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Checklist

ISO 17025

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1. PUPOS! O" #$! C$!C%&IS#

2S '"&! is a global standard for calibration and testing laboratory. peratinglaboratory activities according to the standard 3ualifies laboratories to getaccreditation status and is an excellent foundation to pass regulatory 3ualityre3uirements. %hecklists help to develop, implement and maintain 2S '"&!processes consistently and efficiently. 4ecause each procedure is different goingthrough checklists does not mean that everything is covered nor does it mean thatall checklist items are applicable for each laboratory.

The checklist is aligned with 2S'"&!. 5owever, it does not refer to all items asstated in the standard. $or example, the checklist does not include items that are

considered well known good testing practices. n the other hand, it also includesitems that re3uire further interpretations. Therefore the checklist is not a substituteof the standard but is complementary

2S'"&! re3uirement that are only applicable to calibration laboratories but not totesting laboratories are not included in the checklist

2. SCOP! O" C$!C%&IS#

1pplicable for 1nalytical Laboratories that operate laboratory activities according to

2S'"&!.

'. SI()*#U!S+*PPO,*&S

Prepared by 6eviewed by 1pproved by

*ame

Signature

)ate

www.labcompliance.com (replace with Your Companys Name) FOR INTERN!"#E

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-. C$!C%&IS#

ISO Clause euirement %omment

'.'. 8anagement 6e3uirements+ rgani9ation

:.'' %an the laboratory be held legally responsible;

:.'&. 2s it the responsibility of the laboratory to carry out testing andcalibration activities to meet 2S'"&! re3uirements;

:.'.7 )oes the management cover work carried throughout alllaboratory facilities;

:.'.: 1re the responsibilities of key personnel defined in order toidentify potential conflicts of interest;

:.'.! a )oes the laboratory management and technical personnel havethe authority and resources to carry out all their duties;

:.'.! b )oes the laboratory have arrangements to ensure that it

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:.'.! h )oes the laboratory have technical management which has overallresponsibility for the technical operations

:.'.! i )oes the laboratory appoint a member of staff as 3uality manager

:.'.! = )oes the laboratory appoint deputies for key managementpersonnel;

:.'.! k )oes the laboratory ensure that its personnel are aware of therelevance and importance of their activities;

'.&. 8anagement 6e3uirements+ rgani9ation

:.&.' )oes the laboratory establish, implement and maintain amanagement system appropriate to the cope of its activities;

:.&.& )oes the laboratory management has policies related to 3uality,including a 3uality policy statement, defined in a 3uality manual

:.&.7 )oes the top management provide evidence of commitment to thedevelopment and implementation of the management system andto continually improving its effectiveness;

:.&.: )oes top management communicate to the organi9ation theimportance of meeting customer re3uirements as well as statutoryand regulatory re3uirements;

:.&.! )oes the 3uality manual include or make reference to thesupporting procedures including technical procedures;

:.&.> 1re the roles and responsibilities of technical management and the3uality manager defined;

:.&.. )oes top management ensure that the integrity of themanagement system is maintained when changes to themanagement system are planned and implemented;

'.7. 8anagement 6e3uirements - )ocument %ontrol

:.7.' )oes the laboratory establish and maintain procedures to controlall documents that form part of its management system;

:.7.&.'. 1re all documents issued to personnel in the laboratory as part ofthe management system reviewed and approved for use byauthori9ed personnel prior to issue;


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:.7.&.& a 1re authori9ed documents available at all appropriate locations;

:.7.&.& b 1re documents periodically reviewed;

:.7.&.& c 1re obsolete documents removed;

:.7.&.& d 1re obsolete documents that need to be retained suitably marked;

:.7.7.' 1re changes to documents reviewed and approved;

:.7.7.& 2s changed document text identified in the document;

:.7.7.7 1re procedures to make document changes by hand defined;

:.7.7.: 1re there procedures that describe changes made for electronicdocument management systems;

:.:. 6eview of re3uests, tenders and contracts

:.:.' )oes the laboratory have procedures for the review of re3uests,tenders and contracts;

