[organization name] Appendix 1 ~ Internal Audit Checklist for ISO 9001:2015 TSOSOOT_ | Requirement ofthe Standard Compliant Clause YesINo ‘4.11 | Did the organization determine eternal and ‘internal issues relevant its purpose? 7 ———— — a relevant tits purpose? E2A___ [Bid the organization determine interested pares 7 —— a aso expectations ofthe intrested partis? EI] Does the organization monitor and review tots purpose? |3___| Was the organization determined boundaries ond ET | When determining the sope, Fad the organization nar? 432 | When determining te scope, ad the organization parties referred toin 4.2? 33] When determining the scope, had the organization a] Does the organization maintain documented 35 | Did the organization exude any requirement rom the scope ofits OMS? a” a ms? aI | bia the arganization determine processes needed forits ams? 7 | ———— a a’ application a its processes needed forthe QMS? a [bid the organization determine required inputs? Sa from its processes? EE | bid the organization determine sequence and Interaction of its processes? 7 a a effective operation and control of its processes? Does the organization determine performance indicators, how to monitor and measure effective aera CR ‘er ero] Wom te] Faget (©2057 tmp ma be ey clams ofS Sven. mw ada crac wth ene Agent ‘Comment (9A: te Term “Sonumuto ors mean tthe ard regarestheopatonte esti, scone ‘eb and mama he csr 2note 2 ope of San fe om oe SMirandopecornion conse and mecion toes ‘tamper {fee ocean cn an frm wd Notts ete compete set oregon “a TT ‘hgh eet spam be aaed at coer msl Comment [9A4: Toe sin dang tw sak peat alae steraton atch are[organization name] ‘operation and control offs processes? aay Did the organization determine the resources availability? Did the organization assign the responsibilities and authorities for its processes? the requirements of 6.1? waz Does the organization evaluate Is processes and intended results? Does the organization improve the processes and the Quality Management System? Does the organization retain documented are being carted out as planned? Bint Does the top management demonstrate leadership and commitment to the QMS? Sii2 the effectiveness of the OMS? Sas Does the top management ensure thatthe Quality Policy ows? sare Does the top management ensure that the Quality Policy and qualty sy se sete organization? Sais Does the top management ensure integration of ‘business processes? Sine Does the top management promote the use of the Saa7 Does the top management ensure availability of resources needed for the QMS? sare Does the top management communicate the Its requirements? Sa19 Does the top management ensure that the OMS achieves its intended results? Sano ‘ofthe aM? Sad improvement? Sine Does the top management support other relevant ‘pad eral ase eae ‘er eo Wom te] Page 2atD (©2057 temp ma be dy las ofS Sven. mw adc crac th eine Agent[organization name] ‘management roles to demonstrate their leadership as applies to thelr areas of responsibilty? saad and commitment with respect to customer focus? Sanz Did the top management ensure that customer and met? Sine Did the top management ensure that risk and customer satisfaction are determined and addressed? Sana Did the top management ensure thatthe focus on enhancing customer satisfaction is maintained? Saat and maintain the Quality Policy? 3212 Did the top management ensure that the Tuy direction? 3213 Did the top management ensure thatthe Quality Palcy provides a framework fr setting quality objectives? saia requirements? 3245 Did the top management ensure thatthe Quality Policy includes commitment to continual Jimproverent of the QMS? ant Baa2 Did the top management ensure thatthe Quality Ck. eo within the organization? 5223 Does the organization ensure thatthe Quality Polk] ee a en © appropriate? saa Did the top management ensure thatthe within the organization? Does the top management assign responsibilty the requirements ofI$0 9001:20157 333 Does the top management assign responsibilty ‘pad eral ase eae ‘er eo Wom ted Tages ato {Gams Ts temp may be edb cents PS Sree. wmwaberacom screw he ere Apes[organization name] ‘and authority to enaure that the processes deliver Intended outputs? aa Does the top management assign responsibilty ‘improvement, in particular to top management? Does the top management assign responsibilty {and authority to ensure promotion of customer {focus throughout the organization? Does the top management assign responsibilty planned and implemented? elit ‘When planning for the QMS, did the organization the risks and opportunities? eii2 Does the organization give assurance that the GMS ‘an achieve its intended results? eins Se ee gee eens eee ae 6114 Does the organization prevent or reduce undesired effects? e115 — ee oe 6121 Does the organization plan actions to address risks and opportunities? e1a2 e123 Does the organization plan how to evaluate the effectiveness of these actions? eiza Does the organization ensure that actions taken 10 products and services? ean id the organization establish quality bjeatives at for the ows? 6212 ‘re quality objectives consistent with the Quality Palicy? Sana ‘Are quality objectives measurable? 