5

-

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)

12

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

1

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

5

6

8

7

9

4.4