Iso 9001- 2015品質管理系統條文

1

ISO 90012015 9 15

ISO9001:2015

Quality Management System

-/

2

(07)792-5355

[email protected] http://www.iso22000.com.tw

(07)792-5383

0930-839588

ISO-9001/14001 OHSAS-18001 ISO-22000/QC 080000

ISO-9001/14001

OHSAS-18001 ISO-10015/ 22000 IECQ QC-080000

mailto:[email protected]://www.iso22000.com.tw/

3

ISO

INTERNATIONAL ORGANIZATION FOR

STANDARDIZATION

ISO1946

1987ISO-90001994

20002008 2015

ISO-9000

ISOTC176

CDDISFDISIS

4

150

ISO 9001-

793ISO

9001CNS 12681

30,000

5

ISO 90002015

ISO 9000-

ISO 9001-

ISO 9004-

ISO 190011

6

ISO 9001 2015

Plan-DO-Check-Action P-

D- C-

A-

4.()

5.

6.

7.

8.

9.

10.

7

ISO 90012015

1.

2.

3.

4.

5.

6.

7.

8

ISO-9001:2015-

1.-----------------------------9

2.----------------------------10

3. ----------------------11~21

4.() ------------22~24

5.---------------------------25~27

6.-----------------28~30

7.-----------------------------31~37

8.-----------------------------38~53

9.-------------------------54~59

10.----------------------------60~62

9

ISO-9001:2015

1. (a)

(b)

1.

2.

10

2.

()

ISO 9000

ISO-9001:2015

11

3.

3.1(organization)

3.2(interested party)

3.3(requirement):

3.4(management system)

(3.1)(3.07)(3.8)(3.12)

3.5(top management):

(3.1)

12

3.6(effectiveness):

3.7(policy):(3.1)(3.5)

3.8(objective):

3.

(3.37)

(aim()goal()target(

))

3.9(risk):

1.

4. ()()

5. ()

13

3.10(competence)

(3.53)

3.11(documented information)

(3.1)(3.50)

1.

2.

(3.12)(3.33)

(3.50)()

()

3.12(process):

4. (3.46)(3.18)

14

3.13//(performance):

1.

2. (3.29)(3.12)(3.47)(3.48)(3.31)(3.1)

3.14(outsource, v.)

(3.1)(3.25)(3.12)

3.15(momitoring):(3.67)(3.31)(3.12)

1.

3.16(measurement):(3.67)(3.12)

3.17(audit)

(3.61)(3.60)(3.12)

3.18(conformity)

(3.3)

15

3.19(nonconformity) (3.3) 3.20(corrective action) (3.19) 3.21(continual improvement)://(3.13) 3.22(correction):(3.19) 3.23(involvement):(3.8) 3.24(context of the organization) () (3.1)(3.47)(3.48)(3.2) 1. (3.48)(3.1) 2. (3.1)

16

3.25(function);(3.01) 3.26(customer) 3.27(supplier)/(provider):(3.47)(3.48)(3.1) 3.28(improvement)://(3.13) 3.29(management):(3.1) 3.30(quality management):(3.37)(3.29) 3.31(system): 3.32(infrastructure) (3.1)(3.48)(3.31) 3.33(quality management system):(3.37)(3.4) 3.34(quality policy):(3.37)(3.7) 3.35(strategy): (3.8)

17

3.36(object)

(3.37)(3.48)(3.12)

(3.1)(3.31)

()

()()

3.37(quality)

(3.36)(3.65)(3.3)

3.38(statutory requirement)

3.39(regulatory requirement)

3.40(defect):(3.19)

1. (3.19)

(3.47)(3.48)

18

3.41(traceability)

(3.36)

3.42(innovation)

3.43(contract)

3.44(design and development)

(3.36)(3.3)(3.12)

3.45(quality objective):(3.37)(3.08)

3.46(output):(3.12)

3.47(product)

3.48(service)

(3.46)(3.27)(3.26)

3.49(data):(3.36)

19

3.50(information):(3.49)

3.51(objective evidence)

(3.49)

3.52(information system)

3.53(knowledge)

(3.50)

3.54(verification)

(3.51)(3.3)

3.55/(validation)

(3.51)(3.3)

3.56(feedback)

20

3.57(customer satisfaction):

3.58(complaint)

3.59(audit programme)

(3.17)

3.60(audit criteria)

(3.61)(3.7)

(3.11)(3.3)

3.61/(objective/auditevidence)

(3.60)

(3.50)

3.62(audit finding)

(3.61)(3.60)

21

3.63(concession)

(3.64)(3.3)(3.47)

(3.48)

3.64(release): (3.12)

3.65(characteristic):

3.66(performance indicator)

(3.46)(3.57)

(3.65)

3.67/(determination)

(3.65)

3.68(review)

3.69(measuring equipment)

