南德TUV-ISO90012015外审检查表

Audit Question ListISO 9001:2015Company: Client-no.: Order-no.: Audit type(standard / Revision):Certification Audit (ISO 9001:2015)Audit date (on site):Company / customer:Street / P.O. box:Zip-Code / state / city:Audit representative:Leadauditor/ auditor:Technical expert/ trainee: NA/ NASite / Subsidiary, etc. :Certification based on samplingTotal and effective number of employees:DateLead Auditor(s)Note: Hidden text can be printed by: 1) selecting the “Words Option” in the dialog box; 2) select the “Display” option; 3) scroll down to the “printing area”; 4) select “print hidden text”; click “OK”1 Objective audit evidence shall be documented and uploaded to iCert. 2 This Audit question list is recommended as the primary source of documentation of objective audit evidences. Alternatively, audit notes, process sheets, etc. could be used. 3 As a rule, documented audit evidence (audit question list, audit notes or process sheets) should be completed separately for each audit and for each site (if applicable), for the pertinent process elements. 4 The evaluation can be entered in the audit evaluation column (E):1 = Conformity (including potential for improvement, where applicable).2 = Minor nonconformity (lower-level non-conformity).3 = Nonconformity (major nonconformity)n.a.= not applicable5 The final result of the evaluation shall always be documented in the action list (Annex1)crt_f_07.96ecreated: Sami Gatz page 16 of 16Revision 1reviewed: Michael SchlechtValid from 01/01/2016RequirementsAudit notes(Audit notes identified with “*” are to be reported in the Audit Report)(Implementation / Documented Information / reviewed evidence .)E4Context of the organization4.1Understanding the org. and its contextThe org. shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its QMSThe org. shall monitor and review info. about these external and internal issues.4.2Understanding the needs and expectations of interested parties*Min. of 1 ex.: context of the org.Relevant external / internal issues or conditions determined.e.g. 360 degree analysis, stakeholder mapping, list of interested parties identified with needs and expectations; limitations of scope*Min. of 1 ex.: interested parties*Min. of 1 ex.: statutory/regulatory req.Due to their effect or potential effect on the org.s ability to consistently provide prods & servs that meet customer and applicable statutory and regulatory req., the org. shall determine:a) the interested parties that are relevant to the QMSb) the req. of these interested parties that are relevant to the QMSThe org. shall monitor and review info. about these interested parties and their relevant req.4.3Determining the scope of the QMS*Appropriateness of scope:E.g. process map (business process framework), interfacesThe org. shall determine the boundaries and applicability of the QMS to establish its scope.When determining this scope, the org. shall consider:a) the external and internal issues referred to in 4.1b) the req. of relevant interested parties referred to in 4.2c) the prods & servs of the org.The org. shall apply all the req. of this Int. Standard if they are applicable within the determined scope of its QMS.The scope of the org.s QMS shall be available and be maintained as docu. info. The scope shall state the types of prods and servs covered, and provide justification for any req. of this Int. Standard that the org. determines is not applicable to the scope of its QMS.Conformity to this Int. Standard may only be claimed if the req. determined as not being applicable do not affect the org.s ability or responsibility to ensure the conformity of its prods and servs and the enhancement of customer satisfaction.4.4QMS and its processes*Min. of 1 ex.:checked process(es)e.g. Process-sheets are used for all key processesThe org. shall establish, implement, maintain and continually improve a QMS, incl. the processes needed and their interactions, in accordance with the req. of this Int. Standard.The org. shall determine the processes needed for the QMS and their application throughout the org. and shall:a) determine the inputs required and the outputs expected from these processesb) determine the sequence and interaction of these processesc) determine and apply the criteria and methods (incl. monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processesd) determine the resources needed for these processes and ensure their availabilitye) assign the responsibilities and authorities for these processesf) address the risks and opportunities as determined in accordance with the req. of 6.1g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended resultsh) improve the processes and the QMSTo the extent necessary, the org. shall:a) maintain docu. info. to support operation of its processes b) retain docu. info. to have confidence that the processes are being carried out as planned. 