Iso 9001:2015
October 7, 2022 | Author: Anonymous | Category: N/A
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ISO 9001: 9001:2000 2000 A UDIT CHECKL CHECKLIST IST No .
Qu es t i o n
4 Quality Management System 4.1
Gen e err al al R Re eq ui ui re rem e en n ts ts
1
Has the organization established, documented, implemented and maintained a quality management system in accordance with the requirements of ISO 9001?
2
Is the effectiveness of the quality management system continually improved?
3
Has the organization: a)
Ide Identi ntifie fied d th the e pr proce ocesse sses s ne neede eded d fo forr th the e qu quali ality ty management system including their applications throughout the organization?
b)
Determ Determine ined d th the e se seque quence nce and intera interacti ction on o off tthes hese e processes?
c)
Det Determ ermine ined d the the criter criteria ia and met method hods sn need eeded ed to ensure that both the operation and control of these processes are effective?
d)
Ensure Ensured d the ava availa ilabil bility ity of resour resources ces and information necessary to support the operation and monitoring of these processes?
e)
Measured, moni tored and analyzed these Measured, processes?
f)
Implemented actions needed to achieve planned results and continual improvement of these processes?
4
Does the organization manage these processes in accordance with the requirements of ISO 9001?
5
Where Whe re processes that affe affect ct product conformity w ith requirements are outsourced, are the controls for these processes processes identified withi n the qu ality management system?
6
4.2
Document ation Requirements
4.3
4.2.1 Gener al
Does the quality management system documentation include: a)
Docume Documente nted ds stat tateme ement nt of a q qual uality ity policy policy and quality ob jective jectives s?
b)
Quality Manual?
c)
Do Docu cume ment nted ed pr proc oced edur ures es re requ quir ired ed by IISO SO 9 900 001? 1?
d)
Docume Documents nts needed needed by tthe he org organi anizat zation ion to ens ensure ure the effective planning, operation and control of its processes?
e)
Records required by ISO 9001?
4.2. 4.2.2 2 Qual Quality ity M Man anua uall
7
Has a quality manual been established and maintained that includes: a)
The s scop cope e of the the qua qualit lity y man manage agemen mentt syst system, em, including d eta etails ils of, and justification for any exclusions? exclusions ?
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n b)
Docum Documented ented proce procedures dures estab establishe lished d for for the quali quality ty management system, or reference to them?
c)
Description Description of the i nteraction betwee between n the processes of the quality management system? system ?
4.2. 4.2.3 3 Co Contro ntroll of D Docum ocumen ents ts
8 9
Are documents required for the quality managemen managementt system controlled? Has a documented procedure been established identifying the following controls needed? a) App Approv roval al of do docum cument ents s for ad adequ equacy acy pr prior ior tto o issu issue? e? b)
Rev Review iew,, upd update ate a as s nec necess essary ary an and d rere-app approv roval al of documents?
c)
Ens Ensure ure th that at cha change nges s and th the e curr current ent rrevi evisio sion n stat status us of documents are identified?
d)
Ens Ensure ure tthat hat rrele elevan vantt ver versio sions ns of a appl pplica icable ble documents are available at points of use?
e)
Ensure that documents remain legible and readily identifiable.
f)
Ens Ensure ure tha thatt do docum cument ents s of extern external al o orig rigin in a are re identified and their distribution controlled?
g)
Pre Preven ventin ting g the uninte unintende nded d use o off obs obsole olete te documents, andretained? to apply suitable identification to them if they are
4.2. 4.2.4 4 Co Contro ntroll of Re Record cords s
10
Have records been established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?
11
Has a documented procedure been established to define the following controls needed? a)
Iden Identi tifi fica cati tion on? ?
b)
Storage?
c)
Retrieval?
d)
Protection?
e)
Re Rettent entio ion n tim time? e?
f)
Disposition?
5 Manage Management ment Responsi bili ty 5.1 1
Man ag ag em em e en n t Co Co m mm m it it me men t
Has top management provided evidence of its commitment to the development and implementation of the quality management system and for the continual improvement of its effe effectivene ctiveness ss by: a)
Communicating to the organization the importance of meeting customer as w ell as regulatory and legal requirements? requirements ?
b)
Est Establ ablish ishing ing the qua qualit lity yp poli olicy? cy?
c)
Ensuring that quality objectives are established?
d)
Con Conduc ductin ting g man manage agemen mentt rev review iews? s?
