TECHNICAL REQUIREMENTS OF ISO/IEC 17025: 2017

Transcription

SADCAS F 60 (b)SADCAS Ref. No:TECHNICAL REQUIREMENTS OF ISO/IEC 17025: 2017Date/s of evaluation:Assessor/s & Observers:Laboratory:Area / field of operationLaboratory RepresentativeThis report covers the following:Document Review onlyImplementation on Site Visit onlyREQUIREMENTS & COMMENTS.Compliance C, Non-compliance NCDocument Review and Site VisitOtherNB: The order of assessment does not need to follow the order of the checklist. Assessors are expected to know & have the standard, this worksheet is designed as guidance toprompt detailed recording of the process.REFER TO ISO/IEC 17025:2017 FOR DETAIL AND FOR CLARIFICATION NOTES.NOTE 1: For CAB’s comments: The CAB must provide information on how requirements have been addressed, documented and/or implemented. Make reference to policies /procedures, incl. clause numbers.NOTE 2: For Assessor’s Comments: The Assessor must provide information on the CAB’s conformity with the requirements.Issue no. 2Page 1 of 30Date of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSE6RESOURCE REQUIREMENTS6.1Availability of personnel, facilities, equipment,systems and support services necessary for themanagement and performance laboratory activities.6.2Personnel: How are the following addressed/implemented?6.2.1Personnel, either internal or external, that couldinfluence the laboratory activities act impartially, arecompetent and work in accordance with thelaboratory’s management system.6.2.2Competence requirements are documented foreach function influencing the results of laboratoryactivities, including requirements for education,qualification, training, technical knowledge, skillsand experience.6.2.3Personnel have the competence to performlaboratory activities for which they are responsibleand to evaluate the significance of deviations.6.2.4Laboratory management communicate to personneltheir duties, responsibilities and authorities.6.2.5The laboratory has procedure(s) and retain recordsfor:CAB’s COMMENTSC/NCASSESSOR’s COMMENTSa) determining the competence requirements;b) selection of personnel;c) training of personnel;Issue no.2Page 2 of 30Date of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSECAB’s COMMENTSC/NCASSESSOR’s COMMENTSd) supervision of personnel;e) authorization of personnel;f)6.2.6monitoring of competence of personnel.Personnel authorized to perform specific laboratoryactivities, including but not limited to, the following:a) development, modification,validation of methods;verificationandb) analysis of results, including statements ofconformity or opinions and interpretations;c) report, review and authorization of results.6.3Facilities and environmental conditions: How are the following addressed/implemented?6.3.1Facilities and environmental conditions are suitablefor the laboratory activities and are not adverselyaffecting the validity of results.Note inStd.6.3.2Requirements for facilities and environmentalconditions necessary for the performance of thelaboratory activities are documented.6.3.3Laboratory monitors, controls and recordsenvironmental conditions in accordance withrelevant specifications, methods or procedures orwhere they influence the validity of the results.Issue no. 2Page 3 of 30Date of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSE6.3.4CAB’s COMMENTSC/NCASSESSOR’s COMMENTSMeasures to control facilities are implemented,monitored and periodically reviewed and including,but not be limited to:a) access to and use of areas affecting laboratoryactivities;b) prevention of contamination, interference oradverse influences on laboratory activities;c) effective separation betweenincompatible laboratory activities.areaswith6.3.5Requirements related to facilities and environmentalconditions of this document are met when thelaboratory performs laboratory activities at sites orfacilities outside its permanent control.6.4Equipment: How are the following addressed/implemented?6.4.1Laboratory has access to equipment required forthe correct performance of laboratory activities andwhich can influence the result.Note inStd.6.4.2Requirements for equipment of this document aremet in those cases where the laboratory usesequipment outside its permanent control.6.4.3Procedure for handling, transport, storage, use andplanned maintenance of equipment in order toensure proper functioning and to preventcontamination or deterioration.Issue no.2Page 4 of 30Date of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSE6.4.4Verify that equipment conforms to specifiedrequirements before being placed