01. procedura autorizare laborator

ORDIN nr. 1497 din 13 mai 2011 pentru aprobarea Procedurii

-May -2014. Acest act a fost creat utilizand tehnologia SintAct -Acte Sintetice.

Avnd n vedere prevederile art. 30 din Legea nr. 10/1995 privind calitatea n

272/1994

808/2005 , 63/2001

- 707 /2001

1.335/2010 p

- ISC, n temeiul art. 11 alin. (2)

1.631/2009 onale

emite prezentul ordin.

Art. 1

Art. 2

Art. 3

stat - ISC nr. 153/2010 pentru aprobarea

, publicat n Monitorul Oficial al Romniei, Parte

Art. 4 - ISC va duce la ndeplinire prevederile

prezentului ordin.

- **** -

Gheorghe Nastasia, secretar general

Publica

-May -2014. Acest act a fost creat utilizand tehnologia SintAct -
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PROCEDURA din 13 mai 2011 privind evaluarea laboratoarelor

CAPITOLUL I: Scop Art. 1

10/1995 privind

autorizarea laboratoarelor de 808/2005 .

Art. 2

(1) Aplicarea prezent ei proceduri are drept scop realizarea, n mod unitar, a

(2)

a)

b)

c)

CAPITOLU L II: Domeniul de aplicare Art. 3

exploatare a acestora.

Art. 4 Sunt reglementate potrivit Regulamentului (CE) nr. 765/200 8 al Parlamentului

a Regulamentului (CEE) nr. 339/1993 nr. 622/2004

CAPITOLUL III: Cadrul legal Art. 5

mative: a) Legea nr. 10/1995

b) 1.335/2010
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- ISC;

c) 44/2010 privind trecerea Inspectoratului - ISC din subordinea Guvernului n subordinea Ministerului

204/2010 ; d) 63/2001

- 707/2001 , cu

modific e) 49/2009 privind libertatea de stabilire a

68/2010 ;

f) Regulamentul privin

808/20 05 ; g) - SR

CAPITOLUL IV: Art. 6 (1) n sensul prezentei proceduri, termenii/sintagmele utilizate au

a) autorizare - 10/1995 , cu mo

b) - -

c) - laborator care

n

continuare laborator, d) -

te cu

e) -

f) laborator gradul I -

- - care
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g) laborator gradul II - -

- e rapoarte de

h) laborator gradul III -

i) evaluator - inspector de specialitate din cadrul Inspectoratulu i de Stat n

- evaluarea laboratorului; j) punct de contact unic electronic -

-guvernare din Sistemul Electron

k)

autorizate -

www.isc -web.ro. (2) n tot cuprinsul prezentei proceduri se

ISC - IJC - ICB -

PCU - punct de contact unic.

CAPITOLUL V: Art. 7

Laboratoare

Art. 8 (1)

(2) ul mobil sunt ale laboratorului titular. (3)

(4)

(5)

ncheia un proces -verba

(6) (7) O copie a procesului -verbal de evaluare a laboratorului mobil se va arhiva de

or, la dosarul laboratorului titular.

Art. 9
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Art. 10

Art. 11

- se cont de domeniul de activitate al laboratorului.

CAPITOLUL VI: Procedura de autorizare Art. 12

Autoconstituite la nivelul IJC/ICB.

Art. 13

de autorizare, aprobat prin decizie a secretarului general al ISC.

CAPITOLUL VII: Art. 14 (1)

juridi

a) b) lista cu profilurile

c) - O.N.R.C.;

d) a nr. 6; e)nr. 7;

f)

(2) (3)punctului de contact unic, denumit n continuare PCU, imediat ce va deveni

Art. 15

(1) Dosarul pr

a) b)

c)

(2)
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depunerea acestuia, restituindu -

Art. 16 (1)

ransmite comisiei de autorizare.

(2)

(3) 30 de zile de la data

(4) Din motive obiective, laboratorul poate solicita comisiei de autorizare

modificarea datei de evaluare. (5)

(6)

face pe baza un

domeniu.

(7)

domeniu. (8) Rezult

- -verbal de

care punctajul re

torizare a laboratoarelor va notifica

(9)proces -

-verbal.

(10 )

(11)

(12)
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documente transmise de secretarul comisiei de autorizare constituite la nivelul IJC/ICB:

a) b) cererea de autorizare a laboratorului solicitant;

c) lis d) procesul -verbal/procesele -verbale de evaluare a laboratorului solicitant, ntocmit/ntocmite de evaluatori;

e) raportul de evaluare ntocmit de comisia de autorizare; f) dovada

Art. 17

Art. 18

Art. 19

- ecizia de

Art. 20

(1) -a

respins cererea de autorizare se primesc la secre

(2) n cazul n care

autorizare. Art. 21

CAPITOLUL VIII: Art. 22

(1)

(2)

acestora.

(3)

vederea autori
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(4)ev

a)

b) efectuarea dovedite; c) ntocmirea unui proces -

d) arhivarea proceselor -

refelaboratorului n cadrul IJC/ICB.

(5) -verbal

(6) -

CAPITOLUL IX: Art. 23

(1) n cazul n care laboratorul a

16 alin. (6) - (8).

(2)

documente transmise de secretarul comisiei de autorizare a IJC/ICB:

a)

b) cererea

c) d) procesul -verbal/procesele -verbale de evaluare a laboratorului solicitant

ntocmit/ntocmite de evaluatori; e) raportul de evaluare ntocmit de comisia de autorizare; f)

CAPITOLUL X:

Art. 24
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a) laborator

b) -un proces -

c) n baza procesului -verbal de evaluare, comisia de autorizare a IJC/ICB va ntocmi un raport de evaluare, care va fi transmis la ISC;

d) ISC va elibera o nouraportului de evaluare.

