You are on page 1of 36

-

Quality Management Systems-Requirements

ISO 90012015 DIS

Introduction.....................................................................................................1
0.1 General..............................................................................................1
0.2 ISO The ISO standards for Quality Management...........1
0.3 Process approach......................................................................1
0.4 --- Plan-Do-Check-Act Cycle.................................1
0.5 Risk-based thinking........................................................1
0.6 Compatibility with other management
system.............................................................................................................1
1 Scope...........................................................................................................2
2 Normative references...........................................................................2
3 Terms and definitions........................................................................2
4 Context of the organization..................................................................6
4.1 Understanding the organization and its context..........6
4.2 Understanding the need and expectations
of interested parties.........................................................................................6
4.3 Determining the scope of the quality
management system.......................................................................................6
4.4 Quality management system and its process......7
5 Leadership...................................................................................................8
5.1 Leadership and commitment..................................................8
5.1.1 Leadership and commitment for the
quality management system....................................................................8
5.1.2 Customer focus................................................................8
5.2 Quality Policy..............................................................................9
5.2.1 ..............9
5.2.2 ...................................................................................9
5.3 Organizational roles, responsibilities and
authorities........................................................................................................9
6 Planning for the quality management system..................10
6.1 Action to address risks and opportunities...........10
6.1.1 4.1 4.2
...........................................10
6.1.2 .................................................................................10
6.2 Quality objectives and planning to achieve them...10
6.2.1 .......................10
6.2.2 ..................................11
6.3 Planning of changes.................................................................11
7 Support.......................................................................................................12

7.1 Resources........................................................................................12
7.1.1 General..................................................................................12
7.1.2 People....................................................................................12
7.1.3 Infrastructure..................................................................12
7.1.4 Environment for the operation of processes...........12
7.1.5 Monitoring and measuring resources..................13
7.1.6 Organizational knowledge..............................................13
7.2 Competence.....................................................................................14
7.3 Awareness.......................................................................................14
7.4 Communication................................................................................14
7.5 Documented information.......................................................15
7.5.1 General..................................................................................15
7.5.2 Creating and updating................................................15
7.5.3 Control of documented information.................15
7.5.3.1
................................................................................................................15
7.5.3.2 .........15
8 Operation...................................................................................................17
8.1 Operational planning and control..................................17
8.2 Determination of requirements for products and
services..........................................................................................................17
8.2.1 Customer communication..............................................17
8.2.2 Determination of requirements related
to products and services........................................................................17
8.2.3 Review of requirements related to
products and services............................................................................18
8.3 Design and development of products and
services..........................................................................................................18
8.3.1 General..................................................................................18
8.3.2 Design and development planning.........................19
8.3.3 Design and development inputs.............................19
8.3.4 Design and development controls..........................19
8.3.5 Design and development outputs...........................20
8.3.6 Design and development changes.........................20
8.4 Control of externally provided products and
services..........................................................................................................20
8.4.1 General..................................................................................20
8.4.2 Type and extent of control of external
provision.................................................................................................21
8.4.3 Information for external providers.......................21
8.5 Production and service provision...............................22
8.5.1 Control of production and service provision
................................................................................................................22
8.5.2 Identification and traceability......................................22
8.5.3 Property belonging to customers or