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n e)
Ens Ensuri uring ng th the e ava availa ilabil bility ity o off res resour ources ces? ?
5.2 2
Cu s t o m er F Fo ocus
Has top management ensured that customer requirements are determined and met with the aim of enhancing customer satisfa satisfaction ction? ?
5.3
Qu al i t y P Po olicy
Has top management ensured that the quality policy:
3
a)
Is app approp ropria riate te to th the e purp purpose ose of tthe he org organi anizat zation ion? ?
b)
Inc Includ ludes es a com commit mitmen mentt tto o co compl mply y wi with th requirements and to and to continually improve the effectiveness of the quality management system? system ?
c)
Provides a framework framework for esta establishing blishing and reviewing quality ob jectives? jectives?
d)
Is co commu mmunic nicate ated d and u unde nderst rstood ood w with ithin in th the e organization?
e)
Is reviewed reviewed for continuing suitability? suitability ?
5.4
Pl an n i n g
5.4. 5.4.1 1 Quality Quality Obje Objectives ctives 4
Has top management ensured that quality objectives are established at relevant functions and levels within the organization?
5
Have quality o bjectives needed to meet the requirements requireme nts of the product bee been n established?
6
Ar e qu quali ali ty o bj ect iv es meas ur abl e and c on si st ent wi th the quality policy?
5.4. 5.4.2 2 Qua Quality lity Ma Manage nagement ment System System P Planning lanning 7
Has top management ensured that the resources needed to achieve the quality objectives are objectives are identified and planned?
8
Is the output of the planning documented? (e.g., quality manual, procedures, work instructions, quality plans, etc.)
9
Does top management ensure that the integrity of the quality management system is maintained when changes are planned and implemented?
5.5 5.5 Re Responsib sponsib ility, Authorit y and Communication 5.5. 5.5.1 1 Responsibility Responsibility and and Authority 10
Has top management ensured that responsibilities, authorities are defined and communicated communicated within within the organization?
5.5.2 11
Manage nageme ment nt Repre prese senta ntativ tive e
Has top management appointed member(s) of management who have responsibility and authority for: a)
Ens Ensuri uring ng th that at p proc rocesse esses s are e esta stabli blishe shed, d, implemented and maintained?
b)
Rep Report orting ing tto o top ma manag nageme ement nt on th the e perf perform ormanc ance e of the quality management system, including
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n needs nee ds fo r imp rovement rovement? ? c)
Promoting awareness awareness of customer requirements requireme nts thro ughout the organiza organization tion? ?
5.5.3
Int nte er n na al Commu ommuni nica catt iion on
12
Has top management ensured that appropriate communication processes have been established within the organiza organization? tion?
13
Does communication take place regarding the effectiveness of the quality management system?
14
5.6
Man ag em en t Rev i ew
5.6.1
Gen er er a all
Does the top management review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness?
15
Ar e op oppo po rt un it ies f or im impr pr ov emen ementt an and d t he n eed f or changes to the quality management system, including quality policy and objectives, reviewe reviewed d duri ng the review?
16
Are records of management reviews maintained as quality records?
5.6.2 17
Rev ie iew In In pu pu t
Do the inputs to management review include information on: a)
Re Results sults of audits?
b)
Customer feedback?
c)
Process Proces s performance and product conf ormity?
d)
Status Sta tus o f pr eventive eventive and cor rective actions?
e)
Follow-up actions fro m pr evious manage management ment reviews?
f)
Planned changes that could affect the quality management system?
g)
Recommendations Recommendations for improvement?
5.6.3 18
Rev ie iew Ou ttp p ut ut
Do the outputs fro m the manage management ment revie review w includ e the decisions and actions relate related d to : a)
Improvement of the effectiveness of the quality management system and its processes?
b)
Improvement of the product relate Improvement related d to customer requirements?
c)
Resources needed?
6 Reso Resour urce ce Manage Management ment
1
6
Res o u r c e Man ag em en t
6.1
Pr o ovi visi sion on of Reso sour urce ces s
Have the resources been determined and provided for:
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n a)
Implementing and maintainin g quality management mana gement system and continually impro ving its effectiveness?
b)
Enha Enhancing ncing custome customerr s satisfaction atisfaction by mee meeting ting customer requireme requirements? nts?
