Organization or person requesting an audit.

Transcription

1 Glssary audit Systematic, independent and dcumented prcess fr btaining audit evidence and evaluating it bjectively t determine the extent t which audit criteria are fulfilled. When tw r mre management systems are audited tgether, this is termed a cmbined audit. When tw r mre auditing rganizatins cperate t audit a single auditee, this is termed a jint audit. audit (internal) Internal audits, smetimes called first-party audits, are cnducted by, r n behalf f, the rganizatin itself fr management review and ther internal purpses, and may frm the basis fr an rganizatin s declaratin f cnfrmity. In many cases, particularly in smaller rganizatins, independence can be demnstrated by the freedm frm respnsibility fr the activity being audited. audit (external) External audits include thse generally termed secnd- and third-party audits. Secnd-party audits are cnducted by parties having an interest in the rganizatin, such as custmers, r by ther persns n their behalf. Third-party audits are cnducted by external, independent auditing rganizatins, such as thse prviding certificatin/registratin f cnfrmity t ISO 9001 r ISO audit client Organizatin r persn requesting an audit. The audit client may be the auditee r any ther rganizatin that has the regulatry r cntractual right t request an audit.

2 audit cnclusin Outcme f an audit prvided by the audit team after cnsideratin f the audit bjectives and all audit findings. audit criteria Set f plicies, prcedures r requirements. criteria are used as a reference against which audit evidence is cmpared. audit evidence Recrds, statements f fact r ther infrmatin which are relevant t the audit criteria and verifiable. Audit evidence can be qualitative r quantitative. audit findings Results f the evaluatin f the cllected audit evidence against audit criteria. Audit findings can indicate either cnfrmity r nncnfrmity with audit criteria r pprtunities fr imprvement. audit plan Descriptin f the activities and arrangements fr an audit. audit prgramme Set f ne r mre audits planned fr a specific time frame and directed twards a specific purpse.

3 An audit prgramme includes all activities necessary fr planning, rganizing and cnducting the audits. audit scpe Extent and bundaries f an audit. The audit scpe generally includes a descriptin f the physical lcatins, rganizatinal units, activities and prcesses, as well as the time perid cvered. audit team One r mre auditrs cnducting an audit, supprted if needed by technical experts. One auditr f the audit team is appinted as the audit team leader. The audit team may include auditrs-in-training. auditee Organizatin being audited. auditr Persn with the demnstrated persnal attributes and cmpetence t cnduct an audit. The relevant persnal attributes fr an auditr are described in ISO capability Ability f an rganizatin, system r prcess t realize a prduct that will fulfil the requirements fr that prduct.

4 characteristic Distinguishing feature. A characteristic can be inherent r assigned. A characteristic can be qualitative r quantitative. There are varius classes f characteristic, such as physical, sensry, behaviral, tempral, functinal, etc. cmpetence Demnstrated ability t apply knwledge and skills. cncessin Permissin t use r release a prduct that des nt cnfrm t specified requirements. A cncessin is generally limited t the delivery f a prduct that has nncnfrming characteristics within specified limits fr an agreed time r quantity f that prduct. cnfrmity Fulfilment f a requirement. cntinual imprvement Recurring activity t increase the ability t fulfil requirements. The prcess f establishing bjectives and finding pprtunities fr imprvement is a cntinual prcess thrugh the use f audit findings and audit cnclusins, analysis f data, management reviews r ther means and generally leads t crrective actin r preventive actin.

5 cntract Binding agreement. crrectin Actin t eliminate a detected nncnfrmity. A crrectin can be made in cnjunctin with a crrective actin. A crrectin can be, fr example, rewrk r re-grade. crrective actin Actin t eliminate the cause f a detected nncnfrmity r ther undesirable situatin. There can be mre than ne cause fr a nncnfrmity. Crrective actin is taken t prevent recurrence whereas preventive actin is taken t prevent ccurrence. There is a distinctin between crrectin and crrective actin. custmer Organizatin r persn that receives a prduct. A custmer can be internal r external t the rganizatin. custmer satisfactin Custmer's perceptin f the degree t which the custmer's requirements have been fulfilled. Custmer cmplaints are a cmmn indicatr f lw custmer satisfactin but their absence des nt necessarily imply high custmer satisfactin.