external providers...................................................................................23
8.5.4 Preservation..........................................................................23
8.5.5 Post-delivery activities................................................23
8.5.6 Control of changes.....................................................23
8.6 Release of products and services..............................23
8.7 Control of nonconforming process
outputs, products and services......................................................................24
9 Performance evaluation......................................................................25
9.1 Monitoring, measurement, analysis and
evaluation......................................................................................................25
9.1.1 General..................................................................................25
9.1.2 Customer satisfaction.................................................25
9.1.3 Analysis and evaluation..............................................25
9.2 Internal Audit............................................................................26
9.2.1 . 26
9.2.2 ........................................................................................26
9.3 Management review.................................................................27
9.3.1
........................................................................27
9.3.2 ..................................27
10 Improvement............................................................................................28
10.1 General..........................................................................................28
10.2 Nonconformity and corrective action................28
10.2.1 ..................................................28
10.2.2 ...........................................29
10.3 Continual improvement..........................................................29
A Annex Ainformative......................................................30
A1 Structure and terminology.....................................................30
A2 Products and services...........................................................30
A3 Context of the organization.......................................................30
A4 Risk-based approach.................................................30
A5 Applicability...................................................................................30
A6 Documented information.......................................................30
A7 Organizational knowledge........................................................30
A8 Control of externally provided products and
services..........................................................................................................30
BAnnex Binformative.......................................................31
B.2 1- QMP1 Customer Focus..................................31
B.3 2- QMP2 Leadership..................................................31
B.4 3- QMP3 Engagement of People.......................31
B.5 4- QMP4 Process Approach...............................31
B.6 5- QMP5 Improvement..............................................31

B.7 6- QMP6 Evidence-based Decision


Marking..........................................................................................................31
B.8 7- QMP7 Relationship Management..................31
CAnnex Cinformative.......................................................32

Introduction
0.1 General
0.2 ISO
Management

The ISO standards for Quality

0.3 Process approach

0.4 --- Plan-Do-Check-Act Cycle


0.5 Risk-based thinking
0.6 Compatibility with other
management system

-1-

1 Scope

a)

b)

2
2 Normative references
ISO
3 Terms and definitions
ISO 9000
3.01 organization
3.02 interested parties
3.03 requirement
3.04 management system
3.05 top management
3.06 effectiveness
3.07 policy
3.08 objective
3.09 risk
3.10 competence
3.11 documented information
3.12 process
3.13 performance
3.14 ()outsource(verb)
3.15 monitoring
3.16 measurement
-2-

3.17 audit
3.18 conformity
3.19 nonconformity
3.20 corrective action
3.21 continual improvement
3.22 correction
3.23 involvement
3.24 context of the organization
3.25 function
3.26 customer
3.27 / supplier / provider
3.28 improvement
3.29 management
3.30 quality management
3.31 system
3.32 infrastructure
3.33 quality management system
3.34 quality policy
3.35 strategy
3.36 object
3.37 quality
3.38 statutory requirement
3.39 regulatory requirement
3.40 defect
3.41 traceability
3.42 innovation
3.43 contract
3.44 design and development
3.45 quality objective
3.46 output
-3-

3.47 product
3.48 service
3.49 data
3.50 information
3.51 objective evidence
3.52 information system
3.53 knowledge
3.54 verification
3.55 validation
3.56 feedback
3.57 customer satisfaction
3.58 complaint
3.59 audit programme
3.60 audit criteria
3.61 / objective / audit evidence
3.62 audit findings
3.63 concession
3.64 release
3.65 characteristic
3.66 performance indicator
3.67 determination
3.68 review
3.69 measuring equipment

-4-

4 Context of the organization


4.1 Understanding the organization and its
context

4.2 Understanding the need and


expectations of interested parties

a)
b)

4.3 Determining the scope of the quality


management system

a) 4.1
b) 4.2
c)

-5-

4.4 Quality management system and its


process

a)
b)
c)

d)
e)
f) 6.1

g)

h)

-6-

5 Leadership
5.1 Leadership and commitment
5.1.1 Leadership and commitment for
the quality management system

a)
b)

c)
d)
e)
f)
g)
h)
i)
j)
k)

5.1.2 Customer focus

a)
b)

-7-

c)

d)
5.2 Quality Policy
5.2.1
a)
b)
c)
d)
5.2.2
a)
b)
c)
5.3 Organizational roles, responsibilities
and authorities

a)
b)
c)

d)
e)

-8-

6 Planning for the quality management system


6.1 Action to address risks and opportunities
6.1.1 4.1 4.2

a)
b)
c)
6.1.2
a)
b)
1) 4.4)
2)

6.2 Quality objectives and planning to achieve


them
6.2.1

a)
b)
c)
d)
e)
f)
g)

