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ISO 9001:2015Compa ny:Clie nt- no.:Order- no.:Audit type(sta ndard / Revisi on):Certification Audit (ISO 9001:2015)Audit date (on site):Compa ny / customer:Street / P.O. box:Zip-Code / state / city:Audit represe ntative:Leadauditor/ auditor:Tech ni cal expert/ train ee:NA/ NASite / Subsidiary, etc.:Certification based on samplingTotal and effective nu mber of employees:DateLead Auditor(s)Note:1 Objective audit evide nee shall be docume nted and uploaded to iCert.2 This Audit questi on list is reeomme nded as the primary source of docume ntatio n of objective audit evide nces. Alter natively, audit no tes, 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 pert inent process eleme nts.4 The evaluatio n can be en tered in the audit evaluati on colu mn (E):1 = Con formity (in cludi ng pote ntial for improveme nt, where applicable).2 = Minor noncon formity (lower-level non-con formity).3 = Noncon formity (major noncon formity)n.a. = not applicable5 The final result of the evaluati on shall always be docume nted in the action list (Ann ex1)crt_f_07.96eRevisi on 1Valid from 01/01/2016page 14 of 15Order- no.:Audit no tesRequireme nts(Audit notes identified with“ * ” are to be reported in the Audit Report)(Implementation / Documented Information / reviewed evidence .)4Con text of the orga ni zati on4.1 Understanding the org. and its contextdetermine external and internal issues monitor and review info.4.2 Understanding the needs and expectations of interested partiesdetermine:a) the interested parties relevant to the QMSb) the req. of these interested parties monitor and review info. about interested parties and their relevant req.4.3 Determining the scope of theQMSdetermine the boundaries and applicabilityof the its scope.consider:a) the external and internal issuesb) the req. of relevant interested partiesc) the prods & servs of the org.apply all the req. of this Standard if they are applicable within the scope of its QMS. The scope shall be docu. info . state the types of prods and servs covered, and provide justification for any req. not applicable.*Min. of 1 ex.: context of the org.*Min. of 1 ex.: interested parties*Min. of 1 ex.: statutory/regulatory req.*Appropriateness of scope:4.4 QMS and its processes*Min. of 1 ex.:Order- no.:Requireme ntsAudit no tes(Audit notes identified with“ * ” are to be reported in the Audit Repot(Implementation / Documented Information / reviewed evidence .)t)Eestablish, implement, maintain and continually improve a QMS, incl. the processes their interactions.determine the processes needed and their application and:a) determine inputs and outputsb) determine sequence and interactionc) determine and apply criteria and methods (incl. monitoring, measurements and performance indicators) to ensure operation and control of processesd) determine resources needed and their availabilitye) assign responsibilities and authorities for processesf) address risks and opportunitiesg) evaluate processes and implement changes neededh) improve the processesmaintain docu. info. to support processes retain docu. info. that processes are carried out as planned.checked process(es)5Leadership and commitme nt5.1 Top mngt. shall demonstrate5.1.1 leadership and commitment by:a) taking account the effectiveness of QMSb) ensuring Q-policy and Q-objectives compatible with context and strategic direction of org.c) integration of QMS req. into the business processesd) use of the process approach and risk based thinkinge) ensuring resources for QMSf) communicating importance of QM and conforming to QMSg) ensuring QMS achieves resultsh) engaging, directing and supporting personsi) promoting improvementj) supporting other relevant mngt. roles*Min. of 1 ex.:5.1.2 Customer focusTop mngt. shall ensur:a) customer and statutory and regulatory req. are determinedb) risks and opportunities that can affect prods & servs and customer satisfactionc) enhancing customer satisfaction5.2PolicyOrder- no.:Requireme ntsAudit no tes(Audit notes identified with“ * ” are to be reported in the Audit Repor(Implementation / Documented Information / reviewed evidence .)t)E5.2.1 Top mngt. shall maintain a Q-policy :5.2.2a) appropriate to the purpose and context of the org. and supports its strategic directionb) provide a framework for Q-objectivesc) include a commitment to satisfy applicable req.d) include a commitment to continual improvementThe Q-policy shall:a) be available as docu. info.b) be communicated, understood and appliedc) be available to relevant interested parties*Date of last review:5.3Organizational roles, responsibility and authoritiesTop mngt. shall ensure that responsibilities and authorities are assigned, communicated and understood for:a) ensuring that the QMS conforms to req.b) ensuring that the processes are delivering outputsc) reporting on the performance of QMS and opportunities for improvement.d) ensuring customer focuse) ensuring integrity is maintained when changes to QMS are planned and implemented*Min. of 1 ex.:6Pla nning6.1 Actions to address risks and6.1.1 opportunitiesWhen planning, the org. shall consider 4.1 and 4.2 and determine the risks and opportunities