INTERNATIONAL STANDARD ISO/IEC 17025
STANDARD INTERNATIONAL ISO/IEC 17025
GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND
CALIBRATION LABORATORIES
CERINTE GENERALE CU PRIVIRE LA COMPETENTA LABORATOARELOR DE
INCERCARE SI ETALONARE
FOREWORD
ISO (the International Organization for
Standardization) 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 International Standards
through technical committees established by the respective
organization to deal with particular fields of technical activity.
ISO and IEC technical committees 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.
International Standards are drafted in accordance with
the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical
committees are circulated to member bodies for voting.
Publication as an International Standard requires approval by at
least 75% of the member bodies casting a vote.
Attention is drawn to the possibility that some of the
elements of this International Standard may be the subject of
patent rights. ISO and IEC shall not be held responsible for
identifying any or all such patent rights.
International Standard ISO/IEC 17025 was prepared by
ISO/CASCO, Committee on Conformity Assessment.
This first edition of ISO/IEC 17025 cancels and
replaces ISO/IEC Guide 25:1990.
Annexes A and B of this International Standard are for
information only.
INTRODUCTION
This International Standard has been produced as the
result of extensive experience in the implementation of ISO/IEC
Guide 25 and EN 45001, both of which it now replaces. It
contains all of the requirements that testing and calibration
laboratories have to meet if they wish to demonstrate that they
operate a quality system, are technically competent, and are able
to generate technically valid results.
Accreditation bodies that recognize the competence 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 competence
for the type of tests and/or calibrations the laboratory
CUVANT INAINTE
ISO (Organizatia Internationala pentru Standardizare) si
IEC (Comisia Electrotehnica Internationala) formeaza sistemul
specializat pentru standardizare la nivel mondial. Organismele
nationale membre ISO sau IEC participa la dezvoltarea
standardelor internationale prin intermediul unor comisii tehnice
stabilite de organizatia respectiva pentru a se ocupa de zonele
specifice de activitate tehnica. Comisiile tehnice ISO si IEC
colaboreaza in domeniile de interes reciproc. De asemenea in
activitatea generala sunt implicate si alte organizatii
internationale, guvernamentale si neguvernamentale, aflate in
legaturi cu ISO si IEC.
Standardele internationale sunt emise ca draft in acord cu
regulile prezentate de Directivele ISO/IEC, Partea 3.
Standardele internationale in draft sunt adoptate de
comisiile tehnice si trimise organismelor membre pentru votare.
Publicarea ca si standard international necesita aprobarea a cel
putin 75% dintre organismele membre care voteaza.
Se acorda de asemeni atentie posibilitatii ca unele din
elementele standardului de fata sa fie supuse dreptului de autor.
ISO si IEC nu vor fi trase la raspundere la identificarea unora
sau tuturor acestor drepturi de autor.
Standardul international ISO/IEC 17025 a fost pregatit de
Comisia ISO/CASCO de Evaluare a Conformitatii.
Prima editie din ISO/IEC 17025 anuleaza si inlocuieste
ISO/IEC Ghid 25:1990.
Anexele A si B ale standardului de fata sunt destinate
doar informarii.
INTRODUCERE
Acest standard a fost produs ca rezultat al vastei
experiente a implementarii ISO/IEC Ghid 25 si EN 45001,
inlocuindu-le acum pe amandoua. El contine toate cerintele pe
care laboratoarele de incercare si etalonare trebuie sa le
indeplineasca daca vor sa demonstreze ca lucreaza dupa un
sistem al calitatii, ca sunt competente tehnic si capabile sa
furnizeze rezultate validate tehnic.
Organismele de acreditare care recunosc competenta
laboratoarelor de incercare si etalonare vor utiliza acest standard
ca baza pentru acreditarea lor.
Clauza 4 precizeaza cerintele de management al
sunetului. Clauza 5 precizeaza cerintele privind competenta
tehnica pentru tipul de incercari si/sau etalonari pe care le
intreprinde laboratorul.
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undertakes.
The growth in use of quality systems generally has
increased the need to ensure that laboratories which form part of
larger organizations or offer other services can operate to a
quality system that is seen as compliant with ISO 9001 or ISO
9002 as well as with this International Standard. Care has been
taken, therefore, to incorporate all those requirements of ISO
9001 and ISO 9002 that are relevant to the scope of testing and
calibration services that are covered by the laboratory's quality
system.
Testing and calibration laboratories that comply with
this International Standard will therefore also operate in
accordance with ISO 9001 and ISO 9002.
Certification against ISO 9001 and ISO 9002 does not
of itself demonstrate the competence of the laboratory to
produce technically valid data and results.
The acceptance of testing and calibration results
between countries should be facilitated if laboratories comply
with this International Standard and 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 International Standard will facilitate
cooperation between laboratories and other bodies, and assist in
the exchange of information and experience, and in the
harmonization of standards and procedures.
1. SCOPE
1.1 This International Standard specifies the general
requirements for the competence to carry out tests and
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. They
include, for example, first-, second- and third-party laboratories,
and laboratories where testing and/or calibration forms part of
inspection and product certification.
This International Standard is applicable to all
laboratories regardless of the number of personnel 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 International Standard, such as sampling and the
design/development of new methods, requirements 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.
1.4 This International Standard is for use by
laboratories in developing their quality, administrative and
technical systems that govern their operations. Laboratory
clients, regulatory authorities and accreditation bodies may also
use it in confirming or recognizing the competence of
laboratories.
1.5 Compliance with regulatory and safety requirements on the
operation of laboratories is not covered by this International
Standard.
1.6 If testing and calibration laboratories comply with
the requirements of this International Standard they will operate
a quality system for their testing and calibration activities that
Cresterea utilizarii sistemelor de calitate a sporit in
general nevoia de a asigura ca laboratoarele care fac parte din
organizatii mari sau ofera alte servicii pot opera dupa un sistem
al calitatii care este considerat ca fiind in acord cu ISO 9001 sau
ISO 9002, ca si cu acest standard. Prin urmare s-a ajuns cu grija
la incorporarea in acest standard a tuturor cerintelor din ISO
9001 si ISO 9002 care sunt relevante pentru scopul serviciilor
de incercare si etalonare acoperite de sistemul de calitate al
laboratorului.
Laboratoarele de incercare si etalonare care se supun
regulilor din acest standard vor fi asadar capabile sa opereze in
conformitate cu ISO 9001 sau ISO 9002.
Certificarea pentru ISO 9001 sau ISO 9002 nu
demonstreaza de la sine competenta laboratorului de a produce
rezultate si date valide tehnic.
Acceptarea intre tari a rezultatelor de incercare si
etalonare trebuie facilitata daca laboratoarele se conformeaza
acestui standard si daca obtin acreditarea din partea unor
organisme ce au intrat in acord de recunoastere reciproca cu
organisme asemanatoare din alte tari ce utilizeaza acest
standard.
Utilizarea acestui standard va facilita cooperarea dintre
laboratoare si alte organisme, ajutand la schimbul de informatii
si experienta, si la armonizarea standardelor si procedurilor.
1. SCOP
1.1 Acest standard prezinta cerintele generale pe care
laboratorul trebuie sa le indeplineasca pentru a fi recunoscut ca
fiind competent sa execute incercari si etalonari, inclusiv
esantionare. Acest standard acopera incercarile si etalonarile
care se executa utilizand metode standardizate, metode ne-
standardizate si metode dezvoltate de laboratoare.
1.2 El este aplicabil tuturor organizatiilor care executa
incercari si/sau etalonari. Acestea includ, de exemplu,
laboratoare de prima, de secunda si terta parte si laboratoare in
care incercarile si/sau etalonarile fac parte din inspectie si
certificare.
Acest standard este aplicabil tuturor laboratoarelor
indiferent de numarul de personal si de extinderea domeniului
activitatilor de calibrare si/sau etalonare. Cand un laborator nu
preia una sau mai multe activitati acoperite de acest Standard
International, precum esantionarea si proiectarea/dezvoltarea de
metode noi, cerintele acestor clauze nu se aplica.
1.3 Notele contin clarificari ale textului, exemple si
indicatii. Ele nu contin cerinte si nu formeaza o parte integranta
a acestui Standard.
1.4 Acest Standard este destinat utilizarii de catre
laboratoarele in dezvoltarea sistemelor de calitate,
administrative si tehnice proprii, pe care se bazeaza functionarea
lor. De asemenea el poate fi utilizat de catre clienti, autoritatile
reglementare si organisme de acreditare in confirmarea sau
recunoasterea competentei laboratoarelor.
1.5 Conformitatea cu cerintele de reglementare si de
siguranta cu privire la functionarea laboratoarelor nu este
acoperita de acest standard.
1.6 Daca laboratoarele de incercare si calibrare satisfac
cerintele acestui Standard ele vor opera cu un sistem al calitatii
pentru activitatile de incercare si etalonare, sistem care de
asemenea satisface cerintele din ISO 9001 cand ele se ocupa de
proiectarea/dezvoltarea unor metode noi si/sau dezvoltarea de
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also meets the requirements of ISO 9001 when they engage in
the design/development of new methods, and/or develop test
programmes combining standard and non-standard test and
calibration methods, and ISO 9002 when they only use standard
methods. Annex A provides nominal cross-references between
this International Standard and ISO 9001 and ISO 9002.
ISO/IEC 17025 covers several technical competence
requirements that are not covered by ISO 9001 and ISO 9002.
Note 1: it might be necessary to explain or interpret certain
requirements in this International Standard to ensure
that requirements are applied in a consistent manner.
Guidance for establishing applications for specific
fields, especially accreditation bodies (see ISO/IEC
Guide 58:1993, 4.1.3) is given in Annex B.
Note 2: if a laboratory wishes accreditation for part or all of its
testing and calibration activities, it should select an
accreditation body that operates in accordance with
ISO/IEC Guide 58.
2 NORMATIVE REFERENCES
The following normative documents contain provisions
which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent
amendments to, or revisions of, any of these publications do not
apply. However, parties to agreements based on this
International Standard are encouraged to investigate the
possibility of applying the most recent editions of the normative
documents indicated below. For undated references, the latest
edition of the normative document referred to applies. Members
of ISO and IEC maintain registers of currently valid
International Standards.
ISO 9001:1994, Quality systems - Model for quality assurance
in design, development, production, installation and servicing
ISO 9002:1994, Quality systems - Model for quality assurance
in production, installation and servicing
ISO/IEC Guide 2, General terms and their definitions
concerning standardization and related activities
VIM, International vocabulary of basic and general terms in
metrology, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP
and OIML.
Note 1: further related standards, guides etc. on subjects
included in this International Standard are given in
the bibliography.
Note 2: it should be noted that when this International Standard
was being developed, the revisions of ISO 9001 and
ISO 9002 were anticipated to be published in late
2000 as a merged ISO 9001:2000. This is no longer
the case.
3. TERMS AND DEFINITIONS
For the purposes of this International Standard, the
relevant terms and definitions given in ISO/IEC Guide 2 and
VIM apply.
Note: general definitions related to quality are given in ISO
8402, whereas ISO/IEC Guide 2 gives definitions
specifically related to standardization, certification and
laboratory accreditation. Where different definitions
are given in ISO 8402, the definitions in ISO/IEC
Guide 2 and VIM are preferred.
4. MANAGEMENT REQUIREMENTS
4.1 ORGANIZATION
programe de incercare prin combinarea metodelor standard si
ne-standard de incercare si etalonare, si ISO 9002 cand
utilizeaza numai metode standardizate. Anexa A furnizeaza
corespondente dintre acest standard si ISO 9001 si ISO 9002.
ISO/IEC 17025 acopera mai multe cerinte privind competenta
tehnica neacoperite de ISO 9001 si ISO 9002.
Nota 1: ar putea fi necesara explicarea si interpretarea anumitor
cerinte ale acestui standard pentru a se asigura
aplicarea cerintelor intr-o maniera consistenta.
Indicatii pentru a se stabili aplicarea in diverse
domenii, mai ales in cel al organismelor de acreditare
(vezi ISO/IEC Ghid 58:1993, 4.1.3) sunt date in cadrul
Anexei B.
Nota 2: daca un laborator doreste acreditare pentru o parte sau
pentru toate activitatile sale de incercare si etalonare,
ar trebui sa aleaga un organism de acreditare ce
functioneaza in acord cu cu ISO/IEC Ghid 58.
2 REFERINTE NORMATIVE
Urmatoarele documente normative contin prevederi
care, datorita referintelor din acest text, constituie prevederi ale
acestui standard. Pentru referinte datate, amendamente
ulterioare sau revizii de orice fel nu se aplica nici una din aceste
publicatii. In orice caz, partile la acordurile bazate pe acest
standard sunt incurajate a investiga posibilitatea aplicarii celor
mai recente editii a documentelor normative indicate mai jos.
Pentru referinte nedatate se va aplica ultima editie a
documentului normativ citat. Membrii ISO si IEC pastreaza
cataloage cu standardele internationale valabile in mod curent.
ISO 9001:1994, Sisteme ale calitatii - model pentru asigurarea
calitatii in proiectare, dezvoltare, productie, instalare si service
ISO 9002:1994, Sisteme ale calitatii - model pentru asigurarea
calitatii in productie, instalare si service
ISO/IEC Guide 2, Termeni generali si definitiile lor referitoare
la standardizare si activitatile conexe
VIM, Vocabular international de termeni generali si de baza in
metrologie, editat de BIPM, IEC, IFCC, ISO, IUPAC, IUPAP si
OIML.
Nota 1: standarde asociate suplimentare, ghiduri, etc., pe teme
incluse in acest Standard se gasesc la bibliografie.
Nota 2: trebuie observat ca la elaborarea acestui standard, se
anticipa publicarea reviziilor la ISO 9001 si ISO 9002
spre sfarsitul anului 2000 ca un ISO 9001:2000
unificat. Nu mai e cazul.
3. TERMENI SI DEFINITII
Pentru scopul acestui standard se utilizeaza definitiile
relevante din ISO/IEC- Ghid 2 si VIM.
Nota: ISO 8402 prezinta definitiile generale referitoare la
calitate, in timp ce ISO/IEC Ghid 2 prezinta definitii
referitoare in mod specific la standardizare, certificare
si acreditare a laboratoarelor. Daca in ISO 8402 sunt
date definitii diferite, se prefera cele din ISO/CEI Ghid
2 si VIM.
4. CERINTE PRIVIND SISTEMUL DE MANAGEMENT
4.1 ORGANIZARE
4.1.1 Laboratorul sau organizatia din care acesta face
parte va fi o entitate si trebuie sa poata fi tras(a) in mod legal la
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 4.1.1 The laboratory or the organization of which it is
part shall be an entity that can be held legally responsible.
4.1.2 It is the responsibility 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 client, the regulatory authorities or organizations
providing recognition.
4.1.3 The laboratory management system shall cover
work carried out in the laboratory's permanent facilities, at sites
away from its permanent facilities, 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 influence on the testing and/or calibration
activities of the laboratory shall be defined in order to identify
potential conflicts of interest.
Note 1: where a laboratory is part of a larger organization, 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 it is
impartial and that it and its personnel are free from
any undue commercial, financial and other pressures
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 relation to its testing or calibration activities.
4.1.5 The laboratory shall
a. have managerial and technical personnel with the authority
and resources needed to carry out their duties and to
identify the occurrence of departures from the quality
system or from the procedures for performing tests and/or
calibrations, and to initiate actions to prevent or minimize
such departures (see also 5.2)
b. have arrangements to ensure that its management and
personnel are free from any undue internal or external
commercial, financial and other pressures and influences
that may adversely affect the quality of their work
c. have policies and procedures to ensure the protection of its
clients' confidential information and proprietary rights,
including procedures for protecting the electronic storage
and transmission of results
d. have policies and procedures to avoid involvement in any
activities that would diminish confidence in its competence,
impartiality, judgement or operational integrity
e. define the organization and management structure of the
laboratory, its place in any parent organization, and the
relationships between quality management, technical
operations and support services
f. specify the responsibility, authority and interrelationships
of all personnel who manage, perform or verify work
affecting the quality of the tests and/or calibrations
g. provide adequate supervision of testing and calibration
staff, including trainees, by persons familiar with methods
and procedures, purpose of each test and/or calibration, and
raspundere.
4.1.2 Este responsabilitatea laboratorului sa-si
efectueze activitatile de incercare si etalonare astfel incat sa
satisfaca cerintele acestui standard si sa satisfaca necesitatile
clientului, a autoritatilor reglementare sau a organizatiilor ce se
ocupa de recunoastere.
4.1.3 Sistemul de management al laboratorului va
acoperi activitatile executate in localurile permanente ale
acestuia, in localuri exterioare sau in localuri asociate temporare
sau mobile.
4.1.4 Daca laboratorul face parte dintr-o organizatie
efectuand si alte activitati in afara de incercare si/sau etalonare,
responsabilitatile tuturor cadrelor de conducere din organizatie
care au implicare sau o influenta asupra activitatilor de incercare
si/sau etalonare ale laboratorului, trebuie definite astfel incat sa
se identifice conflictele de interese potentiale.
Nota 1: acolo unde laboratorul este o parte a unei organizatii
mai mari, planul organizatiei trebuie sa fie incat
departamentele avand conflicte de interese ca de pilda
productia, comercialul sau financiarul sa nu
influenteze negativ acordul laboratorului cu cerintele
acestui Standard.
Nota 2: daca laboratorul doreste recunoastere ca laborator de
terta parte el trebuie sa poata demonstra ca este
impartial si ca el personalul sau nu se afla sub vreo
forma de presiune inoportuna de natura comerciala,
financiara etc. care Ie-ar putea influenta judecata in
zona tehnica. Laboratoarele de incercare sau etalonare
de terta parte nu trebuie sa se angajeze in vreo
activitate ce ar putea periclita increderea in
independenta sa de judecata si integritatea sa in raport
cu activitatile sale de incercare sau etalonare.
4.1.5 Laboratorul trebuie:
a. sa aiba personal de conducere sustinut de personal tehnic,
avand autoritatea si resursele necesare realizarii sarcinilor si
identificarii aparitiei de abateri de la sistemul de
management al calitatii sau de la procedurile de efectuare a
incercarilor si/sau etalonarilor, ca si initierii de actiuni
pentru prevenirea sau minimizarea unor astfel de abateri
(vezi si 5.2)
b. sa ia masuri prin care sa asigure ca managementul si
personalul sau nu sunt supusi in nici unui fel la presiuni
interne sau externe, de natura comerciala, financiara sau de
alta natura, care le-ar afecta negativ calitatea activitatii
c. sa aiba politici si proceduri care sa asigure protectia
informatiilor cofidentiale si drepturile de proprietate ale
clientilor sai, inclusiv proceduri de protectie a transmiterii
si stocarii electronice a rezultatelor
d. sa aiba politici si proceduri, pentru a evita implicarea in
orice activitate care ar diminua increderea in competenta sa,
in impartialitatea, aprecierile sau integritatea sa functionala
e. sa defineasca organizarea si structura managementului
laboratorului, locul sau in orice organizatie tutelara si
relatiile intre functiile tehnice, serviciile auxiliare si
sistemul de management al calitatii
f. sa specifice responsabilitatea, autoritatea si interrelatiile
tuturor persoanelor care conduc, efectueaza sau verifica
lucrari afectand calitatea incercarilor si/sau etalonarilor
g. sa asigure o supervizare adecvata a personalului de
incercare si etalonare, inclusiv a personalului in curs de
instruire, din partea unor persoane cunoscand metodele si
procedurile, scopul fiecarei incercari si/sau etalonari, si
evaluarea rezultatelor incercarilor sau etalonarilor
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 with the assessment of the test or calibration results
h. have technical management which has overall
responsibility for the technical operations and the provision
of the resources needed to ensure the required quality of
laboratory operations
i. appoint a member or staff as quality manager (however
named) who, irrespective of other duties and
responsibilities, shall have defined responsibility and
authority for ensuring that the quality system is
implemented and followed at all times; the quality manager
shall have direct access to the highest level of management
at which decisions are made on laboratory policy or
resources
j. appoint deputies for key managerial personnel (see note).
