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    BH Standard 17025

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    BOSANSKOHERCEGOVACKI BANS STANDARD EN ISO/NEC 17025 Drago izdanje April 2006 1€803.120.20 Ukupno strana: 54 Opéi zahtjevi za kompetentnost ispitnih i kalibracionih laboratorija (EN ISO/IEC 17025:2005, IDT) General requirements for the competence of testing and calibration laboratories {EN ISONEC 17025:2005, IDT) BOSN NE KONTRGLISANA KOPHA bro: __ 7 Reterentr bro BAS EN ISOIEC 170252006 (bs, en) * O Unrotasareiikepizre Glog dourrentalrsgpuh clo rie darlene BAS EN ISONEC 17025:2008 Nacionaini predgovor Bosanskohercegovatki standard BAS EN ISO/IEC 17025:2006, Opéi zahtjevi za kompetentnost ispitnih i kalibracionih laboratoriia, drugo izdanje, identi¢an je prijevod engleske verzije evropskog standarda EN ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories, drugo izdanje, i ima status bosanskohercegovatkog standarda. Tekst medunarodnog standarda ISO/IEC 17025:2005, koji je pripremio ISOICASCO, Komitet za ocjenjivanje uskladenosti, u saradnji sa Tehnigkim komitetom CENICLG/TC 1, Kriterji za tijela za ocjenjivanjo uskladenosti, odobrili su evropski komitet 2a standardizaciu (CEN) i evropski komitet za standardizaciju u elektrotehnici (CENELEC) kao evropski standard EN ISO/IEC 17025:2005. Ovo izdanje bosanskohercegovaékog standarda na bosanskom i engleskom jeziku pripremila je Radna grupa BAS/TC 3/NG 1, Ocjenjivanje uskladenosti, a prihvatio Tehnicki komitet BAS/TC 3, Upravijanje kvalitetom i osiguranje kvaliteta. U sluéaju spora u tumatenju teksta mjerodavan je izvorni standard na engleskom jeziku. Bosanskohercegovatki standard BAS EN ISO/IEC 17025:2005 odobrio je direktor BASMP BIH (Odluka OS- 008/08) Ovo izdanje bosanskohercegovatkog standarda_BAS EN ISO/IEC 17025:2006, zamjenjuje prvo izdanjo BASJEN ISO/IEC 17025:2000, Opéi zahtjevi za kompetentnost laboratonja za ispitivanja i kalibracie. NAPOMENA Rijeci "medunarodni standard” u tekstu standarda podrazumijevaju "bosanskohercegovatki standard’. EVROPSKI STANDARD EN ISO/IEC 17025 EUROPEAN STANDARD Maj 2005 NORME EUROPEENNE EUROPAISCHE NORM ICS 03.120.20 Zamijenjuje EN ISONEC 17025:2000 Verzija na bosanskom jeziku Opéi zahtjevi za kompetentnost ispitnih i kalibracionih laboratorija (ISO/IEC 17025:2005, IDT) General requirements for he competence Exigences générales concernant la Aligomeine Anforderungen an die of testing and calibvation laboratories compétence des laboratores Cétalonnages _Kompeteng von Prif- und Kaliviera- (iSONEG 17025:2005, 1DT) fof dessais (ISONEC 17026:2005) boratovion (ISONEC 17025:2005) (Oval evropski standard odobril su CEN |CENELEC 15. marta 2008. Clarice CEN-a i CENELEC-a obavezne su da se pridréavaly intemin pravla CENCENELEC, koja propisuju uvjte za davanje over evropskom standardu statusa nacionalnog standarda bez bilo kakvin izmijena. Najnovije liste i bibliogratske reference, koje se odnose na takve nacionaine standarde, mogu se dobiti na zahijev u Centralnom sekretarljatu il kod bilo koje tlanice CEN-a. Oval evropski standard postoj u tri zvaniéne verzije (verzija na engleskom, francuskom i njemaékom jeziku). Verziia na bilo kom drugom jeziku, koju je na viastity odgovornost élanica CEN-a prevela na nacionaini jezik io tome obavijestila Centraini sekretarat, ima ist status kao i zvaniéne verzie. Glanice CEN-a su nacionalna tila 22 standarde Iz Aust, Belgie, Cotke Republke, Danske, Estonie, Finske, Francuske, Gréke, Holandije,Irsk, Islanda, talje, Kipra, Latvje, Livan, Luksemburga, Madarske, Mato, Njemacke, Norveske, Pojske, Portugala, Siovaéke, Slovenie, Spanie, Svedske, Svajcarske i Velke Britanie. cee Evropski komitet za standardizaciju European Committee for Standardization Comité Européen de Normalisation Europaisches Kornitee far Normung Centar za management ie de Stassart, 36 B-1050 Brussel (© 2004 Clanice CEN zadréavaju prava koristenja wu bilo kejem oblku Ina blo Koj natin, Ret. Br. EN ISOMEC 17000-2006 (bs, en) 2 EN ISOMEC 17025:2005 Predgovor Ovaj dokument (EN ISO/IEC 17025:2005) pri- premio je Tehnitki komitet ISO/CASCO, Komitet a ocjenjivanje uskladenosti, u_saradnji sa Tehni¢kim komitetom CEN/CLC/TCI, Kritenji za tela za ocjenjivanje uskladenosti, ii sekretar- jat vodi SN. ‘Ovom evropskom standardu mora se dati status nacionainog standarda, bilo _publiciranjem identiénog teksta ili progla8avanjem, najkasnije do novembra 2005., a nacionain! standardi koji Su u suprotnosti, moraju se povuél najkasnije do novembra 2005. godine. Ovaj_ dokument zamijenjuje EN ISO/IEC. 17025:2000. U_ skladu sa CEN/CENELEC-ovim Internim praviima, ovaj evtopski standard obavezne su implementirati nacionaine organizacije za standarde sljedecih zemalja: Austrije, Belgile, Kipra, Ce&ke Repubike, Danske, Estonije, Finske, Francuske, Gréke, Holandije, Irske, Islanda, Htalje, Latvije, Litvanija, Luksemburga, Malte, Madarske, Njemaéke, Norveske, Poljske, Portugala, Siovatke, Slovenije, Spanije, Svedske, Svajcarske i Ujedinjenog Kraljevstva. Napomena o preuzimanju CEN i CENELEC odobrii su tekst medunaro- dnog standarda ISO/IEC 17025: 2005 kao evropski standard EN ISO/IEC 17025: 2005 bez bilo kakvih modifikacija. Foreword