Системы менеджмента качества. Требования. ISO 9001

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ɆȿɀȾɍɇȺɊɈȾɇɕɃ ɋɌȺɇȾȺɊɌ

ISO 9001

2000-12-15

ɋɂɋɌȿɆɕ ɆȿɇȿȾɀɆȿɇɌȺ ɄȺɑȿɋɌȼȺ. ɌɊȿȻɈȼȺɇɂə QUALITY MANAGEMENT SYSTEMSREQUIREMENTS

ISO 9001:2000 (R) © ISO 2000

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Ɉɬɤɚɡ ɨɬ ɨɬɜɟɬɫɬɜɟɧɧɨɫɬɢ ɩɪɢ ɪɚɛɨɬɟ ɜ PDF PDF , , ,

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ɋɈȾȿɊɀȺɇɂȿ . 1 1.1 1.2 2 3 4 4.1 4.2 5 5.1 5.2 5.3 5.4 5.5 5.6 6 6.1 6.2 6.3 6.4 7 7.1 7.2 7.3 7.4 7.5 7.6 8 8.1 8.2 8.3 8.4 8.5

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.

8.2.4 Ʉɨɧɬɪɨɥɢɪɨɜɚɧɢɟ ɢ ɢɡɦɟɪɟɧɢɟ ɩɪɨɞɭɤɰɢɢ © ISO 2000 –

,

-

ISO 9001:2000 (R)

24

.Э (7.1). . ( )

( ), (4.2.4). , (7.1), ,

,

.

8.3 ɍɩɪɚɜɥɟɧɢɟ ɧɟɫɨɨɬɜɟɬɫɬɜɭɸɳɟɣ ɩɪɨɞɭɤɰɢɟɣ ,

,

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)

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-

ISO 9001:2000 (R)

25

.

-

, . , ) b) c)

:

(8.2.1); (7.2.1); ,

-

; d)

.

8.5 ɍɥɭɱɲɟɧɢɟ 8.5.1 ɉɨɫɬɨɹɧɧɨɟ ɭɥɭɱɲɟɧɢɟ ,

,

,

,

.

8.5.2 Ʉɨɪɪɟɤɬɢɪɭɸɳɢɟ ɞɟɣɫɬɜɢɹ ,

-

. .

: ) b) )

(

); ; ,

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; d) ) f)

; (4.2.4); .

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-

. : ) © ISO 2000 –

;

ISO 9001:2000 (R)

26

b)

;

) d) )

© ISO 2000 –

; (4.2.4); .

ISO 9001:2000 (R)

27

ɉɊɂɅɈɀȿɇɂȿ Ⱥ ( ) ɋɨɨɬɜɟɬɫɬɜɢɟ ɦɟɠɞɭ ɂɋɈ 9001:2000 ɢ ɂɋɈ 14001:1996 Ɍɚɛɥɢɰɚ Ⱥ.1 – ɋɨɨɬɜɟɬɫɬɜɢɟ ɦɟɠɞɭ ɂɋɈ 9001:2000 ɢ ɂɋɈ 14001:1996 ɂɋɈ 9001:2000 1 ȼɜɟɞɟɧɢɟ 9004

ɂɋɈ 14001:1996 2 ȼɜɟɞɟɧɢɟ

0 0.1 0.2 0.3 0.4

Ɉɛɥɚɫɬɶ ɩɪɢɦɟɧɟɧɢɹ

1 1.1 1.2 ɇɨɪɦɚɬɢɜɧɚɹ ɫɫɵɥɤɚ 2 Ɍɟɪɦɢɧɵ ɢ ɨɩɪɟɞɟɥɟɧɢɹ 3 ɋɢɫɬɟɦɚ ɦɟɧɟɞɠɦɟɧɬɚ ɤɚɱɟ- 4 ɫɬɜɚ 4.1 4.2 4.2.1

1

Ɉɛɥɚɫɬɶ ɩɪɢɦɟɧɟɧɢɹ

2 3 4

ɇɨɪɦɚɬɢɜɧɵɟ ɫɫɵɥɤɢ Ɉɩɪɟɞɟɥɟɧɢɹ Ɍɪɟɛɨɜɚɧɢɹ ɤ ɫɢɫɬɟɦɟ ɦɟɧɟɞɠɦɟɧɬɚ ɨɯɪɚɧɵ ɨɤɪɭɠɚɸɳɟɣ ɫɪɟɞɵ Ɉɛɳɢɟ ɬɪɟɛɨɜɚɧɢɹ

4.1

-

4.4.4 -

4.2.2

-

4.4.4 -

Ɉɬɜɟɬɫɬɜɟɧɧɨɫɬɶ ɞɫɬɜɚ

4.2.3 4.2.4 ɪɭɤɨɜɨ- 5

4.4.5 4.5.3 4.4.1

5.1

4.2

5.2

4.4.1 4.3.1 4.3.2

© ISO 2000 –

-

ISO 9001:2000 (R)