or returned intoservice.6.4.5Equipment used for measurement are capable ofachievingthemeasurementaccuracyormeasurement uncertainty required to provide a validresult.6.4.6Measuring equipment are calibrated when:Note inStd. The measurement accuracy or measurementuncertainty affects the validity of the reportedresults, or Calibration of the equipment is required toestablish the metrological traceability of thereported result.6.4.7Establish a calibration programme, which getsreviewed and adjusted as necessary in order tomaintain confidence in the status of calibration.6.4.8Equipment requiring calibration, or which has adefined period of validity are labelled, coded orotherwise identified.6.4.9Equipment subjected to overloading or mishandling,gives questionable results, or shown to be defectiveor outside specified requirements, are taken out ofservice.See 7.10CAB’s COMMENTSC/NCASSESSOR’s COMMENTSIsolated to prevent its use or clearly labelled ormarked as being out of service until it has beenverified to perform correctly.Issue no. 2Page 5 of 30Date of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSECAB’s COMMENTSC/NCASSESSOR’s COMMENTSExamine the effect of the defect or deviation fromspecified requirements and shall initiate themanagement of nonconforming work procedure.6.4.10When intermediate checks are necessary tomaintain confidence in the performance of theequipment, these checks are carried out accordingto a procedure.6.4.11Reference values and correction factors areupdated and implemented when calibration andreference material data include reference values orcorrection factors.6.4.12Practicable measures are taken to preventunintended adjustments of equipment frominvalidating results.6.4.13Records are retained for equipment which caninfluence laboratory activities. The records shallinclude the following, where applicable:a) the identity of equipment, including softwareand firmware version;b) the manufacturer’s name, type identification,and serial number or other unique identification;c) evidence of verification that equipmentconforms with specified requirements;d) the current location;e) calibration dates, results of calibrations,adjustments, acceptance criteria, and the duedate of the next calibration or the calibrationinterval;Issue no.2Page 6 of 30Date of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSEf)CAB’s COMMENTSC/NCASSESSOR’s COMMENTSdocumentation of reference materials, results,acceptance criteria, relevant dates and theperiod of validity;g) the maintenance plan and maintenance carriedout to date, where relevant to the performanceof the equipment;h) detailsofanydamage,malfunction,modification to, or repair of, the equipment.6.5Metrological traceability: How are the following addressed/implemented?6.5.1Establish and maintain metrological traceability ofmeasurement results by means of a documentedunbroken chain of calibrations, each contributing tothe measurement uncertainty, linking them to anappropriate reference.Note inStd.6.5.2Notes inStdMeasurement results are traceable to theInternational System of Units (SI) through one of thefollowing:a)calibration provided by a competent laboratory;b) certified values of certified reference materialsprovided by a competent producer with statedmetrological traceability to the SI;c)6.5.3direct realization of the SI units ensured bycomparison, directly or indirectly, with nationalor international standards.DemonstrateIssue no. 2metrologicaltraceabilitytoanPage 7 of 30Date of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSECAB’s COMMENTSC/NCASSESSOR’s COMMENTSappropriate reference when metrological traceabilityto the SI units is not technically possible, e.g.a) certified values of certified reference materialsprovided by a competent producer;b) results of reference measurement procedures,specified methods or consensus standards thatare clearly described and accepted as providingmeasurement results fit for their intended useand ensured by suitable comparison.6.6Externally provided products and services: How are the following addressed/implemented?6.6.1Only suitable externally provided products andservices that affect laboratory activities are used,when such products and services:Note inStd.6.6.2a)are intended for incorporationlaboratory’s own activities;intotheb)are provided, in part or in full, directly to thecustomer by the laboratory, as received fromthe external provider;c)are used to support the operation of thelaboratory.Have a procedure and retain records for:a)defining, reviewing and approving thelaboratory’s requirements for