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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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ISO Clause e.uirement %omment
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
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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;
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;
:.&.:
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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;
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;
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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 :.>.:
:./ %omplaints
)oes the laboratory have a policy and procedure for the resolution of complaints received from customers;
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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;
:.'&.&
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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, 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;
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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.
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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;
!.7.7
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.!
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;
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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 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;
)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;
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!.>.7 !.>.7.' !.>.7.& !.>.7.: 6eference standards and reference materials
)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;
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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;
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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;
)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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