22

4. ()

4.1() 1. 2. 4.2 (a) (b)

23

4.3

(a)4.1

(b)4.2

(c)

24

4.4 (a) (b) (c)

(d) (e) (f)6.1

(g)

(h) 4.4.2 (a) (b)

25

5. 5.1 5.1.1 (a) (b) (c) (d) (e) (f) (g) (h) (i) (j)

26

5.1.2

(a)

(b)

(c)

5.2

5.2.1

(a)

(b)

(c)

(d)

27

5.2.2 (a) (b)

(c)

5.3

(a) (b) (c) (d) (e)

28

6.1 6.1.14.1

4.2

(a) (b) (c)

(d)

6.1.2 (a) (b) (1)(4.4) (2) 1. 2.

6.

29

6.2

6.2.1

(a)

(b)

(c)

(d)

(e)

(f)

(g)

30

6.2.2

(a)

(b)

(c)

(d)

(e)

6.3

(4.4)

(a)

(b)

(c)

(d)

31

7. 7.1 7.1.1 (a)

(b)

7.1.2 7.1.3 (a) (b) (c) (d)

32

7.1.4 a)() B)() C)() 7.1.5 7.1.5.1 (a) (b) 7.1.5.2 , a)

33

b) C) 7.1.6 1. 2. (a)(

) (b)()

34

7.2 (a)

(b)

(c)

(d)

7.3 (a) (b) (c)

(d)

35

7.4 (a) (b) (c) (d) (e) 7.5 7.5.1 (a) (b)

(a) (b) (c)

36

7.5.2

(a) (

)

(b)()

()

(c)

37

7.5.3

7.5.3.1

(a)

(b)(

)

7.5.3.2

(a)

(b)

(c)()

(d)()

38

8. 8.1

4.46.1

(a)

(b)

1)

2)

(c)

(d)

(e)

1)

2)

(8.4)

39

8.2 8.2.1 (a) (b) (c) (d)

(e)

8.2.2 (a) 1) 2)

(b)

40

8.2.3 8.2.3.1

(a) (b)

(c) (d) (e)

8.2.3.2 (a) (b) 8.2.4

41

8.3

8.3.1

8.3.2

(a)

(b)

(c)

42

(d)

(e)

(f)

(g)

(h)

(i)

(j)

43

8.3.3

(a)

(b)

(c)

(d)

(e)

44

8.3.4 (a) (b)

(c)

(d)

() (e)

(f)

45

8.3.5 (a) (b) (c) (d)

8.3.6

(a) (b) (c) (d)

46

8.4

8.4.1

(a)

(b)

(c)

47

8.4.2 (a)

(b)

(c) 1)

2) (d)

48

8.4.3

(a)

(b)

1)

2)

3)

(c)

(d)

(e)

(f)

49

8.5 8.5.1 (a) 1) 2) (b) (c)

(d) (e) (f)

(g) (h)

50

8.5.2

8.5.3

51

8.5.4

()

8.5.5

(a)

(b)

(c)

(d)

(e)

52

8.5.6

8.6

(a)

(b)

53

8.7 8.7.1 (a) (b)() (c) (d) 8.7.2 (a) (b) (c) (d)

54

9. 9.1

9.1.1

(a)

(b)

(c)

(d)

55

9.1.2

56

9.1.3

(a)()

(b)

(c)()

(d)()

(e)

(f)()

(g)()

57

9.2 9.2.1 (a) (1) (2) (b) 9.2.2 (a) (b) (c) (d) (e) (f) ISO 19011

58

9.3 9.3.1 9.3.2 (a) (b) (c)

(1) (2) (3) (4) (5) (6) (7) (d) (e)(6.1) (f)

59

9.3.3

(a)

(b)

(c)

60

10. 10.1

(a)

(b)

(c)

()()

()()

()

61

10.2

10.2.1

(a)

(1)

(2)

(b)

(1)

(2)

(3)

(c)

(d)

(e)

62

10.2.2

(a)

(b)

10.3

63

4.

SWOT

SWOT(Strengths) (Weaknesses) (Opportunities)

(Threats)

()()

64

4.

SWOT

(Strengths)

(Weaknesses)

(Opportunities)

(Threats)

65

SWOT

S

W

T O

67

/

1. 2.

4. 3.

68

1.

2.

3.

4.

5.

6.

7.

69

ISO 90012008 & ISO 90012015

4.2.2

1.

2.

3.

4.( 4-10)

5.

5.1 ()

5.2 ()

5.3 () ISO-90012008

5.4 ()

5.5 ()

74

ISO9001:2008:

ISO 9001:2015

ISO9001:2008ISO 9001:2015

ISO9001:2015

ISO 9001:201536

ISO 9001:201536

Iso 9001- 2015品質管理系統條文

Business

Transcript of Iso 9001- 2015品質管理系統條文