28

1

2 -

5.3

4.2

-

5.4 5.4.1 5.4.2

4.3 4.3.3 4.3.4

-

5.5

4.1

-

5.5.1

4.4.1

-

5.5.2 5.5.3

4.4.3

-

5.6

4.6

,

( )

-

5.6.1 - 5.6.2 Ɇɟɧɟɞɠɦɟɧɬ ɪɟɫɭɪɫɨɜ

,

-

5.6.3 6 6.1 6.2 6.2.1 6.2.2

6.3 6.4 ɉɪɨɰɟɫɫɵ ɠɢɡɧɟɧɧɨɝɨ ɰɢɤɥɚ 7 ɩɪɨɞɭɤɰɢɢ 7.1 ,

,

4.4.1

4.4.2

,

4.4.1 4.4 4.4.6 4.4.6

7.2 7.2.1

4.3.1

-

4.3.2

,

© ISO 2000 –

-

7.2.2

4.4.6 4.4.6 4.3.1

-

ISO 9001:2000 (R)

29

1

2 7.2.3 - 7.3

4.4.3

- 7.3.1

4.4.6

- 7.3.2 - 7.3.3 - 7.3.4 - 7.3.5 - 7.3.6 7.3.7 7.4 7.4.1 7.4.2 7.4.3 - 7.5

4.4.6

4.4.6

7.5.1 - 7.5.2 - 7.5.3 - 7.5.4 7.5.5 7.6

4.5.1

8

4.5

ɂɡɦɟɪɟɧɢɟ, ɚɧɚɥɢɡ ɢ ɭɥɭɱɲɟɧɢɟ

( © ISO 2000 –

8.1 8.2 - 8.2.1

4.5.1

- 8.2.2

4.5.4

-

-

ISO 9001:2000 (R)

30

1

2

) 8.2.3

4.5.1

- 8.2.4 - 8.3

-

4.4.7

-

8.4 8.5

4.5.1 4.2

8.5.1

4.3.4

8.5.2

4.5.2

- 8.5.3

© ISO 2000 –

4.5.2

( ) -

ISO 9001:2000 (R)

31

Ɍɚɛɥɢɰɚ Ⱥ.2 – ɋɨɨɬɜɟɬɫɬɜɢɟ ɦɟɠɞɭ ɂɋɈ 14001:1996 ɢ ɂɋɈ 9001:2000 ɂɋɈ 14001:1996 ɂɋɈ 9001:2000 1 2 – ȼɜɟɞɟɧɢɟ 0 ȼɜɟɞɟɧɢɟ 0.1 0.2 0.3 9004 0.4 Ɉɛɥɚɫɬɶ ɩɪɢɦɟɧɟɧɢɹ

1

ɇɨɪɦɚɬɢɜɧɵɟ ɫɫɵɥɤɢ

Ɉɛɥɚɫɬɶ ɩɪɢɦɟɧɟɧɢɹ

2

1 1.1 1.2 2

ɇɨɪɦɚɬɢɜɧɚɹ ɫɫɵɥɤɚ

Ɉɩɪɟɞɟɥɟɧɢɹ

3

3

Ɍɟɪɦɢɧɵ ɢ ɨɩɪɟɞɟɥɟɧɢɹ

Ɍɪɟɛɨɜɚɧɢɹ ɤ ɫɢɫɬɟɦɟ ɦɟɧɟɞɠɦɟɧɬɚ ɨɯɪɚɧɵ ɨɤɪɭɠɚɸɳɟɣ ɫɪɟɞɵ

4

4

ɋɢɫɬɟɦɚ ɦɟɧɟɞɠɦɟɧɬɚ ɤɚɱɟɫɬɜɚ

4.1

4.1 5.5

,

5.5.1 4.2

4.3 -

4.3.1

-

5.1 5.3 8.5 5.4 5.2 7.2.1 7.2.2

, ɡ

-

,

-

4.3.2 5.2 7.2.1

( )

-

4.3.3 4.3.4

5.4.1 5.4.2 8.5.1

© ISO 2000 –

,

-

-

ISO 9001:2000 (R)