to:a) achieve its intended result(s)b) enhance desirable effectsc) prevent, or reduce, undesired effectsd) achieve improvement*Min. of 1 ex.:6.1.2 The 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 actions6.26.2.1Quality objectives and planning to achieve them*Date of last update:Order- no.:Requireme ntsAudit no tes(Audit notes identified with“ * ” are to be reported in the Audit Repot(Implementation / Documented Information / reviewed evidence .)t)EThe org. shall establish Q-objectives.a) consistent with the Q-policyb) measurablec) take into account applicable req.d) relevant to conformity of prods & servs and customer satisfactione) monitoredf) communicatedg) updated as appropriatemaintain docu. info. on the Q-objectives.6.2.2the org. shall determine:a) what will be doneb) what resources will requirec) who will be responsibled) when it will be completede) how results will be evaluated6.3Planning of changeschange to the QMS shall be carried out planned .consider:a) the purpose and potential consequencesb) the integrity of the QMSc) the availability of resourcesd) the responsibilities and authorities7Support7.1Resources*Min. of 1 ex.:7.1.1determine and provide the resources needed consider:a) capabilities and constraints on internal resourcesb) what needs to be obtained from external providers7.1.2Peopledetermine and provide the persons necessary for the implementation of its QMS and the operation and control of its processes.7.1.3 Infrastructure & Environment for the7.1.4 operation of processesdetermine, provide and maintain the infrastructure/environment necessary for the operation of its processes7.1.5Monitoring and measuring resourcesdetermine and provide the resources to ensure valid and reliable results when monitoring or measuring.ensure that the*Evidence of conformity of products and services to specified requirements:Order- no.:Audit no tesRequireme nts(Audit notes identified with“ * ” are to be reported in the Audit Repoit)(Implementation / Documented Information / reviewed evidence .)resources:a) are suitable for the specific type of monitoring and measurementb) are maintained to ensure their fitness retain docu. Info. of fitness for purpose of monitoring and measurement resources.measuring equipment shall be:a) calibrated or verified, or both, at specified intervals, to measurement standards; when no standards exist, the basis for calibration shall be retained as docu. Info.b) identified to determine thestatusc) safeguarded from adjustments, damage or deteriorationdetermine if the validity of previous measurement results has been adversely affected when measuring equipment is found unfit for its intended purpose, and take action .7.16 Organizational knowledgedetermine knowledge for the operation of its processes and conformity of prods & servs.knowledge shall be maintained and made available.When addressing changing needs and trends, consider current knowledge and determine how to acquire additional knowledge and required updates.7.2 Competencea) determine the competence of person(s)b) ensure that persons are competentc) actions to acquire the necessary competence, evaluate the effectiveness of the actionsd) retain docu. Info. of competence7.3 Awarenessensure that persons are aware of:a) Q-policyb) Q-objectivesc) their contribution to the QMS, including the benefits of improved performanced) implications of not conforming with the QMS req.7.4 Communicationdetermine the communications relevant to the QMS:a) whatb) whenc) with whomd) how*Evidence of fitness for purpose of monitoring and measurement resources:*Evidence of basis used for calibration or verification (if applicable):*Min. of 1 ex.:Order- no.:Requireme ntsAudit no tes(Audit notes identified with“ * ” are to be reported in the Audit Repot(Implementation / Documented Information / reviewed evidence .)t)Ee) who7.5Documented information7.5.1The QM system shall include:a) docu. info. required by this Int. Standardb) docu. info. determined by the org.7.5.2 Creating and updatingensure appropriate:a) identification and descriptionb) format and mediac) review and approval for suitability and adequacy7.5.3 Control of documented information7.5.3.17.5.3.2Docu. info. required by the QMS and Int. Standard shall be controlled :a) available and suitable for use, where and when neededb) adequately protected (e.g. loss of confidentiality, improper use, loss of integrity)address the following activities: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 necessary shall be identified as appropriate, and be controlled.evidence of conformity shall be protected8Operati on8.1Operational planning and controlplan, implement and control the processes (4.4), for the provision of prods & servs and implement actions (6.1):a) determining req. for the prod & serv.sb) establishing criteria:1) the processes2) the acceptance of prods & servsc) determining the resources neededd) implementing control of the processese) determining, maintaining and retaining docu. info.:1) confidence that the processes have been carried out as planned*Evidence to show that processes have been carried out as planned:Order- no.:Requireme ntsAudit no tes(Audit notes identified with“ * ” are to be reported in the Audit Repot(Implementation / Documented Information / reviewed evidence .)t)E2) demonstrate the conformity of products and services.The output of this planning shall be suitable for the org.s operations.control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.ensure that outsourced processes are controlled (8.4).8.2Req. for products and services8.2.1Communication 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,*Min. of 2 ex.:*Min. 1 complaint:822Determining the req. for prods andservsensure that:a) the req. are defined, including:1) statutory and regulatory req.2) those considered necessary by the org.b) the org. can meet the claims for the prods & servs8.2.3 Review of req. for prods and servs ensure that it has the ability to meet the req. conduct a review before committing to supply prods & servs to a customer, to include:a) req. specified by the customer, incl. for delivery and post-delivery activitiesb) req. not stated by the customer,c) req. specified by the org.d) statutory and regulatory req. e) contract or order req.ensure that contract or order req. differing from those previously defined are resolved. customer s req. shall be confirmed by the org. before acceptance, retain docu. info.,:a) on the results of the review;b) on any new req. for the prods & servs*Evidence describing the results of the review, incl. Any new or changed requirements:824Changes to req. for prods & servsOrder- no.:Requireme ntsAudit no tes(Audit notes identified with“ * ” are to be reported in the Audit Repor(Implementation / Documented Information / reviewed evidence .)t)Eensure that docu. info. is amended, and persons are aware of the changed req., when the req. are changed.8.3Design and development of8.3.1 products and services8.3.2establish, implement and maintain a des & dev process to ensure provision of prods and servs.consider:a) nature, duration and complexity of des & dev activitiesb) required process stages, incl. des & dev reviewsc) required des & dev verification and validation activitiesd) responsibilities involved in the des & dev processe) internal and external resource needsf) need to control interfaces between persons involvedg) need for involvement of customer and usersh) req. for subsequent provision of prods & servsi) level of control expected by customers and other interested partiesj) docu. info. needed to demonstrate that des & dev req. have been met*Min. of 1 ex. per cycle:8.3.3 Design and development inputs determine the req. essential for the prods and servs to be designed and developed. consider:a) functional and performance req.b) info. derived from previous similar des & dev activitiesc) statutory and regulatory req.d) standards or codes of practice that the org. has committed to implemente) potential consequences of failure of the prods & servsretain docu. info.Evidence showing the inputs for the design and development process:834Design and development controlsapply controls to ensure that:a) results are definedb) reviews are conductedc) verification activities to ensure that outputs meet the input req.d) validation activities to ensure that the resulting prods & servs meet the req. for the specified applicatione) actions are taken on problems determined during the reviews,Evidence showing the actions taken on problems determined during review, verification of validation activities:Order- no.:Requireme ntsAudit no tes(Audit notes identified with“ * ” are to be reported in the Audit Repor(Implementation / Documented Information / reviewed evidence .)t)Ef) docu. info . of these activities is retained8.3.5Design and development outputsensure that outputs:a) meet the input req.b) are adequate for the subsequent processes for the provision of prods & servsc) include or reference monitoring and measuring req.,d) specify the characteristics of the prods and servsretain docu. info. des & dev outputs.Evidence describing the outputs from the design and development process:8.3.6 Design and development changes identify, review and control changes made , that there is no adverse impact on conformity to req.retain Docu. info. on:a) des & dev changesb) results of reviewsc) authorization of the changesd) actions taken to prevent adverse impactsEvidence on design and development changes:8.4Control of externally provided8.4.1 processes, products and services ensure that externally provided processes, products, and services conform to req.determine the controls to be applied to when:a) prods & servs from external providers are intendedb) prods & servs are provided directly to the customer(s)c) a process, or part of a process, is provided by an external provider .determine and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers retain docu. info. of these activities and actions arising from the evaluations.*Min. of 1 ex.:8.4.2 Type and extent of control ensure that externally provided processes, prods & servs do not adversely affect the org. prods & servs .The org. shall:a) externally provided processes remain within controlb) define the controls to apply to an external provider and those to apply to the resulting output
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