Checklist

ISO 17025

This document is a proposal and starting point only. The type and extent of documentation depends on the process environment. The proposed documentation should be adapted accordingly and should be based on individual risk assessments. There is no guarantee that this document will pass a regulatory inspection.

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%hecklist )ocument *umber+ ,-'./ 0er. '.xx &"'& Checklist ISO 17025

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1. PU POS! O" #$! C$!C%&IS#

2S '."&! is a global standard for calibration and testing laboratory. perating laboratory activities according to the standard 3ualifies laboratories to get accreditation status and is an excellent foundation to pass regulatory 3uality re3uirements. %hecklists help to develop, implement and maintain 2S '."&! processes consistently and efficiently. 4ecause each procedure is different going through checklists does not mean that everything is covered nor does it mean that all checklist items are applicable for each laboratory. The checklist is aligned with 2S '."&!. 5owever, it does not refer to all items as stated 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 includes items that re3uire further interpretations. Therefore the checklist is not a substitute of the standard but is complementary 2S '."&! re3uirement that are only applicable to calibration laboratories but not to testing 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+*PP O,*&S

Prepared by *ame Signature )ate 6eviewed by 1pproved by

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-. C$!C%&IS#
ISO Clause e.uirement %omment

'.'. 8anagement 6e3uirements+

:.'' :.'&. :.'.7 :.'.: :.'.! a :.'.! b

rgani9ation

%an the laboratory be held legally responsible; 2s it the responsibility of the laboratory to carry out testing and calibration activities to meet 2S '."&! re3uirements; )oes the management cover work carried throughout all laboratory facilities; 1re the responsibilities of key personnel defined in order to identify potential conflicts of interest; )oes the laboratory management and technical personnel have the authority and resources to carry out all their duties; )oes the laboratory have arrangements to ensure that it<s management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work; )oes the laboratory have policies and procedures to protect the customers confidential information )oes the laboratory have policies and procedures to avoid involvement in any activities that would diminish operational integrity; )oes the laboratory define organi9ation and management structure of the laboratory )oes the laboratory specify responsibility of all personnel who manage or perform work affecting 3uality )oes the laboratory provide ade3uate supervision of testing and calibration staff

:.'.! c :.'.! d

:.'.! e :.'.! f :.'.! g

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:.'.! h :.'.! i :.'.! = :.'.! k

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)oes the laboratory have technical management which has overall responsibility for the technical operations )oes the laboratory appoint a member of staff as 3uality manager )oes the laboratory appoint deputies for key management personnel; )oes the laboratory ensure that its personnel are aware of the relevance and importance of their activities;

'.&. 8anagement 6e3uirements+

:.&.' :.&.& :.&.7

rgani9ation

)oes the laboratory establish, implement and maintain a management 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 )oes the top management provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness; )oes top management communicate to the organi9ation the importance of meeting customer re3uirements as well as statutory and regulatory re3uirements; )oes the 3uality manual include or make reference to the supporting procedures including technical procedures; 1re the roles and responsibilities of technical management and the 3uality manager defined; )oes top management ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented;

:.&.:

:.&.! :.&.> :.&...

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

:.7.' :.7.&.'. )oes the laboratory establish and maintain procedures to control all documents that form part of its management system; 1re all documents issued to personnel in the laboratory as part of the management system reviewed and approved for use by authori9ed personnel prior to issue; FOR INTERN !