This document (EN ISOMEC 17025:2005) has been prepared by Technical Committee ISO/CASCO,,Committee on conformity assessment” in. collaboration with Technical Committees CEN/CLC C1 ,,Criteria for conformity assessment bodies", the secretariat of which Is held by SN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2005, and. conflicting national standards shall be withdrawn at the latest by November 2005. This document supersedes EN ISO/IEC 17025:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, loeland, Ireland, ttaly, Latvia, Lithuania, Luxembourg, Malta, ‘Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO/IEC 17025:2005 has been approved by CEN and CENELEC as EN ISO/IEC 17028:2005 without any modifications. EN ISO/EC Sadriqj Contents Strana Page Predgovor 4 Foreword 4 Uvod 5 Introduction 5 4 Podruéje primjene 7 1 Scope 7 2 Upuéivanja na normativna 8 2 Normative references, 8 dokumenta 3 Termini i definicije 8 3 Terms and defintions 8 4 Zahtjevi u vezi sa upravijanjem 9 4 — Management requirments 9 4.1 Organizacija 8 44 Organization 9 4.2 Sistem upravijanja 11 42 Management system “1 4.3 Kontrota dokumenata 12 43 Document control 2 4.4 Preispitivanje zahtjeva, ponuda i 1444 Review of requests, tenders and 14 ugovora contracts 4.5 Podugovaranje ispitivania i kalibracija 15 4.5 Subconracting of tests and calibra- 15 tions 46 Nabavka usluga i proizvoda 15 4.6 Purchasing services and supplies 16 4.7 Odnosi sa kupcem 18 47 Senvice to the customer 16 48 Prigovori 17 48 Complaints 7 4.9 Kontrota neuskladenosti posia 17 49 Control of nonconforming testing 7 ispitivanja ili kalibraciia and/or calibration work 4.10 PoboliSavanje 18 4.10 Improvement 18 4.11 Korektivna akcija 18 411. Corrective action 18 4.12. Preventivna akcija 19 4.12 Preventive action 19 4.13. Kontrola zapisa 19 4.13. Control of records 19 4.14 Intemi audit 244.44 Internal audits 24 4.15. Preispitivanja od rukovodstva 22 4.18 Management reviews 22 5 Tehniéki zahtjevi 22 8 Technical requirements 22 5.1 Opéenito 22 5.41 General 22 52 Osoblie 23 52 Personnel 23 5.3. Uvjeti za smje8taj i okolinu 24 5.3 Accomodation and enviromental 24 conditions 5.4 Metode za ispitivanja ikalibraciei 25 «5.4 Testand calibration methods and 25 metoda validacije method validation 55 Oprema 30 5.5 Equipment 30 58 Sliedivost mjerenja 325.6 Measurement traceability 32 5.7 Uzorkovanje 365.7 Sampling 36 5.8 Postupanje sa predmetima ispitivanja 38 | 5.8 Handling of test and calibration items 38 i kalibracija 5.9 Osiguranje kvaliteta rezultata 39 5.9 Assuring the quality of test and cali 39 ispitivanja i Kalibracija bration results 5.10. lzvjestavanie o rezultatima 395.10 Reporting the results 39 Dodatak A (informativan) 44 Annex A (informative) 44 Uporedini pregled sa ISO 9001:2000 Nominal cross-references to ISO 9001:2000 Dodatak B (informativan) 48 Annex B (informative) 46 ‘Smjemice za utvrdivanje primjene za speci- Guidelines for establishing applications for ‘lena podrugja specific fields Bibliografija 48 Bibliography 48 4 EN ISOMEC 17025:2005 Predgovor ISO (Medunarodna organizacija za standardi- zaciiu) i IEC (Medunarodna komisija za elekirotehniku) éine specijalzirani sister svjetske standardizacije. Nacionaina tijela, Koja su élanice ISO ili IEC, uéestvuju u razvoju medunarodnin standarda putem —_tehni¢kin—_-komiteta, uspostavijenih pri ovim organizacijama sa ciljem bavienja odredenim —podrugjima _tehni¢kin djelatnosti, Tehnigki komiteti 1SO-a i IEC-a saraduju u podrugjima koja su od medusobnog interesa. U radu, takoder, uzimaju uéeSée i druge medunarodne organizacije, viadine i neviadine, koje imaju vezu sa ISO i IEC. Komitet ISO za ocjeniivanje uskladenosti (CASCO) odgovoran je za razvoj medunarodnih standarda i vodita u podrugju ocjenjivanja usktagenost Medunarodni standardi pripremaju se u skladu sa pravilima datim, u ISO/EC Direktivama, Dio 2. Nacrti medunarodnin standarda dostavijaju se na glasanje tijelima clanica. Da bi se objavili kao medunarodni standard, potrebno je da ih odobri nnajmanje 75% tela Slanica koja su uzela ueesée uglasanju, Skreée se painja na moguénost da neki elementi ‘vog medunarodnog standarda mogu biti predmet patentnin prava. ISO se ne smatra ‘odgovornim za identificiranje bilo kojeg ili svih takvih patentnin prava. ISO/IEC 17025 pripremio je ISO Komitet za ocjenjivanje uskladenosti(CASCO). Standard je dostaviien na glasanje nacionalnim tielima i ISO i IEC i odobren je od obje organizacije. Ovo drugo izdanje ponistava i zamjenjule prvo izdanje (ISONEC 17025:1999) koje je izmijenjeno u tehniékom smislu. Foreword ISO (the International Organization for Standardi- ation) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in the development of Intemational Standards through technical committees established by the respec- tive organization to deal with particular fields of technical activity. ISO and IEC technical commit- tees collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental, in liaison with ISO and IEC also take part in the work. In the field of confor- mity assessment, the ISO Committee on confor- mity assessment (CASCO) is responsible for the development of Intemational Standards and Guides. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. Draft Intemational Standards are circulated to the National bodies for voting. Publication as an In- temational Standard requires approval by at least 75 % of the national bodies casting a vote. Attention is drawn to the possibilty that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights, ISONEC 17025 was prepared by the ISO Com- mittee on conformity assessment (CASCO). It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations. This second edition cancels and replaces the first edition (ISONEC 17025:1999), which has been technically revised. Uvod Prvo_izdanje (1999) ovoga _medunarodnog standarda je nastalo kao rezultat opseznog iskustva u primjeni ISOMEC Vodita 25 i EN 45001, koje je on zamijenio. Standard je sadréavao sve zahtjeve koje moraju zadovolit ispitne i kalibracione laboratorije ako 2ele dokazati da provode sistem upravijanja, da su tehni¢ki kompetentni i da su u stanju dati tehnicki valjane rezultate. Prvo izdanje Je upucivalo na ISO 9001:1994 i ISO 9002:1984. Ove standarde je zamijenio ISO 9001:2000, &to je stvorilo potrebu za uskladivanje ISO/IEC 17025. U ovome drugom izdanju, samo tamo gdje se smatralo potrebnim, dopunjene su ili dodane taéke u svjetlu ISO 9001:2000. Qvaj_medunarodni_ standard trebaju_upotriet tijela za akreditiranje koja se bave priznavanjem kompetentnosti ispitnih i kalibracionih laboratorija, kao osnovu za nijihovo akreditiranje. Tatka 4. specificira zahtjeve za ispravno upravijanje. Tatka 5. specificira zahfjeve za_ tehni¢ku kompetentnost laboratorija u podruéju ispitivanja ili Kalibracija kojima se on bavi Porast primjene sistema upravianja opcenito je poveéao potrebu za osiguranjem da laboratoriji, koji su dio vein organizacija ii nude druge usluge, mogu raditi prema sistemu upravijanja kvalitetom koji se smatra da je u skladu sa ISO 9001 kao i sa ovim medunarodnim standardom. Radi toga, pagnja je posvecena na ukijugivanje svih onih zahtjeva iz ISO 9001 koji su relevantni za podruéje usluga ispitivania i Kalibracija koje su pokrivene sistemom upravijanja laboratorija. Ispitni i kalibracioni taboratorii, koji ispunjavaju Zahtjeve ovog medunarodnog standarda, takoder ¢e radii u skiadu sa ISO 9001 Uskladenost sistema upravijanja kvalitetom koji laboratorj provodi prema zahtjevima ISO 9001 samo po sebi ne dokazuje kompetentnost laboratorija da daje tehnicki valjane podatke i rezultate. Isto tako dokazana uskladenost sa ovim —medunarodnim ——_standardom ne, podrazumijeva ni uskladenost sistema upravijanja kvalitetom, koji laboratori provodi, sa svim zahtjevima ISO 9001 Prihvaganje rezultata_ 0 ispitivanjima i kalibracijama izmedu zemalja trebalo bi biti lakse ako laboratoriji zadovoljavaju ovaj medunarodni EN ISO/IEC 17025:200' introduction The first edition (1999) of this International Stan dard was produced as the result of extensive experience in the implementation of ISO/MEC Guide 25 and EN 45001, both of which it re- placed. it contained all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate 2 management system, are technically competent, and are able to generate technically valid results The first edition referred to ISO 9001:1994 and ISO 9002:1994. These standards have been s\ perseded by ISO 9001:2000, which made an alignment of ISO/MEC 17025 necessary. In this, second edition, clauses have been amended or added only when considered necessary in the light of ISO 9001:2000. ‘Accreditation bodies that recognize the compe- tence of testing and calibration laboratories should use this International Standard as the basis for their accreditation. Clause 4 specifies the requirements for sound management. Clause 5 specifies the requirements for technical compe- tenoe for the type of tests and/or calibrations the laboratory undertakes, Growth in the use of management systems gen- erally has increased the need to ensure that labo- ratories which form part of larger organizations or offer other services can operate to a quality man- agement system that is seen as compliant with 1SO 9001 as well as with this Intemational Stan- dard. Care has been taken, therefore, to incorpo- rate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration services that are covered by the laboratory's management system. Testing and calibration laboratories that comply with this International Standard will therefore also ‘operate in accordance with ISO 9001 Conformity of the quality management system within which the laboratory operates to the require- ments of ISO 9001 does not of itself demonstrate the competence of the laboratory to produce techni- cally valid data and results. Nor does demonstrated conformity to this Intemational Standard imply con- formity of the quality management system within which the laboratory operates to all the require- ments of ISO 9001 ‘The acceptance of testing and calibration results between countries should be facilitated if labora tories comply with this International Standard and 6 EN ISOMEC 17025:2005 standard i ako pribave akreditaciju od tijela koja su ukljuéena u sporazume o medusobnom| priznavanju sa odgovarajucim tijelima iz drugih zemalja, koje primjenjuju ovaj standard. Upotreba_ovog medunarodnog standarda ¢e olakgati saradnju