5Leadership and commitment5.15.1.1Top mngt. shall demonstrate leadership and commitment by:*Min. of 1 ex.:Top mngt.shall demonstrate leadership and commitment with respect to the QMS by:a) taking accountability for the effectiveness of QMSb) ensuring that Q-policy and Q-objectives are established for QMS and are compatible with context and strategic direction of org.c) ensuring the integration of the QMS req. into the org.s business processesd) promoting the use of the process approach and risk based thinkinge) ensuring that resources needed for QMS are availablef) communicating the importance of effective QM and of conforming to QMS req.g) ensuring that QMS achieves its intended resultsh) engaging, directing and supporting persons to contribute to effectiveness of QMSi) promoting improvementj) supporting other relevant mngt. roles to demonstrate their leadership as it applie to their areas of responsibility.5.1.2Customer focusTop mngt. shall demonstrate leadership and commitment with respect to customer focus by ensuring that:a) customer and applicable statutory and regulatory req. are determined, understood and consistently metb) risks and opportunities that can affect conformity of prods & servs and ability to enhance customer satisfaction are determined and addressedc) the focus on enhancing customer satisfaction is maintained5.2Policy5.2.15.2.2Top mngt. shall establish, implement and maintain a Q-policy that:*Date of last review:a) is appropriate to the purpose and context of the org. and supports its strategic directionb) provides a framework for setting Q-objectivesc) includes a commitment to satisfy applicable req.d) includes a commitment to continual improvement of the QMSThe Q-policy shall:a) be available and be maintained as docu. info.b) be communicated, understood and applied within the org.c) be available to relevant interested parties, as appropriate5.3Organizational roles, responsibility and authoritiesTop mngt. shall ensure that responsibilities and authorities for relevant roles are assigned, communicated and understood within org. for:Top mngt. shall assign the responsibility and authority for:a) ensuring that the QMS conforms to req. of this Int. Standardb) ensuring that the processes are delivering their intended outputsc) reporting on the performance of QMS and on opportunities for improvement (see 10.1), in particular to Top mngt.d) ensuring the promotion of customer focus throughout the org.e) ensuring that the integrity of QMS is maintained when changes to QMS are planned and implemented*Min. of 1 ex.:6Planning 6.16.1.1Actions to address risks and opportunities*Min. of 1 ex.:e.g. Risk matrix in useWhen planning for the QMS, the org. shall consider the issues referred to in 4.1 and the req. referred to in 4.2 and determine the risks and opportunities that need to be addressed to:a) give assurance that the QMS can achieve its intended result(s)b) enhance desirable effectsc) prevent, or reduce, undesired effectsd) achieve improvement6.1.2The org. shall plan:a) actions to address these risks and opportunitiesb) how to:1) integrate and implement the actions into its QMS processes (see 4.4)2) evaluate the effectiveness of these actionsActions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of prods & servs.6.26.2.1Quality objectives and planning to achieve them*Date of last update:The org. shall establish Q-objectives at relevant functions, levels and processes needed for the QMS.The Q-objectives shall: a) be consistent with the Q-policyb) be measurablec) take into account applicable req.d) be relevant to conformity of prods & servs and the enhancement of customer satisfactione) be monitoredf) be communicatedg) be updated as appropriateThe org. shall maintain docu. info. on the Q-objectives.6.2.2When planning how to achieve its Q-objectives, the org. shall determine: a) what will be doneb) what resources will be requiredc) who will be responsibled) when it will be completede) how the results will be evaluated6.3Planning of changesWhen the org. determines the need for change to the QMS, the changes shall be carried out in a planned manner (see 4.4).The org. shall consider:a) the purpose of the change and their potential consequencesb) the integrity of the QMSc) the availability of resourcesd) the allocation or reallocation of responsibilities and authorities7Support7.17.1.1ResourcesGeneral*Min. of 1 ex.:e.g. investment plans relating to personnel, equipment and real estate, staffing schedules, job profiles, qualification matrix, contracts, records of appraisal interviews, records of process capability analysis, maintenance schedulesThe org. shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the QMS.The org. shall consider:a) the capabilities of, and constraints on, existing internal resourcesb) what needs to be obtained from external providers7.1.2PeopleThe org. shall determine and provide the persons necessary for the effective implementation of its QMS and for the operation and control of its processes.7.1.37.1.4Infrastructure & Environment for the operation of processesThe org. shall determine, provide and maintain the infrastructure/environment necessary for the operation of its processes and to achieve conformity of prods & servs.7.1.5Monitoring and measuring resources*Evidence of conformity of products and servicesto specified requirements:*Evidence of fitness for purpose of monitoringand measurement resources:*Evidence of basis used for calibrationor verification (if applicable):The org. shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of prods & servs to req.).The org. shall ensure that the resources provided:a) are