6.2
Hu ma man Res o ou u rc rc e es s
6.2. 6.2.1 1 Genera Generall 2
Is competency personnel who work affe affecting cting produ for ct quality quality based based on perform appropriate education, training, skills skills,, and experience?
6.2. 6.2.2 2 Compete Competency, ncy, awareness awareness and training 3
Has the organization: a)
Determined the necessary competency for personnel performing work affecting product quality?
b)
Pro Provid vided ed tra traini ining ng or ta take ke oth other er act action ions s to sat satisf isfy y these needs?
c)
Evaluated the effectiveness of the actions taken?
d)
Ensured that emplo yees are aware of the relevance and importance of their activities and how they contr ibute to the achieveme achievement nt of the quality obj ective ectives? s?
e)
6.3 4
In f r as t r u c t u r e
To achieve conformity of product, does the organization identify, provide, and maintain the facilities including: a)
Bui Buildi ldings ngs,, Workspac Workspace e and asso associa ciated ted ut utili ilitie ties? s?
b)
Pr Proc oces ess s Equ Equip ipme ment nt,, har hardw dwar are e and software? software?
c)
Supporting services?
6.4 5
Mainta Maintaine ined d appr appropr opriat iate e reco records rds of educat education ion,, training, skills skills and and experience
Wo r k En v i r o n m en t
Has the environment needed to achieve conformity of product requireme requirements nts been determined and managed?
7 Product Realization
1
2
7
Pr o d u c t Real i zat i o n
7.1
Planni lanning ng of Realiza lization tion Proce rocess
Is planning of the organization’s product realization consistent with the requirements of the other processes of the quality management system? Are the following being being determined when planni planning ng the product realization: a)
Qua Qualit lity y object objective ives s and rrequ equire iremen ments ts fo forr the product?
b)
The ne need ed to es estab tablis lish h proc process esses, es, do docum cument ents, s, and provide resources specific to the product?
Pr o c . Ref .
Co m m en t s
No .
3
Qu es t i o n c)
Req Requir uired ed verific verificati ation, on, val valida idatio tion, n, mon monito itorin ring, g, inspection and test activities specific to the product and criteria for product acceptance?
d)
Rec Record ords s nee needed ded tto o pro provid vide e evi eviden dence ce th that at tthe he realization processes and resulting product fulfill requirements?
Is the planning output in a form that is suitable s uitable for the organization’s method of operation?
7.2 Cus ustt ome omerr -R -Rel a att ed ed Pr oce ocess sse es 7.2. 7.2.1 1 De Determi termination nation of Requireme Requirements nts Re Relate lated d to the Product 4
Has the organization determined: a)
Requirements specified by the customer , including the requirements for delivery and post-delivery activities?
b)
Requirements Requirements not sta stated ted by the customer but necessary for specified or intended use, where known?
c)
Statutory and regulator y requir ements related to the product?
d)
Any a additional dditional re requirements quirements dete determined rmined by the organization?
7.2. 7.2.2 2 Review Review of Requirements Requirements Related Related to the Product 5
6
Prior to the commitment commitment to the customer (e.g. submission of tenders, acceptance of contracts or orders or acceptance of change orders) are requirements reviewed to ensure that: a)
Pro Produc ductt rrequ equire iremen ments ts a are re defi defined ned? ?
b)
Contr Contract act or order order requi requiremen rements ts d differ iffering ing from those previously expressed are resolved?
c)
The o orga rganiz nizati ation on has has the a abil bility ity tto o mee meett def define ined d requirements?
Are results of reviews and actions arising from these reviews recorded and maintained as records?
7
Where the customer has not provided a documented statement of requirements, are customer requirements confirmed by the organization before acceptance?
8
Where product requirements are changed, does the organization ensure that relevant documentation is amended and relevant personnel are made aware of the changed requirements?
7.2.3 9
Cust ustome omerr Comm Communi unica catio tion n
Has the organization determined and implemented effective effe ctive arrangeme arrangements nts for communicating w ith customers relating to: a)
Product information?
b)
Inquiri es, contr acts, amendments or order
c)
handling? Customer feedback, incl udin g custo mer complaints?