izmedu laboratorija i drugin tijela te pomoéi u razmjeni informacija i iskustava i'u harmonizaciji standarda i procedura. if they obtain accreditation from bodies which have entered into mutual recognition agreements with equivalent bodies in other countries using this International Standard, The use of this Intemational Standard will facili- tate cooperation between laboratories and other bodies, and assist in the exchange of information ‘and experience, and in the harmonization of standards and procedures. Opéi zahtjevi za kompetentnost ispitnih i kalibracionih laboratorija 1 Podruéje primjene 4.4 Ovaj medunarodni standard specificira opée zahtjeve za _kompetentnost za _obavijanje ispitivanja Wil Kalibracija, ukljueujuci uzorkovanje. Standardom su obuhvaéena ispitivanja i kalibracije koje se obavijaju _primjenom standardnih metoda, nestandardnih metoda kao i metoda koje je razvio sam laboratori. 1.2 Ovaj medunarodni standard je primjenjiv na sve organizacije koje obavijaju ispitivanja Vili kalibracije. Tu spadaju, naprimjer, laboratoriji u svojstvu prve, druge i treée strane, kao i laboratoriji u kojima ispitivanje ili Kalibracija cine dio inspekcije i certificiranja proizvoda. Ovaj medunarodni standard je primjenjiv na sve laboratorije bez obzira na broj osoblja ili veli¢inu podrugja ispitivanja vii kalibracia. Kada se laboratorij ne bavi jednom ili vige aktivnosti koje su obuhvaéene ovim medunarodnim standardom, kao Sto su uzorkovanje i planiranje/razvo} novih metoda, tada se zahijevi i tih tacaka ne primjenjuju. 1.3 Date napomene pruzalu pojaénjenje teksta, primjere i smjemnice. One ne sadrée zahtjeve niti Gine sastavni dio ovog medunarodnog standarda, 1.4 Ovaj_medunarodni_ standard je namijenjen laboratorjima za razvoj_njihovog _ sistema upravijanja, vezanog za kvalitet, administrativne i tehnicke aktivnosti. Takoder, ovaj medunarodni standard mogu Koristiti kupci laboratorija, nadlezni organi i tijela za akreditiranje pri potvrdivanju priznavanju Kompetentnosti laboratorija. Oval medunarodni standard nije namijenjen da se koristiu svthu certifciranja laboratoria. NAPOMENA 1 Koristenje izraza “sistem upravijanja" u ‘ovome medunarodnom standardu znati sistem kvaliteta, administrative i tehnicke sisteme kojim se Upravia aktivnostima laboratorja. NAPOMENA 2 Certificianje sistema upravijanja se ponekad naziva i registrirane. 1.5 Ovim medunarodnim standardom nije obuhvacena usaglaSenost sa zakonskim i sigurnosnim zahtjevima u radu laboratorija. EN ISO/IEC 1 General requirements for the competence of testing and calibration laboratories 1 Scope 1.4 This International Standard specifies the gen eral requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. 1.2 This International Standard is applicable to all organizations performing tests and/or calibrations. ‘These include, for example, first-, second- and third-party laboratories, and laboratories where testing andlor calibration forms part of inspection and product certification. This Intemational Standard is applicable to all laboratories regardiess of the number of person- nel or the extent of the scope of testing and/or calibration activities. When a laboratory does not Undertake one or more of the activities covered by this Intemational Standard, such as sampling and the design/development of new methods, the re- quirements of those clauses do not apply. 1.3 The notes given provide clarification of the text, examples and guidance. They do not contain requirements and do not form an integral part of this International Standard. 4.4 This Intemational Standard is for use by labo- ratories in developing their management system for quality, administrative and technical opera- tions. Laboratory customers, regulatory authorities and accreditation bodies may also use it in con- firming or recognizing the competence of laborato- ries. This International Standard is notintended to be used as the basis for certification of laborato- ries. NOTE 1 The term ‘management system’ in this Intema~ tional Standard means the quality, administrative and technical systems that govem the operations of 2 labo- ratory. NOTE 2 Certification of a management system is some- times also called registration. 1.5 Compliance with regulatory and safety re- quirements on the operation of laboratories is not covered by this International Standard. 8 EN ISOMEC 17025:2005 41.6 Ako ispitni i Kalibracioni laboratorijt ispunjavaju zahijeve ovog medunarodnog standarda, oni ée takoder za djelatnosti ispitivanja i kelibracija provoditi sistem upravijanja _kvalitetom koji udovoljava nagelima ISO 9001. Dodatak A prikazuje vezu izmedu ovog medunarodnog standarda i ISO 9001. Ovaj medunarodni standard obuhvata zahtjeve o tehnickoj kompetentnosti Koji nisu pokriveni u ISO 9001. NAPOMENA 1 Kako bi se osiguralo da se zahijevi iz ‘ovog standarda primjenjuju na dosijedan natin, za neke ‘od njh moze biti potrebno dati pojasnjenje il tumatenje ‘Smjemica za_primjene _u specifiénim podrugjima, osobito za tela za akreditiranje (vii ISONEC 17011), data je u Dodatku B. NAPOMENA 2 Ako neki laboratori Zell akreditacju za dio il sve njegove aktivnostiispitivanja i kalibraciia, on treba odabratitjelo za akreditiranje koje radi u skladu sa ISONEC 17011. 