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ISO 90012015
DIS
02
ISO 9001:2015
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ISO 9000 ........................................ 05
ISO 90012015 ................................ 16
ISO 90012015 ........................ 31
ISO ..................................................... 59
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03
IS
O 9001:2008
ISO
2011 12 1,111,698
180
ISO 2014
5 13 ISO 9001:2015 DIS Draft International Standard
ISO
ISO ISO 9001:2015
5
1.
2.
3.
4.
5. commitment and engagement
awareness and competence
04
ISO 9001:2015
ISO 9000
05
ISO 9000
ISO International Organization for Standardization 1947 2 23
ISO 9001
1987 1994 2000
2008 ISO 9001
27
ISO 9000
06
ISO 9001:2015
1ISO 9000
1970 ISO-
1970
BS5750 NF X50-110 ANSI/ASQC Z1-15
CSA Z299 BS5750 ISO 9001
3
ISO 9000
07
1.
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ISO 9004
ISO 9001~3
08
ISO 9001:2015
1994 ISO-
1994
9002 18 19 1 9003 12
16
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ISO ISO 9004-4
ISO 9001 9003
ISO 9000
09
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2. 4.14.3
ISO 9000
ISO 1987
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9000
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2. ISO 9004-3
3. ISO 9004-4
4. ISO 9004-5
5. ISO 9004-6
6. ISO 9000-3 ISO 9001
7. ISO 10005
8. ISO 10006
ISO 9000
1. ISO 9000
2. ISO 9000
10
ISO 9001:2015
4. 1995
5. 1995 7 1
CNS 12681/12682
6. 1995 7 1
2000 ISO-
2000
ISO 9000
11
9001 9003:1994
12
ISO 9001:2015
2000 1994
PDCA
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13
2008
2003 TC176
63 941 1477 ISO
9001:2000
80% ISO 9001:2000
813 55%
4.1
4.2
6.2
7.3
7.5
8.2
8.5
TC176 SC2 WG18
2007 2 8
ISO/CD 9001:2007
1.
2. ISO 9000
3. ISO 14001:2004
14
ISO 9001:2015
20 ISO 9000
1. ISO 9000:2005
2. ISO 9000:2008
3. ISO 9000:2000
4. ISO 9001:2005
ISO 14001
1.
2. 6.4
7.2.1 8.2.1
3.
(1) 8.2.2
ISO 9000
15
ISO
9004:2009
16
ISO 9001:2015
ISO 9001:2015
2015
ISO TC176/SC2 2015
9
ISO 9001:2015
17
1. 10
2.
3.
4.
5. ISO
DIS ISO ISO Annex
SL
2015
1. 2013 6 CD Committee Draft
2. 2014 4 DIS Draft International Standard
3. 2015 7 Final Draft International Standard
4. 2015 9 Published International Standard
18
ISO 9001:2015
3ISO 9001:2015
2015
ISO 9001:2015
1. 8 7
2. 8 10
3.
4.
5.
ISO 9001:2015
19
6.
7.
8.
ISO 9001 2015 DIS
Process Approach
Plan-Do-Check-ActContinual Improvement
Meet Customer Requirements
Enhance Customer Satisfaction
High Level StructureRiskbased Thinking ISO 9001
ISO Annex SL
20
ISO 9001:2015
3. ISO Annex SL
4Annex SL
ISO 9001:2015
Annex SL
ISO Annex SL 10
1. Scope
2. Normative references
3. Terms and Definitions
4. Context of Organization
5. Leadership
6. Planning
21
22
ISO 9001:2015
7. Support
8. Operation
9. Performance Evaluation
10. Improvement
ISO 9001:2008
Customer FocusLeadershipprocess
Engagement of peopleimprovementEvidence-based Decision
MakingRelationship Management
ISO 9001:2015
23
1. Customer Focus
2. Leadership
3. Engagement of people
24
ISO 9001:2015
4. Process approach
5. Improvement
7. Relationship management
ISO 9001:2015
25
26
ISO 9001:2015
8ISO 9001:2008
9ISO/DIS 9001:2015
ISO 9001:2015
27
ISO/DIS 9001:2015
1. Annex SL
2. Top management engagement
A 4 -
B 5 -
C 69 -
D 10 -
3. Enhancement of improvement
10.1&10.3
4. Context of organization
A4.1
B4.2
5. Process approach
4.4
6. Risk thinking
6.1
ISO/DIS 9001:2015
1.
