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1、ISO 9001: 2015Quality management systemsIntroduction0.1 GeneralThe adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performa nee and provide a sound basis for susta in able developme nt in itiatives. The pote ntial ben efits to

2、an orga ni zatio n of implementing a quality management system based on this International Standard are:a) the ability to con siste ntly provide products and services that meet customer and applicable statutory and regulatory requireme nts;b) facilitating opportunities to enhance customer satisfacti

3、on;c) address ing risks and opport un ities associated with its con text and objectives;d) the ability to dem on strate con formity to specified quality man ageme nt system requireme nts.This Intern ati onal Stan dard can be used by internal and exter nal parties.It is not the intent of this Interna

4、tional Standard to imply the need for: un iformity in the structure of differe nt quality man ageme nt systems; alig nment of docume ntati on to the clause structure of this Intern ati onal Stan dard; the use of the specific term ino logy of this Intern ati onal Stan dard with in the orga ni zatio n

5、.The quality man ageme nt system requireme nts specified in this Intern ati onal Stan dard are compleme ntary to requireme nts for products and services.This Intern ati onal Sta ndard employs the process approach, which in corporates the Pla n-Do-Check-Act (PDCA) cycle and risk-based thinking.The pr

6、ocess approach en ables an orga ni zatio n to pla n its processes and their in teract ions.The PDCA cycle en ables an orga ni zati on to en sure that its processes are adequately resourced and man aged, and that opport un ities for improveme nt are determ ined and acted on.Risk-based thinking enable

7、s an organization to determine the factors that could cause its processes and its quality man ageme nt system to deviate from the pla nned results, to put in place preve ntive con trols to mini mize n egative effects and to make maximum use of opport un ities as they arise (see Clause A.4).Con siste

8、 ntly meet ing requireme nts and address ing future n eeds and expectati ons poses a challe nge for orga ni zatio ns in an in creas in gly dyn amic and complex environment. To achieve this objective, the orga ni zati on might find it n ecessary to adopt various forms of improveme nt in additi on to

9、correct ion and continual improveme nt, such as breakthrough cha nge, inno vati on and re-orga ni zatio n.In this International Standard, the following verbal forms are used: shall ” indicates a requirement; should ” indicates a recommendation; may in dicates a permissi on; can” indicates a possibil

10、ity or a capability.Information marked as“ NOTE is for guidanee in understanding or clarifying the associated requirement.0.2 Quality management principlesThis International Standard is based on the quality management principles described in ISO 9000. The descriptions include a stateme nt of each pr

11、in ciple, a rati on ale of why the prin ciple is importa nt for the orga ni zati on, some examples of ben efits associated with the principle and examples of typical actions to improve the organization s performaprinciple. The quality management principles are:customer focus;leadership;en gageme nt

12、of people;process approach;improveme nt;evide nce-based decisi on mak ing;relati on ship man ageme nt.0.3 Process approach0.3.1 GeneralThis Intern atio nal Stan dard promotes the adoptio n of a process approach whe n develop in g, impleme nti ng and improvi ng the effective ness of a quality man age

13、me nt system, to enhance customer satisfact ion by meet ing customer requireme nts.Specific requirements considered essential to the adoption of a process approach are included in 4.4. Understanding and man agi ng in terrelated processes as a system con tributes to the orga ni zati on s effect iven

14、ess and efficie ncyinten ded results. This approach en ables the orga ni zati on to con trol the in terrelati on ships and in terdepe nden cies among the processes of the system, so that the overall performa nee of the orga ni zati on can be enhan ced. The process approach in volves the systematic d

15、efi niti on and man ageme nt of processes, and their in teract ions, so as to achieve the inten ded results in accorda nee with the quality policy and strategic direct ion of the orga ni zati on. Man ageme nt of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2)

16、 with an overall focus on risk-based thinking (see0.3.3) aimed at taking advantage of opportunities and preventing undesirable results. The application of the process approach in a quality management system enables: a) understanding and consistency in meeting requirements; b) the con sideratio n of

17、processes in terms of added value; c) the achieveme nt of effective process performa nee; d) improveme nt of processes based on evaluation of data and information. Figure 1 gives a schematic representation of any process and shows the in teract ion of its eleme nts. The mon itori ng and measuri ng c

18、heck poin ts, which are n ecessary for con trol, arespecific to each process and will vary depending on the related risks.0.3.2 Plan-Do-Check-Act cycleThe PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates howClauses 4 to 10 can be groupe