2 Upuéivanja na normativna dokumenta Sliedeéi dokument, na koje se _upuéuje, neophodni su za primjenu ovoga dokumenta. Za datirana upucivanja primjenjuju_ se iskljutivo navedena izdanja. Za nedatirana upuéivanja primjenjuje se posljednje izdanje dokumenta, (uktjuéujuéi sve ammandmane) na koji se upucuie. ISONEC 17000, Ocjenjivanje uskladenosti — Rieénik i opéi principi, VIM: Medunarodni rjecnik 0 osnovnim i opcim terminima u mjeritelistvu, izdato od strane BIPM, IEC, IFCC, ISO, IUPAC, IUPAP i OIML. NAPOMENA Ostalisrodni_standardi, vodii, itd. 0 Predmetima obuhvatenim —ovim | medunarodnim standardom navedeni su u Bibliograf 3 Termini i definicije Za_potrebe ovog medunarodnog__standarda primjenjuju se odgovarajuée definicije, date u ISO/EC 17000 i VIM. NAPOMENA ISO 9000 daje ope defnicje koje se od- ‘nose na kvalitet, dok ISONEC 17000 daje defnicje koje se odnose na certficranje 1 akreditranje _laboratorja Ukolixo su u ISO 9000 date drugadiie defnicje, prednost se daje definicijama iz ISOMEC 17000 i VIM. 4.6 If testing and calibration laboratories comply with the requirements of this Intemational Standard, they will operate a quality management system for their testing and calibration activities that also meets, the principles of ISO 9001. Annex A provides nomi- nal cross-references between this Intemational Standard and ISO 9001.This Intemational Standard covers technical competence requirements that are not covered by ISO 9001 NOTE 1 It might be necessary to explain or interpret certain requirements in this Intemational Standard to ensure that the requirements are applied in a consistent manner. Guidance for establishing applications. for specific fields, especially for accreditation bodies (cee ISOMEC 17011) is given in Annex B. NOTE 2 If a laboratory wishes accreditation for part or all ofits testing and calibration activities, it should select aan accreditation body that operates in accordance with ISONEC 17011. 2 Normative references The following referenced documents are indis- pensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO/IEC 17000, Conformity assessment— Vo- cabulary and general principles VIM, International vocabulary of basic and general terms in metrology, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML. NOTE Further related standards, guides, etc. on sub- jects included in this International Standard are given in the Bibliography. 3 Terms and definitions For the purposes of this document, the relevant terms and definitions given in ISO/IEC 17000 and VIM apply. NOTE General definitions related to quality are given in ISO 9000, whereas ISO/IEC 17000 gives definitions specifically related to certification and laboratory ac- ccreditation. Where different definitions are given in ISO 9000, the definitions in ISO/IEC 17000 and VIM are preferred 4 Zahtjevi u vezi sa upravijanjem 4.1 Organizacija 4.1.4 Laboratori, il organizacia éij je on dio, mora biti entitet koji se moze smatrati pravno ‘odgovornim. 441.2 Laboratorij je odgovoran da izvréava djelatnosti ispitivanja i kalibracija na nagin kojim e ispuniti zahtjeve ovog medunarodnog standarda i zadovolji potrebe kupca, nadieznih corgana ili organizacija koje obavijaju priznavarie. 44.3 Sistem upravijanja_u_laboratorju_ mora obuhvatiti rad u stalnim objektima laboratorija, na mjestima izvan stalnih objekata, ili na privremenim pomognim ili pokretnim objektima. 441.4 Ako je laboratorij dio organizacije koja obavija i druge djelatnosti_ osim ispitivanja Vili kalibracija, a da bi se identificrali moguéi sukobi interesa, | moraju se _utviditi —odgovornosti ojelokupnog kijuénog osoblja organizacije, koje je Ukljuéeno il koje utjeée na djelatnosti laboratorije. NAPOMENA 1 Ako je laboratori) dio veée organizaci, organizaciona struktura treba biti takva da odjell koji imaju suprotne interese, kao Sto su:_proizvodnja, komercijaini marketing il inanci, ne utjecu nepovolino na udovoljavanje laboratora zahijevima ovog medunarodnog standarda NAPOMENA 2 Ako laboratori Zeli biti priznat kao tre¢a strana, on treba dokazati da je nepristrasan i da on i injegovo osoblie nije izlazeno bilo kakvim komercialnim, financiskim i ostalim pritiscima koji mogu utjecati na rijihovo tehnitko prosudivanje. Ispitni ili kalibracioni laborator kao tre¢a strana ne treba se baviti bilo kojom djelatnoSéu koja moze ugroziti povjerenje u njegovu nezavisnost prosudivanja i integritet_u odnosu na Ajegove djelatnostiispitivania il kalibraciia, 4.1.5 Laboratorij mora: 8) imati rukovodno i tehnigko osoblje koje, bez obzira na ostale odgovornosti, ima oviastenja i resurse, potrebne da izviSava svoje obaveze, ukliuéujuci —provodenje, odréavanje i poboljSavanje sistema upravianja, i da identifica sluéajeve odstupanja od sistema upravijanja ili od procedura za_provodenje ispitivanja ili Kalibracija, te da pokrene akcije za_sprijetavanje ili svodenje na minimum takvih odstupanja (vidi takoder 5.2): EN ISO/IEC 17025:200 4 Management requirements 44 Organization 4.1.4 The laboratory or the organization of which it is part shall be an entity that can be held legally responsible. 