32

1 4.4

7

2 ɉɪɨɰɟɫɫɵ ɠɢɡɧɟɧɧɨɝɨ ɰɢɤɥɚ ɩɪɨɞɭɤɰɢɢ

7.1 4.4.1

-

,

-

-

5 5.1 5.5.1

4.4.2

5.5.2 6 6.1 6.2 6.2.1 6.3 6.4 6.2.2

4.4.3

5.5.3

4.4.5

7.2.3 4.2 4.2.1 4.2.2 4.2.3

4.4.6

7

4.4.4

-

Ɉɬɜɟɬɫɬɜɟɧɧɨɫɬɶ ɪɭɤɨɜɨɞɫɬɜɚ Ɇɟɧɟɞɠɦɟɧɬ ɪɟɫɭɪɫɨɜ

,

-

ɉɪɨɰɟɫɫɵ ɠɢɡɧɟɧɧɨɝɨ ɰɢɤɥɚ ɩɪɨɞɭɤɰɢɢ

7.1 7.2

,

7.2.1 7.2.2

, ,

-

7.3 7.3.1 7.3.2 7.3.3

© ISO 2000 –

-

ISO 9001:2000 (R)

33

1

2 7.3.4 7.3.5

-

7.3.6 7.3.7 7.4 7.4.1 7.4.2 7.4.3 7.5

-

7.5.1 7.5.2

-

7.5.3

-

4.4.7

7.5.4 7.5.5 8.3

-

4.5

8

4.5.1

7.6 8.1 8.2 8.2.1 8.2.3 8.2.4

-

© ISO 2000 –

4.5.2

8.4 8.3

4.5.3

8.5.2 8.5.3 4.2.4

ɂɡɦɟɪɟɧɢɟ, ɚɧɚɥɢɡ ɢ ɭɥɭɱɲɟɧɢɟ

-

ISO 9001:2000 (R)

34

1

© ISO 2000 –

2 -

4.5.4

8.2.2

-

4.6

5.6 5.6.1 5.6.2 5.6.3

(

)

ISO 9001:2000 (R)

35

ɉɊɂɅɈɀȿɇɂȿ ȼ ( ) ɋɨɨɬɜɟɬɫɬɜɢɟ ɦɟɠɞɭ ɂɋɈ 9001:2000 ɢ ɂɋɈ 9001:1994 Ɍɚɛɥɢɰɚ ȼ.1 – ɋɨɨɬɜɟɬɫɬɜɢɟ ɦɟɠɞɭ ɂɋɈ 9001:1994 ɢ ɂɋɈ 9001:2000

9001:1994 1 1 Ɉɛɥɚɫɬɶ ɩɪɢɦɟɧɟɧɢɹ 2 ɇɨɪɦɚɬɢɜɧɚɹ ɫɫɵɥɤɚ 3 Ɉɩɪɟɞɟɥɟɧɢɹ 4 Ɍɪɟɛɨɜɚɧɢɹ ɤ ɫɢɫɬɟɦɟ ɤɚɱɟɫɬɜɚ [

]

[

]

9001:2000 2 1 2 3

4.1 4.1.1 4.1.2

5.1+5.3+5.4.1 [

]

4.1.2.1

-

4.1.2.2 4.1.2.3 4.1.3 4.2

6.1+6.2.1 5.5.2 5.6.1+8.5.1 [

]

4.2.1 4.2.2 4.2.3 4.3

4.1+4.2.2 4.2.1 5.4.2+7.1 [

]

4.3.1 4.3.2 4.3.3 4.3.4 4.4

5.2+7.2.1+7.2.2+7.2.3 7.2.2 7.2.2 [

]

4.4.1 4.4.2 4.4.3 4.4.4 © ISO 2000 –

5.5.1

7.3.1 -

7.3.1 7.2.1+7.3.2

ISO 9001:2000 (R)

36

1

2

4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.5

7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 [

]

4.5.1 4.5.2

4.2.3 4.2.3

-

4.5.3

-

4.6 4.6.1 4.6.2 4.6.3 4.6.4

[

4.7

4.2.3

]

,

4.8

-

7.4.1 7.4.2 7.4.3

-

7.5.4

-

4.9 4.10

7.5.3 6.3+6.4+7.5.1+7.5.2

[

]

4.10.1 4.10.2

-

7.1+8.1 7.4.3+8.2.4

4.10.3

-

8.2.4

4.10.4

8.2.4

4.10.5

7.5.3+8.2.4

4.11

,

[

4.11.1 4.11.2 4.12 4.13 © ISO 2000 –

-

]

7.6 7.6 7.5.3

ISO 9001:2000 (R)

37

1 [

2 ]

4.13.1 4.13.2

8.3 8.3

-

4.14

[

4.14.1 4.14.2 4.14.3 4.15

]

8.5.2+8.5.3 8.5.2 8.5.3 ,

, [

4.15.1 4.15.2

, ]

-

- 7.5.5

4.15.3 4.15.4 4.15.5 4.15.6 4.16

-

4.17 4.18 4.19 4.20

© ISO 2000 –

7.5.5 7.5.5 7.5.5 7.5.1 4.2.4 8.2.2+8.2.3 6.2.2 7.5.1

[

4.20.1 4.20.2

-

]