Art. 25

a) laboratoru

b)

(i

c)

CAPITOLUL XI: Art. 26

(1)

(2)- cu

documente:

a) b)

autor c)

d)original; e) notificarea

Art. 27 (1)

(2)

personal, autorizare. (3) -verbale de
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Art. 28 (1)

comisiei de autorizare constituite la nivelul IJC/ICB: a)

b) cererea de rennoire; c)

d) e) procesul -verbal/procesele -

ntocmit/ntocmite de evaluatori; f) raportul de evaluare ntocmit de comisia de autorizare.

(2)

-a rennoit

Art. 29 (1)

ri, se va aplica procedura de la cap. IX. (2)

-a acordat extinderea.

CAPITOLUL XII: Art. 30 (1)

autorizate, la propunerea IJC/ICB, pe baza referatelor ntocmite de comisiile de

autorizare, pentru a)

b) c)

d) e) utilizarea

(2)

a)

b) Art. 31

(1)

(2)

la propune rea comisiilor de autorizare ale IJC/ICB, pe baza proceselor -verbale ntocmite de evaluatori.
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(3)

evaluatorul. (4)

Art. 32

(1) ul n care echipele de supraveghere

(2)propunerea comisiilor de autorizare ale IJC/ICB, pe baza proceselor -verbale

ntocmite de evaluatori. (3)

(4)

se vor retrage anumite

Art. 33

sau retragerea auto

10/1995 Art. 34

Art. 35

-

Art. 36 Cheltuielile pentru autorizare sunt n valoare de 200 lei pentru un s

Art. 37

(1)

f

(2)timp de 2 ani consecutiv.

CAPITOLUL XIII: Art. 38

(1)

m
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autorizate, cu respectarea prevederilor prezentei proceduri.

(2) ISC va consemna n Re

Art. 39

-a

autorizat laboratorul. Art. 40

a) laboratorul emitent este autorizat, potrivit legii; b) documentele

Art. 41

(1) (2) ul solicitant va

a)duplicat;

b) -un ziar de

Art. 42

Art. 43

Art. 44 Anexele nr. 1 -

- **** -

ANEXA Nr. 1:

1. 1.1.

a) d

b) ui
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laborat

c)

d)

1.2.

a) -

-

b) c) -

d)laborator -

2. Personal 2.1.

a)

avndu - b) personal permanent angajat al

laboratorului. c)

procedurile sistemului de managemen d)

e) Laborator

f)profesionale a

g) -

h)

realizarea acestuia.

2.2.

a)

tandardelor SR EN ISO CEI 17025:2005, SR EN

b)

(ii)unui

c)laborator nu este acee

3. a)

b)

c)

d)

e)

f)

g) Laboratorul t

4. 4.1. Lab

vigoare.

4.2.

4.3.
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n acest scop.

a) amentelor;

b) c)etalonare a unor aparate;

d) contract metrologice.

4.4.

a)

dispozitive auxiliare); b)

date: b.1). denumirea aparaturii;

b.4). caracteristicile tehnice;

b.8). localizarea n cadrul laboratoru lui;

c)(consuma

d)

etichetare;

5. Raportarea rezultatelor

a)

rapoarte de ncercare. b) ncercare vor fi conforme cu prevederile

c)

rezultatelor. d)

6. Proceduri de lucru

a) e metode

b)

c)

7.

propriu de

ISO 9001/2008. 8. Documente administrative

a)

b)

conducerii laboratorului; c)

ANEXA Nr. 2: Date generale

1. 1.1. Denumirea:

....................................................................................................................

............. 1.2. Adresa:

........................................................................ ............................................

....................

1.3. Nr. de telefon/Fax: .......................................................................................................................

1.4. E-mail: ................................... ..............................; web: .............................................................

1.5. Statutul juridic .............................................................................................................................

1.6. Cod un ic de nregistrare ..............................................................................................................

1.7............................................................................................. 1.8.

.............................................................. 2.

2.1. Denumirea/gradul ....................................................................................................................

........

2.2. Adresa ....................................................................................................... .............

..................... 2.3. Nr. de

telefon/Fax.............................................................................................................................

2.4. Efectiv total personal laborator:

.................................. .................................................................., din care personal tehnic:

.................................................................................................................

........................

.......................

L.S. Data: .................

ANEXA Nr. 3:

Societatea ......................

Laboratorul ................ .....

Nr. crt.

Profilul Standardul sau norma care

ncercarea normele tehnice

.................................

...................................

L.S.

......................

.....................

Data .....................

ANEXA Nr. 4:
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PROCES-VERBAL de evaluare laborator

Date de identificare laborator

Proprietar laborator:

CUI societate:

Nr. de telefon:

Banca/cod IBAN:

Numerele de nregistrare de la:

IJC/ICB

- Legea nr. 10/1995 ulterioare - 63/2001

- 707/2001

ulterioare -

272/1994 - Regulamentul privind autorizarea laboratoarelor de analize

Guvernului nr. 808/2005 - SO CE 117025: 2005/AC: 2007 -

-

turismului nr. 1.497/2011 -

ghiduri, metodologii, manuale etc.)

-

Calitatea Telefon:

Calitatea

............................................................................................................................. .......................................................

5.

de construire a laboratorului nr. ......./............

5.3. Certificat sistem de calitate nr. ............../....................

n sistemul de management):
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