:.:.& )oes the laboratory record reviews and changes;

:.:.7 )oes the review cover any work that is subcontracted;

:.:.: 1re customers informed of deviations from contracts;

:.:.! )oes contract amendment follow the same process as for newcontracts;

:.!. Subcontracting of tests and calibrations

:.!.' 2s subcontracted work placed to a competent party;

:.!.& 1re customers made aware of subcontracting work;

:.!.7. 2s the laboratory made responsible to the customer for thesubcontractorPurchasing Services and Supplies

:.>.' )oes the laboratory have a policy and procedures for selectingand purchasing of services and supplies;


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:.>.& )oes the laboratory shall ensure that purchased materials thataffect the 3uality of tests and#or calibrations are not used until theyhave been inspected or otherwise verified as complying with

standard specifications or re3uirements defined in the methods forthe tests and#or calibrations concerned;

:.>.7 )o purchasing documents contain data describing the servicesand supplies ordered;

:.>.: )oes the laboratory evaluate suppliers of critical material andservices;

:.Service to customer

:..' 2s the laboratory willing to cooperate with customers in clarifying acustomer?s re3uest to monitor the laboratory

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:.(.& 1re corrective action procedures promptly followed when nonconforming work could recur;

:.'" 2mprovement

:.'" )oes the laboratory continually improve the effectiveness of itsmanagement system;

:.'' %orrective action

:.''.' 2s there a policy and a procedure for implementing correctiveactions when non conforming work has been identified;

:.''.& )oes the procedure start with a root cause analysis;

:.''.7 )oes the laboratory indentify potential corrective actions;

:.''.: )oes the laboratory monitor corrective actions;

:.''.! 1re appropriate areas of non conforming work audited;

:.'&. Preventive action

:.'&.' 1re needed improvements and potential sources of nonconformities identified and preventive action plans developed,implemented and monitored;

:.'&.& 1re preventive actions ensured that they are effective;

:.'7 %ontrol of records

:.'7.'.' 1re there procedures for identification, collection, indexing, access,filing, maintenance and disposal of 3uality and technical records;

:.'7.'.& 1re records stored such that they are readily available

:.'7.'.7 1re records secure and confidential;

:.'7.'.: 1re there procedures to protect and back-up electronic records and to


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prevent unauthori9ed access;

:.'7.&.& 1re records of original observations, derived data and sufficient

information to establish and audit trail, calibration records, staffrecords, and a copy of each test reports or calibration certificatesretained;

)o records include identification of personnel responsible for samplingand testing;

:.'7.&.7 1re observations, data and calculations recorded at the time they aremade;

:.'7.&.7 1re mistakes in records crossed out, not erased, made illegible ordeleted and the correct value entered alongside;

:.'7 2nternal audits

:.':.' 1re internal audits conducted periodically;

1re internal audits conducted in accordance with a predeterminedschedule and procedure;

)oes the internal audit program address all elements of managementsystem;

)oes the internal audit program address testing activities;

1re auditors trained and independent from the activity to be audited;

:,':.& 1re corrective actions taken timely in case the audit identifieddeviations;

:,':.7 1re audit findings and corrective actions recorded;

:':.: )o follow audit activities record the implementation and theeffectiveness of the corrective actions taken;

:.'! 8anagement reviews

:.'!.' )oes the top management periodically conduct a review of thelaboratory

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2s the review conducted in accordance with a predetermined scheduleand procedure;

)oes the review take account of the suitability of policies andprocedures

)oes the review take account of reports from managerial andsupervisory personnel@

)oes the review take account of the outcome of recent internal audits@

)oes the review take account of corrective and preventive actions

)oes the review take account of assessments by external bodies@

)oes the review take account of the results of interlaboratorycomparisons or proficiency tests@

)oes the review take account of changes in the volume and type ofthe work

)oes the review take account of the results of customer feedback@

)oes the review take account of the results of complaints@

)oes the review take account of recommendations for improvement@@

)oes the review take account of the results of other relevant factors,such as 3uality control activities, resources and staff training.

:.'!.& 1re findings from management reviews and the actions that arise fromthem recorded.