6.2.2
a)
-9-

b) 7.1
c)
d)
e)
6.3 Planning of changes
4.4

a)
b)
c)
d)

-10-

7 Support
7.1 Resources
7.1.1 General

a)
b)
7.1.2 People

7.1.3 Infrastructure

a)
b)
c)
d)
7.1.4 Environment for the operation of processes

-11-

7.1.5 Monitoring and measuring resources

a)
b)

7.1.6 Organizational knowledge

1
2

-12-

a)

b)

7.2 Competence

a)
b)
c)

d)

7.3 Awareness

a)
b)
c)

d)
7.4 Communication

a)
b)
c)
d)

-13-

7.5 Documented information


7.5.1 General

a)
b)

a)
b)
c)
7.5.2 Creating and updating

a)
b)
c
7.5.3 Control of documented information
7.5.3.1

a)
b)
7.5.3.2
a)
b)
c))
d)

-14-

-15-

8 Operation
8.1 Operational planning and control
4.4
6.1
a)
b)
c)
d)
e)

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

a)
b)
c)
d)
e)
8.2.2 Determination of requirements
related to products and services

a)()

b)
8.2.3 Review of requirements related
-16-

to products and services

a)
b)
c)
d)

8.3 Design and development of products and


services
8.3.1 General

1 8.5
2
8.3 8.5

-17-

8.3.2 Design and development planning

a)
b)
c)
d)
e)
f)
g)
8.3.3 Design and development inputs

a)

b)
c)
d)
e)
f)

8.3.4 Design and development controls

a)
b)
c)
d)
()
8.3.5 Design and development outputs

a)
b)
-18-

c)
d)

8.3.6 Design and development changes

8.4 Control of externally provided


products and services
8.4.1 General

a)
b)
c)

-19-

8.4.2 Type and extent of control of


external provision

a)

b)

a) b)

8.4.3 Information for external providers

a)
b)
c)
d)
e)
f)

-20-

8.5 Production and service provision


8.5.1 Control of production and service
provision

a)
b)
c)

d)
e)
f)
g)

h)
8.5.2 Identification and traceability

-21-

8.5.3 Property belonging to customers or


external providers

8.5.4 Preservation

8.5.5 Post-delivery activities

a)
b)
c)
d)

8.5.6 Control of changes

-22-

8.6 Release of products and services

8.7 Control of nonconforming


process outputs, products and services

a)
b)
c)
d)

-23-

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

a)
b)
c)
d)

9.1.2 Customer satisfaction

9.1.3 Analysis and evaluation

a)
b)
c)
d)
e)
f)
g)

-24-

9.2 Internal Audit


9.2.1

a)
1)
2)
b)
9.2.2
a)

b)
c)
d)
e)
f)
ISO 19011

-25-

9.3 Management review


9.3.1

a)
b)
c)
1)
2)
3)
4)
5)
6)
7)
d) 6.1
e)
9.3.2
a)
b)

-26-

10 Improvement
10.1 General

a)
b)
c)

/
10.2 Nonconformity and corrective action
10.2.1
a)
1)
2)
b)

1)
2)
3)
c)
d)
e)

1
2
10.2.2
a)
b)
10.3 Continual improvement
-27-

-28-

A Annex Ainformative
Clarification of new structure, terminology
and concepts
A1 Structure and terminology
A2 Products and services
A3 Context of the organization
A4 Risk-based approach
A5 Applicability
A6 Documented information
A7 Organizational knowledge
A8 Control of externally provided
products and services

-29-

BAnnex Binformative
Quality Management Principles
B.2 1- QMP1 Customer Focus
B.3 2- QMP2 Leadership
B.4 3- QMP3 Engagement of People
B.5 4- QMP4 Process Approach
B.6 5- QMP5 Improvement
B.7 6- QMP6 Evidence-based
Decision Marking
B.8 7- QMP7 Relationship Management

-30-

CAnnex Cinformative
ISO 10000 The ISO 10000portfolio of quality
management standards

-31-