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ISO 9001:2015
(CLAUSES)

REVISIONS HISTORY OF ISO 9000

STANDARD

Fourth revision named

as ISO 9001:2015

Third revision named as

ISO 9001:2008 2015

Second revision named 2008

as ISO 9001:2000

First revision named 2000

as ISO 9001:1994

Originally released 1994

as ISO 9001:1987

1987 ISO 9000 is revised after five-eight years

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THE STRUCTURE OF ISO

9001:2015

Comprises 10 clauses:
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organisation
5. Leadership
6. Planning for the QMS
7. Support
8. Operation
9. Performance evaluation
10. Improvement

ISO 9001:2015 - SCOPE

The requirements are:

for those who need to:
 demonstrate ability to provide consistently product that
meets customer and regulatory requirements
 enhance customer satisfaction and continual improvement

applicable to all organisations

generic

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APPLICATION

No exclusions

Applicability will depend on
 size
 the management model it adopts
 the range of activities
 the nature of the risks and opportunities

Where a requirement can be applied, the organisation cannot decide that it is
not applicable

Where a requirement cannot be applied the non-applicability cannot result in
failure to achieve conformity of products and services or to enhance customer
satisfaction

ISO 9001:2015; CLAUSE 4

4
Context of the
organization

4.2
4.1
Understanding the 4.3 4.4
Understanding the
needs and Determining the QMS and its
organization and
expectation of scope of the QMS processes
its context
interested parties

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ISO 9001:2015; CLAUSE 5

5 Leadership

5.2 Quality policy 5.3 Organizational

5.1 Leadership and roles,
commitment responsibilities
and authorities
5.1.1 General

5.1.2 Customer focus

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ISO 9001:2015; CLAUSE 6

6
Planning for the quality management
system

6.1 6.2
6.3
Actions to address risk Quality objectives and
Planning of changes
and opportunities planning to achieve them

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ISO 9001:2015 CLAUSE 7

7
Support

7.5
7.1 7.2 7.3 7.4
Resources Competence Awareness Communication Documented
information

ISO 9001:2015; CLAUSE 7

7: Support
7.1 Resources

7.1.1 General

7.1.2 People

7.1.3 Infrastructure

7.1.4 Environment for the operation of processes

7.1.5 Monitoring and measuring of resources

7.1.6 Organizational knowledge

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ISO 9001:2015;
CLAUSE 7.5

7.5
Documented information

7.5.3
7.5.1 7.5.2
Control of documented
General Creating and updating
information

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ISO 9001:2015; CLAUSE 8

8: Operation

8.1 Operational planning and control

8.2 Determination of requirements for products and services

8.3 Design and development of products and services

8.4 Control of externally provided products and services

8.5 Product and service provision

8.6 Release of products and services

8.7 Control of nonconforming outputs

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ISO 9001:2015; CLAUSE 8

8.2 Determination of requirements for

products and services

8.2.2 Determination 8.2.3 Review of

8.2.1 Customer of requirements requirements
communication related to products related to products
and services and services

8.2.4 - Changes to requirements for products and

services

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ISO 9001:2015;
CLAUSE 8.3

8: Operation
8.3 Design and development of products and services

8.3.1 General

8.3.2 Design and development planning

8.3.3 Design and development inputs

8.3.4 Design and development controls

8.3.5 Design and development outputs

8.3.6 Design and development changes

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ISO 9001:2015; CLAUSE 8

8.4 Control of externally provided

products and services

8.4.2 Type and 8.4.3 Information

8.4.1 General extent of control for external
of external providers
providers

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ISO 9001:2015
CLAUSE 8.5

8: Operation
8.5 Production and service provision

8.5.1 Control of production and service provision

8.5.2 Identification and traceability

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

8.5.5 Post-delivery activities

8.5.6 Control of changes

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ISO 9001:2015; CLAUSE 9

9 Performance evaluation

9.1 Monitoring, 9.2 Internal audit

measurement, 9.3 Management
analysis and review
evaluation
9.1.1 General

9.1.2 Customer satisfaction

9.1.3 Analysis and evaluation

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ISO 9001:2015;
CLAUSE 10

10 Improvement

10.2 10.3
10.1
Nonconformity and Continual
General
corrective action improvement

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KEY FOR ISO 9001:2008 TO

ISO 9001:2015

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KEY FOR ISO 9001:2008 TO

ISO 9001:2015

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KEY FOR ISO 9001:2008 TO

ISO 9001:2015

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KEY FOR ISO 9001:2008 TO

ISO 9001:2015

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KEY FOR ISO 9001:2008 TO

ISO 9001:2015

8 – Operation
8.1 Operational planning and
control
8.2 Determination of requirements
for products and services
8.3 Design and development of
products and services
8.4 Control of externally provided
products and services
8.5 Production and service
provision
See 7.1.5

8.6 Release of products and

services
8.7 Control of nonconforming process
outputs, products and services
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KEY FOR ISO 9001:2008 TO

ISO 9001:2015

See 8.7
See 9.1

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