6 Even when custmer requirements have been agreed with the custmer and fulfilled, this des nt necessarily ensure high custmer satisfactin. defects Nn-fulfilment f a requirement related t an intended r specified use. The distinctin between the cncepts defect and nncnfrmity is imprtant as it has legal cnntatins, particularly thse assciated with prduct liability issues. Cnsequently the term "defect" shuld be used with extreme cautin. dependability Cllective term used t describe the availability perfrmance and its influencing factrs: reliability perfrmance, maintainability perfrmance and maintenance supprt perfrmance. Dependability is used nly fr general descriptins in nnquantitative terms. design and develpment Set f prcesses that transfrms requirements int specified characteristics r int the specificatin f a prduct, prcess r system. The terms "design" and "develpment" are smetimes used synnymusly and smetimes used t define different stages f the verall design and develpment prcess. A qualifier can be applied t indicate the nature f what is being designed and develped (e.g. prduct design and develpment r prcess design and develpment).

7 deviatin permit Permissin t depart frm the riginally specified requirements f a prduct prir t realizatin. A deviatin permit is generally given fr a limited quantity f prduct r perid f time, and fr a specific use. dcument Infrmatin and its supprting medium. The medium can be paper, magnetic, electrnic r ptical cmputer disc, phtgraph r master sample, r a cmbinatin theref. A set f dcuments, fr example specificatins and recrds, is frequently called "dcumentatin". dcumented prcedure A prcedure which is established, dcumented, implemented and maintained. effectiveness Extent t which planned activities are realized and planned results achieved. efficiency Relatinship between the result achieved and the resurces used. grade Categry r rank given t different quality requirements fr prducts, prcesses r systems having the same functinal use.

8 infrmatin Meaningful data. infrastructure Organizatin system f facilities, equipment and services needed fr the peratin f an rganizatin. inspectin Cnfrmity evaluatin by bservatin and judgment accmpanied as apprpriate by measurement r testing. interested parties Persn r grup having an interest in the perfrmance r success f an rganizatin. management Crdinated activities t direct and cntrl an rganizatin. In English, the term "management" smetimes refers t peple, i.e. a persn r grup f peple with authrity and respnsibility fr the cnduct and cntrl f an rganizatin. When "management" is used in this sense, it shuld always be used with sme frm f qualifier t avid cnfusin with the cncept "management" defined abve.

9 management system System t establish plicy and bjectives and t achieve thse bjectives. A management system f an rganizatin can include different management systems, such as a quality management system, a financial management system r an envirnmental management system. measuring equipment Measuring instrument, sftware, measurement standard, reference material r auxiliary apparatus r cmbinatin theref necessary t realize a measurement prcess. measuring devices Measuring instrument, sftware, measurement standard, reference material r auxiliary apparatus r cmbinatin theref necessary t realize a measurement prcess. measurement Set f interrelated and interacting elements necessary t achieve metrlgical cnfirmatin and cntinual cntrl f measurement prcesses. measurement management system Set f interrelated and interacting elements necessary t achieve metrlgical cnfirmatin and cntinual cntrl f measurement prcesses. measurement prcess Set f peratins t determine the value f a quantity.

10 metrlgical characteristics Distinguishing feature which can influence the results f measurement. Measuring equipment usually has several metrlgical characteristics. Metrlgical characteristics can be the subject f calibratin. metrlgical cnfirmatin Set f peratins required t ensure that measuring equipment cnfrms t the requirements fr its intended use. Metrlgical cnfirmatin generally includes calibratin r verificatin, any necessary adjustment r repair, and subsequent recalibratin, cmparisn with the metrlgical requirements fr the intended use f the equipment, as well as any required sealing and labeling. Metrlgical cnfirmatin is nt achieved until and unless the fitness f the measuring equipment fr the intended use has been demnstrated and dcumented. The requirements fr intended use include such cnsideratins as range, reslutin and maximum permissible errrs. Metrlgical requirements are usually distinct frm, and are nt specified in, prduct requirements. metrlgical functin Functin with administrative and technical respnsibility fr defining and implementing the measurement management system. The wrd "defining" has the meaning f "specifying". It is nt used in the terminlgical sense f "defining a cncept" (in sme languages, this distinctin is nt clear frm the cntext alne).