7.3
Des ig ig n an d Dev e ell o pm pm e en nt
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n 7.3. 7.3.1 1
10 11
12
13
Are product design and development development activities planned and controlled? During design and development planning has the organization determined: a)
Sta Stages ges of des design ign and dev develo elopme pment? nt?
b)
Rev Review iew,, veri verific ficati ation on and v vali alidat dation ion tthat hat a are re appropriate to each design and development stage?
c)
Res Respon ponsib sibili ilitie ties s and au autho thorit rities ies fo forr desi design gn and development?
Are interfaces between different different groups involved in design design and development managed to ensure effective communication and clear assignment of responsibilities? Is planning output updated as the design and development progresses?
7.3. 7.3.2 2 14 15
Design esign a and nd Dev Devel elopme opment nt Pla Planning nning
Design esign a and nd Dev Devel elopme opment nt Inputs Inputs
Are inputs relating to to product requirements define defined, d, documented and maintained as a record? Does design and development input include: a) b)
Fun Functi ctiona onall and pe perfo rforma rmance nce re requi quirem rement ents? s? Appli Applicable cable statu statutory tory and regula regulatory tory requireme requirements? nts?
c) Ap plic pl ic abl e in info fo rm rmati ati on der iv ed f ro m p prev rev io us similar designs? d)
Oth Other er requi requirem rement ents s esse essenti ntial al fo forr desi designs gns an and d development?
16
Are design and development inputs reviewed for adequacy?
17
Are incomplete, unambiguous unambiguous or conflicting requirem requirements ents resolved?
7.3. 7.3.3 3
Design esign a and nd Dev Devel elopme opment nt Output Outputs s
18
Are outputs of the design and development provided in a form that enables verification against the design and development inputs?
19
Are design outputs approved approved prior prior to release?
20
21
22
Does the design and development output: a)
Mee Meett th the e de desig sign n an and d de devel velopm opment ent input input requirements?
b)
Provide appropriate information information for purchasing, production and for service provision?
c)
Con Contai tain n or ref refere erence nce pr produ oduct ct acc accept eptanc ance e crit criteri eria? a?
d)
Spe Specif cify y the pr produ oduct ct ch chara aracte cteris ristic tics s tha thatt are essential to its safe and proper use?
7.3. 7.3.4 4
Design esign a and nd Dev Devel elopme opment nt Rev Revie iew w
Are systematic reviews performed performed in accordance with planned arrangements at suitable stages of the design and development? Do design and development reviews:
Pr o c . Ref .
Co m m en t s
No .
23
24
Qu es t i o n a)
Eva Evalua luate te th the e abi abilit lity y of th the e resu results lts o off des design ign a and nd development to meet requirements?
b)
Identify p roblems and propose necessary Identify actions?
Do review participants include representatives of functions concerned with the design and development stage(s) being reviewed? Are results of reviews and any actions necessary maintained as records?
7.3. 7.3.5 5 25
26
Design esign an and d Deve Developme lopment nt Verifi Verifica cation tion
Is design and development verification performed in accordance with planned arrangements to ensure that the design outputs have met the design and development input requirements? Are results of the verification verification and actions maint maintained ained as records?
7.3. 7.3.6 6
Design esign a and nd Deve Developme lopment nt Val Valida idation tion
27
Is design and development validation performed in accordance with planned arrangements?
28
Is design and development validation performed to confirm that the product is capable of meeting the requirements requireme nts for the specified application or intended
29 30
use, where known? Is validation completed prior to delivery or implementation of the product wherever applicable? Ar e res ul ts o f t he v ali dat io n an and d ac ti on s mai nt ain ed as records?
7.3. 7.3.7 7 31 32
Contro ontroll of D Des esign ign a and nd Dev Devel elopme opment nt Changes
Are design and/or development development changes identified and recorded? Do reviews of design and development changes include evaluation of the effect of the changes on constituent parts and product alrea already dy delivered?
33
Are design and development changes reviewed, verified, validated as validated as appropriate and approved before
34
implementation? Ar e res ul ts o f t he r eview evi ew o off c han ges an d n neces eces sary sar y actions maintained as records?
7.4
Pu r c h as i n g
7.4.1
Pur urch cha asi sing ng Con Contt rol rol
35
Are the purchasing processes controlled controlled to ensure purchased product (or service) conforms to requirements?