Note: individuals may have more than one function and it may
be impractical to appoint deputies for every function.
4.2 QUALITY SYSTEM
4.2.1 The laboratory shall establish, implement and
maintain a quality system appropriate to the scope of its
activities. 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 results. The
system's documentation shall be communicated to, understood
by, available to, and implemented by the appropriate personnel.
4.2.2 The laboratory's quality system policies and
objectives shall be defined in a quality manual (however
named). The overall objectives shall be documented in a quality
policy statement. The quality policy statement shall be issued
under the authority of the chief executive. 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 clients
b. the management's statement of the laboratory's standard of
service
c. the objectives of the quality system
d. a requirement that all personnel concerned with testing and
calibration activities within the laboratory familiarize
themselves with the quality documentation and implement
the policies and procedures in their work
e. the laboratory management's commitment to compliance
with this International Standard.
Note: the quality policy statement should be concise and may
include the requirement that tests and/or calibrations
shall always be carried out in accordance with stated
methods and clients' requirements. When the test and/or
calibration laboratory is part of a larger organization,
some quality policy elements may be in other
documents.
4.2.3 The quality manual shall include or make
reference to the supporting procedures including technical
procedures. It shall outline the structure of the documentation
used in the quality system.
4.2.4 The roles and responsibilities of technical
management and the quality manager, including their
responsibility for ensuring compliance with this International
Standard, shall be defined in the quality manual.
4.3 DOCUMENT CONTROL
4.3.1 General
The laboratory shall establish and maintain procedures
to control all documents that form part of its quality system
(internally generated or from external sources), such as
h. sa dispuna de un management tehnic, avand
responsabilitatea generala pentru activitatea tehnica si
furnizarea resurselor necesare pentru asigurarea calitatii
cerute a activitatii laboratorului
i. sa numeasca un membru al staff-ului ca manager al calitatii
(oricum ar fi acesta definit), care, indiferent de alte sarcini
si responsabilitati, sa aiba definite responsabilitatea si
autoritatea pentru a asigura ca cerintele sistemului calitatii
sunt implementate si urmarite in orice moment; managerul
calitatii trebuie sa aiba acces direct la cel mai inalt nivel al
managementului, la care se iau deciziile privind politica sau
resursele laboratorului;
j. sa numeasca loctiitori pentru principalele functii de
conducere (vezi nota).
Nota: anumite persoane pot avea mai multe functii si poate fi
nepractic sa se numeasca loctiitori pentru fiecare functie
in parte.
4.2 SISTEMUL CALITATII
4.2.1 Laboratorul trebuie sa stabileasca, implementeze si
sa mentina un sistem de management al calitatii corespunzator
obiectului sau de activitate. Laboratorul trebuie sa-si
documenteze politicile, sistemele, programele, procedurile si
instructiunile in extinderea necesara pentru a asigura calitatea
rezultatelor incercarilor si/sau etalonarilor. Toate documentele
folosite in acest sistem de management al calitatii trebuie
transmise, intelese, disponibile si implementate, de catre tot
personalul implicat.
4.2.2. Laboratorul trebuie sa identifice si sa
demonstreze politicile si obiectivele de realizat in domeniul
calitatii intr-un manual al calitatii (indiferent cum este numit).
Declaratia de politica a calitatii trebuie sa fie emisa sub
autoritatea sefului executiv. Ea va include cel putin urmatoarele:
a. angajarea managementului laboratorului pe linia unei bune
practici profesionale si a calitatii incercarilor si etalonarilor
in slujba clientilor
b. o declaratie a intentiilor laboratorului, referitoare la
standardul serviciilor pe care le va oferi
c. scopul sistemului calitatii
d. o cerinta ca tot personalul implicat in activitatile de
incercare si etalonare din laborator sa fie familiarizat cu
documentatia privind calitatea si sa implementeze politicile
si procedurile in permanenta in munca lor
e. angajamentul conducerii laboratorului privind acordul cu
acest Standard.
Nota: declaratia de politica a calitatii trebuie sa fie concisa si
poate include cerinta ca incercarile si/sau etalonarile sa fie
intotdeauna efectuate conform metodelor stabilite si
cerintelor clientilor. Atunci cand laboratorul de incercare
si/sau etalonare face parte dintr-o organizatie mai mare,
unele elemente ale politicii privind calitatea se pot afla in
alte documente.
4.2.3. Manualul calitatii trebuie sa includa sau sa faca
referinte la procedurile de sprijin, inclusiv proceduri tehnice. El
va contura structura documentatiei utilizate in cadrul sistemului
calitatii.
4.2.4 Manualul calitatii trebuie sa defineasca rolurile si
responsabilitatile personalului tehnic si managerului calitatii,
inclusiv responsabilitatea de asigurare a conformitatii cu
prezentul standard.
4.3 CONTROLUL DOCUMENTELOR
4.3.1 Generalitati
5
regulations, standards, other normative documents, test and/or
calibration methods, as well as drawings, software,
specifications, instructions and manuals.
Note 1: in this context "document" could be policy statements,
procedures, specifications, calibration tables, charts,
text books, posters, notices, memoranda, software,
drawings, plans etc. These may be on various media,
whether hard copy or electronic, and they may be
digital, analog, photographic or written.
Note 2: the control of data related to testing and calibration is
covered in 5.4.7. The control of records is covered in
4.12.
4.3.2 Document approval and issue
4.3.2.1 All documents issued to personnel in the
laboratory as part of the quality system shall be reviewed and
approved for use by authorized personnel prior to issue. A
master list or an equivalent document control procedure
identifying the current revision status and distribution of
documents in the quality system shall be established and be
readily available to preclude the use of invalid and/or obsolete
documents.
4.3.2.2 The procedure(s) adopted shall ensure that:
a. authorized editions of appropriate documents are available
at all locations where operations essential to the effective
functioning of the laboratory are performed
b. documents are periodically reviewed and, where necessary,
revised to ensure continuing suitably and compliance with
applicable requirements
c. invalid or obsolete documents are promptly removed from
all points of issue for use, or otherwise assured against
unintended use
d. obsolete documents retained for either legal or knowledge
preservation purposes are suitably marked
4.3.2.3 Quality system documents generated by the
laboratory shall be uniquely identified. Such identification shall
include the date of issue and/or identification, page numbering,
the total number of pages or a mark to signify the end of the
document, and the issuing authority(s).
4.3.3 Document changes
4.3.3.1 Changes to documents shall be reviewed and
approved by the same function that performed the original
review unless specifically designated otherwise. The designated
personnel shall have access to pertinent background information
upon which to base their review and approval.
4.3.3.2 Where practicable, the altered or new text shall
be identified in the document or appropriate attachments.
4.3.3.3 If the laboratory's documentation control
system allows for the amendment of documents by hand
pending the re-issue of the documents, the procedures and
authorities for such amendments shall be defined. Amendments
shall be clearly marked, initialed and dated. A revised document
shall be formally re-issued as soon as practicable.
4.3.3.4 Procedures shall be established to describe how
changes in documents maintained in computerized systems are
made and controlled.
4.4. REVIEW OF REQUESTS, TENDERS AND
CONTRACTS
4.4.1 The laboratory shall established and maintain
procedures for the review of requests, tenders and contracts.
The policies and procedures for these reviews leading to a
Laboratorul trebuie sa stabileasca si sa mentina
proceduri pentru controlul tuturor documentelor (generate intern
sau din surse externe) ce fac parte din documentatia calitatii, ca
de ex. reguli, standarde, alte documente normative, metode de
incercare si/sau etalonare, desene, software, specificatii,
instructiuni si manuale.
Nota 1: in acest context “document” poate insemna declaratii de
politica, proceduri, specificatii, tabele de etalonare,
diagrame, manuale, postere, notite, insemnari, soft-uri,
planuri, desene, etc. Acestea pot fi pe diverse
suporturi, fie hard copy, fie electronic, iar informatiile
pot fi digitale, analogice, fotografice sau scrise.
Nota 2: controlul datelor care se refera la incercare/calibrare
este acoperit de 5.4.7. Controlul inregistrarilor este
acoperit de 4.12.
4.3.2 Aprobarea si difuzarea documentelor
4.3.2.1. Toate documentele difuzate personalului in
laborator ca parte a sistemului calitatii trebuie sa fie analizate si
aprobate pentru folosire de catre un personal autorizat in acest
sens, inainte de difuzare. O lista centralizatoare sau o procedura
echivalenta de control al documentelor, indentificand situatia
curenta a reviziilor documentelor din sistemul calitatii trebuie sa
fie intocmit si usor disponibil, pentru a se impiedica folosirea de
documente nevalabile sau anulate.
4.3.2.2. Procedurile adoptate trebuie sa asigure, de
asemenea, ca :
a. editiile autorizate ale documentelor corespunzatoare sunt
disponibile peste tot unde se efectueaza operatii esentiale
pentru functionarea efectiva a laboratorului
b. documentele sunt revazute in mod periodic si, unde este
necesar, revizuite pentru a se asigura un caracter adecvat si
conformitatea cu cerintele aplicabile
c. documentele nevalabile sau anulate sunt sterse promt de
peste tot unde pot fi folosite sau sunt asigurate in alt mod
impotriva utilizarii lor neintentionate
d. documente anulate retinute in scopuri legale sau pastrarea
informatiilor sunt corespunzator marcate
4.3.2.3 Documentele sistemului de calitate generate de
laborator trebuie sa fie unic identificate, aceasta identificare
incluzand data editarii si/sau ID-ul, numerotarea paginilor,
numarul total de pagini sau un marcaj semnificand sfarsitul
documentului, precum si autoritatea emitenta.
4.3.3 Modificarile documentului
4.3.3.1 Modificarile documentelor trebuie sa fie
analizate si aprobate de aceleasi functii care au efectuat
revizuirea initiala, exceptand cazul in care s-a decis altfel.
Personalul desemnat trebuie sa aiba acces la informatiile de
baza adecvate, pe care sa-si bazeze analiza si aprobarea.
4.3.3.2 Unde este realizabil, textul modificat sau nou
va fi identificat in cadrul documentului sau al anexelor
corespunzatoare.
4.3.3.3 Daca sistemul de control al documentelor
laboratorului permite modificarea de mana a documentelor,
pana la reeditarea acestora, trebuie definite procedurile si
autoritatile pentru aceste modificari si trebuie sa se asigure ca
modificarile sunt vizate, notate si datate cu claritate. Un
document revizuit va fi re-editat in mod formal cat mai rapid
posibil.
4.3.3.4 Trebuie stabilite proceduri care sa descrie cum
se realizeaza si se controleaza modificari in documentele
pastrate in sisteme computerizate.
6
contract for testing and/or calibration shall ensure that:
a. the requirements, including the methods to be used, are
adequately defined, documented and understood (see 5.4.2)
b. the laboratory has the capability and resources to meet the
requirements
c. the appropriate test and/or calibration method is selected
and capable of meeting the clients' requirements (see 5.4.2).
Any differences between the request or tender and the
contract shall be resolved before any work commences. Each
contract shall be acceptable both to the laboratory and the client.
Note 1: the request, tender and contract review should be
conducted in a practical and efficient manner and
effect of financial, legal and time schedule aspects
should be taken into account. For internal clients,
reviews of requests, tenders and contracts can be
performed in a simplified way.
Note 2: the review of capability should established that the
laboratory possesses the necessary physical, personnel
and information resources and that the laboratory's
personnel have the skills and expertise necessary for
the performance of the tests and/or calibrations in
question. The review may also encompass results of
earlier participation in the inter-laboratory and
comparisons of proficiency testing and/or the running
of trial test or calibration programmes using samples
or items of known value in order to determine
uncertainties of measurement, limits of detection,
confidence limits etc.
Note 3: a contract may be any written and oral agreement to
provide a client with testing and/or calibration
services.
4.4.2 Records of reviews, including any significant
changes, shall be maintained. Records shall also be maintained
of pertinent discussions with a client relating to the client's
requirements or the results of the work during the period of
execution of the contract.
Note: for the review of routine and other simple tasks, the date
and the identification (e.g. the initials) of the person
and the laboratory responsible for carrying out the
contracted work are considered adequate. For repetitive
routine tasks, the review need be made only at the
initial inquiry stage or on granting of the contract for
on-going routine work performed under a general
agreement, provided that the clients' requirements
remain unchanged. For new, complex or advanced
testing and/or calibration tasks, a more comprehensive
record should be maintained.
4.4.3 The review shall also cover any work that is
subcontracted by the laboratory.
4.4.4 The client shall be informed of any deviation
from the contract.
4.4.5 If a contract needs to be amended after work has
commenced, the same contract review process shall be repeated
and any amendments shall be communicated to all affected
personnel.
4.5 SUBCONTRACTING OF TESTS AND CALIBRATIONS
4.5.1 When a laboratory subcontracts work whether
because of unforeseen reasons (e.g. workload, need for further
expertise or temporary incapacity) or on continuing basis (e.g.
through permanent subcontracting, agency or franchising
arrangements), this work shall be placed with a competent
4.4 . ANALIZA COMENZII, OFERTEI SAU
CONTRACTULUI
4.4.1 Laboratorul trebuie sa stabileasca si sa mentina
proceduri pentru analiza comenzilor, ofertelor sau contractelor.
Politicile si procedurile pentru analiza fiecarui contract,
comanda sau oferta conducand la un contract pentru incercare
si/sau etalonare vor asigura ca:
a. cerintele, inclusiv metodele ce trebuie folosite sunt adecvat
definite, documentate si intelese (vezi 5.4.2.)
b. laboratorul are capacitatea si resursele sa satisfaca cerintele
c. metoda potrivita de incercare si/sau etalonare este selectata
si capabila sa satisfaca cerintele clientilor (vezi 5.4.2).
Orice diferenta intre cerinta sau oferta si contract
trebuie sa fie rezolvata inainte de inceperea oricarei lucrari.
Fiecare contract trebuie sa fie acceptat atat de laborator cat si de
client.
Nota 1: analiza fiecarei comenzi, oferte sau contract ar trebui
intr-un mod practic si eficient, luandu-se in
considerare aspectele financiar, legal si de termen.
Pentru clienti interni, analiza comenzilor, ofertelor si
contractelor se poate realiza de o maniera simplificata.
Nota 2: analiza capabilitatii trebuie sa demonstreze ca
laboratorul poseda resursele umane, fizice si de
informatie si ca personalul laboratorului are calificarea
si experienta necesare pentru efectuarea incercarilor si
etalonarilor in cauza. Analiza capabilitatii poate
include rezultatele unor participari anterioare la
comparatii interlaboratoare sau incercari de aptitudine
si/sau desfasurarea de incercari de verificare sau
programe de etalonare folosind esantioane sau obiecte
de valoare cunoscuta, pentru a determina incertitudinea
masurarii, limitele de detectie si limitele de incredere,
etc.
Nota 3: un contract poate fi orice acord scris sau verbal pentru
furnizarea catre un client de servicii de incercare si/sau
etalonare.
4.4.2 Trebuie mentinute inregistrari ale acestor analize,
inclusiv ale oricaror modificari. Inregistrarile trebuie de
asemenea sa mentioneze discutiile utile cu clientii referitor la
cerintele acestora sau a rezultatelor lucrarii pe perioada
executarii contractului.
Nota: pentru sarcini de rutina si alte chestiuni simple sunt
considerate adecvate data si initialele persoanei si
laboratorului responsabile pentru executarea
contractului. Pentru sarcini de rutina repetitive, analiza
trebuie facuta numai pentru stadiul initial de ancheta
sau la aprobarea contractului pentru lucrari de rutina in
desfasurare efectuate pa baza unui acord general cu
clientul, in conditiile in care cerintele clientului raman
neschimbate. Pentru sarcini de incercare si/sau
etalonare noi, complexe si avansate trebuie mentinuta o
inregistrare mai cuprinzatoare.
4.4.3.Analiza trebuie sa includa orice lucrare ce trebuie
sa fie subcontractata de catre laborator.
4.4.4 Clientul va fi informat in legatura cu orice
abatere de la contract.
4.4.5 Daca un contract necesita corectari dupa ce s-a
inceput lucrarea, procesul analizei aceluiasi contract trebuie sa
se repete si orice amendamente trebuie communicate tutror
persoanelor afectate.
7
subcontractor. A competent subcontractor is one that, for
example, complies with this International Standard for the work
in question.
4.5.2 The laboratory shall advise the client of the
arrangement in writing and, when appropriate, gain the approval
of the client, preferably in writing.
4.5.3 The laboratory is responsible to the client for the
subcontractor's work, excepting the case where the client or a
regulatory authority specifies which subcontractor is to be used.
4.5.4 The laboratory shall maintain a register of all
subcontractors that it uses for tests and/or calibrations and a
record of evidence of compliance with this International
Standard for the work in question.
4.6 PURCHASING SERVICES AND SUPPLIES
4.6.1 The laboratory shall have a policy and
procedure(s) for the selection and purchasing of services and
supplies it uses that affect the quality of the tests and/or
calibrations. Procedures shall exist for the purchase, reception
and storage of reagents and laboratory consumable materials
relevant for the tests and calibrations.
4.6.2 The laboratory shall ensure that purchased
supplies and reagents and consumable materials that affect the
quality of tests and/or calibrations are not used until they have
been inspected or otherwise verified as complying with standard
specifications or requirements defined in the methods for the
tests and/or calibrations concerned. These services and supplies
used shall comply with
specified requirements. Records of action taken to check
compliance shall be maintained.
4.6.3 Purchasing documents for items affecting the
quality of laboratory output shall contain data describing the
services and supplies ordered. These purchasing documents
shall be reviewed and approved for technical content prior to
release.
Note: the description may include type, class, grade, precise
identification, specifications, drawings, inspection
instructions, other technical data including approval of
test results, the quality required and the quality system
standard under which they were made.
4.6.4 The laboratory shall evaluate suppliers of critical
consumables, supplies and services which affect the quality of
testing and calibration, and shall maintain records of these
evaluations and list those approved.
4.7 SERVICE TO THE CLIENT
The laboratory shall afford clients or their
representatives cooperation to clarify the client's request and to
monitor the laboratory's performance in relation to the work
performed, provided that the laboratory ensures confidentiality
to other clients.
Note 1: such cooperation may include:
a. providing the client or the client's representative
reasonable access to relevant areas of the laboratory
for the witnessing of tests and/or calibrations
performed for the client
b. preparation, packaging and dispatch of test and/or
calibration items needed by the client for verification
purposes.