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:.7.&.& a :.7.&.& b :.7.&.& c :.7.&.& d :.7.7.' :.7.7.& :.7.7.7 :.7.7.: 1re documents periodically reviewed; 1re obsolete documents removed;

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1re authori9ed documents available at all appropriate locations;

1re obsolete documents that need to be retained suitably marked; 1re changes to documents reviewed and approved; 2s changed document text identified in the document; 1re procedures to make document changes by hand defined; 1re there procedures that describe changes made for electronic document management systems;

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

:.:.' :.:.& :.:.7 :.:.: :.:.! )oes the laboratory have procedures for the review of re3uests, tenders and contracts; )oes the laboratory record reviews and changes; )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 new contracts;

:.!. Subcontracting of tests and calibrations

:.!.' :.!.& :.!.7. :.!.:. 2s subcontracted work placed to a competent party; 1re customers made aware of subcontracting work; 2s the laboratory made responsible to the customer for the subcontractor<s work; )oes the laboratory maintain a list of subcontractors;

:.> Purchasing Services and Supplies

:.>.' )oes the laboratory have a policy and procedures for selecting and purchasing of services and supplies; FOR INTERN !

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)oes the laboratory shall ensure that purchased materials that affect the 3uality of tests and#or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or re3uirements defined in the methods for the tests and#or calibrations concerned; )o purchasing documents contain data describing the services and supplies ordered; )oes the laboratory evaluate suppliers of critical material and services;

:.>.7 :.>.:

:.. Service to customer

:...' :...& 2s the laboratory willing to cooperate with customers in clarifying a customer?s re3uest to monitor the laboratory<s performance; )oes the laboratory seek feedback from its customers;

:./ %omplaints
)oes the laboratory have a policy and procedure for the resolution of complaints received from customers;

:.( %ontrol of nonconforming testing and#or calibration work

:.(.' )oes the laboratory have a policy and procedure in case laboratory work does not conform with laboratory procedures or customer expectations 1re actions defined in case laboratory work does not conform with laboratory procedures or customer expectations 2s the significance of the non-conforming work defined; 1re corrective actions taken immediately; 1re customers informed about non-conforming work and is work recalled; 2s the responsibility for authori9ing the resumption of the work defined;

:.(.' a :.(.' b :.(.'. c :.(.' c :.(.' d

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:.(.&

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1re corrective action procedures promptly followed when non conforming work could recur;

:.'" 2mprovement
:.'" )oes the laboratory continually improve the effectiveness of its management system;

:.'' %orrective action

:.''.' :.''.& :.''.7 :.''.: :.''.! 2s there a policy and a procedure for implementing corrective actions when non conforming work has been identified; )oes the procedure start with a root cause analysis; )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 non conformities identified and preventive action plans developed, implemented and monitored; 1re preventive actions ensured that they are effective;

:.'&.&

:.'7 %ontrol of records

:.'7.'.' :.'7.'.& :.'7.'.7 :.'7.'.: 1re there procedures for identification, collection, indexing, access, filing, maintenance and disposal of 3uality and technical records; 1re records stored such that they are readily available 1re records secure and confidential; 1re there procedures to protect and back-up electronic records and to

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prevent unauthori9ed access; :.'7.&.&

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1re records of original observations, derived data and sufficient information to establish and audit trail, calibration records, staff records, and a copy of each test reports or calibration certificates retained; )o records include identification of personnel responsible for sampling and testing;

:.'7.&.7 :.'7.&.7

1re observations, data and calculations recorded at the time they are made; 1re mistakes in records crossed out, not erased, made illegible or deleted and the correct value entered alongside;

:.'7 2nternal audits

:.':.' 1re internal audits conducted periodically; 1re internal audits conducted in accordance with a predetermined schedule and procedure; )oes the internal audit program address all elements of management system; )oes the internal audit program address testing activities; 1re auditors trained and independent from the activity to be audited; :,':.& :,':.7 :':.: 1re corrective actions taken timely in case the audit identified deviations; 1re audit findings and corrective actions recorded; )o follow audit activities record the implementation and the effectiveness of the corrective actions taken;

:.'! 8anagement reviews

:.'!.' )oes the top management periodically conduct a review of the laboratory<s management system and testing and/or calibration activities to ensure their continuing suitability and effectiveness, and to introduce necessary changes or improvements?