36
Is the type and extent of control applied to the supplier and purchased product dependent upon the effect of the purchased product on subsequent product realization or the final product?
37
Are suppliers selected and evaluated evaluated based on their ability to supply product in accordance with the
38
organization’s requirements? Has the organization established criteria for select- ion, evaluation & re-evaluation of re-evaluation of suppliers?
39
Are results of the evaluations evaluations and any necessary actions maintained as records?
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n 7.4.2
40
Purcha urchasin sing g IInfo nforma rmatio tion n
Does purchasing information describe the product to be purchased? Including where appropriate:
41
a)
Req Requir uireme ements nts for for approva approvall of prod product uct,, proc procedu edures, res, processes and equipment?
b)
Req Requir uireme ements nts for for qualifi qualificat cation ion of pe perso rsonne nnel? l?
c)
Qua Qualit lity y man manage agemen mentt sys system tem requir requireme ements nts? ?
Is the adequacy of specified purchased requirements ensured prior to their communication to the supplier?
7.4. 7.4.3 3 42
43
44
Verific erificat ation ion of of Purcha Purchase sed d Product Product
Have the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements been established and implemented? Are verification arrangements arrangements and method of product release specified in the purchasing information where the organization or its customer intends to perform verification at the supplier’s premises?
7.5
Pr od od uc uc ti ti on on a an n d Se Ser v vii c ce e Pr Pr ov ov iis s iio on
7.5. 7.5.1 1
Contro ontroll of of Produc Production tion and and Ser Service vice Provision
Are the production and service provision planned and carried out under controlled conditions including: a)
Avail Availabili ability ty of of iinform nformation ation that describes describes the produc productt characteristics?
b)
Ava Availa ilabil bility ity of wo work rk inst instruc ructio tions, ns, as ne neces cessar sary? y?
c)
Us Use eo off su suit itab able le equi equipm pmen ent? t?
d)
Ava Availa ilabil bility ity an and d use of m moni onitor toring ing an and d mea measur suring ing devices?
e)
Imple Implementa mentation tion of monit monitoring oring and measu measuremen rement? t?
f)
Imp Implem lement entati ation on of releas release, e, delive delivery ry and pos posttdelivery activities?
7.5.2
Va Validation lidation of Processe Processes s for Production and Service Provision
45
Have processes where deficiencies may become apparent only after the product is in use or the service has been delivered been validated?
46
Do the results of validation demonstrate the ability of the processes to achieve planned results?
47
Where applicable, have the arrangements been established for: a)
Def Defini ining ng cr crite iteria ria ffor or re revie view w and a appr pprova ovall of processes?
b)
App Approv roval al of e equi quipme pment nt an and d qua qualif lifica icatio tion n of
c)
personnel? Use of spe specif cific ic m meth ethods ods and pro proced cedure ures? s?
d)
Re Requ quir irem emen ents ts ffor or rrec ecor ords ds? ?
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n e)
7.5. 7.5.3 3
Re-validation?
Identifi dentifica cation tion and and Tra Trace ceab abilit ility y
48
Is the product identified by suitable means throughout product realization?
49
Is the product status identified with respect to monitoring and measurement requirements?
50
When traceability is a requirement, is the product uniquely
51
identified and controlled? Is the unique identification maintained as a record?
7.5.4
Cus ustt ome omerr P rop rope er ty ty
52
Does the organization exercise care with customer property while it is under the organization’s control or being used by the organization?
53
Is customer property identified, verified, protected, and safeguarded?
54
If lost, damaged or otherwise found to be unsuitable for use, is condition recorded, reported to the customer and maintained as a record?
7.5.5
Prese reserva rvatio tion n of P Prod roduct uct
55
Is conformity of delivery product preserved during internal processing and to the intended destination?
56
Does preservation activities include:
57
a)
Iden Identi tifi fica cati tion on? ?
b)
Handling?
c)
Packaging?
d)
Storage?
e)
Prot rotection?
Ar e pr preser eser vat io n act iv it ies app li ed t o co ns ti tu tuent ent parts of a product?
7.6
Cont ontrol rol o off Me Measur suring ing and and Moni Monitor toring ing Devices
58
Has the organization determined the monitoring and measurement to be undertaken and the monitoring and measurement devices needed to provide evidence of conformity of product to determined requirements?