)oes management ensure that those actions are carried out within anappropriate and agreed timescale.

!. Technical 6e3uirements

!.& Personnel

!.&.' )oes the laboratory ensure the competence of laboratory personnel

)oes the laboratory ensure supervision for staff who are undergoingtraining;

2s personnel to perform all assigned tasks through education, training,experience and#or demonstrated skill;


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!.&.& )oes management formulate the goals with respect to the education,training and skills of laboratory personnel;

1re there a policy and procedures for identifying trainingneeds and providing training of personnel.;

2s the the training programme shall be relevant to the present and

anticipated tasks of the laboratory;.

2s the effectiveness of the training actions taken evaluated.

!.&.7 1re all personnel doing 3uality work employed or under contract;

)oes the laboratory ensure that contracted workers supervised inaccordance with the laboratory

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1re measures taken to prevent cross-contamination;

!.7.: 2s access to and use of areas affecting the 3uality of the tests and#or

calibrations controlled;

!.7.! 1re there procedures to ensure good housekeeping in the laboratory;

!.:. Test and calibration methods and method validation

!.:.' 1re there methods and procedures for all tests;

1re there methods and procedures for sampling;

1re there methods and procedures for sample handing;

1re there methods and procedures for sample transport;

1re there methods and procedures for preparation of items to betested;

1re there methods and procedures for measurement uncertainty;

1re there instructions on the use and operation of e3uipment;

1re these instructions up to date;

1re these instructions readily available;

1re deviations from test methods documented, technically =ustified,authori9ed and accepted by customer;

!.:.& 2f standard methods are used, does the laboratory use the latestversion of the standard;

f standard methods are used, does the laboratory confirm that it canproperly operate the method;

2f laboratory-developed methods are they validated;

!.:.7 2s there a procedure to plan the introduction of test methods

developed by the laboratory;

!.:.: 2f non-standard methods are used, is this sub=ect to agreement withcustomers;

2f non-standard methods are used, are there clear specification ofcustomer re3uirements;


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1re there procedures for using new non-standard test methods in alaboratory prior to routine use;

)oes the procedure include an identification;

)oes the procedure include the scope;

)oes the procedure include a description of the type of item to be tested;

)oes the procedure include parameters or 3uantities and ranges to bedetermined;

)oes the procedure include apparatus and e3uipment, including technicalperformance re3uirements;

)oes the procedure include reference standards and reference materialsre3uired;

)oes the procedure include environmental conditions re3uired and anystabili9ation period needed;

)oes the procedure checks to be made before the work is started,

)oes the procedure check that the e3uipment is working properly and,where re3uired, calibration and ad=ustment of the e3uipment before each use

)oes the procedure include the method of recording the observations andresults

)oes the procedure include any safety measures to be observed

)oes the procedure include criteria and#or re3uirements forapproval#re=ection;

)oes the procedure include data to be recorded and method of analysisand presentation

)oes the procedure include the uncertainty or the procedure for estimatinguncertainty.

)oes the procedure include an identification

!.:.! 0alidation of methods

!.:.!.& )oes the laboratory validate non-standard methods;

)oes the laboratory validate laboratory developed methods;

)oes validate standard methods when they are used outside thescope of the standard;

)oes validation of methods include procedures for sampling, handling,transportation and sample handling;


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2s the impact of changes to non-standard methods evaluated anddocumented;

!.:.!.7 )oes validation include setting specifications of re3uirements,determination of the characteristics of the method and check thatre3uirements can be fulfilled;

!.:.> stimation f uncertainty of measurement

!.:.>.' 2s there a procedure to estimate the uncertainty of measurement;

!.:.>.& )oes procedure attempt to identify all components of uncertainties ifthe nature of the test method may preclude rigorous, metrologicallyand statistically valid, calculation of uncertainty of measurement.

