110 ISO 9001 ity management system b) conforms tO the planned arrangements (see 7.1 ) , to the requlrements of this lnternational Standard and to the quality management sys- tem reqmrements established by the organi- Z ation, and is effectively implemented and maintained. An audit programme shall be planned, taking intO consideration the status and importance of the processes and areas to be audited, as well as the results of prevlous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure obJectivity and impartiality of the audit process. Auditors shall not audit their own work. A documented procedure shall be established to define the responsibilities and requlrements for planning and conducting audits, establishing re- cords and reporting results.

54 ISO 9001 A documented procedure shall be established to define the controls needed d) f) g) t0 approve documents for adequacy prior t0 lssue, tO revlew and update as necessary and re-ap- prove documents, t0 ensure that changes and the current revi- SIOn status Of documents are identified, t0 ensure that relevant verslons 0f applicable documents are available at points of use, tO ensure that documents remain leglble and readily identifiable, tO ensure that documents 0f external origln determined by the organization to be neces- sary for the planning and operation 0f the quality management system are identified and their distribution controlled, and tO prevent the unintended use Of obsolete doc- uments, and t0 apply suitable identification t0 them if they are retained for any purpose. 4.2.4 ControI of records Records established to provide evidence of confor-

124 ISO 9001 A documented procedure shall be established t0 define reqmrements for a) b) c) d) determining potential nonconformities and their causes, evaluating the need for action t0 prevent OC- currence Of nonconformlties, determimng and implementing action need- ed, records 0f results 0f action taken (see 4.2.4 ) , and resnewing the effectiveness 0f the preventive action taken.

272 ISO 9000 NOTE 1 The term "qualified" is used to desig- nate the corresponding status. NOTE 2 Qualification can concern persons, products ( 3.4.2 ) , processes or systems ( 3.2.1 ). EXAMPLE Auditor qualification process, mate- rial qualification process. 3.8.7 revrew activlty undertaken t0 determine the suitability, adequacy and effectiveness ( 3.2.14 ) 0f the sub- Ject matter t0 achieve established 0bJectives NOTE Review can also include the determina- tion of efficiency ( 3.2.15 ). EXAMPLE Management revlew, design and development reuew, reuew Of customer reqmre- ments and nonconformity reuew.

64 ISO 9001 5.5.3 lnternal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness 0f the quality management system. 5.6 Management review 5.6.1 General Top management shall reuew the organization's quality management system, at planned intervals, t0 ensure its continuing suitability, adequacy and effectiveness. ThiS reV1e 、 shall include assessing opportunities for improvement and the need for changes t0 the quality management system, 1 Ⅱ - cluding the quality policy and quality objectives. Records fror management revlews shall be mam- tained (see 4.2.4 ). 5.6.2 Review input The input to management review shall include in- formation on

62 ISO 9001 ties and authorities are defined and communicat- e d within the organization. 5.5.2 Management representative Top management shall appoint a member of the organization's management WhO, irrespective Of 0ther responsibilities, shall have responsibility and authority that includes b) ensuring that processes needed for the qual- ity management system are established, im- plemented and maintained, reporting tO top management on the perfor- mance 0f the quality management system and any need for improvement, and ensuring the promotion Of awareness Of cus- tomer reqmrements throughout the organiza- tion. NOTE The responsibility of a management rep- resentative can include liaison With external par- ties on matters relating to the quality manage- ment system.

122 ISO 9001 to the effects of the nonconformities encountered. A documented procedure shall be established to define requn•ements for d) f) reuewmg nonconformities (including custom- er complaints), determlning the causes Of nonconformities, evaluating the need for action tO ensure that nonconformities dO not recur, determming and implementing action need- ed, records 0f the results 0f action taken (see 4.2.4 ) , and revlewing the effectiveness Of the corrective action taken. 8.5.3 Preventive action The organization shall determme action tO elimi- nate the causes 0f potential nonconformities 1 Ⅱ order tO prevent their occurrence. Preventive ac - tions shall be appropmate t0 the effects 0f the po- tential problems.

92 pro duct. ISO 9001 The organization shall evaluate and select sup- pliers based on their ability t0 supply product in accordance With the organization S requn•ements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of eval- uations and any necessary actions ar1Sing from the evaluation shall be maintained (see 4.2.4 ). 7.4.2 Purchasing information Purchasing information shall describe the product t0 be purchased, including, where appropriate, b) requn•ements for approval 0f product, proce- dures, processes and eqmpment, requirements for qualification 0f personnel and quality management system reqmrements. The organization shall ensure the adequacy of specified purchase requlrements prior t0 their communication t0 the supplier.

18 ISO 9001 ISO (the lnternational Organization for Stan- dardization) is a worldwide federation of national standards bodies (ISO member bodies). Thc work 0f preparing lnternational Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right t0 be represented 0 Ⅱ that committee. lnternational organizations, governmental and non-governmental, in liaison with ISO, also take part ⅲ the work. ISO collaborates closely with the lnternational EIectrotechnicaI Commission (IEC) on all matters of electrotechnical standardiza- tion. lnternational Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to pre- pare lnternational Standards. Draft lnternational

60 ISO 9001 5.4.1 Quality objectives Top management shall ensure that quality ob- jectives, including those needed t0 meet requlre- ments for product [see 7.1 a)], are established at relevant functions and levels within the organlza- tion. The quality objectives shall be measurable and consistent with the quality policy. 5.4.2 Quality management system planning Top management shall ensure that b) the planning 0f the quality management sys- tem IS carried out in order tO meet the re- qturements given in 4.1 , as well as the quality objectives, and the integrity 0f the quality management sys- tem is maintained when changes t0 the qual- ity management system are planned and im- plemented. 5.5 Responsibility, authority and communi- cation 5.5.1 Responsibility and authority Top management shall ensure that responsibili-