4.4.2 It is the responsibilty of the laboratory to carry out its testing and calibration activities in such a way as to meet the requirements of this International Standard and to satisfy the needs of the customer, the regulatory authorities or organi- zations providing recognition 44.3The management system shall cover work carried out in the laboratory's permanent faeilties, at sites away from its permanent faciliies, or in associated temporary or mobile facilities 4.1.4 If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or in- fluence on the testing and/or calibration activities of the laboratory shall be defined in order to iden- tify potential conflicts of interest. NOTE 1 Where a laboratory is part of a larger organiza- tion, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory's compliance with the requirements of this International Standard. NOTE 2 If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that itis impartial and that it and its personnel are free from any undue commercial, financial and other pres- sures which might influence their technical judgement. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgement and integrity in rela- tion to its testing or calibration activities. 4.4.5 The laboratory shall a) have managerial and technical personnel who, irrespective of other responsibilties, have the au- thority and resources needed to carry out their du- ties, including the implementation, maintenance ‘and improvement of the management system, and to identify the occurrence of departures from the management system or from the procedures for performing tests andlor calibrations, and to inate actions to prevent or minimize such departures (see also 5.2); 40 EN ISOMEC 17025:2005 b) imati takvo uredenje koje ce osigurati da njegovo rukovodstvo i osoblje nije iziozeno bilo Kojim unutrasnjim ili vanjskim poslovnim, financijskim ili drugim priscima koji mogu Stetno uticati na kvalitet njihovog rada; ©) mati politike i procedure koje osiguravaju zaStitu_povjerlivin informacija i viasni¢kih prava njegovih kupaca, ukijuéujuéi procedure za&tite elektroniskog pohranjivanje i prijenosa rezultata; 4) imati politike i procedure radi izbjegavania Uplitanja u bilo koju djelatnost, koja moze umanjiti povjerenje u njegovu kompetentnost, nepristranost, prosudivanje ii integritet rada; €) definirati organizacionu i upravijaéku strukturu laboratoria, njegovo mjesto u eventualnoj matiéno} organizacij, te odnose izmedu upravijanja_kvalitetom, tehni¢kin aktivnosti i potpornin djelatnosti; 1) specificirati odgovornosti, oviastenja. i medusobne odnose cjelokupnog osoblia koje rukovodi, obavija ili. verificira poslove koji utjegu na kvalitet ispitivanja ili kalibracija; 9) osigurati odgovarajuéi nadzor nad osobljem koje obavia ispitivanje i kalibraciju, ukljuéujuéi ono koje je na obuci, preko osoba koje dobro Poznaju. metode i procedure, svrhu svakog ispitivanja iii Kalibracije, te ocjenjivanje razultata ispitivanja ili kalibracija; h) mati tehni¢ko rukovodstvo koje ima punu ‘odgovornost za tehni¢ke aktivnosti i za pribavijanje resursa, neophodnin da se osigura zahtijevani kvalitet rada laboratorija; i) imenovati nekog od zaposienin kao rukovodioca kvaliteta (kako god ga_nazvali) koji, bez obzira na ostale duznosti i ‘odgovornosti, mora imati—_definiranu ‘odgovornost i oviastenje za osiguranje da se sistem upravijanja, koji se odnosi na kvalitet, stalno provodi i slijedi; rukovodilac kvaliteta mora imati direktan pristup do najviseg nivoa rukovodstva na kojem se usvajaju odluke o politic’ ii resursima laboratorija; i) imenovati_ zamjenike za kljuéno rukovodno osoblje (vidi Napomenu); k) osigurati da je njegovo osoblie _syjesno znataja i vaznosti svojin aktivnosti i na koji agin oni doprinose dostizanju opéih ciljeva sistema upravijanja. ) have arrangements to ensure that its manage- ‘ment and personnel are free from any undue in- temal and extemal commercial, financial and other pressures. and infuences that may ad- versely affect the quality oftheir work, ©) have policies and procedures io ensure the protection of its customers’ confidential infor- mation and proprietary rights, including proce- dures for protecting the electronic storage and transmission of results; d) have policies and procedures to avoid in- volvement in any activities that would diminish confidence in its competence, impartiality, judgement or operational integrity; €) define the organization and management structure of the laboratory, its place in any parent organization, and the relationships be- tween quality management, technical opera- tions and support services; f)_ specify the responsibilty, authority and interre- lationships of all personnel who manage, per- form or verify work affecting the quality of the tests andlor calibrations; 9) provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with methods and procedures, pur- pose of each test andlor calibration, and with the assessment of the test or calibration re- sults; hh) have technical management which has overall responsibilty for the technical operations and the provision of the resources needed fo ensure the required quality of laboratory operations; j) appoint a member of staff as quality manager (however named) who, imespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all times; the quality manager shall have direct access to the highest level of management at which de- cisions are made on laboratory policy or re- sources; i) appoint deputies for key managerial personnel (see Note), ) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system. NAPOMENA Pojedinci mogu ima vise od jedne funkcije te moze biti nepraktiéno imenovati zamjenike za svaku funk, 44.6 Najvi8e rukovodstvo mora _osigurati uspostavijanje podesnih procesa_komuniciranja Uunutar laboratorja i da se komuniciranje obavija uzimajuci u obzir efektivnost sistema upravijanja. 