!.:. %ontrol of data

!.:..' 1re calculations and data transfers sub=ect to appropriate checks;

!.:..& 2s computer software developed by users documented and validated

1re there procedures to protect electronic data

1re there procedures to ensure integrity of electronic data;

1re there procedures to ensure confidentiality of electronic data

1re computers and automated maintained to ensure properfunctioning

1re software configurations and#or modifications of commercial off theshelf software validated;

!.! 3uipment

!.!.& 2s e3uipment and software 3ualified for the intended use;

2s e3uipment calibrated or checked before it is used;

!.!.7 2s e3uipment operated by authori9ed personnel;

1re up to date operating manuals readily available to users;

!.!.: 2s e3uipment uni3uely identified;

!.!.! )o e3uipment records include the e3uipment identity;

)o e3uipment records include the manufacturer?s name, typeidentification, and serial number or other uni3ue identification;

)o e3uipment records include evidence that e3uipment complies with


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the specification;

)o e3uipment records include the current location, where appropriate;

)o e3uipment records include the manufacturer?s instructions, ifavailable, or reference to their location;

)o e3uipment records include the dates, results and copies of reportsand certificates of all calibrations, ad=ustments, acceptance criteria,and the due date of next calibration;

)o e3uipment records include the maintenance plan, whereappropriate, and maintenance carried out to date;

)o e3uipment records include any damage, malfunction, modificationor repair to the e3uipment;

!.!.> 1re there procedures for safe handling, transport, storage, use andplanned maintenance of e3uipment

!.!. 2s e3uipment that has been sub=ected to overloading or mishandling,gives suspect results, or has been shown to be defective or outsidespecified limits, taken out of service;

2s such e3uipment clearly marked as being out of service;

)oes the laboratory examine the effect of defect on previous tests;

!.!./ 2s e3uipment that re3uires calibration labeled with the calibrationstatus

)oes the label indicate the date of last and next calibration;

!.!.'& 2s e3uipment hardware and software safeguarded from ad=ustmentswhich would invalidate the test results;

!.>. 8easurement traceability

!.>.' )oes the laboratory have an established program and procedures fore3uipment calibration

!.>.& Specific re3uirements

!.>.&.' %alibration

1re e3uipment calibrations traceable to primary or national standards,e.g., through an unbroken chain of calibrations;

2f traceability to primary or national standards is not possible, doescalibration provide traceability to certified reference material providedby a competent supplier


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!.>.7 6eference standards and reference materials

!.>.7.' )oes the laboratory have a program and procedures for calibration of

its reference standards;

!.>.7.& 2s reference material traceable to certified reference material;

!.>.7.: )oes the laboratory have procedures for safe handling, transport,storage and use of reference standards in order to preventcontamination or deterioration and in order to protect their integrity;

!. Sampling

!..' )oes the laboratory have a sampling plan and procedures forsampling

1re the sampling plan and procedures available at the location wheresampling is undertaken;

1re sampling plans based on appropriate statistical methods,wherever possible;

)oes the sampling procedure describe the selection, sampling plan,

withdrawal and preparation of a sample;

!..7 1re there procedures for recording relevant data and operationsrelated to sampling;

)o such records include the sampling procedure;

)o such records include the identification of the sample;

)o such records include the environmental conditions;

)o such records include the sampling location;

)o such records include the statistics the sampling was based on, if

appropriate;

!./. 5andling of test and calibration items


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!./.' 1re there procedures for the transportation, receipt, handling,protection, storage, retention and#or disposal of test and#or calibrationitems

!./.& 2s there a system for uni3ue identification of test items;

!./.7 1re abnormalities or departures from specified conditions recorded

!./.: 1re there procedures and facilities for avoiding deterioration, loss ordamage of test items;

2f test items have to be stored and maintained under specifiedconditions, are the conditions recorded;

!.(. 1ssuring the 3uality of test and calibration results

!.(.' 1re there 3uality control procedures for monitoring the validity of testsundertaken;

1re resulting data recorded in such a way that trends are detectableand, where practical, are statistical techni3ues applied for reviewingthe results;

)oes monitoring include regular use of certified reference materialsand#or internal 3uality control using secondary reference

8aterials;

)oes monitoring include participation in inter laboratory comparison orproficiency-testing programs;

)oes monitoring include replicate tests or calibrations using the sameor different methods;