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2s the review conducted in accordance with a predetermined schedule and procedure; )oes the review take account of the suitability of policies and procedures )oes the review take account of reports from managerial and supervisory 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 interlaboratory comparisons or proficiency tests@ )oes the review take account of changes in the volume and type of the 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 from them recorded. )oes management ensure that those actions are carried out within an appropriate and agreed timescale.

!. Technical 6e3uirements !.& Personnel

!.&.' )oes the laboratory ensure the competence of laboratory personnel )oes the laboratory ensure supervision for staff who are undergoing training; 2s personnel to perform all assigned tasks through education, training, experience and#or demonstrated skill;

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!.&.&

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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 training needs 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 in accordance with the laboratory<s management system; !.&.: !.&.! )oes the laboratory maintain current =ob descriptions; )oes the management authori9e specific personnel to perform particular types of sampling, test and#or calibration, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of e3uipment; )oes the laboratory shall maintain records of the relevant authori9ationAsB, competence, educational and professional 3ualifications, training, skills and experience of all technical personnel, including contracted personnel. This information shall be readily available and shall include the date on which authori9ation and#or competence is confirmed;

!.7 1ccommodation and environmental conditions

. !.7.' )ies the laboratory ensure that the environmental conditions do not invalidate the results or adversely affect he re3uired 3uality of any measurement 1re the technical re3uirements for accommodation and environmental conditions that can affect the results of tests and calibrations documented. !.7.& 1re control and record environmental conditions as re3uired by the relevant specifications controlled, monitored and recorded,

!.7.7

2s there effective separation between neighboring areas in which there are incompatible activities.

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1re measures taken to prevent cross-contamination; !.7.: !.7.!

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2s access to and use of areas affecting the 3uality of the tests and#or calibrations controlled; 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 be tested; 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 latest version of the standard; f standard methods are used, does the laboratory confirm that it can properly 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 with customers; 2f non-standard methods are used, are there clear specification of customer re3uirements;

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1re there procedures for using new non-standard test methods in a laboratory 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 be
determined;

)oes the procedure include apparatus and e3uipment, including technical

performance re3uirements;

)oes the procedure include reference standards and reference materials

re3uired;

)oes the procedure include environmental conditions re3uired and any

stabili9ation 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 and
results

)oes the procedure include any safety measures to be observed )oes the procedure include criteria and#or re3uirements for approval#re=ection; )oes the procedure include data to be recorded and method of analysis
and presentation

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

)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 the scope 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 and documented; !.:.!.7 )oes validation include setting specifications of re3uirements, determination of the characteristics of the method and check that re3uirements 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 if the nature of the test method may preclude rigorous, metrologically and 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 proper functioning 1re software configurations and#or modifications of commercial off the shelf 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, type identification, and serial number or other uni3ue identification; )o e3uipment records include evidence that e3uipment complies with

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the specification;

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)o e3uipment records include the current location, where appropriate; )o e3uipment records include the manufacturer?s instructions, if available, or reference to their location; )o e3uipment records include the dates, results and copies of reports and certificates of all calibrations, ad=ustments, acceptance criteria, and the due date of next calibration; )o e3uipment records include the maintenance plan, where appropriate, and maintenance carried out to date; )o e3uipment records include any damage, malfunction, modification or repair to the e3uipment; !.!.> !.!.. 1re there procedures for safe handling, transport, storage, use and planned 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 outside specified 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 calibration status )oes the label indicate the date of last and next calibration; !.!.'& 2s e3uipment hardware and software safeguarded from ad=ustments which would invalidate the test results;

!.>. 8easurement traceability

!.>.' !.>.& !.>.&.' )oes the laboratory have an established program and procedures for e3uipment 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, does calibration provide traceability to certified reference material provided by a competent supplier

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!.>.7 !.>.7.' !.>.7.& !.>.7.: 6eference standards and reference materials