59
Have processes been established to ensure that monitoring and measurement can be carried out in a manner consistent with the monitoring and measurement requirements?
60
Where necessary to ensure valid results, are measuring equipment: a)
Calib Calibrated rated or v verifi erified ed a att sp specifi ecified ed iinterv ntervals, als, or p prior rior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, is the basis used for calibration or verification recorded?
b)
Adj Adjust usted ed or or re-ad re-adjus justed ted as n nece ecessar ssary? y?
c)
Ide Identi ntifie fied d to en enabl able e the c cali alibra bratio tion n sta status tus tto o be
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n determined? Saf Safegu eguard arded ed fr from om a adju djustm stment ents s tha thatt wo would uld invalidate the measurement result?
e)
Pro Protec tected ted fr from om dam damage age an and d dete deterio riorat ration ion du durin ring g handling, maintenance and storage?
Has the organization assessed and recorded the validity of the previous measuring results when the equipment is found not to conform to requirements?, and taken the appropriate action on the equipment and any product
61
62
d)
affected? Are records of the calibration calibration and verification results verification results maintained?
63
Where computer software is used in the monitoring and measurement of specified requirements, is the ability of the computer software to satisfy the intended application confirmed prior to initial use?
64
Is the ability of computer softw are to satisfy the intended application reconfirmed as necessa necessary? ry?
8 Measurement, Analysis and Improvement
1
2
8
Measu surr e eme ment nt,, ana nall y ysi sis s and and i mpr mprov ove eme ment nt
8.1
Gen er al
Have the monitoring, measurement , analysis and improvement pr ocesse ocesses s been planned, and implemented to: a)
De Demo mons nstr trat ate e con confo form rmit ity y of th the e pro produ duct ct? ?
b)
Ens Ensure ure con confor formit mity y of the qua qualit lity ym mana anagem gement ent system?
c)
Continually improve the effectiveness effectiveness of the quality management system?
Have the applicable methods including statistical techniques and their extent of use been determined?
8.2
Mo n nii to to ri ri ng ng an d Meas u urr em em en en t
8.2.1
Cust ustome omerr Sa Satis tisfa facti ction on
3
Is information relating to customer p erce erception ption monitored by the organiza organization tion as to whether customer requirements have been met?
4
Have Have the methodologies for obtaining and using information related to customer perception been determined?
8.2.2 5
6
Int nte er n na al A udi uditt
Are internal audits conducted conducted at planned intervals to to determine whether the quality management system: a)
Con Confor forms ms to plan planned ned arr arrang angeme ements nts,, requi requirem rement ents s of ISO 9001 and the quality management system?
b)
Is ef effec fectiv tively ely im imple plemen mented ted a and nd mai mainta ntaine ined? d?
Are the audit programs programs planned taking into considerat consideration ion the status and importance of the processes and areas to be audited, as well as the results of previous audits?
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n
7
Is the audit criteria, scope, frequency and method defined?
8
Do auditor selection and conduct of audits ensure objectivity and impartiality of the audit process?
9
Is it ensured that auditors do not audit their own work?
10
Has a documented procedure been established to define responsibilities and requirements for planning and conducting audits, reporting results, and maintaining records?
11
Have management responsible for the area being audited ensured that actions have been taken without undue delay to eliminate detected nonconformities and their causes? causes ?
12
Do follow-up activities include the verification of the actions taken, and the reporting of the verification results?
8.2. 8.2.3 3 13
Monitoring onitoring an and d M Mea easure sureme ment nt of Processes
Ar e sui table tab le m meth eth od s app li ed f or mo ni to tori ri ng and where applicable, measurement of the quality management system proc esses necessary to meet customer requireme requirements? nts?
14
Do these methods demonstrate the ability of the processes to achieve planned results?
15
Ar e cor rec tion ti on and co rr ect iv e acti on s tak en w hen planned results are not achieved?
8.2. 8.2.4 4 16
Monitoring onitoring a and nd M Mea easure sureme ment nt of Product Product
Are product characteristics monitored monitored and measured to verify that product requirements are met?
17
Is monitoring and measurement of product characteristics carried out at appropriate stages of the product realization process in accordance with the planned arrangements?