A5.1.1
B
2. 7.5
A7.5
3. 7.1.6
4. 8.4
A8.4.1
B8.4.2
C8.4.3
ISO/DIS 9001:2015
1. 4.3 Annex
2.
6.3
8.1
8.3.6
8.5.6
3.
7.2 7.3
4.
7.4 7.1.2
5.
6.
28
ISO 9001:2015
ISO 9001:2015
29
30
ISO 9001:2015
ISO 9001:2015
1. CSR
2.
3. ISO 9001:2015
ISO 9001:2015
8.4.1
8.4.2
8.4.3
ISO 9001:2015
31
ISO 9001:2015
ISO
9001:2015 DIS
0.1 General
(1)
(2)
(3)
(4)
(5)
(6)
(7)
32
ISO 9001:2015
ISO 9001
ISO 9004
ISO 9004
4.4
PDCA
ISO 9001:2015
33
0.4
ISO 9001
ISO 31000
34
ISO 9001:2015
4.2
(1)
(2)
4.3
(1) 4.1
(2) 4.2
(3)
ISO 9001:2015
35
4.4
(1)
(2)
(3)
(4)
(5)
(6) 6.1
(7)
(8)
5.1
5.1.1
(1)
36
ISO 9001:2015
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
5.1.2
(1)
(2)
(3)
(4)
5.2
ISO 9001:2015
37
5.2.1
(1)
(2)
(3)
(4)
(1)
(2)
(3)
5.3
(1)
(2)
(3)
(4)
(5)
ISO 9001:2008
5.5.2
(1)
38
ISO 9001:2015
(2)
(3)
ISO/DIS 9001:2015
6.
6.1
6.1.1 4.1
4.2
(1)
(2)
(3)
6.1.2
(1)
(2)
A
B
ISO 9001:2015
39
6.2
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(1)
(2)
(3)
(4)
(5)
6.3 Planning of changes
4.4
(1)
40
ISO 9001:2015
(2)
(3)
(4)
7. Support
7.1 Resources
7.1.1 General
(1)
(2)
7.1.2 People
7.1.3 Infrastructure
(1)
(2)
(3)
ISO 9001:2015
41
(4)
7.1.4 Environment for the operation of
processes
(1)
(2)
42
ISO 9001:2015
2
(1)
(2)
7.2 Competence
(1)
(2)
(3)
(4)
7.3 Awareness
(1)
(2)
(3)
(4)
ISO 9001:2015
43
7.4 Communication
(1)
(2)
(3)
(4)
7.5 Documented information
7.5.1 General
(1)
(2)
7.5.2 Creating and updating
(1)
(2)
(3)
7.5.3 Control of documented Information
7.5.3.1
44
ISO 9001:2015
(1)
(2)
7.5.3.2
(1)
(2)
(3)
(4)
8. Operation
8.1 Operational planning and control
4.4
6.1
(1)
ISO 9001:2015
45
(2)
(3)
(4)
(5)
8.4
8.2 Determination of requirements for
products and services
8.2.1 Customer communication
(1)
(2)
(3)
(4)
(5)
8.2.2 Determination of
requirements related to products and services
46
ISO 9001:2015
(1)
(2)
(1)
(2)
(3)
(4)
8.3 Design development of products
and services
8.3.1 General
(1)
(2)
ISO 9001:2015
47
(3)
(4)
(5)
(6)
(7)
8.3.3 Design and development Inputs
(1)
(2)
(3)
(4)
(5)
(6)
(1)
(2)
(3)
(4)
48
ISO 9001:2015
(1)
(2)
(3)
(4)
(1)
(2)
ISO 9001:2015
49
(3)
8.4.1 General
(1)
(2)
8.4.2 Type and extent of
control of external provision
a b
50
ISO 9001:2015
(1)
(2)
(3)
(4)
(5)
(6)
(1)
(2)
(3)
(4)
ISO 9001:2015
51
(5)
(6)
(7)
(8)
8.5.2 Identification and traceability
8.5.4 Preservation
52
ISO 9001:2015
ISO 9001:2015
53
(1)
(2)
(3)
(4)
9. Performance evaluation
9.1 Monitoring, measurement, analysis
and evaluation
9.1.1 General
(1)
54
ISO 9001:2015
(2)
(3)
(4)
(1)
(2)
(3)
ISO 9001:2015
55
(4)
(5)
(6)
(7)
(1)
A
B
(2)
9.2.2
(3)
(4)
(5)
(6)
(7)
56
ISO 9001:2015
(8)
9.3 Management review
9.3.1
(1)
(2)
(3)
A
B
C
D
E
F
G
(4) 6.1
(5)
9.3.2
ISO 9001:2015
57
10. Improvement
10.1 General
(1)
(2)
(3)
10.2 Nonconformity and corrective
action
10.2.1
(1)
A
B
(2)
(3)
A
58
ISO 9001:2015
B
(4)
(5)
(6)
(7)
10.2.2
(1)
(2)
10.3 Continual improvement
ISO
59
ISO
ISO 9001:2015 DIS ISO 9001:2015
1.
