01ISO 9001:2015國際標準DIS
description
Transcript of 01ISO 9001:2015國際標準DIS
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Quality Management Systems-RequirementsISO 90012015DIS
1 Introduction
10.1 General
10.2ISO The ISO standards for Quality Management
10.3 Process approach
10.4--- Plan-Do-Check-Act Cycle
10.5Risk-based thinking
10.6Compatibility with other management system
21 Scope
22 Normative references
23 Terms and definitions
64 Context of the organization
64.1 Understanding the organization and its context
64.2 Understanding the need and expectations of interested parties
64.3 Determining the scope of the quality management system
74.4 Quality management system and its process
85Leadership
85.1Leadership and commitment
85.1.1Leadership and commitment for the quality management system
85.1.2Customer focus
95.2Quality Policy
95.2.1
95.2.2
95.3Organizational roles, responsibilities and authorities
106 Planning for the quality management system
106.1Action to address risks and opportunities
106.1.1 4.14.2
106.1.2
106.2Quality objectives and planning to achieve them
106.2.1
116.2.2
116.3Planning of changes
127Support
127.1Resources
127.1.1General
127.1.2People
127.1.3Infrastructure
127.1.4Environment for the operation of processes
137.1.5Monitoring and measuring resources
137.1.6Organizational knowledge
147.2Competence
147.3Awareness
147.4Communication
157.5Documented information
157.5.1General
157.5.2Creating and updating
157.5.3Control of documented information
157.5.3.1
157.5.3.2
178Operation
178.1Operational planning and control
178.2Determination of requirements for products and services
178.2.1Customer communication
178.2.2Determination of requirements related to products and services
188.2.3Review of requirements related to products and services
188.3Design and development of products and services
188.3.1General
198.3.2Design and development planning
198.3.3Design and development inputs
198.3.4Design and development controls
208.3.5Design and development outputs
208.3.6Design and development changes
208.4Control of externally provided products and services
208.4.1General
218.4.2Type and extent of control of external provision
218.4.3Information for external providers
228.5Production and service provision
228.5.1Control of production and service provision
228.5.2Identification and traceability
238.5.3Property belonging to customers or external providers
238.5.4Preservation
238.5.5Post-delivery activities
238.5.6Control of changes
238.6Release of products and services
248.7Control of nonconforming process outputs, products and services
259Performance evaluation
259.1 Monitoring, measurement, analysis and evaluation
259.1.1General
259.1.2Customer satisfaction
259.1.3Analysis and evaluation
269.2 Internal Audit
269.2.1
269.2.2
279.3Management review
279.3.1
279.3.2
2810 Improvement
2810.1 General
2810.2Nonconformity and corrective action
2810.2.1
2910.2.2
2910.3 Continual improvement
30A Annex Ainformative
30A1 Structure and terminology
30A2 Products and services
30A3 Context of the organization
30A4 Risk-based approach
30A5 Applicability
30A6 Documented information
30A7 Organizational knowledge
30A8 Control of externally provided products and services
31BAnnex Binformative
31B.21-QMP1 Customer Focus
31B.32-QMP2 Leadership
31B.43-QMP3 Engagement of People
31B.54-QMP4 Process Approach
31B.65-QMP5 Improvement
31B.76-QMP6 Evidence-based Decision Marking
31B.87-QMP7 Relationship Management
32CAnnex Cinformative
Introduction
0.1 General
0.2ISO The ISO standards for Quality Management
0.3 Process approach
0.4--- Plan-Do-Check-Act Cycle
0.5Risk-based thinking0.6Compatibility with other management system
1 Scope
a)
b)
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2 Normative referencesISO
3 Terms and definitionsISO 9000
3.01organization
3.02interested parties
3.03requirement
3.04management system
3.05top management
3.06effectiveness
3.07policy
3.08objective
3.09risk
3.10competence
3.11documented information
3.12process
3.13performance
3.14()outsource(verb)3.15monitoring
3.16measurement
3.17audit
3.18conformity
3.19nonconformity
3.20corrective action
3.21continual improvement
3.22correction
3.23involvement3.24context of the organization
3.25function
3.26customer
3.27/supplier / provider
3.28improvement
3.29management
3.30quality management
3.31system
3.32infrastructure
3.33quality management system
3.34quality policy