18
Is evidence of conformity with the acceptance criteria documented and maintained?
19 20
Are records maintained to to indicate the person(s) authorizing release of product? Unless otherwise approved by a relevant authority or where applicable, the customer, are all planned arrangements satisfactorily completed prior to proceeding with release?
8.3
Cont ontrol rol of Nonc onconf onform orming ing Product roduct
21
Is nonconforming product identified and controlled to prevent unintended use or delivery?
22
Has a documented procedure been established to define controls and related responsibilities and authorities for dealing with nonconforming product?
23
Are nonconforming product dealt with by one or m more ore of the following ways: a) Act Action ion ttake aken n to eelim limina inate te the the de detec tected ted nonc nonconf onform ormity ity?? b)
Aut Author horize ized d use, use, releas release e or or accep acceptan tance ce und under er concession by a relevant authority and, where applicable, by the customer
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n c)
24
25
26
Act Action ion tak taken en tto o pr precl eclude ude its origin original al inte intende nded d use or application
Are records maintained identifying identifying the nature of nonconformities and any subsequent actions taken, including any concessions? When nonconforming product is corrected, is it subject to re-verification to demonstrate conformity to the requirements? When nonconf orming pr oduct is dete When detected cted afte after r delivery, or use has started, is appropriate action taken by the organization to the effect or potential effect?
8.4
A n al al y si si s o f Dat a
27
Is appropriate data determined, collected and analyzed to demonstrate the suitability and effectiveness of the quality management system and to evaluate where where continual impr oveme ovement nt of the effectiveness of the quality management system can be made?
28
Does this data included data generated from monit orin g, measurement and other rele relevant vant sources?
29
Does Doe s the analysis of this data provide in formation related to: a) Customer satisfaction?
30 31
b)
Conformance to product requireme requirements? nts?
c)
Characteristics and trends of processes and products includin g, opportunities for preve preventive ntive action?
d)
Suppliers?
8.5
Im p r o v em en t
8.5.1
Cont ontinu inua al IImpr mprove oveme ment nt
Does Doe s the or ganiz ganization ation continually improve the effectiveness of the quality management system? Ar e res ul ts o f au audi di ts , anal analys ys is o f data, d ata, co rr ect iv e and preventive actions, management reviews, quality Policy and quality objectives used for continu al improvement?
8.5.2
Cor orrr e ect ctii v ve e Act Actii on on
32
Are corrective actions taken to to eliminate the cause of nonconformities and to prevent recurrence?
33
Are corrective actions appropriate to the effects of the nonconformities encountered?
34
Has a documented procedure been established to define the requirements for: a)
Rev Review iewing ing non noncon confor formit mities ies,, inclu includin ding g custo customer mer complaints?
b)
Det Determ ermini ining ng th the e caus causes es of n nonc onconf onform ormity ity? ?
c)
Eva Evalua luatin ting g the nee need d for a acti ction on tto o ens ensure ure tthat hat nonconformities do not recur?
d)
Det Determ ermini ining ng and iimpl mpleme ementi nting ng act action ion ne neede eded? d?
Pr o c . Ref .
Co m m en t s
No .
Qu es t i o n e)
Rec Record ording ing an and d mai mainta ntaini ining ng the rresu esults lts of a acti ction on taken?
f)
Revi Review ewin ing g co corre rrect ctiv ive e ac acti tion on ttak aken en? ?
8.5.3 35
36 37
Pr ev en en ttii v e A c ttii on on
Has the organization determined actions to eliminate the causes of potential nonconformities in order to prevent occurrence? Are preventive actions appropriate appropriate to the effects of the potential problems? Has a documented procedure been established to define the requirements for: a)
Deter Determinin mining g poten potential tial noncon nonconform formities ities and their causes?
b)
Eva Evalua luatin ting g the nee need d for a acti ction on tto o pre preven ventt occurrence of nonconformities?
c)
Det Determ ermini ining ng and iimpl mpleme ementi nting ng act action ions s need needed? ed?
d)
Rec Record ording ing an and d mai mainta ntaini ining ng the rresu esults lts of a acti ction on taken?
e)
Rev Review iewing ing of prev prevent entive ive a acti ction on ttake aken? n?
Pr o c . Ref .
Co m m en t s
Notes
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