Note 2: clients value the maintenance of good communication,
4.5 SUBCONTRACTAREA INCERCARILOR SI
ETALONARILOR
4.5.1 Cand un laborator contracteaza lucrari, fie
datorita unor circumstante neprevazute (de ex. volum de lucru,
necesitatea unei noi expertize sau incapacitate temporara), fie pe
baza de continuitate (de ex. subcontractare permanenta,
aranjamente de agentie sau prioritati), subcontractarea se va
realiza cu un subcontractant eficient. Acesta este acela care, de
ex, se conformeaza acestui standard in privinta lucrarii in
discutie.
4.5.2 Laboratorul trebuie sa avizeze in scris clientul si,
cand este cazul, sa ceara aprobarea acestuia, preferabil in scris.
4.5.3 Laboratorul este de asemenea responsabil fata de
clientii sai pentru executarea lucrarii subcontractantului, cu
exceptia cazului in care clientul sau o autoritate reglementara
specifica ce subcontractor va fi utilizat.
4.5.4 Laboratorul trebuie sa mentina un registru al
subcontractantilor pe care ii foloseste pentru incercari si/sau
etalonari si o inregistrare a dovezilor de conformitate cu
standardul de fata in privinta lucrarilor in discutie.
4.6 APROVIZIONAREA CU SERVICII SI FURNITURI
4.6.1 Laboratorul trebuie sa aiba politici si proceduri
pentru selectarea si procurarea serviciilor si furniturilor utilizate
care afecteaza calitatea incercarilor si/sau etalonarilor. Trebuie
sa existe proceduri pentru achizitionarea, primirea si depozitarea
reactivilor si materialelor consumabile relevante pentru
incercari si etalonari.
4.6.2 Laboratorul trebuie sa se asigure ca echipamentul
aprovizionat, reactivii si materialele consumabile care afecteaza
calitatea incercarilor si/sau etalonarilor nu sunt utilizate pana
cand nu au fost inspectate sau altcumva verificate ca sunt
conforme cu specificatiile standardelor sau cu cerintele definite
in metodele de incercare si/sau etalonare implicate.
Serviciile si furniturile utilizate trebuie sa satisfaca cerintele
specificate. Inregistrarile actiunilor intreprinse trebuie sa
verifice conformitatea si sa o mentina.
4.6.3 Documentele achizitionate pentru elementele ce
afecteaza calitatea iesirilor laboratorului vor contine date despre
serviciile si furniturile comandate. Aceste documente vor fi
analizate si aprobate ca si continut tehnic inaintea editarii.
Nota: prezentarea poate cuprinde tipul, clasa, gradul,
identificarea precisa, specificatii, desene, instructiuni de
inspectie, alte date tehnice inclusiv aprobarea
rezultatelor de incercare, calitatea ceruta si standardul
sistemului calitatii in lumina caruia au fost realizate.
4.6.4 Laboratorul va evalua furnizorii de consumabile,
furnituri si servicii importante ce afecteaza calitatea incercarii si
etalonarii si va pastra inregistrari ale acestor evaluari, listandu-le
pe cele aprobate.
4.7 SERVICIUL CATRE CLIENTI
Laboratorul trebuie sa asigure clientului sau
reprezentantului sau o cooperare care sa-i permita acestuia sa
clarifice cerintele clientului si sa monitorizeze performanta
laboratorului relativ la lucrarea efectuata, cu conditia ca
laboratorul sa asigure confidentialitate fata de alti clienti.
Nota 1: aceasta cooperare poate include:
a. asigurarea accesului clientului sau reprezentantului sau
in zonele relevante ale laboratorului, pentru a asista la
incercarile si/sau etalonarile efectuate pentru client
b. pregatirea, ambalarea si expedierea obiectelor
incercate sau etalonate necesare clientului pentru
scopuri de verificare.
8
 advice and guidance in technical matters, and
opinions and interpretations based on results.
Communication with the client, especially in large
assignments, should be maintained throughout the
work. The laboratory should inform the client of any
delays or major deviations in the performance of the
tests and/or calibrations.
Note 3: laboratories are encouraged to obtain other feedback,
both positive and negative, from their clients (e.g.
client surveys). The feedback should be used to
improve the quality system, testing and calibration
activities and client service.
4.8 COMPLAINTS
The laboratory shall have a policy and procedure for
the resolution of complaints received from clients or other
parties. Records shall be maintained of all complaints and of the
investigations and corrective actions taken by the laboratory
(see also 4.10).
4.9 CONTROL OF NONCONFORMING TESTING AND/OR
CALIBRATION WORK
4.9.1 The laboratory shall have a policy and procedures
that shall be implemented when any aspect of its testing and/or
calibration work, or the results of this work, do not conform to
its own procedures or the agreed requirements of the client. The
policy and procedures shall
ensure that:
a. the responsibilities and authorities for the management of
nonconforming work are designated and actions (including
halting of work and withholding of test reports and
calibration certificates, as necessary) are defined and taken
when nonconforming work is identified
b. an evaluation of the significance of the nonconforming
work is made
c. corrective actions are taken immediately, together with any
decision about the acceptability of the nonconforming work
d. where necessary, the client is notified and work is recalled
e. the responsibility for authorizing the resumption of work is
defined.
Note: identification of nonconforming work or problems with
the quality system or with testing and/or calibration
activities can occur at various places within the quality
system and technical operations. Examples are customer
complaints, quality control, instrument calibration,
checking of consumable materials, staff observations or
supervision, test report and calibration certificate
checking, management reviews and internal or external
audits.
4.9.2 Where the evaluation indicates that the
nonconforming work could recur or that there is doubt about the
compliance of the laboratory's operations with its own policies
and procedures, the corrective action procedures given in 4.10
shall be promptly followed.
4.10 CORRECTIVE ACTION
4.10.1 General
The laboratory shall establish a policy and procedure
and shall designate appropriate authorities for implementing
corrective action when nonconforming work of departures from
the policies and procedures in the quality system or technical
operations have been identified.
Nota 2: clientii apreciaza mentinerea unei bune comunicari,
sfatuirea si indrumarea in zona tehnica, interpretari si
recomandari bazate pe rezultate. Trebuie mentinuta pe
timpul lucrarii comunicarea cu clientul, in special la
sarcini mari. Laboratorul trebuie sa informeze clientii
de orice intarziere sau abatere majora in efectuarea
incercarilor si/sau etalonarilor.
Nota 3: laboratoarele sunt incurajate sa obtina si alte
comunicari, pozitive si negative, cu clientii (de ex.
supravegherea clientului). Acestea trebuie utilizate
pentru imbunatatirea sistemului calitatii, a activitatilor
de incercare si etalonare si a serviciilor catre client.
4.8 RECLAMATII
Laboratorul trebuie sa aiba o politica si proceduri
pentru rezolvarea reclamatiilor primite de clienti sau din alte
parti. Trebuie mentinute inregistrari ale tuturor reclamatiilor,
investigatiilor si actiunilor corective intreprinse de laborator
(vezi de asemeni 4.10).
4.9 CONTROLUL LUCRARILOR DE INCERCARE SI
ETALONARE NECONFORME
4.9.1 Laboratorul trebuie sa aiba o politica si proceduri
ce trebuie implementate cand se stabileste ca anumite aspecte
ale lucrarilor de incercare si/sau etalonare sau rezultatele acestor
lucrari nu sunt conforme cu procedurile proprii sau cu cerintele
convenite cu clientul.
Politica si procedurile trebuie sa se asigure ca:
a. au fost desemnate responsabilitatile si autoritatile pentru
managementul lucrarilor neconforme si sunt definite si
intreprinse actiuni (inclusiv oprirea lucrului si stoparea
rapoartelor de incercare si certificatelor de etalonare, dupa
cum e necesar) cand se identifica o lucrare neconforma
b. se face o evaluare a semnificatiei lucrarii neconforme
c. actiunile de remediere sunt intreprinse imediat, impreuna cu
orice decizii legate de acceptabilitatea lucrarii neconforme
d. daca este necesar, clientul este avertizat si se repeta
procedura
e. este definita responsabilitatea autorizarii reluarii lucrarii.
Nota: identificarea lucrarii neconforme sau problemelor cu
sistemul de management al calitatii sau activitatile de
incercare si/sau etalonare pot aparea in diferite locuri ale
sistemului management al calitatii; cum ar fi:
reclamatiile clientilor, controlul calitatii, etalonarea
aparatelor, verificarea materialelor consumabile,
observatiile sau supervizarea personalului, verificarea
rapoartelor de verificare si a certificatelor de etalonare,
analizele managementului si auditurile interne sau
externe.
4.9.2 Daca evaluarea indica faptul ca lucrarea
neconforma poate sa reapara sau ca exista dubii privind
conformitatea laboratorului cu propriile sale politici si
proceduri, trebuie urmate prompt procedurile actiunilor
corective date la pct. 4.10.
4.10 ACTIUNI CORECTIVE
4.10.1 Generalitati
Laboratorul trebuie sa stabileasca o politica si
proceduri si sa desemneze autoritatile corespunzatoare pentru
implementarea actiunii corective, atunci cand au fost
identificate lucrari neconforme sau abateri de la politici,
proceduri ale sistemului calitatii.
9
Note: a problem with the quality system or with the technical
operations of the laboratory may be identified through a
variety of activities, such as control of nonconforming
work, internal or external audits, management reviews,
feedback from clients or staff observations.
4.10.2 Cause analysis
The procedure for corrective action shall start with an
investigation to determine the root cause(s) of the problem.
Note: cause analysis is the key and sometimes the most difficult
part in the corrective action procedure. Often the root
cause is not obvious and thus a careful analysis of all
potential causes of the problem is required. Potential
causes could include client requirements, the samples,
sample specifications, methods and procedures, staff
skills and training, consumables, or equipment and its
calibration.
4.10.3 Selection and implementation of corrective
actions
Where corrective action is needed, the laboratory shall
identify potential corrective actions. It shall select and
implement the action(s) most likely to eliminate the problem
and to prevent recurrence.
Corrective actions shall be to a degree appropriate to the
magnitude and the risk of the problem.
The laboratory shall document and implement any
required changes resulting from corrective action investigations.
4.10.4 Monitoring of corrective actions
The laboratory shall monitor the results to ensure that
the corrective actions taken have been effective.
4.10.5 Additional audits
Where the identification of nonconformances or
departures casts doubts on the laboratory's compliance with its
own policies and procedures, or on its compliance with this
International Standard, the laboratory shall ensure that the
appropriate areas of activity are audited in accordance with 4.13
as soon as possible.
Note: such additional audits often follow the implementation of
the corrective actions to confirm their effectiveness. An
additional audit should be necessary only when a
serious issue or risk to the business is identified.
4.11 PREVENTIVE ACTION
4.11.1 Needed improvements and potential sources of
nonconformances, either technical or concerning the quality
system, shall be identified. If preventive action is required,
action plans shall be developed, implemented and monitored to
reduce the likelihood of the occurrence of nonconformances and
to take advantage of the opportunities for improvement.
4.11.2 Procedures for preventive actions shall include
the initiation of such actions and application of controls to
ensure that they are effective.
Note 1: preventive action is a pro-active process to identify
opportunities for improvement rather than a reaction to
the identification of problems or complaints.
Note 2: apart from the review of the operational procedures, the
preventive action might involve analysis of data,
including trend and risk analyses and proficiency-
testing results.
4.12 CONTROL OF RECORDS
Nota: o problema cu sistemul calitatii sau cu operatiile tehnice
ale laboratorului pot fi identificate printr-o varietate de
actiuni: controlul actiunilor neconforme, audituri interne
sau externe, analizele managementului, feedback de la
clienti sau observatii ale personalului.
4.10.2 Analiza cauzelor
Procedura de actiuni corective va incepe cu o
investigare pentru a determina cauza (cauzele) problemei.
Nota: aceasta este uneori cel mai dificil, dar este partea cheie a
procedurii de actiuni corective. Adesea, cauzele nu sunt
evidente si atunci se cere o analiza atenta a tuturor
cauzelor potentiale ale problemei. Cauzele potentiale pot
include, intre altele, esantioane, specificatii ale
esantionului, cerintele clientului, metodele si
procedurile, calificarea si experienta personalului,
materialele consumabile sau echipamentul si etalonarea
sa.
4.10.3 Selectarea si implementarea actiunilor
corective
Unde sunt necesare astfel de actiuni, laboratorul
trebuie sa identifice actiunile corective potentiale. El trebuie sa
aleaga si sa implementeze actiunea (actiunile) cele mai
probabile de a elimina problema si a preveni repetarea
acesteia.
Orice actiune corectiva trebuie sa fie de un nivel
corespunzator marimii problemelor si riscului implicat.
Laboratorul va documenta si implementa orice
modificari cerute ce rezulta din investigarea actiunilor corective.
4.10.4 Monitorizarea actiunilor corective
Laboratorul trebuie sa monitorizeze rezultatele, pentru
a se asigura ca actiunile corective intreprinse au fost eficiente.
4.10.5 Audituri suplimentare
Atunci cand identificarea neconformitatilor sau
abaterilor arunca dubii asupra conformitatii laboratorului cu
propriile politici si proceduri sau asupra conformitatii cu acest
standard, laboratorul trebuie sa se asigure ca zonele
corespunzatoare de activitate sunt promt auditate, in
concordanta cu clauza 4.13, si asta cat mai rapid.
Nota: astfel de audituri suplimentare urmeaza adeseori
implementarii actiunilor corective, pentru a le confirma
acestora eficienta. Un audit suplimentar este necesar
doar cand a fost identificata o sursa serioasa de risc.
4.11 ACTIUNI PREVENTIVE
4.11.1 Imbunatatirile necesare si sursele potentiale ale
neconformitatilor, fie tehnice, fie in sistemul de management al
calitatii, trebuie identificate. Daca e necesara o actiune de tip
preventiv trebuie intocmite, implementate si urmarite planuri de
actiune pentru reducerea probabilitatilor de aparitie a unor astfel
de neconformitati si obtinerea avantajelor oportunitatilor de
imbunatatire.
4.11.2 Procedurile de actiune preventiva vor cuprinde
initierea de astfel de actiuni si aplicarea de controale in scopul
asigurarii eficientei.
Nota 1: actiunea preventiva este mai degraba un proces de
identificare a oportunitatilor de imbunatatire a
calitatii decat o relatie de identificare de probleme
sau reclamatii.
Nota 2: separat de analiza procedurilor operationale, actiunea
preventiva poate cuprinde analiza datelor, incluzand
analizele de tendinte si riscuri analizelor si rezultatele
testarii competentei.
10
 4.12.1 General
4.12.1.1 The laboratory shall establish and maintain
procedures for identification, collection, indexing, access, filing,
storage, maintenance and disposal of quality and technical
records. Quality records shall include reports from internal
audits and management reviews as well as records of corrective
and preventive actions.
4.12.1.2 All records shall be legible and shall be stored
and retained in such a way that they are readily retrievable in
facilities that provide a suitable environment to prevent damage
or deterioration and to prevent loss. Retention times of records
shall be established.
Note: records may be in any media, such as hard copy or
electronic media.
4.12.1.3 All records shall be held secure and in
confidence.
4.12.1.4 The laboratory shall have procedures to
protect and back-up records stored electronically and to
prevent unauthorized access to or amendment of these records.
4.12.2 Technical records
4.12.2.1 The laboratory shall retain records of original
observations, derived data and sufficient information to
establish an audit trail, calibration records, staff records and a
copy of each test report or calibration certificate issued, for a
defined period. The records for each test or calibration shall
contain sufficient information to facilitate, if possible,
identification of factors affecting the uncertainty and to enable
the test or calibration to be repeated under conditions as close as
possible to the original. The records shall include the identity of
personnel responsible for the sampling, performance of each
test and/or calibration and checking of results.
Note 1: in certain fields it may be impossible or impractical to
retain records of all original observations.
Note 2: technical records are accumulations of data (see 5.4.7)
and information which result from carrying out tests
and/or calibrations and which indicate whether
specified quality or process parameters are achieved.
They may include forms, contracts, work sheets, work
books, check sheets, work notes, control graphs,
external and internal test reports and calibration
certificates, clients' notes, papers and feedback.
4.12.2.2 Observations, data and calculations shall be
recorded at the time they are made and shall be identifiable to
the specific task.
4.12.2.3 When mistakes occur in records, each mistake
shall be crossed out, not erased, made illegible or deleted, and
the correct value entered alongside. All such alterations to
records shall be signed or initialled by the person making the
correction. In the case of records stored electronically,
equivalent measures shall be taken to avoid loss or change of
original data.
4.13 INTERNAL AUDITS
4.13.1 The laboratory shall periodically, and in
accordance with a predetermined schedule and procedure,
conduct internal audits of its activities to verify that its
operations continue to comply with the requirements of the
quality system and this International Standard. The internal
audit programme shall address all elements of the quality
system, including the testing and/or calibration activities. It is
4.12 INREGISTRARI
4.12.1 Generalitati
4.12.1.1 Laboratorul trebuie sa stabileasca si sa
mentina proceduri de identificare, colectare, indexare, acces,
completare, depozitare, mentenanta si folosire a inregistrarilor
tehnice si de calitate. Inregistrarile calitatii trebuie sa includa
rapoartele auditurilor interne si analizele managementului ca si
inregistrarile actiunilor corective si preventive.
4.12.1.2 Toate inregistrarile trebuie sa fie lizibile,
depozitate si mentinute astfel incat sa fie promt regasibile, in
incaperi ce asigura un mediu adecvat pentru prevenirea
deteriorarilor si pierderilor. Trebuie stabilita si durata de
pastrare a inregistrarilor.
Nota: inregistrarile pot fi sub forma oricarui tip de suport, cum
ar fi hard copy sau suport electronic.
4.12.1.3 Toate inregistrarile trebuie sa se pastreze in
securitate si confidentialitate.
4.12.1.4 Laboratorul trebuie sa aiba proceduri pentru
protectia si salvarea datelor stocate in computere si
pentru prevenirea accesului neautorizat sau a modificarii acestor
date.
4.12.2 Inregistrari tehnice
4.12.2.1 Laboratorul trebuie sa pastreze observatiile
inregistrate in original, datele derivate si informatie suficienta
pentru a stabili un traseu de audit, inregistrari de etalonare,
inregistrari de personal si copii dupa fiecare raport de incercare
sau certificat de etalonare eliberat, pentru o perioada definita.
Inregistrarile pentru fiecare incercare si/sau etalonare trebuie sa
contina suficiente informatii care sa faciliteze, daca este posibil,
identificarea factorilor care afecteaza incertitudinea si sa
permita ca incercarea sau etalonarea sa se repete sub conditii cat
mai apropiate posibil de cele initiale. Inregistrarile trebuie sa
includa identitatea personalului responsabil pentru esantionare,
indeplinirea fiecarei incercari si/sau etalonari si verificarea
rezultatelor.
Nota 1: in anumite domenii este imposibil sau nepractic sa se
retina inregistrarile tuturor observatiilor initiale.
Nota 2: inregistrarile tehnice sunt acumulari de date (vezi 5.4.7)
si informtii ce rezulta din desfasurarea procedurilor de
incercare si etalonare si care indica care din parametrii
specificati ai calitatii sau procesului au fost realizati.
