216 nization ( 3.3.1 ). 3.2.6 management ISO 9000 coordinated activities to direct and control an or- ganization ( 3.3.1 ) NOTE ln English, the term 'management' sometimes refers tO people, i. e. a person or group 0f people with authority and responsibility for the conduct and control 0f an organization. When management ” is used in this sense, it should al- ways be used with some form 0f qualifier t0 avoid confusion with the concept "management" defined above. For example, 。 management shall . is dep- recated whereas top management ( 3.2. の shall IS acceptable. 3.2.7 top management person or group 0f people wh0 directs and controls an organization ( 3.3.1 ) at the highest level

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

218 3.2.8 ISO 9000 quality management coordinated activities to direct and control an or- ganization ( 3.3.1 ) with regard t0 quality ( 3.1.1 ) NOTE Direction and control with regard to qual- ity generally includes establishment 0f the qual- ity policy ( 3.2.4 ) and quality objectives ( 3.2.5 ) , quality planning ( 3.2.9 ) , quality control ( 3.2.10 ) , quality assurance ( 3.2.11 ) and quality improvement ( 3.2.12 ). 3.2.9 quality planning part 0f quality management ( 3.2.8 ) focused on setting quality objectives ( 3.2.5 ) and specifying necessary operational processes ( 3.4.1 ) and re- lated resources t0 fulfil the quality objectives NOTE Establishing quality plans ( 3.7.5 ) can be part 0f quality planning. 3.2.10 quality control

250 3.6.2 nonconformity ISO 9000 non-fulfilment of a requirement ( 3.1.2 ) 3.6.3 defect non-fulfilment of a requirement ( 3.1.2 ) related t0 an intended or specified use NOTE 1 The distinction between the concepts defect and nonconformity ( 3.6.2 ) is important as it has legal connotations, particularly those asso- ciated with product liability issues. Consequently the term "defect ” should be used with extreme caution. NOTE 2 The intended use as intended by the customer ( 3.3.5 ) can be affected by the nature 0f the information, such as operatmg or mamtenance instructions, provided by the supplier ( 3.3.6 ). 3.6.4 preventive action

36 ISO 9001 for certification, regulatory or contractual use. 0.4 Compatibility with other management systems During the development ofthis lnternational Stan- dard, consideration glven t0 the provlsl()ns of ISO 14001 : 2004 to enhance the compatibility of the two standards for the benefit of the user com- munity. Annex A shows the correspondence be- tween ISO 9001 : 2008 and ISO 14001 : 2004. This lnternational Standard does not include re- qmrements specific t0 0ther management systems, such as those particular tO envlronmental man- agement, occupational health and safety manage- ment, financial management or riSk management. However, this lnternational Standard enables an organization t0 align or integrate its own quality management system with related management system requmements. lt is possible for an organl- zation t0 adapt its existing management system(s)

58 ISO 9001 d) conducting management revlews, and e) ensuring the availability of resources. 5.2 Customer focus Top management shall ensure that customer re- quirements are determined and are met with the aim Of enhancing customer satisfaction (see 7.2.1 and 8.2.1 ). 5.3 QuaIity policy Top management shall ensure that the quality policy b) d) IS appropriate t0 the purpose 0f the organlza- tion, includes a commitment to comply with re- qumements and continually improve the effec- tiveness 0f the quality management system, provldes a framework for establishing and re- uewmg quality 0bJectives, IS communicated and understood within the organization, and IS reuewed for continuing suitability. 5.4 Planning

116 ISO 9001 completed, unless otherwise approved by a rele- vant authority and, where applicable, by the cus- tomer. 8.3 ControI of nonconforming product The organization shall ensure that product which does not conform tO product reqmrements iS iden- tified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming pro duct. Where applicable, the organization shall deal with nonconforming product by one or more 0f the fol- lowing ways: d) by taking action t0 eliminate the detected nonconformity; by author1Zing itS use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; by taking action t0 preclude its orlginal in- tended use or application; by taking action appropriate to the effects, or

86 b) d) ISO 9001 meet the input requirements for design and develop ment , provlde appropriate information for purchas- lng, production and servlce pr0VISIon, contain or reference product acceptance crite- rla, and specify the characteristics Of the product that are essential for itS safe and proper use. NOTE lnformation for production and servlce prouslon can include details for the preservation 0f product. 7.3.4 Design and development review At suitable stages, systematic revlews of design and development shall be performed ⅲ accordance with planned arrangements (see 7.3.1 ) a) t0 evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose neces- sary actions. Particip ants in such revlews shall include repre - sentatives Of functions concerned with the design

88 ISO 9001 and development stage(s) being reviewed. Records of the results of the revlews and any necessary ac- tions shall be maintained (see 4.2.4 ). 7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements (see 7.3.1 ) tO ensure that the design and development outputs have met the design and development input requirements. Re- cords Of the results 0f the verification and any nec- essary actions shall be maintained (see 4.2.4 ). 7.3.6 Design and development validation Design and development validation shall be per- formed in accordance With planned arrangements (see 7.3.1 ) tO ensure that the resulting product is capable 0f meeting the requlrements for the specl- fied application or intended use, where known. Wherever practicable, validation shall be complet- ed prior t0 the delivery or implementation of the product. Records 0f the results 0f validation and any necessary actions shall be maintained (see 4.2.4 ).

212 ISO 9000 3.2 Terms relating t0 management 3.2.1 system set Of interrelated or interacting elements 3.2.2 management system system ( 3.2.1 ) t0 establish policy and objectives and t0 achieve those 0bJectives NOTE A management system of an organiza- tion ( 3.3.1 ) can include different management systems, such as a quality management sys- tem ( 3.2.3 ) , a financial management system or an envmonmental management system. 3.2.3 quality management system management system ( 3.2.2 ) t0 direct and con- trol an organization ( 3.3.1 ) with regard t0 qual- ity ( 3.1.1 )