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1、LAFM03/ 02 April 2018Page 11 of 28Type of Assessme ntLaboratoryAddressTel / FaxLaboratory Assessme nt Checklist (IS017025:2017)Names ofpers onssee nFieldDate of visitTech ni calAssessor(s)/Expert(s)Lead AssessorRefere ncesISO/IEC 17025: 2017, SAC-01, SAC-02, SAC-SINGLAS 001, SAC-SINGLAS 002, SAC-SIN
2、GLAS 006, PROF 001Descripti onTo ProduceMan datory to meet the requireme ntTo Con siderGuida nee to meet the requireme ntClause No.Descripti onYesNoN.ARemarks4.Gen eral Requireme nts4.1ImpartialityClause No.Descripti onYesNoN.ARemarks4.1.2Does the laboratorydem on strate management commitment to imp
3、artiality?To con sider* Man ageme nt review* Code of con duct* Declarati on forms relat ing to con fide ntiality / impartiality4.1.4Does the laboratory identify risks to its impartiality on an ongoing basis?-Risk from activities-Risk from its relati on ships-Risk from the relati on ships of its pers
4、 onnelTo con sider* Risk assessme nt* Risk matrix4.1.5Does the laboratory elim in ate or mini mize the risks ide ntified?4.2Con fide ntiality4.2.1How is the laboratory resp on sible for the con fide ntiality of i nformatio n obta ined or created duri ng the performa nee of laboratory activities, and
5、 proprietary rights of its customers?To con sider* Code of con duct* Con tractual agreeme nt4.2.2Does the laboratory no tify its customers whe n the laboratory is legally obliged to release con fide ntial in formati on of its customers?4.2.3Does the laboratory en sure that in formati on about its cu
6、stomers received from sources other tha n the customersare kept con fide ntial?Does the laboratory en sure that the source(s) of information about its customers is not revealed to the customers unl ess agreed by the source(s)?4.2.4How does the laboratory en sure that pers onnel keep con fide ntial a
7、ll in formati on obta ined or created duri ng the performa nee of laboratory activities?5.Structural Reauireme nts5.1Is the laboratory or the orga ni zati on legally resp on sible?Clause No.Descripti onYesNoN.ARemarksTo produce* Valid ACRA Certificate* Compa ny registrati on n umber5.2Does the labor
8、atory ide ntify man ageme nt that has overall resp on sibility for the laboratory?To con sider* Job descripti on* Orga ni sati on chart5.35.4Does the laboratory defi ne and docume nt the range of laboratory activities which conforms to ISO 17025:2017?Does it cover work carried out in:* perma nent fa
9、cilities?* sites away from its perma nent facilities?* associated temporary facilities?* mobile facilities?* customer s facilities?Do these activities con form to customer and regulatory requireme nts?5.5Does the laboratory:a)define the organization and management structure of the laboratoryb)specif
10、y the resp on sibility, authority and in terrelati on ship of all pers onnel who man age, perform or verify work affect ing the resultsc)docume nt n ecessary procedures to en sure con siste nt applicati on of its activities and the validity of its results?To considerJob description, Organisation cha
11、rt, Roles and Resp on sibilities, Stan dard Operat ing Procedures5.6Does the laboratory have authorized and sufficie nt pers onnel to:a)impleme nt, main tain and improve the man ageme nt system?b)Ide ntify deviati ons and in itiate acti ons to mini mize or preve nt such deviati ons?c)Report to man a
12、geme nt on the performa nee of the man ageme nt system and any n eed for improveme nts?Clause No.Descripti onYesNoN.ARemarksd)En sure the effective ness of laboratory activities?5.7Does the laboratory commu ni cate to staff about the effective ness and in tegrity of the man ageme nt system whe n cha
13、 nges are made to it?6.Resource Requireme nts6.1Gen eralDoes the laboratory have sufficie nt pers onn el, facilities, equipme nt, systems and support services n ecessary to man age and perform its laboratory activities?6.2Pers onnel6.2.2Does the laboratory docume nt the compete nee requireme nts for
14、 each fun cti on that may in flue nce the results of laboratory activities?-Educati on-Qualificati on-Training required-Tech ni cal kno wledge-Skills-Experie nceTo con sider* Trai ning and Compete ncy Matrix* Job descripti on* Trai ning records* Curriculum vitae6.2.4Are the duties, resp on sibilitie
15、s and authorities of laboratory pers onnel commu ni cated to them?6.2.5Does the laboratory have procedures and retain records for:a)Determi ning the compete nce requireme nts?b) to f)Selecti on, training, supervisi on, authorizati on, and mon itor ing of compete nce of pers onnel perform ing laborat