Ele pot cuprinde formulare, contracte, foi de lucru,
carti de lucru, foi de verificare, note de lucru, grafice
de control, rapoarte de incercare si certificate de
etalonare interne si externe, note ale clientilor, acte si
feedback.
4.12.2.2 Observatiile, datele si calculele trebuie sa fie
inregistrate in momentul colectarii si vor fi identificabila per
sarcina.
4.12.2.3 Cand apar greseli in inregistrari, fiecare
greseala trebuie taiata, nu stearsa sau facuta ilizibila, iar
valoarea corecta trebuie inscrisa alaturi. Toate aceste modificari
ale inregistrarilor trebuie semnate bsau marcate cu initiale de
catre persoana care a facut corectia. In cazul datelor stocate in
calculator, trebuie luate masuri similare, pentru a evita
modicarea sau pierderea datelor originale.
4.13 AUDITURI INTERNE
4.13.1 Laboratorul trebuie sa efectueze periodic si
conform unei planificari si proceduri dinainte stabilite, audituri
interne ale activitatilor sale, pentru a verifica daca functionarea
sa continua sa satisfaca cerintele sistemului calitatii si pe cele
ale acestui standard. Programul de audit intern trebuie sa
cuprinda toate elementele sistemului calitatii, inclusiv
11
the responsibility of the quality manager to plan and organize
audits as required by the schedule and requested by
management. Such audits shall be carried out by trained and
qualified personnel who are, wherever resources permit,
independent of the activity to be audited.
Note: the cycle for internal auditing should normally be
completed in one year.
4.13.2 When audit findings cast doubt on the
effectiveness of the operations or on the correctness or validity
of the laboratory's test or calibration results, the laboratory shall
take timely corrective action, and shall notify clients in writing
if investigations show that the laboratory results may have been
affected.
4.13.3 The area of activity audited, the audit findings
and corrective actions that arise from them shall be
recorded.
4.13.4 Follow-up audit activities shall verify and
record the implementation and effectiveness of the corrective
action taken.
4.14 MANAGEMENT REVIEWS
4.14.1 In accordance with a predetermined schedule
and procedure, the laboratory's executive management shall
periodically conduct a review of the laboratory's quality system
and testing and/or calibration activities to ensure their
continuing suitability and effectiveness, and to introduce
necessary changes or improvements.
The review shall take account of:
- the suitability of policies and procedures
- reports from managerial and supervisory personnel
- the outcome of recent internal audits
- corrective and preventive actions
- assessments by external bodies
- the results of inter-laboratory comparisons or proficiency
tests
- changes in the volume and type of the work
- client feedback
- complaints
- other relevant factors, such as quality control activities,
resources and staff training.
Note 1: a typical period for conducting a management review is
once every 12 months.
Note 2: results should feed into the laboratory planning system
and should include the goals, objectives and action
plans for the coming year.
Note 3: a management review includes consideration of related
subjects at regular management meetings.
4.14.2 Findings from management reviews and the
actions that arise from them shall be recorded. The management
shall ensure that those actions are carried out within an
appropriate and agreed timescale.
5 TECHNICAL REQUIREMENTS
5.1 GENERAL
5.1.1 Many factors determine the correctness and reliability of
the tests and/or calibrations performed by a laboratory. These
factors include contributions from:
activitatile de etalonare si/sau incercare. Managerul calitatii are
responsabilitatea planificarii si organizarii auditurilor, asa cum
este cerut de planificare si impus de management. Astfel de
audituri trebuie efectuate de un personal instruit si calificat, care
este – cand resursele o permit – independent de activitatile
auditate.
Nota: planificarea pentru auditurile interne trebuie in mod
normal sa fie completa intr-un an.
4.13.2 Cand constatarile auditului conduc la dubii
asupra efectivitatii functionarii sau asupra corectitudinii sau
validitatii rezultatelor incercarilor sau etalonarilor laboratorului,
laboratorul trebuie sa intreprinda la timp actiuni corective si sa-
si anunte in scris clientii daca investigatiile indica faptul ca
rezultatele laboratorului s-ar putea sa fi fost afectate.
4.13.3 Zona de activitate supusa auditarii, constatarile
auditului si actiunile corective care deriva din
aceasta trebuie inregistrate.
4.13.4 Activitatile de auditare realizate in continuare
vor verifica si inregistra implementarea si eficienta actiunii
corective intreprinse.
4.14 ANALIZA EFECTUATA DE CATRE CONDUCERE
4.14.1 Conform unui program si unei proceduri
prestabilite, conducerea la varf a laboratorului trebuie sa
efectueze periodic o analiza a sistemului propriu de
management al calitatii si activitatilor de incercare si/sau
etalonare, pentru a le asigura continua adecvare si eficienta si
pentru a efectua orice modificare sau imbunatatire necesara.
Analiza trebuie sa tina cont de:
- adecvarea politicilor si procedurilor
- rapoartele primite de la personalul managerial si de
supervizare
- rezultatele auditurilor interne recente
- actiunile corective si preventive
- evaluarile de catre organismele externe
- de rezultatele comparatiilor inter-laboratoare sau ale
incercarilor de aptitudine
- modificari in volumul si tipul lucrarilor
- feedback-ul de la clienti.
- reclamatii
- alti factori relevanti, precum activitatile de control al calitatii,
resursele si pregatirea personalului.
Nota 1: o perioada tipica pentru efectuarea unei analize a
conducerii este considerata a fi o data la 12 luni.
Nota 2: rezultatele trebuie sa fie cuprinse in sistemul de
planificare al laboratorului si trebuie sa includa:
scopurile obiectivele si planurile de actiuni pentru anul
urmator.
Nota 3: analiza managementului cuprinde considerarea
subiectelor descrise la intalniri regulate ale conducerii.
4.14.2 Constatarile rezultate in urma analizei efectuate
de catre conducere si actiunile ce decurg din aceasta trebuie sa
fie inregistrate. Managerul trebuie sa asigure ca aceste actiuni
vor fi realizate intr-un interval de timp corespunzator si
acceptat.
5 CERINTE TEHNICE
5.1 GENERALITATI
5.1.1 Multi factori determina corectitudinea si
increderea incercarilor si/sau etalonarilor efectuate de un
laborator. Acesti factori includ contributia:
- factorul uman (5.2)
- localurile si conditiile de mediu (5.3)
12
- human factors (5.2)
- accommodation and environmental conditions (5.3)
- test and calibration methods and method validation (5.4)
- equipment (5.5)
- measurement traceability (5.6)
- sampling (5.7)
- the handling of test and calibration items (5.8).
5.1.2 The extent to which the factors contribute to the
total uncertainty of measurement differs considerably between
(types of) tests and between (types of) calibrations. The
laboratory shall take account of these factors in developing test
and calibration methods and procedures, in the training and
qualification of personnel, and in the selection and calibration of
the equipment it uses.
5.2 PERSONNEL
5.2.1 The laboratory management shall ensure the
competence of all who operate specific equipment, perform
tests and/or calibrations, evaluate results, and sign test reports
and calibration certificates. When using staff who are
undergoing training, appropriate supervision shall be provided.
Personnel performing specific tasks shall be qualified on the
basis of appropriate education, training, experience and/or
demonstrated skills, as required.
Note 1: in some technical areas (e.g. non-destructive testing) it
may be required that the personnel performing certain
tasks hold personnel certification. The laboratory is
responsible for fulfilling specified personnel
certification requirements. The requirements for
personnel certification might be regulatory, included in
the standards for the specific technical field, or required
by the client.
Note 2: the personnel responsible for the opinions and
interpretation included in test reports should, in addition
to the appropriate qualifications, training, experience
and satisfactory knowledge of the testing carried out,
also have:
- relevant knowledge of the technology used for the
manufacturing of the items, materials, products etc.
tested, or the way they are used or intended to be
used, and of the defects or degradations which may
occur during or in service
- knowledge of the general requirements expressed in
the legislation and standards
- an understanding of the significance of deviations
found with regard to the normal use of the items,
materials, products, etc. concerned.
5.2.2 The management of the laboratory shall
formulate the goals with respect to the education, training and
skills of the laboratory personnel. The laboratory shall have a
policy and procedures for identifying training needs and
providing training of personnel. The training programme shall
be relevant to the present and anticipated tasks of the laboratory.
5.2.3 The laboratory shall use personnel who are
employed by, or under contract to, the laboratory. Where
contracted and additional technical and key support personnel
are used, the laboratory shall ensure that such personnel are
supervised and competent and that they work in accordance
with the laboratory’s quality system.
5.2.4 The laboratory shall maintain current job
- metodele de incercare si etalonare si validarea metodelor
(5.4)
- echipamentul (5.5)
- trasabilitatea masurarii (5.6)
- prelevarea (5.7)
- manipularea obiectelor de incercare si etalonare (5.8).
5.1.2 Masura in care factorii contribuie la
incertitudinea totala de masurare difera considerabil de la (tipuri
de) incercare la incercare si de la (tipuri de) etalonare la
etalonare. Laboratorul trebuie sa tina cont de acesti factori in
dezvoltarea metodelor si procedurilor de incercare si etalonare,
in instruirea si calificarea personalului si in alegerea si
etalonarea echipamentelor pe care le utilizeaza.
5.2 PERSONALUL
5.2.1 Conducerea laboratorului trebuie sa se asigure de
competenta intregului personal ce deserveste echipamentele
specifice, care efecturaza incercari si/sau etalonari, evalueaza
rezultatele si semneaza rapoarte de incercare si certificate de
etalonare. Daca se utilizeaza personal in curs de instruire,
trebuie asigurata o supervizare corespunzatoare. Personalul care
executa sarcini specifice trebuie sa fie calificat pe baza unei
formari adecvate, a instruirii, experientei si/sau priceperii
demonstrate, dupa cum se cere.
Nota 1: in anumite domenii tehnice (cum ar fi incercarile
nedustructive) este necesar ca personalul care
indeplineste anumite sarcini sa aiba o certificare de
personal. Laboratorul este responsabil pentru
indeplinirea cerintelor de certificare a personalului.
Cerintele de certificare a personalului pot fi
reglementare sau pot fi cuprinse in standarde pentru
domenii tehnice specifice sau cerute de catre client.
Nota 2: personalul responsabil cu pozitiile si interpretarea din
rapoartele de incercare mai trebuie, pe langa calificarea
corespunzatoare, instruire, experienta si cunostinte
satisfacatoare cu privire la incercarile efectuate, sa mai
detina:
- cunostinte relevante despre tehnologia utilizata la
fabricarea elementelor, materiale, produse etc. testate,
sau despre modul in care acestea sunt folosite sau se
intentioneaza utilizarea lor, precum si despre defectele
sau defectiunile ce ar putea interveni in timpul lucrului
- cunostinte adecvate cu privire la cerintele generale din
legislatie si standarde
- o intelegere a semnificatiei abaterilor descoperite in
raport cu utilizarea normala a elementelor, materiale,
produse etc. in discutie.
5.2.2 Conducerea laboratorului trebuie sa formuleze
scopurile, tinand cont de educatia si priceperea personalului
laboratorului. Laboratorul trebuie sa aiba o politica si proceduri
pentru identificarea necesitatilor de instruire si asigurarea
instruirii personalului. Programul de instruire trebuie sa fie
relevant pentru perioada de aplicare si sa anticipeze sarcinile
laboratorului.
5.2.3 Laboratorul trebuie sa foloseasca personal care este
angajat permanent sau pe baza de contract cu laboratorul. Cand
se utilizeaza personal tehnic si de sprijin important, cu contract
si suplimentar, laboratorul trebuie sa asigure ca acest personal
este supervizat si competent si ca lucrarile pe care acesta le
executa sunt in concordanta cu sistemul calitatii laboratorului.
5.2.4 Laboratorul trebuie sa pastreze fise ale postului
pentru personalul managerial, tehnic si de sprijin important
implicat in incercari si/sau etalonari.
Nota: fisa postului poate fi definita in diverse moduri. In mod
obligatoriu, aceasta trebuie sa defineasca
13
descriptions for managerial, technical and key support personnel
involved in tests and/or calibrations.
Note: job descriptions can be defined in many ways. As a
minimum, the following should be defined:
- the responsibilities with respect to performing tests
and/or calibrations
- the responsibilities with respect to the planning of
tests and/or calibrations and evaluation of results
- the responsibilities for reporting opinions and
interpretations
- the responsibilities with respect to method
modification and development and validation of
new methods
- expertise and experience required
- qualifications and training programmes
- managerial duties.
5.2.5 The management shall authorize 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 equipment. The laboratory shall maintain records of the
relevant authorization(s), competence, educational and
professional qualifications, training, skills and experience of all
technical personnel, including contracted personnel. This
information shall be readily available and shall include the date
on which authorization and/or competence is confirmed.
5.3 ACCOMODATION AND ENVIRONMENTAL
CONDITIONS
5.3.1 Laboratory facilities for testing and/or
calibration, including but not limited to energy sources, lighting
and environmental conditions, shall be such as to facilitate
correct performance of the tests and/or calibrations.
The laboratory shall ensure that the environmental
conditions do not invalidate the results or adversely affect the
required quality of any measurement. Particular care shall be
taken when sampling and tests and/or calibrations are
undertaken at sites other than a permanent laboratory facility.
The technical requirements for accommodation and
environmental conditions that can affect the results of tests and
calibrations shall be documented.
5.3.2 The laboratory shall monitor, control and record
environmental conditions as required by the relevant
specifications, methods and procedures or where they influence
the quality of the results. Due attention shall be paid, for
example, to biological sterility, dust, electromagnetic
disturbances, radiation, humidity, electrical supply, temperature,
and sound and vibration levels, as appropriate to the technical
activities concerned. Tests and calibrations shall be stopped
when the environmental conditions jeopardize the results of the
tests and/or calibrations.
5.3.3 There shall be effective separation between
neighbouring areas in which there are incompatible activities.
Measures shall be taken to prevent cross-contamination.
5.3.4 Access to and use of areas affecting the quality of
the tests and/or calibrations shall be controlled. The laboratory
shall determine the extent of control based on its particular
circumstances.
5.3.5 Measures shall be taken to ensure good
housekeeping in the laboratory. Special procedures shall be
prepared where necessary.
responsabilitatile privind:
- efectuarea incercarilor si/sau etalonarilor
- planificarea incercarilor si/sau etalonarilor si evaluarea
rezultatelor
- modificarea metodelor, dezvoltarea si validarea de noi
metode
- cunostinte de specialitate si experienta
- calificari si programe de instruire
- obligatii manageriale.
5.2.5 Conducerea trebuie sa autorizeze un personal
specific pentru efectuarea unor tipuri particulare de prelevari,
incercari si/sau etalonari, sa autorizeze emiterea rapoartelor de
incercare si a certificatelor de etalonare, sa emita opinii si
interpretari si sa deserveasca tipuri particulare de echipament.
Laboratorul trebuie sa pastreze inregistrari ale unor autorizari
relevante, ale competentei, calificarii educationale si
profesionale, ale instruirii si experientei intregului personal
tehnic, inclusiv cel cu contract. Aceste informatii trebuie sa
poata deveni imediat disponibile si sa mentioneze data la care
este confirmata autorizatia si/sau competenta.
5.3 LOCALURI SI CONDITII DE MEDIU
5.3.1 Instalatiile laboratorului pentru incercare si/sau
etalonare, incluzand, dar nefiind limitate la surse de energie,
iluminat si conditii de mediu trebuie sa fie astfel incat sa
faciliteze efectuarea corecta a incercarilor si/sau etalonarilor.
Laboratorul trebuie sa se asigure ca mediul ambiant nu
invalideaza rezultatele sau afecteaza negativ calitatea ceruta a
oricarei masurari. Trebuie acordata o atentie deosebita situatiilor
in care esantionarea, incercarea si/sau etalonarea sunt efectuate
in alte locuri decat siturile permanente ale laboratorului.
Cerintele tehnice privind localurile si conditiile de mediu ce pot
afecta rezultatele incercarilor si etalonarilor vor fi documentate.
5.3.2 Laboratorul trebuie sa monitorizeze, sa controleze
si sa inregistreze conditiile ambientale, asa cum e cerut de
specificatiile relevante, metode si proceduri sau atunci cand
acestea influenteaza calitatea rezultatelor. Trebuie acordata o
atentie corespunzatoare, de exemplu, sterilizarii biologice,
prafului, interferentelor electromagnetice, radiatiilor, umiditatii,
alimentarii electrice, temperaturii, nivelului sunetului si
vibratiilor, dupa cum este adecvat la activitatile tehnice in
cauza. Incercarile si etalonarile trebuie oprite, daca conditiile de
mediu afecteaza (invalideaza) rezultatele incercarilor si/sau
etalonarilor.
5.3.3 Trebuie sa existe o separatie efectiva intre zonele
invecinate, in care se desfasoara activitati incompatibile.
Trebuie luate masuri pentru prevenirea contaminarilor
incrucisate.
5.3.4 Trebuie controlat accesul si folosirea zonelor
afectand calitatea incercarilor si/sau etalonarilor. Laboratorul va
determina dimensiunile controlului pe baza circumstantelor.
5.3.5 Trebuie luate masuri pentru a asigura curatenia in
laborator. In caz de nevoie, se vor pregati proceduri speciale.
5.4 METODE DE INCERCARE SI ETALONARE SI
VALIDAREA METODELOR
5.4.1 Generalitati
Laboratorul trebuie sa foloseasca metode si proceduri
adecvate pentru toate incercarile si/sau etalonarile din domeniul
14
 5.4 TEST AND CALIBRATION METHODS AND METHOD
VALIDATION
5.4.1 General
The laboratory shall use appropriate methods and
procedures for all tests and/or calibrations within its scope.
These include sampling, handling, transport, storage and
preparation of items to be tested and/or calibrated, and, where
appropriate, an estimation of the measurement uncertainty as
well as statistical techniques for analysis of
test and/or calibration data.
The laboratory shall have instructions on the use and
operation of all relevant equipment and on the handling and
preparation of items for testing and/or calibration, or both,
where the absence of such instructions could jeopardize the
results of tests and/or calibrations. All instructions, standards,
manuals and reference data relevant to the work of the
laboratory shall be kept up to date and shall be made readily
available to personnel (see 4.3). Deviation from test and
calibration methods shall occur only if the deviation has been
documented, technically justified, authorized, and accepted by
the client.
Note: international, regional or national standards or other
recognized specifications that contain sufficient and
concise information on how to perform the tests and/or
calibrations do not need to be supplemented or rewritten
as internal procedures if these standards are written in a
way that they can be used as published by the operating
staff in a laboratory. It may be necessary to provide
additional documentation for optional steps in the method
or additional details.
5.4.2 Selection of methods
The laboratory shall use test and/or calibration
methods, including methods for sampling, which meet the needs
of the client and which are appropriate for the tests and/or
calibrations it undertakes. Methods published in international,
regional or national standards shall preferably be used. The
laboratory shall ensure that it uses the latest valid edition of a
standard unless it is not appropriate or possible to do so. When
necessary, the standard shall be supplemented with additional
details to ensure consistent application.