2. ISO 9001:2015 ISO 9001:2008
3. ISO
4.
5.
6. 2018
ISO 9001:2015
ISO 9001:2015
60
ISO 9001:2015
ISO 9001:2015
ISO 11
3
11
1. ISO 9001:2008 => ISO 9001:2015
2. ISO 14001:2004 => ISO 14001:2015
3. ISO/IEC 27001:2005 => ISO/IEC 27001:2013
4. OHSAS 18001:2007 => ISO 45001:2016
5. BS 25999 => ISO 22301:2013
6. ISO 22000:2005 => ISO 22000:201x
7. TL 9000
8. AS 9100
9. ISO 13485
10. ISO/TS 16949
11. IECQ QC 080000
ISO
3
1. ISO 55001:2014Asset management system
2. ISO 39001:2013In land transportation safety management
system
3. ISO 20121:2012Event Sustainability management system
61
62
ISO 9001:2015
QQuality
1.
2. Process
3.
10TQM
63
TQM
1.
2.
3.
4.
5.
6.
1.
2.
3.
4.
5.
TQM
64
ISO 9001:2015
1.
2.
1.
2.
3.
4.
5.
6.
7.
TQM
1.
65
2.
3.
4.
5.
1.
2.
3.
4.
TQM
66
ISO 9001:2015
11TQM
ISO 9001:2000
67
PDCA
ISO 9001:2008
68
ISO 9001:2015
TQM
69
P-D-C-A
PDCAPlan-Do-Check-Action
PDCA P D
C A
PPlan-DDo-CCheck-AAction
PPlan
DDo
CCheck
70
ISO 9001:2015
AAction
Act
Adjust PDCA A
A
D
71
NQA
ISO 9001:2015
72
ISO 9001:2015
13ISO 9001:2015
14
73
NQA
8 26 78
5.
5.1
5.1.1
5.1.2
5.2
5.3
7.3
7.4
1. 120
1.1
1.1.1.
1.1.2
1.1.3
1.1.4
1.1.5
4.2
4.3
1.2
1.2.1
1.2.2
1.2.3
2. 80
2.1
2.1.1
2.2.2
4.
4.1
2.2
2.2.1
2.2.2
6.
6.1
2.3
2.3.1
2.3.2
6.2
6.3
3. 80
74
ISO 9001:2015
9001
7 28 59
NQA
8 26 78
3.1
3.2
3.3
4. 100
4.1
4.1.1
4.1.2
8.2
8.2.1
8.2.2
8.2.3
9.1.2
4.2
4.2.1
4.2.2
4.2.3
4.2.4
4.2.5
4.2.6
5. 80
7.1.2
5.1
7.2
5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
5.1.6
5.2
5.3
5.3.1
5.3.2
5.3.3
5.3.4
7.1.6
6. 80
6.1
7.1.3
6.2
9001
7 28 59
7. 110
7.1
7.1.1
7.1.2
7.1.3
7.1.4
7.1.5
75
NQA
8 26 78
4.4
7.1.4
7.1.5
7.5
8.
8.1
8.3
8.5
8.6
8.7
10.
10.1
10.2
10.3
7.2
7.3
7.3.1
7.3.2
7.3.3
7.
7.1
8.4
8.4.1
8.4.2
8.4.3
8.
8.1
8.1.1
8.1.2
9.
9.1
9.1.2
8.2
8.3
8.4
8.5
9.1.3
8.6
76
ISO 9001:2015
9001
7 28 59
NQA
8 26 78
8.7
9.2
9.3
77
ISO Annex SL
ISO 19011:2011
ISO
ISO
ISO 9001:2015
78
ISO 9001:2015
2015
ISO 9001:2015
79
3. 2015http://zh.wikipedia.org/wiki/Wikipedia
4. 2014 http://nqa.cpc.tw/
NQA/web/RE.aspx
5. 1991.11
SGS
10646 95 3
(02)2368-6858
(02)2367-8540
http://www.moeasmea.gov.tw
2014 12
103
ISO 90012015
DIS
953
792
(02)2368-6858
(02)2698-2989
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