6214 requirements? 6215 ‘Are quality objectives relevant Tor conformity of customer satisfaction? eaie Does the organization monitors qualiy objectives? ‘pad eral ase eae ‘er eo Wom ted Faget {Gams Ts temp may be edb cents PS Sree. mwa screw he ere Aen[organization name] ‘GLE7 _] Does the organization communicate ts quality objectives? it | —— == a 2 appropriate? GLES_| Does the organization maintain documented information onthe quality objectives? ‘G22 | When planning how to achieve its quality willbe done? ‘GZ21_ | When planning how to achieve ts quality esources willbe required? 6222 | When planning how to achieve ts quality ‘beresponsible? 622-3 | When planning how to achieve its quality completion date? ‘GIZA | When planning how to achieve is quality ‘esuls willbe evaluated? G31 | Did the organization carry out needed changes ina planned manner? ‘G32 | Does the organization consider the purpose ofthe 63:3 | Does the organization consider the integrity ofthe os? | ——— a E35] Does the organization ensure proper allocation oF ‘eallocation of responsibilities and authorities? 7aE1 _ | Does the organization determine and provide the Improvement of the QMS? 7442 — | Does the organization consider the capabilities of, and constraints on, existing internal resources? Le implementation ofits OMS? 722 | Does the organization determine and provide the control of ts processes? 74.34 _ | Does the organization determine, provide, and ‘operation ofits processes? ‘pad eral ase eae ‘er eo Wom ted Pages (©2057 temp may be dy clas Sree. mw abraca ccriceth e ineAennt[organization name] 7i32 Does the organization determine, provide, and ‘operation and control ofits processes? Tiat Does the organization determine, provide, and ‘operation and conformity ofits processes? 7asit Does the organization determine and provide the verify the conformity of products and services? Taisae Does the organization ensure thatthe provided ‘monitoring and measurement activities? 74513 Does the organization ensure thatthe provided continuing fitness for their purpose? 7asi4 Does the organization retain appropriate resources? Tis2t Does the organization calibrate or verify measuring equipment? Tais22 Does the organization calibrate or verify measuring measurement standards? FIs23 Does the organization safeguard its measuring status and subsequent measurement results? Tasaa Does the organization take appropriate action its intended purpose? TaeT Did the organization determine knowledge achieve conformity of products and services? 7462 Does the organization access current knowledge knowledge? Does the organization determine necessary competence ofits employees? Does the organization ensure that employees are training or experience? 723 | Does the organization take action to acquire the necessary competence, and evaluate the “Rape neal ast Chast veers Wom tay (©2057 temp may be ey lassen. mw adr crac th ene Agent[organization name] effectiveness of the actions taken? 724 | Does the organization retain appropriate competence? 73a [Are employees aware of the Quality Paley? = —— —— objectives? 733 | Are employees aware oftheir contribution to the 73-4 [Are employees aware of the implications of not Ta1__| Does the organization determine what it wil communicate? Tat = > = a communicate? 73 | How does the organization determine with whom to.communicate? Tea ~~ —- - ‘communicates? 71 | Does the organization's OMS indude documented standard? 75.12 _ | Does the organization's OMS include documented bing necessary forthe effectiveness of the QMS? 752-1} Does the organization ensure appropriate ‘updating documented information? 7522 _ | Does the organization ensure appropriate format ‘when creating and updating documented information? 7523 = — > and approval for suitability and adequacy? FSH | Does the organization control that its documented and when itis needed? 75312 | Does the organization ensure that ls documented information is adequately protected? 75324 ~~ om ont ‘order to control it? FESR | Does the organization adress storage and ‘ts decumented information in order to contel i? 75323 | Does the organization address control of changes ofits documented information in order to control ‘pad eral ase eae ‘er eo Wom ted Tage Tat (2057p may be ey laoreet. mw abraca ccriceth e neAgennt[organization name] ® 75324 | Does the organization address retention and to.control it? 75325 | Does the organization control and dently ows? TELE | Does the organization protect documented {information from unintended alterations? BIT] Does the organization plan, implement, and services? “BHI | Does the organization determine the requirements ‘BIS | Does the organization establish criteria for the processes? De —— —— acceptance of products and services? ‘BIS | Does the organization determine the resources service requirements? ‘BIE | Does the organization implement control af the ‘B17 | Does the organization determine and keep carted out as planned? ‘BAB | Does the organization determine and keep ‘services to their requirements? ‘BAS | Does the organization control planned changes and ‘BIO | Does the organization ensure that outsourced ‘processes