11 nncnfrmities Nn-fulfilment f a requirement. bjective evidence Data supprting the existence r verity f smething. Objective evidence may be btained thrugh bservatin, measurement, test, r ther means. rganizatin Grup f peple and facilities with an arrangement f respnsibilities, authrities and relatinships. The arrangement is generally rderly. An rganizatin can be public r private. rganizatinal structure Arrangement f respnsibilities, authrities and relatinships between peple. The arrangement is generally rderly. A frmal expressin f the rganizatinal structure is ften prvided in a quality manual r a quality plan fr a prject. The scpe f an rganizatinal structure can include relevant interfaces t external rganizatins. precisin A measure f clseness f agreement between results.

12 preventive actin Actin t eliminate the cause f a ptential nncnfrmity r ther undesirable ptential situatin. There can be mre than ne cause fr a ptential nncnfrmity. Preventive actin is taken t prevent ccurrence whereas crrective actin is taken t prevent recurrence. prcedure Specified way t carry ut an activity r a prcess. Prcedures can be dcumented r nt. When a prcedure is dcumented, the term "written prcedure" r "dcumented prcedure" is frequently used. The dcument that cntains a prcedure can be called a "prcedure dcument". prcess Set f interrelated r interacting activities which transfrms inputs int utputs. Inputs t a prcess are generally utputs f ther prcesses. Prcesses in an rganizatin are generally planned and carried ut under cntrlled cnditins t add value. A prcess where the cnfrmity f the resulting prduct cannt be readily r ecnmically verified is frequently referred t as a "special prcess". prducts Result f a prcess. There are fur generic prduct categries, as fllws: Services, Sftware, Hardware and Prcessed materials. Many prducts cmprise elements belnging t different generic prduct categries.whether the prduct is then

13 called service, sftware, hardware r prcessed material depends n the dminant element. Service is the result f at least ne activity necessarily perfrmed at the interface between the supplier and custmer and is generally intangible. prject Unique prcess, cnsisting f a set f crdinated and cntrlled activities with start and finish dates, undertaken t achieve an bjective cnfrming t specific requirements, including the cnstraints f time, cst and resurces. An individual prject can frm part f a larger prject structure. In sme prjects the bjectives are refined and the prduct characteristics defined prgressively as the prject prceeds. The utcme f a prject can be ne r several units f prduct. qualificatin prcess Prcess t demnstrate the ability t fulfil specified requirements. The term "qualified" is used t designate the crrespnding status. Qualificatin can cncern persns, prducts, prcesses r systems. quality Degree t which a set f inherent characteristics fulfils requirements. quality assurance Part f quality management fcused n prviding cnfidence that quality requirements will be fulfilled.

14 quality characteristic Inherent characteristic f a prduct, prcess r system related t a requirement. Inherent means existing in smething, especially as a permanent characteristic. A characteristic assigned t a prduct, prcess r system (e.g. the price f a prduct, the wner f a prduct) is nt a quality characteristic f that prduct, prcess r system. quality cntrl Part f quality management fcused n fulfilling quality requirements. quality imprvement Part f quality management fcused n increasing the ability t fulfil quality requirements. The requirements can be related t any aspect such as effectiveness, efficiency r traceability. quality management Crdinated activities t direct and cntrl an rganizatin with regard t quality. Directin and cntrl with regard t quality generally includes establishment f the quality plicy and quality bjectives, quality planning, quality cntrl, quality assurance and quality imprvement.

15 quality management system Management system t direct and cntrl an rganizatin with regard t quality. quality manual Dcument specifying the quality management system f an rganizatin. Quality manuals can vary in detail and frmat t suit the size and cmplexity f an individual rganizatin. quality bjectives Smething sught, r aimed fr, related t quality. Quality bjectives are generally based n the rganizatin's quality plicy. Quality bjectives are generally specified fr relevant functins and levels in the rganizatin. quality plan Dcument specifying which prcedures and assciated resurces shall be applied by whm and when t a specific prject, prduct, prcess r cntract. These prcedures generally include thse referring t quality management prcesses and t prduct realizatin prcesses. A quality plan ften makes reference t parts f the quality manual r t prcedure dcuments. A quality plan is generally ne f the results f quality planning.