When the client does not specify the method to be
used, the laboratory shall select appropriate methods that have
been published either in international, regional or national
standards, or by reputable technical organizations or in relevant
scientific texts or journals, or as specified by the manufacturer
of the equipment. Laboratory-developed methods or methods
adopted by the laboratory may also be used if they are
appropriate for the intended use and it they are validated. The
client shall be informed as to the method chosen. The laboratory
shall confirm that it can properly operate standard methods
before introducing the tests or calibrations. If the standard
method changes, the confirmation shall be repeated.
The laboratory shall inform the client when the method
proposed by the client is considered to be inappropriate or out
of date.
5.4.3 Laboratory-developed methods
The introduction of test and calibration methods
developed by the laboratory for its own use-shall be a planned
activity and shall be assigned to qualified personnel equipped
with adequate resources.
Plans shall be updated as development proceeds and
sau, pentru esantionare, manipulare, transport, depozitare si
pregatirea elementelor (obiectelor) pentru incercare si/sau
etalonare si, atunci cand este cazul, o estimare a incertitudinii de
masurare, ca si tehnici statistice
de analiza a datelor de incercare si/sau etalonare.
Laboratorul trebuie sa aiba instructiuni privind
functionarea si utilizarea tuturor echipamentelor mai importante
si pentru manipularea si pregatirea obiectelor pentru incercare
si/sau etalonare – sau ambele - atunci cand absenta acestor
instructiuni ar putea periclita rezultatele incercarilor si/sau
etalonarilor. Toate instructiunile, standardele, manualele si
datele de referinta relevante pentru activitatea laboratorului
trebuie mentinute la zi si trebuie sa fie usor accesibile
personalului (vezi 4.3). Abaterile de la metodele de incercare
si/sau etalonare pot surveni numai daca abaterea a fost
documentata, justificata tehnic, autorizata si acceptata de client.
Nota: standardele internationale, regionale sau nationale sau alte
specificatii recunoscute ce contin informatii suficiente si
concise privind efectuarea incercarilor si/sau etalonarilor
nu este necesar sa fie amendate sau rescrise ca si proceduri
interne daca aceste standarde au fost scrise intr-un mod in
care pot fi utilizate asa cum au fost publicate, de catre
personalul operativ al laboratorului. S-ar putea sa fie
necesara o documentatie suplimentara pentru fazele
optionale ale metodei, sau detalii suplimentare.
5.4.2 Alegerea metodelor
Laboratorul trebuie sa foloseasca metode de incercare
si/sau etalonare, inclusiv pentru esantionare, care satisfac
nevoile clientului si care sunt corespunzatoare incercarilor si/sau
etalonarilor pe care le efectueaza. Sunt preferabile metodele
publicate in standarde nationale, regionale sau internationale.
Laboratorul trebuie sa se asigure ca utilizeaza ultima editie
valida a standardului, cu exceptia cazului cand nu este
corespunzator sau posibil sa procedeze astfel. Atunci cand este
necesar, standardul trebuie sa fie suplimentat cu detalii pentru a
se asigura o aplicare consistenta.
Cand clientul nu specifica metoda care trebuie utilizata,
laboratorul trebuie sa aleaga metodele corespunzatoare care au
fost publicate fie in standardele internationale, regionale sau
nationale, fie de catre organizatii tehnice reputate sau in texte si
publicatii stiintifice relevante, sau dupa specificatiile
producatorului echipamentului. Pot fi utilizate si metode proprii
sau adoptate de laboratorul in cauza, daca acestea sunt
corespunzatoare utilizarii dorite si daca sunt validate. Clientul
trebuie informat de metoda aleasa. Laboratorul va confirma ca
poate opera corespunzator cu metode standard inaintea inceperii
incercarilor si etalonarilor. Daca metoda standard se modifica,
confirmarea se va repeta.
Laboratorul trebuie sa-l informeze pe client, atunci cand
metoda propusa de acesta este considerata ca fiind inadecvata
sau depasita.
5.4.3 Metode dezvoltate in laborator
Introducerea metodelor de incercare si etalonare
dezvoltate in laborator pentru folosinta proprie va fi o activitate
planificata si repartizata unui personal calificat, echipat cu
resurse adecvate.
Planurile vor fi actualizate pe masura dezvoltarii si se va
asigura o comunicare eficienta intre toti membrii personalului
implicati.
5.4.4 Metode nestandadrizate
Atunci cand este necesar sa se foloseasca metode
neacoperite de specificatii ale standardelor, trebuie sa existe un
acord cu clientul si se va avea in vedere o specificatie clara a
cerintelor clientului si a obiectivelor incercarii si/sau
15
effective communication amongst all personnel involved shall
be ensured.
5.4.4 Non-standard methods
When it is necessary to use methods not covered by
standard methods, these shall be subject to agreement with the
client and shall include a clear specification of the client’s
requirements and the purpose of the test and/or
calibration. The method developed shall have been validated
appropriately before use.
Note: for new test and/or calibration methods, procedures
should be developed prior to the tests and/or
calibrations being performed and should contain at
least the following information:
a. appropriate identification
b. scope
c. description of the type of item to be tested or
calibrated
d. parameters or quantities and ranges to be
determined
e. apparatus and equipment, including technical
performance requirements
f. reference standards and reference materials
required
g. environmental conditions required and any
stabilization period needed
h. description of the procedure, including
-affixing of identification marks, handling,
transporting, storing and preparation of items
-checks to be made before the work is started
-checks that the equipment is working properly
and, where required, calibration and adjustment
of the equipment before each use
-the method of recording the observations and
results
-any safety measures to be observed
i. criteria and/or requirements for approval/rejection
j. data to be recorded and method of analysis and
presentation
k. the uncertainty or the procedure for estimating
uncertainty.
5.4.5 Validation of methods
5.4.5.1 Validation is the confirmation by examination
and the provision of objective evidence that the partlcular
requirements for a specific intended use are fulfilled.
5.4.5.2 The laboratory shall validate non-standard
methods, laboratory-designed/developed methods, standard
methods used outside their intended scope, and amplifications
and modifications of standard methods to confirm that the
methods are fit for the intended use. The validation shall be as
extensive as is necessary to meet the needs of the given
application or field of application. The laboratory shall record
the results obtained, the procedure used for the validation, and a
statement as to whether the method is fit for the intended use.
Note 1: validation may include procedures for sampling,
handling and transportation.
Note 2: the techniques used for the determination of the
performance of a method should be one of, or a
combination of the following:
- calibration using reference standards or reference
materials
- comparison of results achieved with other
methods
etalonarii. Metoda dezvoltata trebuie sa fi fost validata in mod
corespunzator inainte de folosire.
Nota: in cazul metodelor noi de incercare si/sau etalonare,
procedurile trebuie dezvoltate anterior lucrarilor si
trebuie sa contina cel putin urmatoarele informatii:
a. o identificare corespunzatoare
b. obiectul
c. descrierea tipului obiectului care trebuie incercat sau
etalonat
d. parametrii sau marimile si intervalele care vor fi
determinate
e. aparatele si echipamentele, inclusiv cerinte de
functionare tehnica
f. standardele de referinta si materialele de referinta
cerute
g. conditiile de mediu cerute si perioada de stabilizare
necesara
h. descrierea procedurii, incluzand:
- aplicarea de marcaje de identificare, manipularea,
transportul, depozitarea si pregatirea obiectelor
- verificarile ce trebuie efectuate inaintea inceperii
lucrarii
- verificarea ca echipamentele functioneaza corect si,
unde se cere, etalonarea sau ajustarea echipamentului
inainte de fiecare utilizare
- metoda de inregistrare a observatiilor si rezultatelor
- masurile de securitate care trebuie respectate
i. criteriile si/sau cerintele de acceptare/respingere
j. datele care se inregistreaza si metoda de analiza si
prezentare
k. incertitudinea sau procedura de estimare a ei.
5.4.5 Validarea metodelor
5.4.5.1 Validarea este confirmarea prin examinare si
furnizarea de dovezi obiective ca cerintele particulare cu privire
la o utilizare specifica intentionata sunt toate indeplinite.
5.4.5.2. Laboratorul trebuie sa valideze metodele de
incercare si/sau etalonare nestandardizate, metode
dezvoltate/elaborate in laborator, metode standard utilizate in
afara domeniului pentru care au fost proiectate, precum si
amplificari si modificari de metode standard, pentru a confirma
ca metodele sunt adecvate pentru utilizarea avuta in vedere.
Validarea trebuie sa fie extinsa atat cat este necesar pentru a
indeplini necesitatile aplicatiei sau domeniului de aplicare dat.
Laboratorul trebuie sa inregistreze rezultatele obtinute,
procedura folosita pentru validare si o declaratie daca metoda
este potrivita sau nu pentru intentia de utilizare.
Nota 1: validarea poate cuprinde proceduri de esantionare,
manuire si transport.
Nota 2: tehnicile utilizate pentru determinarea functionarii unei
metode trebuie sa fie una dintre sau o combinatie intre
urmatoarele:
- etalonare cu standarde de referinta sau materiale de
referinta
- comparare de rezultate obtinute prin alte metode
- comparare intre laboratoare
- evaluare sistematica a factorilor ce influenteaza
rezultatul
- evaluare a incertitudinii rezultatelor pe baza
intelegerii stiintifice a principiilor teoretice ale
16
 - inter-laboratory comparisons
- systematic assessment of the factors influencing
the result
- assessment of the uncertainly of the results based
on scientific understanding of the theoretical
principles of the method and practical experience.
Note 3: when some changes are made in the validated non-
standard methods, the influence of such changes
should be documented and, if appropriate, a new
validation should be carried out.
5.4.5.3 The range and accuracy of the values
obtainable from validated methods, e.g. the uncertainty of the
results, detection limit, selectivity of the method, linearity, limit
of repeatability and/or reproducibility, robustness against
external influences and/or cross-sensitivity against interference
from the matrix of the sample/test objects as assessed for the
intended use, shall be relevant to the clients’ needs.
Note 1: validation includes specification of the requirements,
determination of the characteristics of the methods, a
check that the requirements can be fulfilled by using
the method, and a statement on the validity.
Note 2: as method-development proceeds, regular review should
be carried out to verify that the needs of the client are
still being fulfilled. Any change in requirements
requiring modifications to the development plan
should be approved and authorized.
Note 3: validation is always a balance between costs, risks and
technical possibilities. There are many cases in which
the range and uncertainty of the values (e.g. accuracy,
detection limit, selectivity, linearity, repeatability,
reproducibility, robustness and cross-sensitivity) can
only be given in a simplified way due to lack of
information.
5.4.6 Estimation of uncertainty of measurement
5.4.6.1 A calibration laboratory, or a testing laboratory
performing its own calibrations, shall have and apply a
procedure to estimate the uncertainty of measurement for all
calibrations and types of calibrations.
5.4.6.2 Testing laboratories shall have and shall apply
procedures for estimating uncertainty of measurement. In
certain cases the nature of the test method may preclude
rigorous, metrologically and statistically valid, calculation of
uncertainty of measurement. In these cases the laboratory shall
at least attempt to identify all the components of uncertainty and
make a reasonable estimation, and shall ensure that the form of
reporting of the result does not give a wrong impression of the
uncertainty. Reasonable estimation shall be based on knowledge
of the performance of the method and on the measurement
scope and shall make use of, for example, previous experience
and validation data.
Note 1: the degree of rigor needed in an estimation of
uncertainty of measurement depends on factors such
as:
- the requirements of the test method
- the requirements of the client
- the existence of narrow limits on which decisions on
conformance to a specification are based.
Note 2: in those cases where a well-recognized test method
specifies limits to the values of the major sources of
uncertainty of measurement and specifies the form
metodei si pe baza experientei practice.
Nota 3: cand se fac schimbari in metodele nestandardizate
validate, influenta acestor schimbari trebuie
documentata si, daca e cazul, efectuata o noua
validare.
5.4.5.3 Domeniul si acuratetea valorilor ce pot fi
obtinute prin metode validate, de ex. incertitudinea rezultatelor,
limita de detectie, selectivitatea metodei, liniaritatea, limita de
repetabilitate si/sau reproductibilatate, robustetea fata de
influentele exterioare si/sau sensibilitatea incrucisata fata de
interferenta din partea matricei obiectelor pentru
esantion/testare asa cum s-a evaluat pentru utilizarea dorita,
trebuie sa fie relevant pentru necesitatile clientului.
Nota 1: validarea cuprinde specificarea cerintelor, determinarea
caracteristicilor metodelor, verificarea daca cerintele
pot fi indeplinite cu ajutorul acelei metode, precum si
o precizare in legatura cu validitatea.
Nota 2: pe masura progresului dezvoltarii de metoda vor fi
necesare revizii regulate care sa verifice daca
necesitatile clientului sunt inca indeplinite. Orice
modificare a cerintelor legate de modificarea planului
de dezvoltare va trebui aprobata si autorizata.
Nota 3: validarea este intotdeauna un echilibru intre costuri,
riscuri si posibilitati tehnice. Exista numeroase cazuri
in care intervalul si incertitudinea valorilor (de ex.
precizia, limita de detectie, selectivitatea, liniaritatea,
fidelitatea, reproductibilitatea, robustetea si finetea
incrucisata) se pot da doar intr-o forma simplificata,
din cauza lipsei de informatii.
5.4.6 Estimarea incertitudinii in masurare
5.4.6.1 Un laborator de etalonare sau unul de incercare
care-si realizeaza singur etalonarile trebuie sa aiba si sa aplice o
procedura de estimare a incertitudinii masurarii pentru toate
etalonarile si tipurile de etalonari.
5.4.6.2 Laboratoarele de incercare vor detine si aplica
proceduri de estimare a incertitudinii in masurare. In anumite
cazuri, natura metodei de incercare poate exclude o calculare
riguroasa, valida din punct de vedere metrologic si statistic, a
incertitudinii. In aceste cazuri laboratorul va incerca macar sa
identifice toate componentele incertitudinii si sa realizeze o
estimare rezonabila, precum si sa se asigure ca forma de
prezentare a rezultatului nu da o impresie gresita despre
incertitudine. O estimare rezonabila se va axa pe cunoasterea
performantelor metodei precum si pe campul masurarii si va
folosi, spre ex, experienta anterioara si datele cu privire la
validare.
Nota 1: gradul de rigoare necesar la estimarea incertitudinii in
masurare depinde de factori precum:
- cerintele metodei de incercare
- cerintele clientului
- existenta unor limite inguste pe care se
fundamenteaza deciziile asupra conformitatii la o
specificatie.
Nota 2: in cazurile in care o metoda de incercare recunoscuta
specifica limite pentru valorile surselor majore de
incertitudine in masurare, precum si
forma de prezentare a rezultatelor calculate, se considera ca
laboratorul a satisfacut aceasta clauza prin respectarea
metodei de incercare si prezentarea instructiunilor
(vezi 5.10).
5.4.6.3 Cand se estimeaza incertitudinea trebuie luate in
considerare toate componentele incertitudinii care sunt
17

of presentation of calculated results, the laboratory is
considered to have satisfied this clause by following
the test method and reporting instructions (see 5.10).
5.4.6.3 When estimating the uncertainty of
measurement, all uncertainty components which are of
importance in the given situation shall be taken into account
using appropriate methods of analysis.
Note 1: sources contributing to the uncertainty include, but are
not necessarily limited to, the reference standards and
reference materials used, methods and equipment used,
environmental conditions, properties and condition of
the item being tested or calibrated, and the operator.
Note 2: the predicted long-term behaviour of the tested and/or
calibrated item is not normally taken into account
when estimating the measurement uncertainty.
Note 3: for further information, see ISO 5725 and the Guide to
the Expression of Uncertainty in Measurement (see
bibliography).
5.4.7 Control of data
5.4.7.1 Calculations and data transfers shall be subject
to appropriate checks in a systematic manner.
5.4.7.2 When computers or automated equipment are
used for the acquisition, processing, recording, reporting,
storage or retrieval of test or calibration data, the laboratory
shall ensure that:
a. computer software developed by the user is documented in
sufficient detail and is suitably validated as being adequate
for use
b. procedures are established and implemented for protecting
the data; such procedures shall include, but not be limited
to, integrity and confidentiality of data entry or collection,
data storage, data transmission and data processing
c. computers and automated equipment are maintained to
ensure proper functioning and are provided with the
environmental and operating conditions necessary to
maintain the integrity of test and calibration data.
Note: commercial off-the-shelf software (e.g. word processing,
database and statistical programmes) in general use
within their designed application range may be
considered to be sufficiently validated. However,
laboratory software configuration/ modifications should
be validated as in 5.4.7.2 a).
5.5 EQUIPMENT
5.5.1 The laboratory shall be furnished with all items
of sampling, measurement and test equipment required for the
correct performance of the tests and/or calibrations (including
sampling, preparation of test and/or calibration items,
processing and analysis of test and/or calibration data). In those
cases where the laboratory needs to use equipment outside its
permanent control, it shall ensure that the requirements of this
International Standard are met.
5.5.2 Equipment and its software used for testing,
calibration and sampling shall be capable of achieving the
accuracy required and shall comply with specifications relevant
to the tests and/or calibrations concerned. Calibration
programmes shall be established for key quantities or values of
the instruments where these properties have a significant effect
on the results. Before
being placed into service, equipment (including that used for
sampling) shall be calibrated or checked to establish that it
meets the laboratory's specification requirements and complies
with the relevant standard specifications. It shall be checked
importante in situatia data, folosindu-se metode acceptate de
analiza.
Nota 1: sursele contribuind la incertitudine cuprind, dar nu sunt
limitate neaparat la standardele de referinta si
materialele de referinta folosite, la metodele si
echipamentele utilizate, la conditiile de mediu, la
proprietatile si starea obiectului incercat sau etalonat
sau la operator.
Nota 2: comportarea prezisa pe termen lung a obiectului
incercat si/sau etalonat nu este in mod normal luata
in considerare atunci cand se estimeaza
incertitudinea masurarii.
Nota 3: pentru informatii suplimentare, vezi ISO 5725 si
"Ghidul de exprimare a incertitudinii in masurare"
(vezi bibliografia).
5.4.7 Controlul datelor
5.4.7.1 Calculele si transferul de date trebuie sa fie
supuse unor verificari corespunzatoare, in mod sistematic.
5.4.7.2 Daca se folosesc calculatoare sau echipament
automat pentru achizitia, procesarea, inregistrarea, prezentarea,
stocarea sau recuperarea datelor de incercare sau etalonare,
laboratorul trebuie sa se asigure ca:
a. soft-ul calculatorului dezvoltat de utilizator este documentat
suficient de detaliat si validat corespunzator ca fiind adecvat
pentru utilizare
b. sunt stabilite si implementate proceduri pentru protectia
datelor; aceste proceduri trebuie sa cuprinda, fara insa a se
limita la acestea, integritatea si caracterul confidential ale
intrarii sau colectarii de date, stocarea de date, transmisia de
date si procesarea de date
c. calculatoarele si echipamentul automat trebuie intretinute,
pentru a se asigura functionarea corecta si ca dispun de
conditiile de functionare si de mediu necesare mentinerii
integritatii datelor de incercare si etalonare.
Nota: softurile comerciale neoficiale (de ex. de procesare texte,
baze de date si programe de statistica), pentru o utilizare
generala in cadrul intervalului proiectat de aplicare, pot fi
considerate ca fiind suficient validate. Totusi,
modificarile/configuratiile soft-urilor de laborator trebuie
validate conform cu 5.4.7.2 a).