are controlled? ‘E241 | Does the communication with customers include services? ‘BI12_ | Does the communication with customers include changes? ELL3 | Does the communication with customers include ‘pad eral ase eae ‘er eo Wom ted Faget (2057p ma be dy lassen. mw adc crac wth e ine Aen[organization name] alia ‘Does the communication with customers include handling or controling customer property? a2is Does the communication with customers include actions, when relevant? aaat Does the organization ensure that the defined? ESes] Do the requirements for the produdls and services requirements? aa2a Do the requirements for the products and services organization? Bae ‘Can the organization meet the daims forthe products and services i offers? azatd Does the organization ensure thatithas the ability services to be offered to customers? Ererey Does the organization conduct a review of customer? Eresey Does the organization conduct a review of supply products and services to a customer? aaad Does the organization conduct a review of ee a oes ow eee customer? aaais Does the organization conduct a review af ome oe oe eee supply products and services to a customer? aaare Does the organization conduct a review of contract differ from those previously expressed? aaai7 Does the organization ensure that contract or defined ace cesolved? B2318 Does the organization confirm the customer's ‘customer does not provide a documented statement of theicrequtements? eua2 Does the organization retain documented Sra CR ‘er eo Wom ted Faget (©2057 temp may be ey laf Sree. mw abc ccc e ine Agent[organization name] Information on any new requirements forthe products and services? a2322 Does the organization retain documented Information about results of the review? aaa ‘When the requirements for products and services ‘that relevant persons are made aware of the changed requirements? aaa Does the organization establish, implement, and products and services? Ba21 Does the organization consider the nature, a oe we oe development activites? aaa? Does the organization consider the required one ee development reviews? aana Does the organization consider required desian activities? aaz4 Does the organization consider responsibilities and process? Ba25 Does the organization consider internal and development process? aa26 Does the organization consider the need for ‘and development process? aan7 Does the organization consider requirements for subsequent provision of products and services? 3328 Does the organization consider the level of contral parties? aa29 Does the organization consider the documented determining the stages and contro for design and development? aazt Does the organization determine requirements services to be designed and developed? aa32 Does the organization consider functional and “Rape neal ast Chast waren] Wom ita] Page 10 aTD {G25 Ts temp may be edb cents PS Sree. wnwabieracom ascrace wth eer Apes[organization name] ‘performance requirements? a development activities? “EIS | Does the information consider statutory and regulatory requirements? SS a implement? ‘BSHE_ | Does the organization consider potential products and services? ‘B337_ | Does the organization use adequate inputs for design and development? a and development, when discovered? ‘BSAA | Does the organization apply controls tothe design results to be achieved are defined? ‘BSA | Does the organization apply controls tothe design ‘of design and development? ‘BSAS_ | Does the organization apply controls to the design the design and development outputs meet the requirements? Eada] Does the organization apply controls to the design resulting products and services meet the requirements? ‘BSAS_ | Does organization apply controls to the design and the reviews, or verification and validation activities? ‘B36 | Does the organization document information development process? ‘B3S1_ | Does the organization ensure that design and equitements? ‘B352 _ | Does the organization ensure that design and development outputs are adequate for the “Repco ast Chast ver ero Wom ta] (©2057 temp may be ey laoreet. mw aba crac ine Agent[organization name] ‘subsequent processes forthe provision of products and services? 3353 Does the organization ensure that design and appropriate, and acceptance criteria? 3354 Does the organization ensure that design and their intended purpose and their safe and proper provision? 3355 Does the organization retain documented Information on design and development outputs? 8361 we ee ee products and services? aa62 Does the organization retain documented Information on design and development changes? 3363 information onthe results of reviews? aa64 Does the organization retain documented changes? 