4.2 Sistem upravijanja 42.1 Laboratorij_mora_uspostaviti, provoditi i odrzavati sistem upravijanja, prikiadan za podrugje njegovih djelatnosti, Laboratori) mora dokumentirati svoje politike, sisteme, programe, procedure i uputstva do mjere neophodne da osigura kvalitet rezultata ispitivanja ili kalibracija, Dokumentacja sistema mora biti objaviena i razumijva te stajati__ na raspolaganju odgovarajuéem osoblju, koje je mora provodit. 422 Poltike sisteria upravianja laboratorja, koje se odinose na kvalitet, ukjuéuju zjavu o poliici kvaliteta, moraju biti denirane u poslovniku o kvalitetu (ma kako se Zva0_ ovaj. dokument). Moraju se uspostaviti sveukupni opéi cijevi i biti preispitvani tokom preispitivanja od strane rukovodstva. Izjavu o poitic! kvaiteta mora izdati najviée rukovodstvo. Ona mora sadrZavati najmarie siedese: a) obavezu rukovodstva laboratorija da Ge se kod pruzanja usluga ispitivanja i kalibracija svojim kupcima pridZavati dobre struéne prakse i kvaiiteta; b) izjavu rukovodstva o standardnoj laboratorijskoj usluzi; ©) svrhu sistema upravijanja u odnosu na kvalitet; d) zahtjev da je cjelokupno osoblie laboratoria, koje je u vezi sa aktivnostima ispitivanja i kalibracija, upoznato sa dokumentacijom o kvalitetu i dau svom radu provodi politike i procedure, te @) obavezu rukovodstva laboratorija da ispunjava Zahtjeve ovog medunarodnog standarda te da neprekidno poboljgava efektivnost sistema upravijanja. NAPOMENA.lzjava o poli Kvalteta treba bi koncizna i mode ukljusi zahfjev da se ispitvania itt Kalibracje uvjek rmoraju.izvodti uw skladu sa_objavjenim metodama i _zahijavima kupca. Ukoiko je isp il kalbracionilaboraior do vese organizacie, nek! elementi politke kvaltsta mogu bit u drugim dokumentima. NOTE Individuals may have more than one function and it may be impractical to appoint deputies for every function 4.1.8 Top management shall ensure that appro- priate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system. 4.2 Management system 4.2.4 The laboratory shall establish, implement and maintain a management system appropriate to the scope of its actives. The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration resuits. The sys- tem's documentation shall be communicated to, un- derstood by, available to, and implemented by the appropriate personnel 4.2.2 The laboratory's management sysiem policies related to quality, including a quality policy state- ment, shall be defined in a quality manual (however named). The overall objectives shall be established, and shall be reviewed during management review. ‘The quailty policy statement shall be issued under the authority of top management. It shall include at least the following: a) the laboratory management's commitment to good professional practice and to the quality of its testing and calibration in servicing its cus- tomers; b) the management's statement of the labora- tory’s standard of service; ©) the purpose of the management system related to quality; 4) a requirement that all personnel concerned with testing and calibration activities within the labo- ratory familiarize themselves with the quality documentation and implement the policies and procedures in their work; and e) the laboratory management's commitment to comply with this Intemational Standard and to continually improve the effectiveness of the management system. NOTE The quaity policy statement should be concise and may include the requirement that tests and/or calibrations shall always be cartied out in accordance with stated meth- feds and customers’ requirements. When the test andlor calibration laboratory is part of a larger organization, some quality policy elements may be in other documents 12 EN ISOMEC 17025:2005 4.2.3 Najvige rukovodstvo mora prugiti dokaze o obavezi razvoja i primjenjivanja sistema upravijanja i neprekidnog poboliSavanja njegove efektivnosti 4.2.4 NajviSe rukovodstvo mora objaviti_u organizaciji znataj udovoljavanja _zahtjevima kupca kao i zahtjevima zakona i propisa 4.2.8 Poslovnik 0 kvalitetu mora sadrzavat i upucivat na potpore procedure, ukljuujuéi i tehnitke procedure. On mora ilozit stukturu: dokumentacie koja se koristiu sistemu upraviania. 4.2.6 U posiovniku 0 kvalitetu moraju se definirati uloge i odgovomosti tehniékog rukovodstva i rukovodiocakvaliteta,_ukijuéujuci__nithovu odgovornost za osiguranjem — ispunjavanja zahtjeva ovog medunarodnog standarda. 