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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
66
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 ()
70
71
72
73
74
ISO9001:2008:
ISO 9001:2015
ISO9001:2008ISO 9001:2015
ISO9001:2015
ISO 9001:201536
ISO 9001:201536