5.5 ECHIPAMENTUL
5.5.1 Laboratorul trebuie sa fie dotat cu toate
echipamentele de prelevare, masurare si incercare cerute pentru
efectuarea corecta a incercarilor si/sau etalonarilor (inclusiv
prelevarea, pregatirea obiectelor de incercare si/sau etalonare,
procesare si analiza datelor de incercare si/sau etalonare). In
cazurile in care laboratorul trebuie sa utilizeze echipament din
afara controlului sau permanent, el trebuie sa se asigure ca sunt
indeplinite cerintele prezentului Standard.
5.5.2 Echipamentul si soft-ul sau, utilizat pentru
incercare, etalonare si prelevare trebuie sa fie capabil sa obtina
exactitatea ceruta si sa fie conform cu specificatiile relevante
pentru incercarile si/sau etalonarile respective. Trebuie sa se
intocmeasca programe de etalonare pentru marimile sau valorile
-cheie ale instrumentelor atunci cand aceste proprietati au un
efect semnificativ asupra
rezultatelor. Inainte de plasarea in serviciu, echipamentul
(inclusiv cel de prelevare), trebuie etalonat sau verificat pentru a
se stabili daca indeplineste cerintele din specificatiile
laboratorului si se conformeaza specificatiilor standardelor
relevante. El va fi verificat si/sau etalonat inainte de utilizare
(vezi 5.6).
5.5.3 Echipamentul trebuie operat de catre personal
18
and/or calibrated before use (see 5.6).
5.5.3 Equipment shall be operated by authorized
personnel. Up-to-date instructions on the use and maintenance
of equipment (including any relevant manuals provided by the
manufacturer of the equipment) shall be readily available for
use by the appropriate laboratory personnel.
5.5.4 Each item of equipment and its software used for
testing and calibration and significant to the result shall, when
practicable, be uniquely identified.
5.5.5 Records shall be maintained of each item of
equipment and its software significant to the tests and/or
calibrations performed. The records shall include at least the
following:
a. the identity of the item of equipment and its software
b. the manufacturer's name, type identification, and serial
number or other unique identification
c. checks that the equipment complies with the specification
(see 5.5.2)
d. the current location, where appropriate
e. the manufacturer's instructions, if available, or reference to
their location
f. dates, results and copies of reports and certificates of all
calibrations, adjustments, acceptable criteria, and the due
date of next calibration
g. the maintenance plan, where appropriate, and maintenance
carried out to date
h. any damage, malfunction, modification or repair to the
equipment.
5.5.6 The laboratory shall have procedures for safe
handling, transport, storage, use and planned maintenance of
measuring equipment to ensure proper functioning and in order
to prevent contamination or deterioration.
Note: additional procedures may be necessary when measuring
equipment is used outside the permanent laboratory for
tests, calibrations or sampling.
5.5.7 Equipment that has been subjected to overloading
or mishandling, gives suspect results, or has been shown to be
defective or outside specified limits, shall be taken out of
service. It shall be isolated to prevent its use or clearly labelled
or marked as being out of service until it has been repaired and
shown by calibration or test to perform correctly. The laboratory
shall examine the effect of the defect or departure from
specified limits on previous tests and/or calibrations and shall
institute the "Control of non-conforming work" procedure (see
4.9).
5.5.8 Whenever practicable, all equipment under the
control of the laboratory and requiring calibration shall be
labelled, coded or otherwise identified to indicate the status of
calibration, including the date when last calibrated and the date
or expiration criteria when re-calibration is due.
5.5.9 When, for whatever reason, equipment goes
outside the direct control of the laboratory, the laboratory
shall ensure that the function and calibration status of the
equipment are checked and shown to be satisfactory before the
equipment is returned to service.
5.5.10 When intermediate checks are needed to
maintain confidence in the calibration status of the equipment,
these checks shall be carried out according to a defined
autorizat. Instructiunile actualizate de utilizare si intretinere a
echipamentului (inclusiv orice manuale relevante furnizate de
fabricant) trebuie sa fie usor accesibile pentru utilizare de catre
personalul corespunzator din laborator.
5.5.4 Fiecare echipament si soft-ul sau, utilizat pentru
incercare si etalonare si semnificativ pentru rezultat trebuie sa
fie, dupa caz, unic identificat.
5.5.5 Trebuie pastrate inregistrari pentru fiecare
echipament in parte si soft-ul sau (semnificative pentru
incercarile si/sau etalonarile efectuate). Inregistrarile vor contine
cel putin urmatoarele:
a. identificarea echipamentului si soft-ului sau
b. numele fabricantului, identificarea tipului si nr de serie sau
alta identificare unica
c. verificarea daca echipamentul satisface specificatia (vezi
5.5.2)
d. amplasarea curenta, unde este cazul
e. instructiunile fabricantului, daca sunt disponibile, sau o
referire despre unde pot fi gasite
f. date, rezultate si copii ale rapoartelor si certificatelor
tuturor etalonarilor, reglarilor, criterii acceptabile si data
corespunzatoare a urmatoarei etalonari
g. planul de intretinere, unde este cazul, si mentenanta
efectuata pana la data respectiva
h. defectari, functionari defectuase, modificari sau reparatii
ale echipamentului.
5.5.6 Laboratorul va detine proceduri de manuire,
transport, depozitare, utilizare si intretinere planificata sigure
pentru echipamentul de masurare pentru a asigura functionarea
corespunzatoare si a evita contaminarea sau deteriorarea.
Nota: ar putea fi necesare proceduri suplimentare atunci cand
echipamentul este utilizat in afara incintei permanente a
laboratorului pentru incercari, etalonari sau prelevari.
5.5.7 Echipamentul care a fost supus la suprasarcini sau
manipulare gresita, care da rezultate suspecte sau despre care s-
a constat la verificari ca este defect sau iese din limitele
specificate, trebuie scos din serviciu. Aceste echipamente vor fi
izolate pentru a nu fi folosite sau etichetate ori marcate in mod
clar ca nefiind disponibile, pana cand sunt reparate si se
demonstreza prin etalonare sau incercare ca functioneaza corect.
Laboratorul va examina efectul la nivelul defectarii sau abaterii
de la limitele specificate la incercarile si/sau etalonarile
anterioare si va institui procedura denumita ”Controlul lucrarilor
neconforme”(vezi 4.9).
5.5.8 Intotdeauna cand este posibil, toate echipamentele
tinute sub control de laborator si necesitand etalonare vor fi
etichetate, codate sau altfel identificate pentru a indica situatia
etalonarii, inclusiv data ultimei etalonari precum si data sau
conditiile expirarii, atunci cand se impune re-etalonarea.
5.5.9 Cand, indiferent din ce motiv, echipamentul iese de
sub controlul direct al laboratorului, acesta trebuie sa se
asigure ca functionarea si situatia etalonarii echipamentului
sunt verificate si se arata a fi satisfacatoare, inainte ca
echipamentul sa se reintoarca in serviciu.
5.5.10 Cand sunt necesare verificari intermediare pentru
a se mentine increderea in starea de etalonare a echipamentului,
acestea vor fi efectuate conform unei proceduri definite.
5.5.11 Cand etalonarile conduc la aparitia unui set de
factori de corectie, laboratorul trebuie sa aiba proceduri pentru a
asigura ca orice copie (de ex. in calculator) este corect
actualizata.
5.5.12 Echipamentul de incercare si etalonare,
19
procedure.
5.5.11 Where calibrations give rise to a set of
correction factors, the laboratory shall have procedures to
ensure that copies (e.g. in computer software) are correctly
updated.
5.5.12 Test and calibration equipment, including both
hardware and software, shall be safeguarded from adjustments
which would invalidate the test and/or calibration results.
5.6 MEASUREMENT TRACEABILITY
5.6.1 General
All equipment used for tests and/or calibrations,
including equipment for subsidiary measurements (e.g. for
environmental conditions) having a significant effect on the
accuracy or validity of the result of the test, calibration or
sampling shall be calibrated before being put into service. The
laboratory shall have an established programme and procedure
for the calibration of its equipment.
Note: such a programme should include a system for selecting,
using, calibrating, checking, controlling and
maintaining measurement standards, reference
materials used as measurement standards, and
measuring and test equipment used to perform tests and
calibrations.
5.6.2 Specific requirements
5.6.2.1 Calibration
5.6.2.1.1 For calibration laboratories, the programme
for calibration of equipment shall be designed and operated so
as to ensure that calibrations and measurements made by the
laboratory are traceable to the International System of Units (Sl)
(Systeme intemational d’unites).
A calibration laboratory establishes traceability of its
own measurement standards and measuring instruments to the
Sl by means of an unbroken chain of calibrations or
comparisons linking them to relevant primary standards of the
Sl units of measurement. The link to Sl units may be achieved
by reference to national measurement standards. National
measurement standards may be primary standards, which are
primary realizations of the Sl units or agreed representations of
Sl units based on fundamental physical constants, or they may
be secondary standards which are standards calibrated by
another national metrology institute. When using external
calibration services, traceability of measurement shall be
assured by the use of calibration services from laboratories that
can demonstrate competence, measurement capability and
traceability. The calibration certificates issued by these
laboratories shall contain the measurement results, including the
measurement uncertainty and/or a statement of compliance with
an identified metrological specification (see also 5.10.4.2).
Note 1: calibration laboratories fulfilling the requirements of
this International Standard are considered to be
competent. A calibration certificate bearing an
accreditation body logo from a calibration Iaboratory
accredited to this International Standard, for the
calibration concerned, is sufficient evidence of
traceability of the calibration data reported.
Note 2: traceability to Sl units of measurement may be achieved
by reference to an appropriate primary standard (see
VIM: 1993, 6.4) or by reference to a natural constant,
the value of which in terms of the relevant Sl unit is
incluzand atat hard cat si soft, trebuie aparat de reglaje ce ar
putea invalida rezultatele incercarii si/sau etalonarii.
5.6 TRASABILITATEA MASURARII
5.6.1 Generalitati
Toate echipamentele folosite pentru incercari si/sau
etalonari, inclusiv cel pentru masurari subsidiare (de ex. pentru
conditiile de mediu), si care au un efect semnificativ asupra
acuratetii sau validitatii rezultatului incercarii, etalonarii sau
esantionarii trebuie etalonate inainte de a fi plasate in serviciu.
Laboratorul trebuie sa aiba stabilite un program si o procedura
de etalonare a echipamentului sau.
Nota: un astfel de program trebuie sa cuprinda un sistem pentru
selectarea, utilizarea, etalonarea, verificarea, controlarea
si mentinerea etaloanelor, a celor de referinta ca si a
etaloanelor si a echipamentului de masurare si incercare
utilizat la efectuarea incercarilor si etalonarilor.
5.6.2 Cerinte specifice
5.6.2.1 Etalonarea
5.6.2.1.1 Pentru laboratoarele de etalonare, programul de
etalonare a echipamentului trebuie conceput si derulat astfel
incat sa asigure ca etalonarile si masurarile efectuate de
laborator sunt trasabile la Sistemul International de Unitati (SI).
Un laborator de etalonare stabileste trasabilitatea la SI a
etaloanelor si aparatelor de masura proprii prin intermediul unui
lant neintrerupt de etalonari sau comparatii care le leaga de
etaloanele primare relevante ale unitatilor de masura SI.
Legatura cu unitatile SI poate fi obtinuta prin referinta la
etaloanele nationale. Acestea pot fi etaloane primare, adica
realizari primare ale unitatilor SI sau reprezentari prin conventie
ale acestor unitati, pe baza unor constante fizice fundamentale,
sau etaloane secundare, adica etaloane etalonate la randul lor de
un alt institut national de metrologie. In cazul utilizarii
serviciilor externe de etalonare, trasabilitatea masurarii se va
asigura cu ajutorul serviciilor de etalonare din partea unor
laboratoare care pot sa-si demonstreze competenta, capabilitatile
de masurare si trasabilitatea. Certificatele de etalonare emise de
aceste laboratoare trebuie sa contina rezultatele masurarilor,
inclusiv incertitudinea de masurare si/sau o declaratie a
acordului cu o specificatie metrologica identificata (vezi de
asemeni 5.10.4.2.).
Nota 1: laboratoarele de etalonare care indeplinesc cerintele
acestui Standard sunt considerate a fi competente. Un
certificat de etalonare purtand marca unui organism de
acreditare, emis de un laborator de
etalonare acreditat in raport acest Standard International, pentru
etalonarea in discutie, reprezinta o garantie suficienta a
trasabilitatii datelor de etalonare prezentate.
Nota 2: trasabilitatea la unitatile de masura SI se poate obtine
prin referinta la un etalon primar potrivit (vezi VIM:
1993, 6.4.) sau prin referinta la o constanta universala
a carei valoare, in termenii unitatilor relevante SI, este
cunoscuta si recomandata de Conferinta Generala
pentru Greutati si Masurari (CGGM) si Comitetul
International pentru Masuri si Greutati (CIPM).
Nota 3: laboratoarele de etalonare care-si mentin propriul etalon
primar sau reprezentare a unitatilor SI pe baza unor
constante fizice fundamentale pot pretinde trasabilitate
20
 known and recommended by the General Conference
of Weights and Measures (CGPM) and the
International Committee for Weights and Measures
(CIPM).
Note 3: calibration laboratories that maintain their own primary
standard or representation of Sl units based on
fundamental physical constants can claim traceability
to the Sl system only after these standards have been
compared, directly or indirectly, with other similar
standards of a national metrology institute.
Note 4: the term "identified metrological specification" means
that it must be clear from the calibration certificate
which specification the measurements have been
compared with, by including the specification or by
giving an unambiguous reference to the specification.
Note 5: when the terms "International standard" or "national
standard" are used in connection with traceability, it
is assumed that these standards fulfil the properties of
primary standards for the realization of Sl units.
Note 6: traceability to national measurement standards does not
necessarily requires the use of the national metrology
institute of the country in which the laboratory is
located.
Note 7: if a calibration laboratory wishes or needs to obtain
traceability from a national metrology institute other
than in its own country, this laboratory should select
a national metrology institute that actively
participates in the activities of BIPM either directly
or through regional groups.
Note 8: the unbroken chain of calibrations or comparisons may
be achieved in several steps carried out by different
laboratories that can demonstrate traceability.
5.6.2.1.2 There are certain calibrations that currently
cannot be strictly made in Sl units. In these cases calibration
shall provide confidence in measurements by establishing
traceability to appropriate measurement standards such as:
- the use of certified reference materials provided by a
competent supplier to give a reliable physical or chemical
characterization of a material
- the use of specified methods and/or consensus standards
that are clearly described and agreed by all parties
concerned.
Participation in a suitable programme of inter-laboratory
comparisons is required where possible.
5.6.2.2 Testing
5.6.2.2.1 For testing laboratories, the requirements
given in 5.6.2.1 apply for measuring and test equipment with
measuring functions used unless it has been established that the
associated contribution from the calibration contributes little to
the total uncertainty of the test result. When this situation arises,
the laboratory shall ensure that the equipment used can provide
the uncertainty of measurement needed.
Note: the extent to which the requirements in 5.6.2.1 should be
followed depends on the relative contribution of the
calibration uncertainty to the total uncertainty. If
calibration is the dominant factor, the requirements
should be strictly followed.
5.6.2.2.2 Where traceability of measurements to Sl
units is not possible and/or not relevant, the same requirements
la sistemul SI numai dupa ce aceste etaloane au fost
comparate, direct sau indirect, cu alte etaloane
asemanatoare ale unui institut national de metrologie.
Nota 4: termenul “specificatie metrologica identificata”
inseamna ca trebuie sa reiasa clar din certificatul de
etalonare cu ce specificatie au fost comparate
masurarile, prin includerea specificatiei sau prin
acordarea unei referinte neambigue la specificatie.
Nota 5: cand termenii “etalon international” sau “etalon
national” sunt folositi in legatura cu trasabilitatea, se
presupune ca aceste etaloane indeplinesc
proprietatile etaloanelor primare pentru realizarea
unitatilor SI.
Nota 6: trasabilitatea la etaloanele nationale nu necesita in mod
necesar folosirea institutului national de metrologie
al tarii in care se afla laboratorul.
Nota 7: daca un laborator de etalonare doreste sau are nevoie de
trasabilitate de la un institut national de metrologie,
altul decat cel din tara in care se afla, el trebuie sa
aleaga un institut care participa in mod activ la
activitatile BIPM fie direct, fie prin grupuri
regionale.
Nota 8: lantul neintrerupt de etalonari sau comparatii se poate
obtine in mai multe etape efectuate de laboratoare
diferita care-si pot demonstra trasabilitatea.
5.6.2.1.2 Exista unele etalonari ce nu se pot realiza in
mod curent strict in unitati SI. In aceste cazuri etalonarea va
furniza incredere in masurari prin stabilirea trasabilitatii la
etaloane adecvate precum:
- utilizarea materialelor de referinta certificate asigurate de un
furnizor competent pentru a oferi o caracterizare de incredere a
materialului, din punct de vedere fizic si chimic
- utilizarea de metode specificate si/sau etaloane prin consens
care sunt descrise si intelese in mod clar la fel de catre toate
partile implicate.
Participarea la un program corespunzator de comparatii inter-
laboratoare este necesara acolo unde este posibila.
5.6.2.2 Incercarea
5.6.2.2.1 Pentru laboratoarele de incercare, cerintele
cuprinse in 5.6.2.1. se aplica pentru echipamentul de masurare si
incercare cu functiile de masurare utilizate, cu exceptia cazului
in care s-a stabilit ca incertitudinea de masurare asociata
etalonarii contribuie foarte putin la incertitudinea totala a
rezultatului incercarii. Cand apare aceasta situatie, laboratorul se
va asigura ca echipamentul folosit poate asigura incertitudinea
de masurare necesara.
Nota: masura in care trebuie urmate cerintele 5.6.2.1. depinde
de contributia relativa a incertitudinii etalonarii, in
incertitudinea totala. Daca etalonarea este un factor
dominant, cerintele trebuie sa fie strict respectate.
5.6.2.2.2 Daca trasabilitatea masurarilor nu este posibila
si/sau relevanta la unitatile SI, atunci trebuie aplicate aceleasi
cerinte de trasabilitate la, de ex, materiale de referinta
certificate, aceleasi metode in consens si/sau etaloane de
consens ca pentru laboratoarele de etalonare (vezi 5.6.2.12).
5.6.3 Etaloane de referinta si materiale de referinta
5.6.3.1 Etaloane de referinta
21
for traceability to, for example, certified reference materials,
agreed methods and/or consensus standards are required as for
calibration laboratories (see 5.6.2.12).
5.6.3 Reference standards and reference materials
5.6.3.1 Reference standards
The laboratory shall have a programme and procedure
for the calibration of its reference standards. Reference
standards shall be calibrated by a body that can provide
traceability as described in 5.6.2.1. Such reference standards of
measurement held by the laboratory shall be used for calibration
only and for no other purpose, unless it can be shown that their
performance as reference standards would not be invalidated.
Reference standards shall be calibrated before and after any
adjustment.
5.6.3.2 Reference materials
Reference materials shall, where possible, be traceable
to Sl units of measurement, or to certified reference materials.
