. ;valuate and select suppliers based on their ability to supply product in accordance "ith the requirements. ;stablish the criteria for selection, evaluation, and reevaluation. (Purchasing information) Purchasing information shall describe the product to be purchased, including, "here appropriate 4equirements for approval of product, procedures, processes and equipment 4equirements for qualification of personnel (5lso include quality management system requirements in the purchasing information) Once all necessary information is on the PO (Purchasing Order), ma2e sure that it is verified before it is sent out. (Ierification of Purchased Product) ;stablish and implement the inspection or other necessary activities for ensuring the purchased products meet the specified purchase requirements. If the organization or its customer proposes to verify the product at the supplier location, state the intended verification arrangements and method of product release in the purchasing information. +.) Production Provision (.ontrol of production and service provision) -he organization shall plan and carry out production and service provision under controlled conditions. -here are si1 areas in "hich control is required 5vailability of information that describes the characteristics of the product 5vailability of "or2 instructions, as necessary Fse of suitable equipment 5vailability and use of monitoring and measuring equipment Implementation of monitoring and measurement activities Implementation of product release, delivery, and post/delivery activities (Ialidation of processes for production and service provision) -he organization shall validate any processes for production and service provision "here the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. Process validation consists of all or some of these 8ualification of the process

8ualification of the equipment 8ualification of the personnel Fse of defined methods Fse of defined procedures Process and process validation records Process re/validation (Identification and traceability) $. Identification / Identify, "here appropriate, the product by suitable means during product realization. &. Status / -he organization shall identify the product status "ith respect to monitoring and measurement requirements throughout product realization. -here are three basic states J useableB not useableB not sureK '. -raceability / =here traceability is a requirement, control the unique identification of the product and maintain records. (.ustomer Property) ;1ercise care "ith any customer property "hile it is under the control of, or being used by, the organization. Identify, verify, protect, and safeguard customer property provided for use, or for incorporation into the product. 4ecord and report any lost, damaged, or unsuitable property to the customer. 6ote .ustomer property can include intellectual property and personal data. (Preservation of product) -he organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. 5s applicable, preservation shall include $) Identification &) <andling ') Pac2aging %) Storage )) Protection Preservation shall also apply to the constituent parts of a product. +.* .ontrol of :onitoring and :easuring ;quipment -his is all about control and calibration of the test and measuring equipment "hich is used to prove that product conforms to specifications. =here necessary to ensure valid results, measuring equipment shall

.alibrate and7or verify the measuring equipment at specified intervals or prior to use .alibrate the equipment to national or international standards (or record other basis) 5d9ust or re/ad9ust as necessary Identify the measuring equipment in order to determine its calibration status Safeguard them from improper ad9ustments Protect them from damage and deterioration :aintain records of the calibration and verification results. S(')IO+ 7 - !(/S.R(!(+)8 /+/01SIS /+D I!&RO9(!(+) ,.$ Ceneral Plan and implement the monitoring, measurement, analysis, and improvement processes needed to 3emonstrate conformity to product requirements ;nsure conformity of the system .ontinually improve effectiveness ,.& :onitoring and :easurement ,.&.$ .ustomer satisfaction 5s one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to "hether the organization has met customer requirements. -he methods for obtaining and using this information shall be determined. 6ote :onitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, "arranty claims and dealer reports. ,.&.& Internal 5udit .onduct internal audits at planned intervals to determine if the quality management system .onforms to planned arrangements (see +.$) .onforms to requirements of ISO (##$ Is effectively implemented and maintained -he organization must Plan the audit program .onsider the status and importance of the audited areas .onsider the results of prior audits 3efine the audit criteria, scope, frequency, and methods Select and use impartial and ob9ective auditors (not audit their o"n "or2)

;stablish a documented procedure to address responsibilities and requirements to Plan audits and conduct audits ;stablish records and report results -he management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are ta2en "ithout undue delay to eliminate detected nonconformities and their causes. ,.&.' :onitoring and measurement of processes -he organization shall apply suitable methods for monitoring and, "here applicable, measurement of the quality management system processes. -hese methods shall demonstrate the ability of the processes to achieve planned results. =hen planned results are not achieved, correction and corrective action shall be ta2en, as appropriate. ,.&.% :onitoring and measurement of product -he organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. ;vidence of conformity "ith the acceptance criteria shall be maintained. 4ecords shall indicate the person(s) authorizing release of product for delivery to the customer

,.' .ontrol of 6onconforming Product ;nsure any nonconforming product is identified and controlled to prevent its unintended use or delivery. ;stablish a documented procedure to define the controls and related responsibilities and authorities for dealing "ith nonconforming product. =here applicable, deal "ith the nonconforming product by one or more of the follo"ing "ays -a2e action to eliminate the detected nonconformity 5uthorize its use, release, or acceptance by concession -a2e action to preclude its original intended use or application -a2e action appropriate to the effects, or potential effects, of the nonconformity "hen nonconforming product is detected after delivery or use has started :aintain records of the nature of the nonconformity, and any subsequent actions, (including any concessions). =hen the nonconformity is corrected, re/verify it to sho" conformity. ,.% 5nalysis of 3ata

3etermine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system, as "ell as, evaluate "here continual improvement of the effectiveness of the quality management system can be made. -he analysis of data shall provide information relating to .ustomer satisfaction .onformity to product requirements .haracteristics and trends of processes and products, including opportunities for preventive action Suppliers ,.) Improvement ,.).$ .ontinual Improvement .ontinually improve the effectiveness of the quality management system through 8uality policy 8uality ob9ectives 5udit results 5nalysis of data .orrective and preventive action :anagement revie" ,.).& .orrective 5ction -a2e corrective action to eliminate the causes of nonconformities and prevent recurrence. .orrective action must be appropriate to effects of the problem. ;stablish a documented procedure for corrective action that defines requirements to 4evie" nonconformities (including customer complaints) 3etermine the causes of nonconformities ;valuate the need for actions to prevent recurrence 3etermine and implementing the needed action :aintain records of the results of the action ta2en 4evie" the effectiveness of corrective action ta2en ,.).' Preventive 5ction 3etermine the action to eliminate the causes of potential nonconformities in order to prevent their occurrence. ;nsure preventive actions are appropriate to the anticipated effects of the potential problem. ;stablish a documented procedure for preventive action to define requirements to

3etermine potential nonconformities and their causes ;valuate the need for actions to prevent occurrence 3etermine and implementing the needed action :aintain records of the results of the action ta2en 4evie" the effectiveness of preventive action ta2en