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ISO 9001:2015 0.1 General

0.1 General: A robust quality management system help an organization


to improve its overall performance and forms an integral component
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ISO 9000
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16

ISO 9001:2015

ISO 9001:2015

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ISO 9001:2015

ISO 9001:2015

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2. 2014 4 DIS Draft International Standard
3. 2015 7 Final Draft International Standard
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18

ISO 9001:2015

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2015
ISO 9001:2015

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ISO 9001:2015

19

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ISO 9001 2015 DIS
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20

ISO 9001:2015

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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

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7. Support
8. Operation
9. Performance Evaluation
10. Improvement

ISO 9001:2008
Customer FocusLeadershipprocess
Engagement of peopleimprovementEvidence-based Decision
MakingRelationship Management

ISO 9001:2015

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1. Customer Focus

2. Leadership

3. Engagement of people

24

ISO 9001:2015

4. Process approach

5. Improvement

6. Evidence-based decision making

7. Relationship management

ISO 9001:2015

25

ISO 9001:2008 ISO/DIS 9001:2015

26

ISO 9001:2015

8ISO 9001:2008

9ISO/DIS 9001:2015

ISO 9001:2015

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ISO 9001:2008 ISO/DIS 9001:2015

1ISO 9001:2008 ISO/DIS 9001:2015

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B 5 -

C 69 -

D 10 -
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10.1&10.3
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5. Process approach
4.4
6. Risk thinking
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ISO/DIS 9001:2015

1.

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2. 7.5

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3. 7.1.6
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ISO/DIS 9001:2015

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2.
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7.4 7.1.2
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6.

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ISO 9001:2008 2015 DIS


ISO 9001:2008 2015 DIS

2ISO 9001:2008 ISO 9001:2015

ISO 9001:2015

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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

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ISO
9001:2015 DIS

ISO 9001:2015 DIS

0.1 General

(1)
(2)
(3)
(4)
(5)
(6)
(7)

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0.2 ISOThe ISO standard for quality


management
ISO
ISO 9000

ISO 9001

ISO 9004

ISO 9004

0.3 Process approach

4.4

PDCA

ISO 9001:2015

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0.4

0.5 Risk-based thinking

ISO 9001

ISO 31000

4. Context of the organization


4.1 Understanding the organization and its
context

34

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4.2

(1)
(2)

4.3

(1) 4.1
(2) 4.2
(3)

ISO 9001:2015

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4.4

(1)
(2)
(3)
(4)
(5)
(6) 6.1
(7)

(8)

5.1
5.1.1

(1)

36

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(2)

(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)

5.1.2

(1)
(2)

(3)

(4)
5.2

ISO 9001:2015

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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)
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(1)
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A
B

ISO 9001:2015

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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

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(4)
7.1.4 Environment for the operation of
processes

7.1.5 Monitoring and measuring resources

(1)
(2)

7.1.6 Organizational knowledge

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(1)

(2)

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(1)
(2)
(3)
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(2)
(3)

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ISO 9001:2015

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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)

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7.5.3.1

44

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(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

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(2)
(3)
(4)
(5)

8.4
8.2 Determination of requirements for
products and services
8.2.1 Customer communication

(1)
(2)
(3)
(4)
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requirements related to products and services

46

ISO 9001:2015

(1)
(2)

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related to products and services

(1)
(2)

(3)
(4)
8.3 Design development of products
and services
8.3.1 General

8.3.2 Design and development planning

(1)
(2)

ISO 9001:2015

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(3)
(4)
(5)
(6)
(7)
8.3.3 Design and development Inputs

(1)
(2)
(3)
(4)
(5)
(6)

8.3.4 Design and development controls

(1)
(2)
(3)
(4)

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8.3.5 Design and development outputs

(1)
(2)
(3)
(4)

8.3.6 Design and development changes

8.4 Control of externally provided


products and services
8.4.1 General

(1)

(2)

ISO 9001:2015

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(3)

8.4.1 General

8.4.2 Type and extent of


control of external provision

(1)

(2)
8.4.2 Type and extent of
control of external provision

a b

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8.4.3 Information for external providers

(1)
(2)
(3)
(4)
(5)
(6)

8.5 Production and service provision


8.5.1 Control of production and
service provision

(1)
(2)
(3)

(4)

ISO 9001:2015

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(5)
(6)
(7)

(8)
8.5.2 Identification and traceability

8.5.3 Property belonging to


customers or external providers

8.5.4 Preservation

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8.5.5 Post-delivery activities

8.5.6 Control of changes

8.6 Release of products and services

8.7 Control of nonconforming process outputs, products and services

ISO 9001:2015

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(1)
(2)
(3)
(4)

9. Performance evaluation
9.1 Monitoring, measurement, analysis
and evaluation
9.1.1 General

(1)

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ISO 9001:2015

(2)

(3)
(4)

9.1.2 Customer satisfaction

9.1.3 Analysis and evaluation

(1)
(2)
(3)

ISO 9001:2015

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(4)
(5)
(6)
(7)

9.2 Internal Audit


9.2.1

(1)
A
B
(2)
9.2.2
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(5)
(6)
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56

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(8)
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9.3.1

(1)
(2)

(3)

A
B
C
D
E
F
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ISO 9001:2015

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10. Improvement
10.1 General

(1)
(2)
(3)
10.2 Nonconformity and corrective
action
10.2.1

(1)
A
B
(2)

(3)
A

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B
(4)
(5)
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ISO

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ISO 9001:2015 DIS ISO 9001:2015

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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
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2. ISO 39001:2013In land transportation safety management
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61

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77

ISO Annex SL

ISO 19011:2011

ISO

1. Greater focus on the customer


2. Risk-based thinking
3. Aligning QMS policy and objectives
with the strategy of an organization
4. Greater flexibility with documentation

ISO
ISO 9001:2015

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2015
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10. 2003.8 ISO 9001

ISO 9001:2015 DIS

SGS

10646 95 3
(02)2368-6858
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http://www.moeasmea.gov.tw
2014 12

103

ISO 90012015

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(02)2368-6858

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