externallyprovided products and services;b)defining the criteria for evaluation, selection,monitoring of performance and re-evaluation ofthe external providers;Issue no.2Page 8 of 30Date of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSE6.6.3c)ensuring that externally provided products andservicesconformtothelaboratory’sestablished requirements, or when applicable,to the relevant requirements of this document,before they are used or directly provided to thecustomer;d)taking any actions arising from evaluations,monitoring of performance and re-evaluationsof the external providers.CAB’s COMMENTSC/NCASSESSOR’s COMMENTSCommunicate its requirements to external providersfor:a) the products and services to be provided;b) the acceptance criteria;c) competence, including any requiredqualification of personnel;d) activities that the laboratory, or its customer,intends to perform at the external provider’spremises.7Process Requirements: How are the following addressed/implemented?7.1Review of requests, tenders and contracts7.1.1Procedure for the review of requests, tenders andcontracts. The procedure shall ensure that:Note inStd.a)Issue no. 2the requirements are adequately defined,documented and understood;Page 9 of 30Date of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSEb)the laboratory has the capability and resourcesto meet the requirements;c)where external providers are used, therequirements of 6.6 are applied and thelaboratory advises the customer of the specificlaboratory activities to be performed by theexternal provider and gains the customer’sapproval;d)the appropriate methods or procedures areselected and are capable of meeting thecustomers’ requirements.7.1.2Inform the customer when the method requested bythe customer is considered to be inappropriate orout of date.7.1.3When the customer requests a statement ofconformity to a specification or standard for the testor calibration (e.g. pass/fail, in-tolerance/out-oftolerance) the specification or standard, and thedecision rule is clearly defined, communicated toand agreed with the customer.7.1.4Any differences between the request or tender andthe contract are resolved before laboratory activitiescommence.7.1.5Customer is informed of any deviation from thecontract7.1.6Contract amended after work has commenced, thecontract review is repeated and any amendmentscommunicated to all affected personnel.Issue no.2CAB’s COMMENTSPage 10 of 30C/NCASSESSOR’s COMMENTSDate of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSE7.1.7Note inStd.7.1.8CAB’s COMMENTSC/NCASSESSOR’s COMMENTSCooperate with customers or their representativesin clarifying the customer’s request and inmonitoring the laboratory’s performance in relationto the work performed.Records of reviews, pertinent discussions with acustomer relating to the customer’s requirements orthe results, including any significant changes, areretained.7.2Selection, verification and validation of methods: How are the following addressed/implemented?7.2.1Selection and verification of methods7.2.1.1 Use appropriate methods and procedures for allNote inlaboratory activities and, where appropriate, forStd.evaluation of the measurement uncertainty as wellas statistical techniques for analysis of data.7.2.1.2 Allmethods,proceduresandsupportingNote indocumentation, such as instructions, standards,Std.manuals and reference data are kept up to date andmade readily available to personnel.7.2.1.3 When the customer does not specify the method tobe used, the laboratory selects an appropriatemethod and inform the customer of the methodchosen.Use of methods published either in international,regional or national standards, or by reputabletechnical organizations, or in relevant scientific textsor journals, or as specified by the manufacturerrecommended.Laboratory-developed or modified methods can alsobe used.Issue no. 2Page 11 of 30Date of issue: 2018-11-20

SADCAS F 60 (b)ISO/IEC 17025:2017 REQUIREMENTSHow are the following addressed / implementedCLAUSECAB’s COMMENTSC/NCASSESSOR’s COMMENTS7.2.1.4 Methods verified before introducing them byensuring that it can achieve the requiredperformance. Records of the verification areretained. If the method is revised b

ISO/IEC 17025:2017 REQUIREMENTS How are the following addressed / implemented CAB’s COMMENTS C/ NC ASSESSOR’s COMMENTS c) ensuring that e xternally provided products and services conform to the laboratory’s established requirements, or when applicable, to the relevant requirements of this document, before they are used or directly provided to the customer; d) taking