Internal reference materials shall be checked as far as is
technically and economically practicable.
5.6.3.3 Intermediate checks
Checks needed to maintain confidence in the
calibration status of reference, primary, transfer or working
standards and reference materials shall be carried out according
to defined procedures and schedules.
5.6.3.4 Transport and storage
The laboratory shall have procedures for safe handling,
transport, storage and use of reference standards and reference
materials in order to prevent contamination or deterioration and
in order to protect their integrity.
Note: additional procedures may be necessary when reference
standards and reference materials are used outside the
permanent laboratory for tests, calibrations or sampling.
5.7 SAMPLING
5.7.1 The laboratory shall have a sampling plan and
procedures for sampling when it carries out sampling of
substances, materials or products for subsequent testing or
calibration. The sampling plan as well as the sampling
procedure shall be available at the location where sampling is
undertaken. Sampling plans shall, whenever reasonable, be
based on appropriate statistical methods. The sampling process
shall address the factors to be controlled to ensure
the validity of the test and calibration results.
Note 1: sampling is a defined procedure whereby a part of a
substance, material or product is taken to provide for
testing or calibration of a representative sample of the
whole. Sampling may also be required by the
appropriate specification for which the substance,
material or product is to be tested or calibrated. In
certain cases (e.g. forensic analysis), the sample may not
be representative but is determined by availability.
Note 2: sampling procedures should describe the selection,
sampling plan, withdrawal and preparation of a sample
or samples from a substance, material or product to yield
the required information.
5.7.2 Where the client requires deviations, additions
or exclusions from the documented sampling procedure, these
Laboratorul trebuie sa aiba un program si o procedura
pentru etalonarea etaloanelor sale de referinta. Etaloanele de
referinta de masura trebuie etalonate de catre un organism care
poate asigura trasabilitatea, conform cu 5.6.2.1. Astfel de
etaloane de referinta detinute de laborator trebuie sa fie utilizate
numai pentru etalonare si nu in alte scopuri, in afara cazului in
care se poate demonstra ca performanta lor ca etaloane de
referinta nu va fi invalidata. Aceste etaloane vor fi etalonate
inainte si dupa orice reglaj.
5.6.3.2 Materiale de referinta
Materialele de referinta trebuie, atunci cand este posibil,
sa fie trasabile la unitati SI sau la materialele de referinta
certificate. Materialele de referinta interne trebuie verificate pe
cat este posibil, tehnic si economic vorbind.
5.6.3.3 Verificari intermediare
Verificarile necesare mentinerii increderii in situatia de
etalonare a etaloanelor de referinta, primare, de transfer sau de
lucru si a materialelor de referinta vor fi realizate in
conformitate cu planificarile si procedurile definite.
5.6.3.4 Transport si depozitare
Laboratorul trebuie sa aiba proceduri pentru siguranta
manipularii, transportului, depozitarii si utilizarii etaloanelor de
referinta si materialelor de referinta, pentru a preveni
contaminarea sau deteriorarea acestora in scopul protectiei
integritatii lor.
Nota: pot fi necesare proceduri suplimentare atunci cand
etaloanele de referinta si materialele de referinta sunt
folosite in afara incintei permanente a laboratorului pentru
incercari, etalonari sau prelevari.
5.7 ESANTIONAREA/PRELEVAREA
5.7.1 Laboratorul trebuie sa aiba un plan si proceduri de
esantionare atunci cand efectueaza prelevarea de substante,
materiale sau produse in scopul incercarii sau etalonarii
ulterioare. Planul si procedura de esantionare trebuie sa fie
disponibile in locul in care se desfasoara esantionarea. Planurile
de esantionare se vor baza, acolo unde este cazul, pe metode
statistice corespunzatoare. Procesul de esantionare va tine cont
de factorii care trebuie
controlati pentru a se asigura validitatea rezultatelor de
incercare si etalonare.
Nota 1: prelevarea este o procedura definita prin care o parte
dintr-o substanta, material sau produs este luata pentru
a asigura incercarea sau etalonarea unui esantion
reprezentativ pentru intreg. Esantionarea poate fi de
asemeni solicitata de specificatii corespunzatoare
conform carora trebuie sa fie etalonate sau incercate
substanta, materialul sau produsul. In anumite cazuri
(ca de ex. analizele medico-legale, esantionul ar putea
sa nu fie reprezentativ, fiind determinat insa prin
disponibilitate.
Nota 2: procedurile de esantionare trebuie sa prezinte selectarea,
planul de prelevare, retragerea si pregatirea unui
esantion/esantioane dintr-o substanta, material sau
produs, in scopul de a se obtine informatiile cerute.
5.7.2 Cand clientul impune abateri, adaugiri sau
omisiuni din procedura de esantionare documentata, acestea
trebuie inregistrate in detaliu, cu datele corespunzatoare de
esantionare, fiind incluse in toate documentele continand
rezultatele incercarii si/sau etalonarii si communicate
personalului corespunzator.
5.7.3 Laboratorul trebuie sa aiba proceduri pentru
22
shall be recorded in detail with the appropriate sampling data
and shall be included in all documents containing the test and/or
calibration results, and shall be communicated to the
appropriate personnel.
5.7.3 The laboratory shall have procedures for
recording relevant data and operations relating to sampling that
forms part of the testing or calibration that is undertaken. These
records shall include the sampling procedure used, the
identification of the sampler, environmental conditions (if
relevant) and diagrams or other equivalent means to identify the
sampling location as necessary and, if appropriate, the statistics
the sampling procedures are based upon.
5.8 HANDLING OF TEST AND CALIBRATION ITEMS
5.8.1 The laboratory shall have procedures for the
transportation, receipt, handling, protection, storage, retention
and/or disposal of test and/or calibration items, including all
provisions necessary to protect the integrity of the test or
calibration item, and to protect the interests of the laboratory
and the client.
5.8.2 The laboratory shall have a system for identifying
test and/or calibration items. The identification shall be retained
throughout the life of the item in the laboratory. The system
shall be designed and operated so as to ensure that items cannot
be confused physically or when referred to in records or other
documents. The system shall, If appropriate, accommodate a
sub-division of groups of items and the transfer of items within
and from the laboratory.
5.8.3 Upon receipt of the test or calibration item,
abnormalities or departures from normal or specified conditions,
as described in the test or calibration method, shall be recorded.
When there is doubt as to the suitability of an item for test or
calibration, or when an item does not conform to the description
provided, or the test or calibration required is not specified in
sufficient detail, the laboratory shall consult the client for
further instructions before proceeding and shall record the
discussion.
5.8.4 The laboratory shall have procedures and
appropriate facilities for avoiding deterioration, loss or damage
to the test or calibration item during storage,
handling and preparation. Handling instructions provided with
the item shall be followed. When items have to be stored or
conditioned under specified environmental conditions, these
conditions shall be maintained, monitored and recorded. Where
a test or calibration item or a portion of an item is to be held
secure, the laboratory shall have arrangements for storage and
security that protect the condition and integrity of the secured
items or portions concerned.
Note 1: where test items are to be returned into service after
testing, special care is required to ensure that they are
not damaged or injured during the handling, testing or
storing/waiting processes.
Note 2: a sampling procedure and information on storage and
transport of samples, including information on
sampling factors influencing the test or calibration
result, should be provided by those responsible for
taking and transporting the samples.
Note 3: reasons for keeping a test or calibration item secure can
be for reasons of record, safety or value, or to enable
inregistrarea datelor relevante si a operatiilor legate de
esantionare parte a incercarii sau etalonarii efectuate. Aceste
inregistrari vor cuprinde procedura de esantionare folosita,
identificarea celui care preleveaza, conditiile de mediu (daca
sunt relevante), precum si schite sau alte modalitati echivalente
destinate identificarii locatiei esantionarii daca este necesar si,
daca e cazul, statisticile pe care se axeaza procedurile de
prelevare.
5.8 MANIPULAREA OBIECTELOR DE INCERCARE SI
ETALONARE
5.8.1 Laboratorul trebuie sa aiba proceduri pentru
transportul, primirea, manipularea, protectia, depozitarea,
retinerea sau eliberarea obiectelor de incercare si/sau etalonare,
inclusiv toate prevederile necesare protejarii integritatii
obiectelor destinate incercarii sau etalonarii, precum si a
intereselor laboratorului si clientului.
5.8.2 Laboratorul trebuie sa aiba un sistem de identificare
a obiectelor de incercare si/sau etalonare. Identificarea trebuie
pastrata pe toata durata existentei obiectului in laborator.
Sistemul trebuie conceput si aplicat astfel incat sa asigure ca
obiectul nu poate fi confundat fizic sau in referintele din
inregistrari sau alte documente. Sistemul, daca este cazul, va
organiza o subdiviziune de grupuri de obiecte si transferul
obiectelor in si din laborator.
5.8.3 La receptia obiectului de incercare sau etalonare
trebuie sa fie inregistrate orice anormalitate sau abatere de la
conditiile normale sau specificate descrise in metoda de
incercare si/sau etalonare. Atunci cand exista dubii cu privire la
adecvarea unui obiect pentru incercare sau etalonare, sau atunci
cand un obiect nu este conform cu descrierea furnizata, sau cand
incercarea sau etalonarea cerute nu sunt specificate in suficiente
detalii, laboratorul trebuie sa consulte clientul pentru alte
instructiuni inainte de a actiona si sa inregistreze rezultatul
discutiei.
5.8.4 Laboratorul trebuie sa aiba proceduri si amenajari
corespunzatoare pentru a evita deteriorarea, pierderea sau
defectarea obiectelor de incercare sau
etalonare in timpul depozitarii, manipularii si pregatirii.
Trebuie urmate instructiunile de manipulare primite odata cu
obiectul. Atunci cand obiectele trebuie depozitate sau restranse
la conditii de mediu specificate, aceste conditii trebuie
mentinute, monitorizate si inregistrate. Cand un obiect de
incercare sau etalonare sau o portiune a acestuia trebuie pastrate
in siguranta, laboratorul trebuie sa dispuna de aranjamente
pentru depozitare si securitate, care sa protejeze starea si
integritatea obiectelor sau partilor in discutie.
Nota 1: cand obiectele pentru incercare trebuie sa se intoarca
imediat in serviciu se cere atentie ca sa nu se strice sau
sa fie afectate in timpul manipularii, incercarii sau
proceselor de depozitare/asteptare.
Nota 2: o procedura de esantionare, precum si informatiile
despre depozitarea si transportul esantioanelor,
inclusiv date cu privire la factorii de esantionare cu
influenta asupra rezultatului incercarii sau etalonarii,
toate acestea trebuie furnizate de cei responsabili cu
preluarea si transportarea esantioanelor.
Nota 3: motivele pentru a securiza un obiect de incercare sau
etalonare pot fi legate de inregistrare, siguranta sau
valoare, sau pentru a se permite efectuarea ulterioara a
unor incercari si/sau etalonari complementare.
5.9 ASIGURAREA CALITATII REZULTATELOR DE
INCERCARE SI ETALONARE
23
 complementary tests and/or calibrations to be
performed later.
5.9 ASSURING THE QUALITY OF TEST AND
CALIBRATION RESULTS
The laboratory shall have quality control procedures
for monitoring the validity of tests and calibrations undertaken.
The resulting data shall be recorded in such a way that trends
are detectable and, where practicable, statistical techniques shall
be applied to the reviewing of the results. This monitoring shall
be planned and reviewed and may include, but not be limited to,
the following:
a. regular use of certified reference materials and/or internal
quality control using secondary reference materials
b. participation in inter-laboratory comparison or proficiency-
testing programmes
c. replicate tests or calibrations using the same or different
methods
d. re-testing or re-calibration of retained items
e. correlation of results for different characteristics of an item.
Note: the selected methods should be appropriate for the type
and volume of the work undertaken.
5.10 REPORTING THE RESULTS
5.10.1 General
The results of each test, calibration, or series of tests or
calibrations carried out by the laboratory shall be reported
accurately, clearly, unambiguously and objectively, and in
accordance with any specific instructions in the test or
calibration methods.
The results shall be reported, usually in a test report or
a calibration certificate (see note 1), and shall include all the
information requested by the client and necessary for the
interpretation of the test or calibration and all information
required by the method used. This information is normally that
required by 5.10.2 and 5.10.3 or 5.10.4.
In the case of tests or calibrations performed for
internal clients, or in the case of a written agreement with the
client, the results may be reported in a simplified way. Any
information listed in 5.10.2 to 5.10.4 which is not reported to
the client shall be readily available in the laboratory which
carried out the tests and/or calibrations.
Note 1: test reports and calibration certificates are sometimes
called test certificates and calibration reports,
respectively.
Note 2: the test reports or calibration certificates may be issued
as hard copy or by electronic data transfer provided
that the requirements of this International Standard are
met.
5.10.2 Test reports and calibration certificates
Each test report or calibration certificate shall include
at least the following information, unless the laboratory has
valid reasons for not doing so:
a. a title (e.g. "Test Report" or "Calibration Certificate")
b. the name and address of the laboratory, and the location
where the tests and/or calibrations were carried out, if
different from the address of the laboratory
c. unique identification of the test report or calibration
certificate (such as the serial number), and on each page an
identification in order to ensure that the page is recognized
as a part of the test report or calibration certificate, and a
Laboratorul trebuie sa detina proceduri de control al
calitatii pentru a monitoriza validitatea incercarilor si
etalonarilor efectuate. Datele ce rezulta vor fi inregistrate astfel
incat eventualele tendinte sa fie detectabile si, unde se poate, la
revizuirea rezultatelor vor fi aplicate tehnici statistice.
Monitorizarea va fi planificata si revizuita si poate include, fara
a se limita insa la, urmatoarele:
a. utilizarea regulata de materiale de referinta certificate si/sau
controlul intern al calitatii folosindu-se materiale de
referinta secundare
b. participarea la programe de comparatii interlaboratoare sau
de testare a competentei
c. repetarea incercarilor sau etalonarilor, folosind aceleasi
metode sau metode diferite
d. re-incercarea sau re-etalonarea obiectelor retinute
e. corelarea rezultatelor pentru diferite caracteristici ale unui
obiect.
Nota: metodele alese trebuie sa fie corespunzatoare tipului si
volumului lucrarilor efectuate.
5.10 PREZENTAREA REZULTATELOR
5.10.1 Generalitati
Rezultatele fiecarei incercari, etalonari sau serii de
incercari sau etalonari efectuate de laborator trebuie prezentate
precis, clar, neambiguu si obiectiv, in conformitate cu oricare
instructiuni specifice ale metodelor de incercare si etalonare.
Rezultatele vor fi communicate de obicei intr-un raport
de incercare sau un certificat de etalonare (vezi nota 1) si trebuie
sa includa toate informatiile solicitate de client si necesare
pentru interpretarea incercarii sau etalonarii, precum si toate
informatiile cerute de metoda folosita. Aceste informatii sunt in
mod normal cele cerute de 5.10.2 si 5.10.3 sau 5.10.4.
In situatia in care incercarile sau etalonarile se executa
pentru clienti interni, sau in cazul unei intelegeri scrise cu
clientul, rezultatele pot fi prezentate in mod simplificat.
Informatia de la 5.10.2-5.10.4 neprezentata clientului, trebuie sa
fie usor disponibila in laboratorul care a realizat incercarile
si/sau etalonarile.
Nota 1: rapoartele de incercare sau certificatele de etalonare
sunt uneori denumite certificate de incercare, respectiv
rapoarte de etalonare.
Nota 2: rapoartele de incercare sau certificatele de etalonare pot
fi eliberate ca “hard copy” sau prin transfer electronic de
date, cu conditia respectarii cerintelor acestui Standard
International.
5.10.2 Rapoarte de incercare si certificate de etalonare
Fiecare raport de incecare sau certificat de etalonare
trebuie sa cuprinda cel putin urmatoarele informatii, cu exceptia
cazului in care laboratorul are motive valide sa nu procedeze
astfel:
a. un titlu (de ex. ”raport de incercare” sau “certificat de
etalonare”)
b. numele si adresa laboratorului si locul de desfasurare,
atunci cand incercarile si/sau etalonarile se efectueaza in
alta parte decat la adresa laboratorului
c. identificarea unica a raportului de incercare sau a
certificatului de etalonare (cum ar fi seria) si, pe fiecare
pagina, o identificare care sa ateste faptul ca pagina e
recunoscuta ca parte a raportului sau certificatului, precum
si o identificare clara a finalului documentului
d. numele si adresa clientului
e. identificarea metodei utilizate
24
 clear identification of the end of the test report or
calibration certificate
d. the name and address of the client
e. identification of the method used
f. a description of, the condition of, and unambiguous
identification of the item(s) tested or calibrated
g. the date of receipt of the test or calibration item(s) where
this is critical to the validity and application of the results,
and the date(s) of performance of the test or calibration
h. 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
i. the test or calibration results with, where appropriate, the
units of measurement
j. the name(s), function(s) and signature(s) or equivalent
identification of person(s) authorizing the test report or
calibration certificate
k. where relevant, a statement to the effect that the results
relate only to the items tested or calibrated.
Note 1: hard copies of test reports and calibration certificates
should also include the page number and total
number of pages.
Note 2: it is recommended that laboratories include a statement
specifying that the test report or calibration certificate
shall not be reproduced except in full, without written
approval of the laboratory.
5.10.3 Test reports
5.10.3.1 In addition to the requirements listed in 5.10.2,
test reports shall, where necessary for the interpretation of the
test results, include the following:
a. deviations from, additions to, or exclusions from the test
method, and information on specific test conditions,
such as environmental conditions
b. where relevant, a statement of compliance/non-compliance
with reqirements and/or specifications
c. 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 client's instruction so requires, or
when the uncertainty affects compliance to a specification
limit
d. where appropriate and needed, opinions and interpretations
(see 5.10.5)
e. additional information which may be required by specific
methods, clients or groups of clients.
5.10.3.2 In addition to the requirements listed in 5.10.2
and 5.10.3.1, test reports containing the results sampling shall
include the following, where necessary for the interpretation of
test results:
a. the date of sampling
b. unambiguous identification of the substance, material or
product sampled (including the name of the manufacturer,
the model or type of designation and serial numbers as
appropriate)
c. the location of sampling, including any diagrams, sketches
or photographs
d. a reference to the sampling plan and procedures used
e. details of any environmental conditions during sampling
that may affect the interpretation of the test results
f. descierea, situatia si identificarea neambigua a obiectului
(obiectelor) incercat(e) sau etalonat(e)
g. data primirii obiectului (obiectelor) de incercat sau etalonat
- acolo unde aspectul este esential pentru validitatea si
aplicarea rezultatelor, precum si data (datele) efectuarii
incercarii sau etalonarii
h. referire la planul de esantionare si la procedurile folosite de
laborator sau de alte organisme, daca acestea au relevanta
pentru validitatea sau utilizarea rezultatelor
i. rezultatele de incercare sau etalonare cu (unde este cazul)
unitatile de masura
j. numele, titlul (titlurile) si semnatura (semnaturile) sau o
identificare echivalenta a persoanei (persoanelor) care
autorizeaza raportul de incercare sau certificatul de
etalonare
k. daca este cazul, o declaratie privind faptul ca rezultatele se
refera numai la obiectele incercate sau etalonate.