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)oes the laboratory have a program and procedures for calibration of its reference standards; 2s reference material traceable to certified reference material; )oes the laboratory have procedures for safe handling, transport, storage and use of reference standards in order to prevent contamination or deterioration and in order to protect their integrity;

!.. Sampling
!...' )oes the laboratory have a sampling plan and procedures for sampling 1re the sampling plan and procedures available at the location where sampling 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 operations related 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 calibration items 2s there a system for uni3ue identification of test items; 1re abnormalities or departures from specified conditions recorded 1re there procedures and facilities for avoiding deterioration, loss or damage of test items; 2f test items have to be stored and maintained under specified conditions, are the conditions recorded;

!./.& !./.7 !./.:

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

!.(.' 1re there 3uality control procedures for monitoring the validity of tests undertaken; 1re resulting data recorded in such a way that trends are detectable and, where practical, are statistical techni3ues applied for reviewing the results; )oes monitoring include regular use of certified reference materials and#or internal 3uality control using secondary reference 8aterials; )oes monitoring include participation in inter laboratory comparison or proficiency-testing programs; )oes monitoring include replicate tests or calibrations using the same or different methods; )oes monitoring include retesting or recalibration of retained items )oes monitoring include correlation of results for different characteristics 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;

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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 and address of the laboratory; The location where the tests were carried out, if different from the address of the laboratory; )o test reports and calibration certificates include uni3ue identification of the test report or calibration certificate Asuch as the serial numberB, and on each page an identification in order to ensure that the page is recogni9ed as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate; )o test reports and calibration certificates include the name and address of the customer@ )o test reports and calibration certificates include an identification of the method used; )o test reports and calibration certificates include a description of, the condition of, and unambiguous identification of the itemAsB tested or calibrated; )o test reports and calibration certificates include the date of receipt of the test or calibration itemAsB where this is critical to the validity and application of he results, and the dateAsB of performance of the test or calibration; )o test reports and calibration certificates include a reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results; )o test reports and calibration certificates include the test or calibration results with, where appropriate, the units of measurement; )o test reports and calibration certificates include the nameAsB, functionAsB and signatureAsB or e3uivalent identification of personAsB authori9ing the test report or calibration certificate )o test reports and calibration certificates include a statement to the effect 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 of pages;

!.'".7.'

)o test reports include when necessary+ deviations from, additions to, or exclusions from the test method, and information on specific test FOR INTERN !

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conditions, such as environmental conditions;

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)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 estimated uncertainty of measurement@ information on uncertainty is needed in test reports when it is relevant to the validity or application of the test results, when a customer?s instruction so re3uires, or when the uncertainty affects compliance to a specification limit@ )o test reports include where appropriate and needed, opinions and interpretations )o test reports include when necessary+ additional information which may be re3uired by specific methods, customers or groups of customers; !.'".7.& )o test reports containing the results of sampling include, where necessary for the interpretation of results+ the date of sampling; )o test reports containing the results of sampling include, where necessary for the interpretation of results+ unambiguous identification of the substance, material or product sampled Aincluding the name of the manufacturer, the model or type of designation and serial numbers as appropriateB; )o test reports containing the results of sampling include, where necessary 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, where necessary for the interpretation of results+ a reference to the sampling plan and procedures used; )o test reports containing the results of sampling include, where necessary for the interpretation of results+ details of any environmental conditions during sampling that may affect the interpretation of the test results; )o test reports containing the results of sampling include, where necessary for the interpretation of results+ any standard or other specification 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 necessary for the interpretation of calibration results+ the conditions Ae.g. environmentalB under which the calibrations were made that have an influence 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 of measurement and#or a statement of compliance with an identified metrological specification or clauses thereof; )o calibration certificates also include the following, where necessary for the interpretation of calibration results+ evidence that the measurements are traceable !.'"./ Chen amendments to a test report after issue are made, is this made in a form of a further document or as a DSupplement yp Test 6eportE

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