suitable for the specific type of monitoring and measurement activities being undertakenb) are maintained to ensure their continued fitness for their purposeThe org. shall retain appropriate docu. Info. as evidence of fitness for purpose of monitoring and measurement resources.When measurement traceability is a req., or is considered by the org. to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as docu. Info.b) identified in order to determine their statusc) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement resultsThe org. shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.7.1.6Organizational knowledgeThe org. shall determine the knowledge necessary for the operation of its processes and to achieve conformity of prods & servs.This knowledge shall be maintained and be made available to the extent necessary.When addressing changing needs and trends, the org. shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.7.2Competence*Min. of 1 ex.:e.g. investment plans relating to personnel, equipment and real estate, staffing schedules, job profiles, qualification matrix, contracts, records of appraisal interviews, records of process capability analysis, maintenance schedulesThe org. shall:a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the QMSb) ensure that these persons are competent on the basis of appropriate education, training, or experiencec) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions takend) retain appropriate docu. Info. as evidence of competence7.3AwarenessThe org. shall ensure that persons doing work under the org.s control are aware of:a) the Q-policyb) relevant Q-objectivesc) their contribution to the effectiveness of the QMS, including the benefits of improved performanced) the implications of not conforming with the QMS req.7.4CommunicationThe org. shall determine the internal and external communications relevant to the QMS, incl.:a) on what it will communicateb) when to communicatec) with whom to communicated) how to communicatee) who communicates7.57.5.1Documented informationGeneralThe org.s QM system shall include:a) docu. info. required by this Int. Standardb) docu. info. determined by the org. as being necessary for the effectiveness of the QMS7.5.2Creating and updatingWhen creating and updating docu. Info. the org. shall ensure appropriate:a) identification and description (e.g. a title, date, author, or reference number)b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic)c) review and approval for suitability and adequacy7.5.37.5.3.17.5.3.2Control of documented informationDocu. info. required by the QMS and by this Int. Standard shall be controlled to ensure:a) it is available and suitable for use, where and when it is neededb) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity)For the control of docu. info., the org. shall address the following activities, as applicable:a) distribution, access, retrieval and useb) storage and preservation, incl. preservation of legibilityc) control of changes (e.g. version control)d) retention and dispositionDocu. info. of external origin determined by the org. to be necessary for the planning and operation of the QMS shall be identified as appropriate, and be controlled.Documented information retained as evidence of conformity shall be protected from unintended alterations.8Operation 8.1Operational planning and control*Evidence to show that processeshave been carried out as planned:The org. shall plan, implement and control the processes (4.4), needed to meet req. for the provision of prods & servs and to implement the actions (6.1), by:a) determining req. for the prod & serv.sb) establishing criteria for:1) the processes2) the acceptance of prods & servsc) determining the resources needed to achieve conformity to prod & serv req.d) implementing control of the processes in accordance with the criteriae) determining, maintaining and retaining docu. info. to the extent necessary: 1) to have confidence that the processes have been carried out as planned2) to demonstrate the conformity of products and services to their req.The output of this planning shall be suitable for the org.s operations.The org. shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.The org. shall ensure that outsourced processes are controlled (8.4).8.28.2.1Req. for products and services*Min. of 2 ex.:e.g. specific customer requirements, contracts; handling of customer property*Min. 1 complaint:Communication with customers shall include:a) providing info. relating to prods & servsb) handling enquiries, contracts or orders, incl. changesc) obtaining customer feedback relating to prods & servs, incl. customer complaintsd) handling or controlling customer propertye) establishing specific req. for contingency actions, when relevant8.2.2Determining the req. for prods and servsWhen determining the req. for the prods & servs to be offered to customers, the org. shall ensure that:a) the req. for the prods & servs are defined, including:1) any applicable statutory and regulatory req.2) those considered necessary by the org.b) the org. can meet the claims for the prods & servs it offers8.2.3Review of req. for prods and servs*Evidence describing the results of the review,incl. 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