8.1+8.2.3+8.2.4+8.4 8.1+8.2.3+8.2.4+8.4

ISO 9001:2000 (R)

38

Ɍɚɛɥɢɰɚ ȼ.2 – ɋɨɨɬɜɟɬɫɬɜɢɟ ɦɟɠɞɭ ɂɋɈ 9001:2000 ɢ ɂɋɈ 9001:1994 9001:2000 1 1 Ɉɛɥɚɫɬɶ ɩɪɢɦɟɧɟɧɢɹ 1.1 1.2 2 ɇɨɪɦɚɬɢɜɧɚɹ ɫɫɵɥɤɚ 3 Ɍɟɪɦɢɧɵ ɢ ɨɩɪɟɞɟɥɟɧɢɹ 4 ɋɢɫɬɟɦɚ ɦɟɧɟɞɠɦɟɧɬɚ ɤɚɱɟɫɬɜɚ [

9001:1994 2 1

2 3

]

4.1 4.2

4.2.1 [

]

4.2.1 4.2.2 4.2.3 4.2.4 5 Ɉɬɜɟɬɫɬɜɟɧɧɨɫɬɶ ɪɭɤɨɜɨɞɫɬɜɚ [

4.2.2 4.2.1 4.5.1+4.5.2+4.5.3 4.16

]

5.1 5.2 5.3 5.4

4.1 4.3.2 4.1.1 [

]

5.4.1 5.4.2

4.1.1 - 4.2.3

5.5

, [

]

5.5.1 5.5.2 5.5.3 5.6

4.1.2.1 4.1.2.3

[

]

5.6.1 5.6.2 5.6.3 6 Ɇɟɧɟɞɠɦɟɧɬ ɪɟɫɭɪɫɨɜ [

6.1

© ISO 2000 –

4.1.3

]

4.1.2.2

ISO 9001:2000 (R)

39

1

2

6.2 [

]

6.2.1 6.2.2

4.1.2.2 4.18

,

6.3 4.9 6.4 4.9 7 ɉɪɨɰɟɫɫɵ ɠɢɡɧɟɧɧɨɝɨ ɰɢɤɥɚ ɩɪɨɞɭɤɰɢɢ [

]

7.1

4.2.3+4.10.1

7.2

,

-

[

]

7.2.1

,

7.2.2

,

- 4.3.2+4.4.4 4.3.2+4.3.3+4.3.4

7.2.3 7.3

4.3.2 [

]

7.3.1

4.4.2+4.4.3

7.3.2

- 4.4.4

7.3.3

4.4.5

7.3.4 7.3.5 7.3.6 7.3.7

4.4.6 4.4.7 4.4.8 4.4.9

7.4 7.4.1 7.4.2 7.4.3

[

]

4.6.2 4.6.3 - 4.6.4+4.10.2

7.5 [

7.5.1 7.5.2

© ISO 2000 –

]

- 4.9+4.15.6+4.19 4.9

ISO 9001:2000 (R)

40

1

2

7.5.3

-

7.5.4 7.5.5 7.6

4.8+4.10.5+4.12 4.7 4.15.2+4.15.3+4.15.4+4.15.5 - 4.11.1+4.11.2

8 ɂɡɦɟɪɟɧɢɟ, ɚɧɚɥɢɡ ɢ ɭɥɭɱɲɟɧɢɟ [

]

8.1 8.2

4.10.1+4.20.1+4.20.2 [

]

8.2.1 8.2.2 8.2.3 8.2.4

(

)

8.3 8.4 8.5 8.5.1 8.5.2 8.5.3

© ISO 2000 –

4.17 4.17+4.20.1+4.20.2 - 4.10.2+4.10.3+4.10.4+4.10.5+4.20.1+ 4.20.2 - 4.13.1+4.13.2 4.20.1+4.20.2

[

]

4.1.3 4.14.1+4.14.2 4.14.1+4.14.3

ISO 9001:2000 (R)

41

ȻɂȻɅɂɈȽɊȺɎɂə [1]

9000-3:1997

.Ч ,

9004:2000

[3]

10005:1995

М

[4]

10006:1997

М

[5]

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М

[6]

10011-1:1990

10011-2:1991

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[2]

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3. 9001:1994

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10011-3:1991

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[9]

10012-1:1992

[10]

10012-2:1997

[11]

10013:1995

,

,

3. М

. Ч

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1.

2.

-

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ISO 9001:2000 (R)

[12]

/

42

10014:1998 М

[13]

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10015:1999 М

[14]

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14001:1996

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10017:1999

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web-

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:

http://www.iso.ch http://www.bsi.org.uk/iso-tc176-sc2

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Web -

.( 9000-4:1993) :http://www.iso.ch ([email protected]).

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