19、d in relati on to the PDCA cycle.貓果立品聞戕務(wù)mote timbers id bradwts relier m the clauses in (hks ntenntunul陽(yáng)耳款芋去不豐國(guó)忑準(zhǔn)中的章節(jié)曲盒本抵準(zhǔn)中fPDCA循町梗式The PDCA cycle can be briefly described as follows:Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accord

20、anee with customers requirements and the organization s policies; and identify and address riiskss and oppDo: impleme nt what was pla nn ed;Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requireme nts and pla nned acti

21、vities, and report the results;Act: take actions to improve performa nee, as n ecessary.0.3.3 Risk-based thinkingRisk-based thi nking (see Clause A.4) is esse ntial for achievi ng an effective quality man ageme nt system. Thecon cept ofrisk-based thinking has been implicit in previous editions of th

22、is International Standard including, for example, carrying out preve ntive actio n to elimi nate pote ntial noncon formities, an alyz ing any noncon formities that do occur, and tak ing acti on to prevent recurrenee that is appropriate for the effects of the nonconformity. To conform to the requirem

23、ents of this International Standard, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negati

24、ve effects. Opportunities can arise as a result of a situation favorable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Acti ons to address opport un ities

25、 can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or n egative effects. A positive deviati on aris ing from a risk can provide an opport un ity, but not all positive effects of risk result in opport un ities.0.4 Relati o

26、n ship with other man ageme nt system sta ndards 與其他管理體系標(biāo)準(zhǔn)的關(guān)系This Intern ati onal Standardapplies the framework developed by ISO to improve alig nment among its Intern ati onal Stan dards for man ageme nt systems (see Clause A.1). This International Standard enables an organization to use the proces

27、s approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other man ageme nt system sta ndards.This In ternatio nal Sta ndard relates to ISO 9000 and ISO 9004 as follows: ISO 9000Quality man ageme nt systems Fun dame

28、 ntals and vocabulary provides esse ntial backgro und for the proper un dersta nding and impleme ntati on of this Intern atio nal Stan dard;ISO 9004 Man agi ng for the susta ined success of anorga ni zati on A quality man ageme nt approach provides guida nee for orga ni zati ons that choose to progr

29、ess bey ond the requirements of this International Standard. Annex B provides details of other International Standards on quality management and quality management systems that have been developed by ISO/TC176. This International Standard does not include requirements specific to other management sy

30、stems, such as those for environmental management, occupational health and safety management, or financial management.Sector-specific quality management systemsta ndards based on the requireme nts of this Intern ati onal Stan dard have bee n developed for a nu mber of sectors. Some of these standard

31、s specify additional quality management system requirements, while others are limited to providing guidance to the application of this International Standard within the particular sector.1 ScopeThis Intern atio nal Stan dard specifies requireme nts for a quality man ageme nt system whe n an orga ni

32、zati on: a) n eeds to dem on strate its ability to con siste ntly provide products and services that meet customer and applicable statutory and regulatory requireme nts, and b) aims to enhance customer satisfact ion through the effective applicati on of the system, in cludi ng processes for improvem

33、e nt of the system and the assura nee of con formity to customer and applicable statutory and regulatory requireme nts.All the requireme nts of this Intern ati onal Stan dard are gen eric and are inten ded to beapplicable to any organization, regardless of its type or size, or the products and servi

34、ces it provides. NOTE 1 In this International Standard, the terms“ product ” or “ service ” only apply to products and services intended for, or recustomer. NOTE 2 Statutory and regulatory requireme nts can be expressed as legal requireme nts.2 Normative referencesThe following documents, in whole o

35、r in part, are normatively refereneed in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2015, Quality management systems

36、Fun dame ntals and vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.4 Context of the organization4.1 Understanding the organization and its contextThe orga ni zati on shall determ ine exter nal and internal issues that are rel

37、eva nt to its purpose and its strategic directi on and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review in formatio n about these exter nal and internal issues.NOTE 1 Issues can in clude positive and n egative facto

38、rs or con diti ons for con siderati on.NOTE 2 Un dersta nding the external con text can be facilitated by con sideri ng issues aris ing from legal, tech no logical, competitive, market, cultural, social and econo mic environmen ts, whether intern ati on al, n ati on al, regi onal or local. NOTE 3 Un

39、 dersta nding the in ternal con text can be facilitated by con sideri ng issues related to values, culture, kno wledge and performa nee of the orga ni zati on.4.2 Understanding the needs and expectations of interested partiesDue to their effect or potential effect on the organization s ability to co

40、nsistently provide products and services that meetcustomer and applicable statutory and regulatory requireme nts, the orga ni zati on shall determ ine: a) the in terested parties that are releva nt to the quality man ageme nt system; b) the requireme nts of these in terested parties that are releva