4.2.7 Najvise rukovodstvo mora __osigurati odr2avanje integrteta sistema upravijanja i onda ada se planiraju i provode izmjene u sistemu upraviianja 4.3 Kontrola dokumenata 4.3.1 Opéenito Laboratorij mora uspostaviti | odrZavati procedure za kontrolu svih dokumenata (interih ili vanjskih) koji Eine dio njegovog sistema upravijanja, kao So su propisi, standardi | ostali normativni dokumenti, metode ispitivanja ili kalibracija, te crtezi, softver, specifikacije, uputstva i priruénici NAPOMENA 1 U ovom kontoksts “dokument” mogu bi ijave 0 pol, procedure, spectikacie, table u vezi sa kalbraciama, gafkoni, ud2benic plakat, saopéenja, bileske, softer, ce, plano, id. Oni magu bit na raznim meciima, bio kao fwd kopja i eleKronska, te mogu bi dita, analog u vidu foografia psa NAPOMENA 2 Tatka 6.4.7 opisuje Kontrolu podataka koji se odnose na ispitivanje i Kalibraciju. Kontrola zapisa je opisana u tatki 4.13. 4.3.2 Odobravanje i izdavanje dokumenta 4324 Sve dokumente koji se izdaju za osoblje laboratoria, @ koj su dio sistema upravjanja mora, pile njhovog izdavanja, preispital i odobriti za upotrebu oviasteno osobje. Da bi se sprietia upotreba Nevaeh iii zastarjelh dokumenata, mora biti uspostaviiena i lako dostupna glavna lista ii njoj ekvivalentna procedura_kontrole dokumenata za uvrdivanje trenuinog stanja revizije i distibudje dokumenata sistema upraviania. 4.2.3 Top management shall provide evidence of commitment to the development and implemen tion of the management system and to continually improving its effectiveness, 4.24 Top management shall communicate to the orge- nization the importance of meeting customer require- ments 2s well as statutory and regulatory requirements 42.5 The quality manual shall include or make refer- tence to the supporting procedures including technical procedures. It shall outline the structure of the docu- ‘mentation used in the management system, 4.2.6 The roles and responsibilities of technical management and the quality manager, including their responsibilty for ensuring compliance with this International Standard, shail be defined in the quality manual. 4.2.7 Top management shall ensure that the in- tegrity of the management system is maintained when changes to the management system are planned and implemented. 4.3 Document control 43.1 General ‘The laboratory shall establish and maintain proce- dures to control all documents that form part of its management system (intemally generated or from extemal sources), such as regulations, standards, other normative docu-ments, test andior calibration methods, as well as drawings, software, specifica- tions, instructions and manuals. NOTE 1 In this context “document” could be policy statements, procedures, specifications, calibration ta- bles, charts, text books, posters, notices, memoranda, software, drawings, plans, etc. These may be on vari- ‘ous media, whether hard copy or electronic, and they ‘may be digital, analogue, photographic or written. NOTE 2 The control of data related to testing and call bration is covered in 5.4.7. The control of records is covered in 4.13 4.3.2, Document approval and issue 43.21 All documents issued to personnel in the labo- ratory as part of the management system shall be reviewed and approved for use by authorized person- nel prior to issue. A master ist or an equivalent docu- ment control procedure identifying the current revision status and distibuton of documents in the manage- ment system shall be established and shall be readily available to preclude the use of invalid andior obsolete documents. 4.3.2.2 Usvojena(e) osigurati procedura(e) _mora(ju) a) da su vazeta izdanja odgovarajutin dokume- nata dostupna na svim lokacijama gdje se obaviiaju aktivnosti, bitne za _efektivno funkcioniranje laboratorija, b) da se dokumenti periodiéno preispituju i, ukoli- ko je potrebno, revidiraju kako bi se osigurao kontinuitet njihove prikladnosti i udovoljavanje primijenjivim zahtjevima; ©) da se nevagedi ili zastarjeli dokumenti odmah povuku sa svih mjesta izdavanija ili upotrebe, ili na bilo Koji drugi natin sprijeti njihova nenamjemna upotreba; ¢) da se zastarjeli dokumenti, koji se Guvaju iz zakonskih razioga ili u svrhu_pohranjivanja znanja, oznaée na odgovarajuti nagin 4.3.2.3 Dokumenti sistema upravijanja, nastali u laboratory, moraju biti jednoznaéno prepoznatiivi. Ova identifikacija mora obuhvatit datum izdavanja ili identifkaciju revizije, redni broj strane, ukupan broj strana ili znak koji oznatava kraj dokumenta i odobrenje(a) za izdavanie. 4.3.3 lzmjene dokumenata 4.3.3.1 lzmjene u dokumentima mora preispitivati i codobriti ista funkcija koja je provela podetno preispitivanje i odobravanje, osim ako nije drugaéije odredeno, Imenovano osoblje mora imati pristup informaciima koje su osnova za njihovo preispitivanje i odobravanje. 4.3.3.2 Gdje je to praktiéno, u dokumentu ili codgovarajucim dodacima, mora se identificiati promijenjeni il novi tekst. 4.3.3.3 Ako sistem _kontrole _dokumenata laboratorja dozvoljava njihovo ruéno ispravijanje do ponovnog izdavanja, moraju se utvrditi procedure i oviaStenja za takve ispravke. Ispravke moraju biti jasno oznagene, obiljezene inicijalima i datirane. Revidirani dokument se mora formaino onovno izdati sto je mogue prile 4.3.3.4 Moraju se ustanoviti procedure koje opisuju kako se obavjaju i kontrolraju izmjeneu

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