Nota 1: copiile hard ale rapoartelor de incercare si certificatelor
de etalonare trebuie sa cuprinda de asemenea nr
paginii si nr total al paginilor.
Nota 2: li se recomanda laboratoarelor sa includa o declaratie
specificand faptul ca raportul de incercare sau
certificatul de etalonare nu trebuie reproduse, decat
in totalitate, fara aprobarea scrisa a laboratorului.
5.10.3 Rapoartele de incercari
5.10.3.1 Pe langa cerintele de la 5.10.2, rapoartele de
incercare vor cuprinde, acolo unde este necesar pentru
interpretarea rezultatelor incercarii, sa cuprinda urmatoarele:
a. abaterile, suplimentarile sau omisiunile din metoda de
incercare si informatii despre conditiile specifice de
incercare, cum ar fi conditiile de mediu
b. unde este relevant, o declaratie de
conformitate/neconformitate cu cerintele si/sau
specificatiile
c. unde se aplica, o declaratie asupra incertitudinii estimate a
masurarii; informatiile despre incertitudine sunt necesare in
rapoartele de incercari cand sunt relevante pentru validarea
sau utilitatea rezultatelor incercarii, cand o cere o
instructiune a clientului sau cand incertitudinea afecteaza
conformitatea cu o limita specificata
d. unde este potrivit si necesar, opinii si interpretari (vezi
5.10.5)
e. informatii suplimentare ce ar putea fi cerute de metode,
clientela sau grupuri de clientela specifice.
5.10.3.2 Suplimentar fata de cerintele de la 5.10.2 si
5.10.3.1, rapoartele de incercare continand rezultatele
esantionarii trebuie sa includa, unde este necesar pentru
interpretarea rezultatelor de incercare, urmatoarele:
a. data esantionarii
b. identificarea neambigua a substantei, rocii, materialului sau
produsului prelevat (inclusiv numele fabricantului, modelul
sau tipul de desemnare si seriile, dupa cum este cazul)
c. locul esantionarii, inclusiv orice diagrame, schite sau
fotografii
d. referirea la planul de esantionare si procedurile folosite
e. detalii ale orcaror conditii de mediu din timpul esantionarii
care ar putea afecta interpretarea rezultatelor incercarii
f. standardul sau alta specificatie pentru metoda sau
procedura de esantionare, precum si abaterile, adaugirile
sau eliminarile din specificatia in discutie.
5.10.4 Certificate de etalonare
5.10.4.1 Suplimentar fata de cerintele cuprinse de la
5.10.2, certificatele de etalonare vor contine, acolo unde este
25
f. any standard or other specification for the sampling method
or procedure, and deviations, additions to or exclusions
from the specification concerned.
5.10.4 Calibration certificates
5.10.4.1 In addition to the requirements listed in
5.10.2, calibration certificates shall include the following, where
necessary for the interpretation of calibration results:
a. the conditions (e.g. environmental) under which the
calibrations were made that have an influence on the
measurement results
b. the uncertainty of measurement and/or a statement of
compliance with an identified metrological specification or
clauses thereof
c. evidence that the measurements are traceable (see note 2 In
5.6.2.1.1).
5.10.4.2 The calibration certificate shall relate only to
quantities and the results of functional tests. If a statement of
compliance with a specification is made, this shall identify
which clauses of the specification are met or not met.
When a statement of compliance with a specification is
made omitting the measurement results and associated
uncertainties, the laboratory shall record those results and
maintain them for possible future reference.
When statements of compliance are made, the
uncertainty of measurement shall be taken into account.
5.10.4.3 When an instrument for calibration has been
adjusted or repaired, the calibration results before and after
adjustment or repair, if available, shall be reported.
5.10.4.4 A calibration certificate (or calibration label)
shall not contain any recommendation on the calibration interval
except where this has been agreed with the client. This
requirement may be superseded by legal regulations.
5.10.5 Opinions and interpretations
When opinions and interpretations are included, the
laboratory shall document the basis upon which the opinions
and interpretations have been made. Opinions and
interpretations shall be dearly marked as such in a test report.
Note 1: opinions and interpretations should not be confused
with inspections and product certifications as intended
in ISO/IEC 17020 and ISO/IEC Guide 65.
Note 2: opinions and interpretations included in a test report
may comprise, but not be limited to, the following:
- an opinion on the statement of compliance/non-
compliance of the results with requirements
- fulfilment of contractual requirements
- recommendations on how to use the results
- guidance to be used for improvements.
Note 3: in many cases it might be appropriate to communicate
the opinions and interpretations by direct dialogue
with the client. Such dialogue should be written
down.
5.10.6 Testing and calibration results obtained from
subcontractors
When the test report contains results of tests performed
by subcontractors, these results shall be clearly identified. The
necesar pentru interpretarea rezultatelor de etalonare,
urmatoarele:
a. conditiile (de ex. de mediu) in care s-au desfasurat
etalonarile si care au o oarecare influenta asupra
rezultatelor masurarii
b. incertitudinea de masurare si/sau o declaratie de
conformitate cu o specificatie metrologica identificata sau
clauzele din aceasta
c. proba ca masurarile sunt trasabile (vezi nota 2 de la
5.6.2.1.1).
5.10.4.2 Certificatul de etalonare trebuie sa se refere
numai la marimi si la rezultatele incercarilor functionale. Daca
se face o declaratie de conformitate cu o specificatie, ea va
identifica ce clauze ale acelei specificatii sunt sau nu sunt
indeplinite.
Daca se face o declaratie de conformitate cu o
specificatie omitandu-se rezultatele masurarilor si incertitudinile
asociate, laboratorul trebuie sa inregistreze aceste rezultate si sa
le pastreze pentru posibile referinte ulterioare.
Atunci cand se fac declaratii de conformitate trebuie sa
se tina cont de incertitudinea masurarii.
5.10.4.3 Cand un aparat pentru etalonare a fost reglat sau
reparat se vor comunica rezultatele etalonarii (daca sunt
disponibile) si pentru inainte si pentru dupa reglare sau reparatii.
5.10.4.4 Un certificat de etalonare (sau o marca de
etalonare) nu trebuie sa contina nici o recomandare asupra
intervalului de etalonare, cu excepti cazului in care acest lucru
s-a stabilit prin acord cu clientul. Aceasta cerinta poate fi
inlocuita de reglementari legale.
5.10.5 Opinii si interpretari
Cand opiniile si interpretarile sunt incluse in raport,
laboratorul va documenta fundamentul acestora. Ele trebuie sa
fie clar marcate intr-un raport de incercare.
Nota 1: opiniile si interpretarile nu trebuie confundate cu
inspectarile si certificarile de produs conform ISO/IEC
17020 si Ghidul ISO/IEC 65.
Nota 2: opiniile si interpretarile incluse intr-un raport de
incercare pot cuprinde dar nu sunt limitate la
urmatoarele:
- o opinie asupra declaratiei de conformitate/
neconformitate a rezultatelor cu cerintele
- indeplinirea cerintelor contractuale
- recomandari asupra modului in care sa fie utilizate
rezultatele
- indicatii care sa fie utilizate pentru imnbunatatiri.
Nota 3: in multe cazuri poate fi mai bine sa se comunice opiniile
si interpretarile prin dialog direct cu clientul. Un
astfel de dialog trebuie scris.
5.10.6 Rezultate de incercare si etalonare obtinute de
la subcontractanti
Atunci cand raportul de incercare contine rezultate ale
unor incercari efectuate de subcontractanti, aceste rezultate
trebuie sa fie clar identificate. Subcontractantul va prezenta
rezultatele in scris sau electronic.
Daca a fost subcontractata o etalonare, laboratorul care
efectueaza lucrarea va emite certificatul de etalonare catre
laboratorul care a subcontractat.
5.10.7 Transmiterea electronica a rezultatelor
26
subcontractor shall report the results in writing or electronically.
When a calibration has been subcontracted, the
laboratory performing the work shall issue the calibration
certificate to the contracting laboratory.
5.10.7 Electronic transmission of results
In the case of transmission of test or calibration results
by telephone, telex, facsimile or other electronic or
electromagnetic means, the requirements of this International
Standard shall be met (see also 5.4.7).
5.10.8 Format of reports and certificates
The format shall be designed to accommodate each
type of test or calibration carried out and to minimize the
possibility of misunderstanding or misuse.
In cazul transmiterii rezultatelor incercarii sau
etalonarii prin telefon, fax, telex sau prin alte mijloace
electronice sau electromagnetice, cerintele prezentului Standard
trebuiesc indeplinite (vezi de asemenea 5.4.7).
5.10.8 Formatul rapoartelor si certificatelor
Formatul trebuie sa fie astfel conceput incat sa se poata
adapta fiecarui tip de incercare sau etalonare efectuat si sa
minimalizeze posibilitatea de neintelegere sau utilizare gresita.
Nota 1:trebuie acordata atentie prezentarii rapoartelor si
certificatelor, in special in ceea ce priveste prezentarea
datelor de incercare sau etalonare si intelegerea usoara
din partea cititorului.
Nota 2: capitolele trebuie sa fie, pe cat posibil, tipizate.

Note 1: attention should be given to the lay-out of the test report

5.10.9 Amendamente la rapoarte si certificate
or calibration certificate, especially with regard to the
presentation of the test or calibration data and ease of
Amendamentele materiale la un raport de incercare sau
assimilation by the reader.
certificat de etalonare dupa difuzare trebuie realizate numai sub
Note 2: the headings should be standardized as far as possible.
forma unui alt document sau ca transfer de date, incluzand
declaratia: “Supliment la raportul de incercare [sau certificatul
5.10.9 Amendments to test reports and calibration
de etalonare], seria…[sau alta identificare]”
certificates
sau o modalitate echivalenta de formulare.
Material amendments to a test report or calibration
certificate after issue shall be made only in the form of a further
Astfel de amendamente se vor conforma tuturor cerintelor
document, or data transfer, which includes the statement:
prezentului Standard.
"Supplement to Test Report [or Calibration Certificate], serial
Cand este necesar sa se elaboreze un raport sau un
number…[or as otherwise identified]",
certificat complet nou, acesta trebuie sa fie unic identificat si sa
or an equivalent form of wording.
contina o referire la originalul pe care il inlocuieste.
Such amendments shall meet all the requirements of
this International Standard.
When it is necessary to issue a complete new test
report or calibration certificate, this shall be uniquely identified
and shall contain a reference to the original that it replaces.

ANNEX A (informative) NOMINAL CROSS-REFERENCES TO ISO 9001:1994 AND ISO 9002:1994

ANEXA A (informativa) REFERINTE INCRUCISATE NOMINALE LA ISO 9001:1994 SI ISO 9002:1994
ISO 9001:1994 ISO 9002:1994 ISO/IEC 17025
Clause 1 Clause 1 Clause 1
Clause 2 Clause 2 Clause 2
Clause 3 Clause 3 Clause 3
4.1.1 4.1.1 4.1.3 , 4.2.2
4.1.2.1 4.1.2.1 4.1.5 a), f), h) ; 4.2.4 ; 4.9.1 a) ;
4.10.1 ; 5.2.5
4.1.2.2 4.1.2.2 4.1.5 a), f), h) ; 5.5.1
4.1.2.3 4.1.2.3 4.1.5 j)
4.1.3 4.1.3 4.14
4.2.1 ; 4.2.2 4.2.1 ; 4.2.2 4.2.1 ; 4.2.2 ; 4.2.3
4.2.3 4.2.3 4.2.1 ; 4.2.2 ; 4.14
4.3 4.3 4.4
4.4 4.4 (n.a.) 1.5 ; 5.4.2 ; 5.4.3 ; 5.4.4 ; 5.4.5
4.5 4.5 4.3 ; 5.4.7 ; 5.5.11
4.6.1 4.6.1 4.6 ; 5.5 ; 5.6.1 ; 5.6.2.1 ; 5.6.2.2
4.6.2 4.6.2 4.5 ; 4.6
4.6.3 4.6.3 4.6
4.6.4 4.6.4 4.5 ; 4.6.4 ; 4.7 ; 5.5.2
4.7 4.7 5.8 ; 5.10.6
4.8 4.8 5.5.4 ; 5.8
4.9 4.9 4.12 ; 5.3 ; 5.4 ; 5.5 ; 5.6
4.10.1 4.10.1 5.4
4.10.2 4.10.2 4.5 ; 4.6 ; 5.5.2 ; 5.8
4.10.3 4.10.3 4.9 ; 5.5.9 ; 5.8.3 ; 5.8.4 ; 5.9
4.10.4 4.10.4 5.4.7 ; 5.9 ; 5.10.1
27
4.10.5 4.10.5
4.11.1 4.11.1
4.11.2 4.11.2
4.12 4.12
4.13 4.13
4.14 4.14.1
4.15 4.15
4.16 4.16
4.17 4.17
4.18 4.18
4.19 4.19
4.20 4.20
n.a. = not applicable [ne-aplicabil]
ISO/IEC 17025 covers several technical competence requirements that are not covered by ISO 9001:1994 and ISO 9002:1994
[ISO/IEC 17025 acopera mai multe cerinte de competenta tehnica neacoperite de ISO 9001:1994 si ISO9002:1994].
ANNEX B (informative) GUIDELINES FOR
ESTABLISHING APPLICATIONS FOR SPECIFIC
FIELDS
B.1 The requirements specified in this
International Standard are stated in general terms and,
while they are applicable to all test and calibration
laboratories, explanations might be needed. Such
explanations on applications are herein referred to as
applications. Applications should not include additional
general requirements not included in this International
Standard.
B.2 Applications can be thought of as an
elaboration of the generally stated criteria (requirements)
of this International Standard for specified fields of test
and calibration, test technologies, products, materials or
specific tests or calibrations. Accordingly, applications
should be established by persons having appropriate
technical knowledge and experience, and should address
items that are essential or most important for the proper
conduct of a test or calibration.
B.3 Depending on the application at hand, it may
be necessary to establish applications for the technical
requirements of this International Standard. Establishing
applications may be accomplished by simply providing
detail or adding extra information to the already generally
stated requirements in each of the clauses (e.g. specific
limitations to the temperature and humidity in the
laboratory).
In some cases the applications will be quite
limited, applying only to a given test or calibration
method or to a group of calibration or test methods. In
other cases the applications may be quite broad, applying
to the testing or calibration of various products or items or
to entire fields of testing or calibration.
B.4 If the applications apply to a group of test or
calibration methods in an entire technical field, common
wording should be used for all of the methods.
Alternatively, it may be necessary to develop a
separate document of applications to supplement this
4.12.2
5.4 ; 5.5 ; 5.6
5.3 ; 5.4.1 ; 5.4.5 ; 5.5 ; 5.6
5.5.12 ; 5.8 ; 5.9.2
4.9
4.10 ; 4.11
5.9
4.12
4.10.5 ; 4.13 (4.12)
5.2 ; 5.5.3
4.7 ; 5.2.1 ; 5.10.5
5.9
ANEXA B (informativa) LINII DIRECTOARE
PENTRU STABILIREA APLICARII IN DOMENII
SPECIFICE
B.1 Cerintele stabilite in acest Standard sunt in
termeni generali si, aplicandu-se in toate laboratoarele de
incercari si etalonari, pot fi necesare unele explicatii.
Astfel de explicatii in legatura cu aplicarea sunt denumite
aici aplicatii.
Aplicatiile nu trebuie sa cuprinda cerinte generale
suplimentare ce nu se gasesc in acest Standard
International.
B.2 Aplicatiile pot fi gandite ca o elaborare a
criteriilor (cerintelor) general stabilite ale acestui Standard
pentru anumite domenii de incercare si etalonare,
tehnologii de incercare, produse, materiale sau incercari
sau etalonari specifice. In consecinta, trebuie stabilite
aplicatii de catre persoane posedand cunostinte si
experienta tehnica corespunzatoare si trebuie sa se refere
la obiecte esentiale sau cele mai importante pentru
desfasurarea corespunzatoare a unei incercari sau
etalonari.
B.3 In functie de aplicatia la indemana, poate fi
necesara stabilirea de aplicatii pentru cerintele tehnice ale
prezentului Standard. Stabilirea aplicatiilor poate fi
realizata prin simpla furnizare de detalii sau prin
adaugarea de informatii noi cerintelor deja general
stabilite la nivelul fiecareia dintre clauze (ca de ex.
limitele specifice ale temperaturii si umiditatii din
laborator).
In anumite cazuri, aplicatiile vor fi destul de
limitate, aplicandu-se numai la o metoda de incercare sau
etalonare data sau la un grup de metode de etalonare sau
incercare. In celelalte situatii, aplicatiile pot fi chiar
extinse, aplicandu-se la incercarea sau etalonarea
diverselor produse sau obiecte sau la domenii integrale ale
incercarii sau etalonarii.
B.4 Daca aplicatiile sunt valabile pentru un grup de
metode de incercare sau etalonare pe un intreg domeniu
tehnic, se va utiliza limbajul comun pentru toate metodele.
In mod alternativ, poate fi necesara dezvoltarea
unui document separat al aplicatiilor in scopul
suplimentarii acestui Standard International pentru tipuri
28
International Standard for specific types or groups of tests
or calibrations, products, materials or technical fields of
tests or calibrations. Such a document should provide only
the necessary supplementary information, while
maintaining this International Standard as the governing
document through reference. Applications which are too
specific should be avoided in order to limit the
proliferation of detailed documents.
B.5 The guidance in this annex should be used by
accreditation bodies and other types of evaluation bodies
when they develop applications for their own purposes
(e.g. accreditation in specific areas).
specifice de grupuri de incercari sau etalonari, produse,
materiale sau domenii tehnice de incercare sau etalonare.
Un astfel de document trebuie sa furnizeze numai
informatiile suplimentare necesare, mentinand Standardul
de fata ca si document principal, de referinta. Trebuie
evitate aplicatiile prea specifice, pentru a se limita
proliferarea documentelor detaliate.
B.5 Precizarile din aceasta anexa trebuie utilizate
de catre organismele de acreditare sau de alte tipuri de
organisme de evaluare atunci cand acestea isi dezvolta
aplicatii in scop propriu (de ex. acreditarea in domenii
specifice).

BIBLIOGRAPHY
BIBLIOGRAFIE

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[3] ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results - Part 3: Intermediate measures of the
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[4] ISO 5725-4, Accuracy (trueness and precision) of measurement methods and results - Part 4: Basic methods for the
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[5] ISO 5725-6, Accuracy (trueness and precision) of measurement methods and results - Part 6: Use in practice of accuracy
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[12] ISO 10011-2, Guidelines for auditing quality systems - Part 2: Qualification criteria for quality system auditors
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[16] ISO/IEC 17020, General criteria for the operation of various types of bodies performing inspection
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[18] ISO Guide 31, Contents of certificates of reference materials
[19] ISO Guide 32, Calibration in analytical chemistry and use of certified reference materials
[20] ISO Guide 33, Uses of certified reference materials
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[22] ISO Guide 35, Certification of reference materials - General and statistical principles
[23] ISO/IEC Guide 43-1, Proficiency testing by inter-laboratory comparisons - Part 1: Development and operation of
proficiency testing schemes

29
[24] ISO/IEC Guide 43-2, Proficiency testing by inter-laboratory comparisons - Part 2: Selection and use of proficiency testing
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30