16、ory activities?To produce* Procedures of the above* Records of the above6.2.6Does the laboratory authorize pers onnel to perform laboratory activities perta ining to:a)development, modification, verification and validati on of methods?Clause No.Descripti onYesNoN.ARemarksb)c)an alysis of results, in
17、 cludi ng stateme nts of conformity or opinions and interpretations? report, review and authorizati on of results?6.3Facilities and en viro nmen tal con diti ons6.3.16.3.2Does the laboratory docume nt and en sure control of the facilities and environmental con diti ons n ecessary for the performa ne
18、e of the laboratory activities?To produce* Procedures of the above6.3.3Does the laboratory mon itor, con trol and record the en viro nmen tal con diti ons?To produce Records of the above6.3.4Does the laboratory mon itor and periodically review the measures to con trol facilities? For example:-Access
19、 to and use of laboratory areas?-Preve nti on of con tam in ati on, in terfere nee or other adverse in flue nces?-Effective separati on betwee n areas with in compatible laboratory activities?6.3.5Does the laboratory en sure complia nee to Section 6.3 of ISO 17025:2017 when laboratory activities are
20、 performed at sites or facilities outside its perma nen t con trol?6.4Equipme nt6.4.1Does the laboratory have access to equipme nt required for the correct performa nee of laboratory activities, and which can in flue nee results?6.4.2Does the laboratory en sure complia nee to Section 6.4 of ISO 1702
21、5:2017 when using equipme nt outside its perma nent eon trol?6.4.3Does the laboratory have a procedure for han dli ng, tra nsport, storage, use and pla nned maintenance of equipme nt?To produce* Procedures of the above6.4.4Does the laboratory verify that equipme nt eon forms to specified requireme n
22、ts before being placed or returned into service?Clause No.Descripti onYesNoN.ARemarks645646Does the laboratory ensure that measuring equipme nt is calibrated and capable of achiev ing the measureme nt accuracy or measureme nt un certa inty required to provide a valid result?647Does the laboratory ha
23、ve an established calibrati on programme and review the suitability and freque ncy of calibrati on?To produce* Calibrati on programme* Records of review of calibrati on programmeTo con sider* Equipme nt Master List6.4.8Is there a system of labelling, coding or identification of all equipment requiri
24、ng calibration or which has a defined period of validity?649Does the laboratory have a process of han dli ng equipme nt that no lon ger meets specified requireme nts?Does the process in clude exam ining the effect of the deviati on from specified requireme nts?6.4.106.4.11Does the laboratory perform
25、 periodic checks or updates to maintain con fide nee in the performa nee of its equipme nt?Note: This in cludes refere nee values or correcti on factors.6.4.12Does the laboratory take practicable measures to preve nt uninten ded adjustme nts of equipme nt from in validati ng results?6.4.13Does the l
26、aboratory reta in records for equipme nt which can in flue nee laboratory activities? For example:a)the ide ntity of equipme nt, i ncludi ng software and firmware versi on;b)the manufacturer s name, type identification, and serial number or other unique identification;c)evidence of verification that
27、 equipment con forms with specified requireme nts;d)the curre nt locati on;Clause No.Descripti onYesNoN.ARemarkse)calibrati on dates, results of calibrati ons, adjustments, acceptance criteria, and the due date of the n ext calibrati on or the calibrati on in terval;f)docume ntati on of refere nce m
28、aterials, results, accepta nce criteria, releva nt dates and the period of validity;g)the maintenance pla n and maintenance carried out to date, where releva nt to the performa nce of the equipme nt;h)details of any damage, malfu ncti on, modificati on to, or repair of, the equipme nt.To produce* Re
29、cords of the above6.5Metrological traceability6.5.1Does the laboratoryestablish and maintain metrological traceability of its measureme nt results by means of a docume nted un broke n cha in of calibrati ons, each con tribut ing to the measureme nt uncertainty, linking them to an appropriate refere