16 quality planning Part f quality management fcused n setting quality bjectives and specifying necessary peratinal prcesses and related resurces t fulfil the quality bjectives. Establishing quality plans can be part f quality planning. quality plicy Overall intentins and directin f an rganizatin related t quality as frmally expressed by tp management. Generally the quality plicy is cnsistent with the verall plicy f the rganizatin and prvides a framewrk fr the setting f quality bjectives. re-grade Alteratin f the grade f a nncnfrming prduct in rder t make it cnfrm t requirements differing frm the riginal nes. recrds Dcument stating results achieved r prviding evidence f activities perfrmed. Recrds can be used, fr example, t dcument traceability and t prvide evidence f verificatin, preventive actin and crrective actin. release Permissin t prceed t the next stage f a prcess. In English, in the cntext f cmputer sftware, the term "release" is frequently used t refer t a versin f the sftware itself.

17 repair Actin n a nncnfrming prduct t make it acceptable fr the intended use. Repair includes remedial actin taken n a previusly cnfrming prduct t restre it fr use, fr example as part f maintenance. Unlike rewrk, repair can affect r change parts f the nncnfrming prduct. requirement Need r expectatin that is stated, generally implied r bligatry. expressin in the cntent f a dcument cnveying criteria t be fulfilled if cmpliance with the dcument is t be claimed and frm which n deviatin is permitted. review Activity undertaken t determine the suitability, adequacy and effectiveness f the subject matter t achieve established bjectives. Review can als include the determinatin f efficiency. rewrk Actin n a nncnfrming prduct t make it cnfrm t the requirements.

18 scraps Actin n a nncnfrming prduct t preclude its riginally intended use. In a nncnfrming service situatin, use is precluded by discntinuing the service. specificatin Dcument stating requirements. A specificatin can be related t activities (e.g. prcedure dcument, prcess specificatin and test specificatin), r prducts (e.g. prduct specificatin, perfrmance specificatin and drawing). supplier Organizatin r persn that prvides a prduct. A supplier can be internal r external t the rganizatin. In a cntractual situatin, a supplier is smetimes called "cntractr". system Set f interrelated r interacting elements. technical expert Persn wh prvides specific knwledge r expertise t the audit team. Specific knwledge r expertise relates t the rganizatin, the prcess r activity t be audited, r language r culture. A technical expert des nt act as an auditr in the audit team.

19 test Determinatin f ne r mre characteristics accrding t a prcedure. traceability Ability t trace the histry, applicatin r lcatin f that which is under cnsideratin. When cnsidering prduct, traceability can relate t the rigin f materials and parts, the prcessing histry, and the distributin and lcatin f the prduct after delivery. In the field f tests and calibratins, traceability is understd as the prperty f the result f a measurement r the value f a standard whereby it can be related t stated references, usually natinal r internatinal standards, thrugh an unbrken chain f cmparisns, all having stated uncertainties. trueness A measure f clseness f agreement between the arithmetic mean f a large number f test results and the true r accepted reference value. tp management Persn r grup f peple wh directs and cntrls an rganizatin at the highest level. uncertainty The parameter assciated with the result f a measurement that characterizes the dispersin f the values that culd reasnably be attributed t the measurand.

20 validatin Cnfirmatin, thrugh the prvisin f bjective evidence, that the requirements fr a specific intended use r applicatin have been fulfilled. The term "validated" is used t designate the crrespnding status. The use cnditins fr validatin can be real r simulated. verificatin Cnfirmatin, thrugh the prvisin f bjective evidence, that specified requirements have been fulfilled. The term "verified" is used t designate the crrespnding status. Cnfirmatin can cmprise activities such as: perfrming alternative calculatins, cmparing a new design specificatin with a similar prven design specificatin, undertaking tests and demnstratins reviewing dcuments prir t issue. wrk envirnment Set f cnditins under which wrk is perfrmed. Cnditins include physical, scial, psychlgical and envirnmental factrs (such as temperature, recgnitin schemes, ergnmics and atmspheric cmpsitin).