)oes monitoring include retesting or recalibration of retained items

)oes monitoring include correlation of results for differentcharacteristics of an item;

!.(.& 2s there a procedure on how to handle situations when 3uality control

data are out of predefined criteria

)oes the procedure include corrective and preventive action plans;

!.'" 6eporting of results


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!.'".' 2s there a procedure for recording test and calibration results;

!.'".& )o test reports and calibration certificates include a title;

)o test reports and calibration certificates include the name andaddress of the laboratory;

The location where the tests were carried out, if different from theaddress of the laboratory;

)o test reports and calibration certificates include uni3ue identificationof the test report or calibration certificate Asuch as the serial numberB,and on each page an identification in order to ensure that the page isrecogni9ed as a part of the test report or calibration certificate, and aclear identification of the end of the test report or calibration

certificate;

)o test reports and calibration certificates include the name andaddress of the customer@

)o test reports and calibration certificates include an identification ofthe method used;

)o test reports and calibration certificates include a description of, thecondition of, and unambiguous identification of the itemAsB tested orcalibrated;

)o test reports and calibration certificates include the date of receipt ofthe test or calibration itemAsB where this is critical to the validity and

application of he results, and the dateAsB of performance of the test orcalibration;

)o test reports and calibration certificates include a reference to thesampling plan and procedures used by the laboratory or other bodieswhere these are relevant to the validity or application of the results;

)o test reports and calibration certificates include the test orcalibration results with, where appropriate, the units of measurement;

)o test reports and calibration certificates include the nameAsB,functionAsB and signatureAsB or e3uivalent identification of personAsBauthori9ing the test report or calibration certificate

)o test reports and calibration certificates include a statement to theeffect that the results relate only to the items tested or calibrated,where relevant.

)o printed test reports include a page number and the total number ofpages;

!.'".7.' )o test reports include when necessary+ deviations from, additions to,or exclusions from the test method, and information on specific test


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conditions, such as environmental conditions;

)o test reports include where relevant+ a statement of

compliance#non-compliance with re3uirements and#or specifications

)o test reports include where applicable+ a statement on the estimateduncertainty of measurement@ information on uncertainty is needed intest reports when it is relevant to the validity or application of the testresults, when a customer?s instruction so re3uires, or when theuncertainty affects compliance to a specification limit@

)o test reports include where appropriate and needed, opinions andinterpretations

)o test reports include when necessary+ additional information whichmay be re3uired by specific methods, customers or groups ofcustomers;

!.'".7.& )o test reports containing the results of sampling include, wherenecessary for the interpretation of results+ the date of sampling;

)o test reports containing the results of sampling include, wherenecessary for the interpretation of results+ unambiguous identificationof the substance, material or product sampled Aincluding the name ofthe manufacturer, the model or type of designation and serial numbersas appropriateB;

)o test reports containing the results of sampling include, wherenecessary for the interpretation of results+ t the location of sampling,including any diagrams, sketches or photographs;

)o test reports containing the results of sampling include, wherenecessary for the interpretation of results+ a reference to the samplingplan and procedures used;

)o test reports containing the results of sampling include, wherenecessary for the interpretation of results+ details of any environmentalconditions during sampling that may affect the interpretation of the test

results;

)o test reports containing the results of sampling include, wherenecessary for the interpretation of results+ any standard or otherspecification for the sampling method or procedure, and deviations,additions to or exclusions from the specification concerned.

!.'".: %alibration certificates

)o calibration certificates also include the following, where necessaryfor the interpretation of calibration results+ the conditions Ae.g.environmentalB under which the calibrations were made that have aninfluence on the measurement results;

)o calibration certificates also include the following, where necessary


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for the interpretation of calibration results+ the uncertainty ofmeasurement and#or a statement of compliance with an identifiedmetrological specification or clauses thereof;

)o calibration certificates also include the following, where necessaryfor the interpretation of calibration results+ evidence that themeasurements are traceable

!.'"./ Chen amendments to a test report after issue are made, is this madein a form of a further document or as a DSupplement yp Test 6eportE


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