A simple way to understand and practice the clauses covered by ISO 17025.docx

8/20/2019 A simple way to understand and practice the clauses covered by ISO 17025.docx

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A simple way to understandand practice the clausescovered by ISO 17025:2005I have been a part of an accredited laboratory for 10 years now and have successfullyfaced more than 12 audits based on the ISO 17025 standard. In the early days I used tothink that the ISO standard is a complete waste of time and nothin but unnecessarypaperwork burdenin the scientists and other team members in the lab! keepin themaway from the more important thins.

"ut over the years I#ve come to realise that in essence the standard provides a

comprehensive framework coverin all the critical activities that must be carried out in asystematic manner to run the laboratory and keep our customers happy.

$he ISO 17025 standard is the outcome of the %oint effort and combined knowlede andwisdom of e&perts from all over the world! layin down the framework for successfullymeetin the customer#s re'uirement by the laboratory.

I#m sure if you even tried readin the standard! let alone tried to memorise the clauses! itcan seem very dry! borin and somewhat overwhelmin. $o overcome this problem! Ihave decided to present the clauses of the standard in the loical se'uence makin it

more fun and simpler to understand .(ow I feel that it is more important that youunderstand the loical flow in which the clauses have been presented in the standardand put them in practice in your daily practice.

)ou miht say that one doesn#t need to remember all the clauses! and that one canalways refer back to the standard when there is a need. On the other hand if you canidentify the benefits that you can reap by adherein to and practisin the standard inyour laboratory you will over a period of time have the clauses on your finertips withoutthe need for memori*in. It is more important to ac'uire the lon term ains that willcome your way in earnin respect of clients and acceptance of your analysis reportsanywhere in the world. In this topic I have made your task easy by simply presentin the

benefits of each clause of the standard in a loical succession without oin into thetechnicalities so that you can visualise the benefits from day one.

So now let#s et started+

ISO 17025 is the first internationally accepted standard for laboratory 'uality systemsthat provides a basis for accreditation .It comprises of two sub,sections of clauses!namely -anaement re'uirements and technical re'uirements.


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ISO 17025

ere is how the se'uence flows./isualise that you are oin to set up a laboratory. $heob%ective is to provide analysis and contract service to your customers to their satisfaction.$o efficiently run the laboratory you will have to have a manaement team aswell as technical facilities.ISO 17025 precisely addresses the roles and responsibilitiesof manaement as well as technical re'uirements..

Manaement !e"uirements


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-anaement e'uirements

#lause $%1&Orani'ation& your laboratory has its own identity

"efore anythin else there has to be an oranisation and so the leal identity! type of oranisation and the scope of activities of the oranisation are addressed in this clause.

#lause $%2&Manaement system& (uality )olicy manual


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Once you have an oranisation! you need a manaement system based on 'ualityob%ectives of the laboratory. ocuments and their adherence in riht earnestness is theessence of clause .2.

#lause $%*&+ocument #ontrol& review and approval

$o create the manaement system and implement it the first and foremost thin is needto properly document the system and the procedures. 3lause .4 covers documentcontrol! issuance of document and chanes to the documents.

#lause $%$&!eview o, re"uests-tenders and contracts&accept challenes ahead

(ow that the oranisation manaement system and basic documentation are in place !you are all set to review re'uests! tenders and contracts under the clause ..

#lause $%5&Subcontractin o, tests and calibrations&outsource i, you need to

hile reviewin the re'uest tenders and contract that miht arise you may need tooutsource or sub contract some of the test parameters. $he task should be outsourcedonly with client#s consent to another accredited laboratory

#lause $%.&)urchasin -Services and supplies&(uality o, inputs decides theoutputs

(ow that you have reviewed the re'uests and contracts the laboratory is all set to startworkin! but to work 'uickly to have supplies like chemicals lassware and services likecalibration seek approval of 6uality ssurance -anaer before releasin the orders.

#lause $%7&Service to the customerustomer ,eedbac/ always matters

(ow the contract is in place! materials are there in the lab and it is time to ive the bestservice to the customer. -aintain friendly customer relations throuh oodcommunication! timely e&ecution of analysis! maintainin confidentiality and seekinreular feedback.

#lause $%omplaints&satis,ied customer is you ,ree o, cost advertiser

hile servin the customer there are bound to be complaints which must be addressedand investiated properly and also the corrective action must be taken promptly.8rovidin solutions will also enrich your e&perience.

$%ontrol o, noncon,ormin testin and or calibration wor/&3eep options open,or ,air investiations

s such there will always be complaints. $here is also a possibility of other nonconformin work bein carried out by the laboratory. $hus it is important to control


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nonconformin testin and calibration and procedures and policies to handlenonconformin work. 8owers should be deleated to manae such situations.

#lause $%10&Improvements& s/y is the limit ,or improvements

3omplaints are a reat way to identify potential areas for improvement.I3reate specialistteams for identification and monitorin of improvement plans.

#lause $%11orrective Action&always /eep an open mind

(ow that subse'uent to a complaint immediate action has been taken on thenonconformin work! it is critical to carry out the re'uired correction! root cause analysisand corrective actions. It is important to prevent the same mistakes from occurrin aainin the future.

#lause $%12&)reventive Action&)revention is better than cure

proactive approach based on feedbacks! 'uality checks! trend analysis! etc to preventcomplaints and customer dissatisfaction from occurrin. 8olicies and procedures shouldbe in place to identify potential causes for nonconformity and solvin them before thenonconformity occurs.