41、nt to the quality man ageme nt system. The orga ni zati on shall mon itor and review in formatio n about these in terested parties and their releva nt requireme nts.4.3 Determining the scope of the quality management systemThe organization shall determine the boundaries and applicability of the qual

42、ity management system to establish its scope.Whe n determ ining this scope, the orga ni zati on shall con sider: a) the exter nal and internal issues referred to in 4.1; b) the requireme nts of releva nt in terested parties referred to in 4.2; c) the products and services of the orga ni zati on.Theo

43、rganization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.The scope of the organization s quality management systemavaalableand be maintained as documented information. The scope shall state the typ

44、es of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system. Conformity to this International Standard may only be claimed if the requirements determ

45、ined as not being applicable do not affect the organization s ability or responsibility t(con formity of its products and services and the enhan ceme nt of customer satisfact ion.4.4 Quality man ageme nt system and its processes4.4.1 The organization shall establish, implement, maintain and continua

46、lly improve a quality management system, in cludi ng the processes n eeded and their in teract ions, in accorda nee with the requireme nts of this Intern ati onal Stan dard.The organization shall determine the processes needed for the quality management system and their application throughout the or

47、ga ni zati on, and shall:a) determ ine the in puts required and the outputs expected from these processes;b) determ ine the seque nee and in teracti on of these processes;c) determ ine and apply the criteria and methods (in clud ing mon itori ng, measureme nts and related performa nee in dicators) n

48、 eeded to en sure the effective operati on and con trol of these processes;d) determ ine the resources n eeded for these processes and en sure their availability;e) assign the responsibilities and authorities for these processes;f) address the risks and opportunities as determined in accordance with

49、 the requirements of 6.1;g) evaluate these processes and impleme nt any cha nges n eeded to en sure that these processes achieve their inten ded results;h) improve the processes and the quality man ageme nt system.4.4.2 To the extent necessary, the organization shall:a) maintain docume nted in forma

50、ti on to support the operati on of its processes;b) retain docume nted in formatio n to have con fide nce that the processes are being carried out as pla nned.5 Leadership5.1 Leadership and commitment5.1.1 GeneralTop man ageme nt shall dem on strate leadership and commitme nt with respect to the qua

51、lity man ageme nt system by:a) tak ing acco un tability for the effective ness of the quality man ageme nt system;b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the con text and strategic direct ion of the orga ni

52、zati on;c) en suri ng the in tegrati on of the quality man ageme nt system requir eme nts into the orga ni zati on s bus in ess processes;d) promoting the use of the process approach and risk-based thinking;e) en suri ng that the resources n eeded for the quality man ageme nt system are available;f)

53、 com muni cati ng the importa nce of effective quality man ageme nt and of con formi ng to the quality man ageme nt system requireme nts;g) en suri ng that the quality man ageme nt system achieves its inten ded results;h) en gagi ng, direct ing and support ing pers ons to con tribute to the effect i

54、ven ess of the quality man ageme nt system;i) promoti ng improveme nt;j) support ing other releva nt man ageme nt roles to dem on strate their leadership as it applies to their areas of resp on sibility. NOTE Refere nce to “ bus in ess ” in this Intern ati onal Stan dard can rprened broadly to mea n

55、 those activities that arecore to the purposes of the organization s existence, whether the organization is public, private, for profit oritn ot for prof5.1.2 Customer focusTop man ageme nt shall dem on strate leadership and commitme nt with respect to customer focus by en suri ng that:a) customer a

56、nd applicable statutory and regulatory requireme nts are determ in ed, un derstood and con siste ntly met;b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfact ion are determ ined and addressed;c) the focus on enhancing custo

57、mer satisfact ion is maintain ed.5.2 Policy5.2.1 Establishing the quality policyTop man ageme nt shall establish, impleme nt and maintain a quality policy that:a) is appropriate to the purpose and con text of the orga ni zatio n and supports its strategic direct ion;b) provides a framework for sett

58、ing quality objectives;c) in cludes a commitme nt to satisfy applicable requireme nts;d) in cludes a commitme nt to continual improveme nt of the quality man ageme nt system.5.2.2 Communicating the quality policyThe quality policy shall:a) be available and be maintained as docume nted in formati on;b) be com muni cated, un derstood and applied with in the orga ni zati on;c) be available to releva nt in terested parties, as appropriate.5.3 Organizational roles, responsibilities and authoritiesTop man ageme nt shall en sure that the resp on sibilities