30、nce?6.5.26.5.3Does the laboratory en sure that measureme nt results are traceable to the In ter nati onal System (SI) of Un its where possible?To con sider* Calibrati on provided by compete nt laboratory* Certified refere nce materials by compete nt producer* Direct realizati on of SI un its6.6Exter
31、 nally provided products and services6.6.1Does the laboratory en sure the suitability of exter nally provided products and services?6.6.2Does the laboratory have procedures and records for the followi ng?a)defi nin g, review ing and approv ing the laboratory s requirements for externally provided pr
32、oducts and services;b)defi ning the criteria for evaluati on, selection, monitoring of performance and re-evaluati on of the exter nal providers;c)en suri ng that exter nally provided products and services con form to the laboratorysClause No.Descripti onYesNoN.ARemarksestablished requireme nts, or
33、whe n applicable, to the releva nt requireme nts of Section 6.6 of ISO 17025:2017, before they are used or directly provided to the customer;d)taking any actions arising from evaluations, mon itori ng of performa nee and re- evaluati ons of the exter nal providers.To produce* Procedures of the above
34、* Records of the above6.6.3Does the laboratory commu ni cate its requireme nts to exter nal providers for the followi ng?a)the products and services to be provided;b)the accepta nee criteria;c)compete nee, in cludi ng any required qualification of personnel;d)activities that the laboratory, or its c
35、ustomer, i ntends to perform at the exter nal provider s premises.To Con sider Ten ders Con tracts Specificati ons Purchase Orders7.Process Requireme nts7.1Review of requests, ten ders and con tracts7.1.1Does the laboratory have a procedure for the review of requests, ten ders and con tracts? The pr
36、ocedure shall en sure that:a)the requireme nts are adequately defi ned, docume nted and un derstood;b)the laboratory has the capability and resources to meet the requireme nts;c)where exter nal providers are used, the requireme nts of Secti on 6.6 are applied and the laboratory advises the customer
37、of the specific laboratory activities to be performed by the exter nal provider and gains the customer s approval;d)the appropriate methods or procedures are selected and are capable of meet ing the customers requirements.Clause No.Descripti onYesNoN.ARemarks7.1.27.1.4Does the laboratory no tify the
38、 customer of any in appropriate or outdated methods, and en sure that the con tract shall be acceptable to both the laboratory and the customer?Does the laboratory en sure that deviati ons requested by the customer do not impact the in tegrity of the laboratory or the validity of the results?7.1.3Is
39、 the decision rule clearly defined, commu ni cated, and agreed by both the laboratory and the customer whe n a statement of conformity is required to be appe nded on the test/calibrati on/sampli ng report?7.1.57.1.67.1.8Does the laboratory no tify customers of any deviati ons from the con tract an d
40、, if the deviati ons occur after work has comme need, repeat the con tract review and no tify all affected pers on al?To produce Records of con tract review Records of any cha nges andpert inent discussi onson customer srequireme nts7.1.7Does the laboratory cooperate with customers or their represe
41、ntatives in clarifying the customer s request and inmonitoring the laboratory s performanee inrelati on to the work performed?7.2Selection, verification and validation of methods7.2.1Selection and verification of methods7.1.2.17.2.1.2Are all methods, procedures, and support ing docume ntati on appro
42、priate to laboratory activities, releva nt, up to date, and readily available to pers onn el?7.2.1.3Does the laboratory en sure that it uses the most appropriate vers ion of a method?7.2.1.4Does the laboratory select and inform the customer of the method chose n if the customer does not specify the
43、method?7.2.1.5Has the laboratory verified that it can properly perform the methods and achieve the required performa nee before in troduc ing them?To produce* Records of verificati on7.2.1.6Does the laboratory have a formal pla n forClause No.Descripti onYesNoN.ARemarksmethod developme nt, performed
44、 by compete nt pers onnel with adequate resources?Are periodic reviews carried out to en sure that the n eeds of the customer are fulfilled?721.7Does the laboratory docume nt, justify, authorize and seek accepta nee from the customer for any deviations to methods prior to perform ing them?7.2.2Validati on of me