3.35strategy
3.36object
3.37quality
3.38statutory requirement
3.39regulatory requirement
3.40defect
3.41traceability
3.42innovation
3.43contract
3.44design and development
3.45quality objective
3.46output
3.47product
3.48service
3.49data
3.50information
3.51objective evidence
3.52information system
3.53knowledge
3.54verification
3.55validation
3.56feedback
3.57customer satisfaction
3.58complaint
3.59audit programme3.60audit criteria
3.61 / objective / audit evidence
3.62audit findings
3.63concession
3.64release
3.65characteristic
3.66performance indicator
3.67determination
3.68review
3.69measuring equipment
4 Context of the organization4.1 Understanding the organization and its context
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2
4.2 Understanding the need and expectations of interested parties
a)b)
4.3 Determining the scope of the quality management system
a)4.1b)4.2
c)
4.4 Quality management system and its process
a)
b)
c)
d)
e)
f)6.1
g)
h)
5Leadership5.1Leadership and commitment5.1.1Leadership and commitment for the quality management system
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
5.1.2Customer focusa)
b)
c)
d)
5.2Quality Policy5.2.1
a)
b)
c)
d)
5.2.2
a)
b)
c)
5.3Organizational roles, responsibilities and authorities
a)
b)
c)
d)
e)
6 Planning for the quality management system
6.1Action to address risks and opportunities
6.1.1 4.14.2
a)
b)
c)
6.1.2
a)
b)1)4.4)
2)
6.2Quality objectives and planning to achieve them6.2.1
a)
b)c)
d)
e)f)
g)
6.2.2
a)
b)7.1
c)
d)
e)
6.3Planning of changes4.4
a)
b)
c)
d)
7Support7.1Resources7.1.1General
a)
b)7.1.2People
7.1.3Infrastructure
a)
b)c)d)7.1.4Environment for the operation of processes)
7.1.5Monitoring and measuring resources
a)
b)
7.1.6Organizational knowledge
1
2
a)b)7.2Competence
a)
b)c)
d)
7.3Awareness
a)
b)
c)d)7.4Communication
a)b)c)d)7.5Documented information7.5.1General
a)b)
a)
b)
c)
7.5.2Creating and updating
a)b)c
7.5.3Control of documented information7.5.3.1a)
b)7.5.3.2
a)
b)
c))
d)
8Operation8.1Operational planning and control4.46.1
a)
b)c)
d)e)
8.4
8.2Determination of requirements for products and services8.2.1Customer communication
a)
b)
c)d)
e)
8.2.2Determination of requirements related to products and services
a)()
b)
8.2.3Review of requirements related to products and services
a)
b)
c)
d)
8.3Design and development of products and services8.3.1General
18.5
28.38.5
8.3.2Design and development planning
a)
b)
c)
d)
e)
f)g)
8.3.3Design and development inputs
a)
b)
c)
d)
e)
f)
8.3.4Design and development controls
a)
b)
c)
d)()
8.3.5Design and development outputs
a)
b)
c)d)
8.3.6Design and development changes
8.4Control of externally provided products and services8.4.1General
a)
b)c)
8.4.2Type and extent of control of external provision
a)
b)
a)b)8.4.3Information for external providers
a)
b)
c)
d)
e)
f)
8.5Production and service provision8.5.1Control of production and service provision
a)b)c)d)
e)f)g)
h)
8.5.2Identification and traceability
8.5.3Property belonging to customers or external providers
8.5.4Preservation
8.5.5Post-delivery activities
a)
b)
c)
d)
8.5.6Control of changes
8.6Release of products and services
8.7Control of nonconforming process outputs, products and services
a)
b)
c)
d)
9Performance evaluation9.1 Monitoring, measurement, analysis and evaluation9.1.1General
a)b)
c)d)
9.1.2Customer satisfaction
9.1.3Analysis and evaluation
a)
b)c)
d)
e)
f)
g)
9.2 Internal Audit9.2.1
a)
1)
2)
b)
9.2.2
a)
b)
c)
d)e)f)
ISO 19011
9.3Management review9.3.1
a)b)c)
1)
2)
3)
4)5)6)7)
d)6.1e)
9.3.2
a)
b)
10 Improvement10.1 General
a)b)c)
/10.2Nonconformity and corrective action10.2.1
a)1)2)
b)1)
2)3)
c)
d)
e)
1
2
10.2.2a)
b)
10.3 Continual improvement
A Annex Ainformative Clarification of new structure, terminology and concepts
A1 Structure and terminologyA2 Products and servicesA3 Context of the organizationA4 Risk-based approachA5 ApplicabilityA6 Documented informationA7 Organizational knowledgeA8 Control of externally provided products and servicesBAnnex BinformativeQuality Management PrinciplesB.21-QMP1 Customer FocusB.32-QMP2 LeadershipB.43-QMP3 Engagement of PeopleB.54-QMP4 Process ApproachB.65-QMP5 Improvement
B.76-QMP6 Evidence-based Decision MarkingB.87-QMP7 Relationship ManagementCAnnex CinformativeISO 10000 The ISO 10000portfolio of quality management standards_1489607890.vsd
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