#lause $%1* #ontrol o, !ecords&records preserve the se"uence o, activities

ll the activities relatin to! purchase! service to the customer! complaints! improvementand corrective and preventive action! audit reports!etc will enerate a lot of documents.$here is a pressin re'uirement for policies and procedures pertainin to control of records.

#lause $%1$ Internal audit& sel, inspection always pays

ll these records enerated and different activities carried out in the laboratory must beperiodically audited internally to ensure that the systems are bein followed. $o achievethese oals policy and procedures need to be defined for carryin out internal audits.

#lause $%15&Manaement !eview&Involve your manaement in up/eep o, "ualitysystems

$op,down and bottom,up communication in the oranisation is the key to success. It isimportant to discuss any new re'uirements! audit findins !etc with the top manaementin an open and interactive forum.

nd with this we come to the end of the manaement re'uirement of ISO 17025 coveredunder clauses .1 to .15.


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4echnical !e"uirements

$echnical e'uirements

(ow that the manaement system is in place. $he second! and perhaps even moreimportant part is the technical re'uirements.

#lause 5%1& eneral& wor/out the s/ills re"uiremets o, your manpower in advance

$he clause talks about the technical re'uirements in eneral! statin the differentheadins under which the technical re'uirements are covered and emphasisin thatthese factors contribute to the total uncertainty of measurement and must be consideredas important factors while developin methods procedure! trainin! 'ualification of personnel and in the selection and calibration of e'uipment.

#lause 5%2&)ersonnel& reular updation o, technical s/ills is a must

$he first and foremost technical component of any laboratory is the technical staff! so 5.2starts by talkin about the re'uirements related to personnel. $he personnel must be


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suitably 'ualified and trained. $he laboratory must have a plan for onoin traininbased on the %ob descriptions and responsibilities of the personnel.

#lause 5%*&Accommodation and 6nvironmental #onditions&ood house/eepinplans improve "uality

fter personnel! the accommodation and environmental conditions should be iven aserious thouht. $he laboratory staff and e'uipment re'uire suitable accommodationand environmental conditions to be able to carry out the testin and calibration activities.3lause number 5.4 states that the facility should be neat and tidy! with controlled accessand ade'uate separation between incompatible activities. It is very important to providethe necessary utilities like sufficient lihtin! temperature! humidity control! etc so thatthe work can be carried out accurately.

#lause 5%$&4est and #alibration methods and method validation& validate all in&

house methods be,ore adoptin

$he personnel and the laboratory infrastructure are now in place! but for carryin out anytest or calibration activities there is need to have suitable methods for testin andcalibration. 3lause number 5. talks about the selection of suitable methods be itstandard methods! laboratory developed methods or non,standard methods. hen non,standard or laboratory developed methods are used! they must be suitably validated.3lause number 5. also talks about estimation of uncertainty of measurement for themethod used in the laboratory and control of data enerated from the test and calibrationactivities.

#lause 5%5&6"uipment&/eep your e"uipment maintained and calibrated at all times

(ow that the personnel have suitable accommodation and the methods are in place tomeet to carry out the test or calibration activities! clause number 5.5 lays down there'uirements related to e'uipment such as the e'uipment should comply to thespecifications laid down in the methods! there should be a reular calibration proram!authorised personnel for usin the e'uipment! proper identification of the e'uipment!maintenance plan! etc.

#lause 5%.&Measurement 4raceability and #alibration&establish traceability o,

standards be,ore calibration

(ow we have all the re'uired infrastructure in place! like a ood team! proper accommodation! suitable methods and e'uipment. It is essential to have measurementtraceability to national and international standards to make sure that the resultsproduced by the laboratory are compatible to the results produced by any other competent laboratory anywhere in the world. 3lause 5.9 talks about the re'uirementsspecific for both testin and calibration laboratories for maintainin these measurementtraceability by usin suitable reference standards! reference materials! and performinreular intermediate checks as per defined procedures and schedules.

#lause 5%7&Samplin& always ,ollow established norms ,or sample collection andpreparation


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:aboratory with duly calibrated e'uipment! suitably validated methods and trainedpersonnel is ready for carryin out testin. "ut before testin the samples collection andtreatment must be based on established procedures.. $his clause number 5.7 lays downthe re'uirements of samplin! statin that the laboratory must have suitable procedureand plan for samplin and should also maintain proper records related to this activity.

#lause 5%&andlin o, #alibration and test samples&preserve interity o, standards and samples%

fter samplin the samples have to reach the laboratory and have to be appropriatelyhandled durin transportation to the laboratory and also handled properly within thelaboratory to maintain their interity. 3lause number 5.; clearly states that the laboratorymust have procedure for receivin samples and standards. andlin! storae andretention should have a system for identifyin the samples throuhout the life of the itemin the laboratory. It also states the re'uirement for havin suitable facilities for avoidinincorrect analytical results.

#lause 5%&Assurin the "uality o, test and calibration results&assure the validityo, data enerated by the lab

3lause number 5.< talks about ensurin the 'uality of testin calibration results! which isan essential routine activity now that samples are in the laboratory and are bein tested.It suests that this can be achieved by reular use of certified materials or participationin into laboratory comparison and replicate testin ! etc.

#lause 5%10&!eportin the results& your analysis report layout e8presses your

level o, pro,essionalism

$he last and final step of workin in the laboratory eneration of the report and the lastclause of the standard clause number 5.10 very elaborately e&plains what all must bepresented in the final test report. It states that the report must have information like atitle! name and address of the laboratory ! uni'ue identification number for the report!etc.

A simple way to understand and practice the clauses covered by ISO 17025.docx

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