3365 Does the organization retain documented adverse impacts? Bart Does the organization ensure that externally conform to requirements? Ean? Does the organization apply controls to externally Incorporation into the organization's products and services? Bara Does the organization apply controls to externally providers on behalf of the organization? Baia Does the organization apply controls to externally provider asa result of a decision by the foranization? Bais Does the organization determine and apply enteria performance and re-evaluation of external “Repco ast Chast veer Wom ta] Page ato (©2057 temp may be dy laoreet. mw abc crac eine Agent[organization name] ‘providers, Based on ther ability to provide ‘processes or products and services in accordance with the requirements? Eane ‘actions arising from the evaluations? want Does the organization ensure the adequacy of external provider? ‘Ba22 Does the organization communicate to external products, and services tobe provided? wane Does the organization communicate to dernal products and services? Bana Does the organization communicate to external methods, processes, and equipment? Bars Does the organization communicate to external release of products and services? Bare Does the organization communicate to external persons, including any required qualifications? Baa7 Does the organization communicate to external providers’ interaction withthe organization? aa28 Does the organization communicate to external 1o.be applied bythe organization? Bane Does the organization communicate to external customer, intends to perform atthe external providers’ premises? a5it Does the organization implement production and ‘service provision under controlled conditions? as12 Do the organization's controlled conditions include produced, the services to be provided, or the activities to be performed? a5i3 Do the organization's contraied conditions clude defines the results tobe achieved? ‘pad eral ase eae ‘er eo Wom ted Page ato (2057p may be ey laf TS Sree. mw abraca ccriceth e ineAennt[organization name] asia Do the organization's controlled conditions include ‘the availabilty and use of suitable monitoring and ‘measuring resources? E55 Do the organization's controled conditions nude ‘outputs, and acceptance criteria for products and services, have been met? E516 Do the organization's controlled conditions include {or the operation of processes? a5i7 Do the organization’ controled conditions clude any requiced qualifications? a518 Do the organization's controlled conditions Include the validation, and periodic revalidation, ofthe resulting output cannot be verified by subsequent monitoring or measurement? a515 Do the organization's controled conditions Include a5110 Do the organization's controlled conditions nude delivery activities? as20 Does the organization use sultable means to conformity of products and services? a522 Does the organization identify the status of production and sevice provision? 3523 Does the organization control the unique equitement? a524 Does the organization retain the documented information necessary to enable traceability? ESa1 belonging to customers or external providers? 3532 Does the organization identify, very, protect, and products and services? 3533 Does the organization report tothe customer or “Rp ast Chast ver ero Wom ita] Page Tat (©2057 temp may be ey clas Sree. mw adc cic wth e ineAennt[organization name] ‘external provider when ther property is ost, ‘damaged, or otherwise found to be unsuitable for asa4 Does the organization retain documented ‘otherwise found to be unsuitable for use? asaT Does the organization preserve the outputs during necessary to ensure conformity to requirements? a551 Does the organization meet requirements for post services? 8552 Does the organization consider statutory and ‘of post delivery activities that are required? 3553 Does the organization consider the potential postdelivery activities that are required? Basa Does the organization consider the nature, Use, that are required? 8555 Does the organization consider customer livery activities that are required? B56 Does the organization consider customer feedback that are required? a5e1 Does the organization review and control changes requirements? 3562 Does the organization retain documented any necessary actions arising from the review? ae Does the organization implement planned met? Bez Does the organization proceed withthe release of aes Does the organization retain documented “Repco ast Chast verano Wom ita] Page 15 0 (©2057 temp may be dy lassen. mw abr cic th e ineAennt[organization name] ‘information onthe release of products and services? Bee ‘conformity withthe acceptance criteria? aes Does the documented information onthe release ‘person authorizing the release? arnt Does the organization ensure that outputs that do delivery? Erne Does the organization take appropriate action ‘based on the nature ofthe nonconformity and its ceffecton the conformity of products and services? e742 Does the organization take appropriate action detected after delivery of products, during or after the provision? aire Does the organization deal with nonconforming ‘outputs by correction? e718 ‘suspension of provision of products and services? ‘a7i6 Does the organization deal wth nonconforming ‘outputs by informing the customer? a7a7 Does the organization deal with nonconforming Lunder concession? a718 Does the organization verify conformity tothe ‘requirements when nonconforming outputs are corrected? Brat Information that describes the nonconformity? ‘a722 Does the organization retain documented ‘information that descrites the actions taken? e723 Does the organization retain documented ‘obtained? B724 Does the organization retain documented the action with respect to the nonconformity? ‘onnt ‘monitored and measured? 3ii2 Does the organization determine the methods for “Rape neal ast Chast ver ero Wom ta] OT Page 1600 {@2ms Ts temp may be dy cents PS Sree. wmwabiercom screw he ere Apes[organization name] ‘monitoring, measurement, analysis, and evaluation ‘needed to ensure valid results? a ‘monitoring and measuring is performed? ‘SAE | Does the organization determine when the results analyzed and evaluated? ‘SA.E5 | Does the organization evaluate the performance and effectiveness of its QMS? i results? ‘BAZ | Does the organization monitor customers” ‘expectations have been fuliled? ‘912-2 _ | Did the organization determine the methods for satisfaction information? ‘SAST | Does the organization analyze and evaluate ‘monitoring and measurement? ‘9132 | Does the organization use results of analysis to evaluate conformity of products and services? 2 ‘evaluate the degree of customer satisfaction? ‘S134 | Does the organization use results of analysis to ows? ‘SASS _ | Does the organization use results of analysis to cffectively? ‘BASE | Does the organization use results of analysis to ‘BIST _ | Does the organization use results of analysis to ‘evaluate the performance of extemal providers? 7 evaluate the need for improvements to its QMS? ‘32E1 | Does the organization establish, implement, and ‘maintain an internal auit programs)? ‘3242 _ | Did the organization determine the frequency, and reporting of its internal auelts? 82.241 | When establishing the internal audit program, id previous audits? ‘pad eral ase eae ‘er eo Wom ted Page 17020 (2057p ma be ey lassen. mw adc crac th eine Agent[organization name] ‘3222 _] When establishing the internal audit program, did lof the processes concerned? ‘3223 | Did the organization define the audi criteria and scope of each audit? 2 audit process? ‘92.25 | Does the organization communicate audit results tothe relevant management? ‘3226 | Does the organization document information ‘S321 | When planning and carrying out management ‘management reviews? ‘932-2 | When planning and carrying out management Issues that ae relevant to its OMS? ‘93.23 | When planning and carrying out management effectiveness ofits QMS? ‘83.24 | When planning and carrying out management. and feedback from relevant interested partes? ‘3325 When planning and carrying out management. quality objectives have been met? ‘3326 | When planning and carrying out management and conformity of products and services? ‘3327 | When planning and carrying out management corrective actions? ‘9328 _ | When planning and carrying out management ‘measurement results? ‘33.23 When planning and carrying out management ‘view, does the organization take into consideration information on aut results? “Repco ast Chast veer Wom ita] OT (©2057 temp may be ey laf Sven. mw abraca ccraceth eineAennt[organization name] aa210 ‘When planning and carrying out managernent ae te ee me external providers? oaaT ‘When planning and carrying out management resources? oan2 ‘When planning and carrying Out management oe ee eee actions taken to addeess risks and opportunities? oanie ‘When planning and carrying out management improvement? gaat Do management review outputs indude decisions improvement? 3332 ‘Do management review outputs include decisions ee er ee ee ows? 3333 ‘Do management review outputs include decisions and actions related to resources needed? 3334 ‘Does the organization retain documented ‘management reviews? Tort ‘Does the organization determine and seleg ‘opportunities for improvement? Tord ‘Does the organization implement any necessary ‘enhance customer satisfaction? To1s ‘Does the organization improve products and adress future needs and expectations? wore ‘Does the organisation carect, prevent, or reduce undesired effects? iors — = ee and effectiveness of its QMS? watt ‘Does the organization take actions to contraland ey aren ee omnes woa1? ‘Does the organization evaluate the need for action Corder to prevent its reoccurrence? q213 snonconformity? ‘pa Ta a ‘er eo Wom ted Page ato (2057p may be dy lassen. mw abr crac th ene Agent[organization name] i214 Does the organization determine the causes of the ‘noncontormity? wo21s TO2RT6 ‘When a nonconformity occurs, does the ‘organization implement any ction needed? 247 ‘When a nonconformity occurs, does the corrective action taken? wo2Te ‘When a nonconformity occurs, does the determined during plancing it necessary)? Tote ‘When a nonconformity occurs, does the ee ae me ee if necessary)? T0210 Does the organization undertake corrective actions encountered? STEEET Does the organization retain documented Information as evidence of the nature of the snoncontormites? i222 taken? T0223 Does the organization retain documented corrective action? 134 Does the organization continually improve the ows? waz Does the organization consider the results oF ‘needs or opportunites that should be addressed as part of continual improvement? Sra CR ‘er eo Wom ted Page 2010 (©2057 temp may be ey laf Sven. mw abraca ccraceth e ineAannt