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ISO 9001:2008 to

ISO 9001:2015
Summary of Changes

ISO/TC 176/SC 2/N1267


1

Purpose of presentation

ISO/TC 176/SC 2/ N1267

The intention of this presentation is to:


 Provide a summary of notable changes
from ISO 9001:2008 to ISO 9001:2015

2
Date:

Key perspectives
ISO 9001 needs to change, to:
 adapt to a changing world
 reflect the increasingly complex environments in which
organizations operate

ISO/TC 176/SC 2/ N1267

 provide a consistent foundation for the future


 reflect the increasingly complex environments in which
organizations operate
 ensure the new standard reflects the needs of all relevant
interested parties
 Ensure alignment with other management system
standards

3
Date:

ISO/TC 176/SC 2/ N1267

Key feature changes


 10-clause structure and core text for all Management System
Standards (MSS)
 More compatible with services and non-manufacturing users
 Clearer understanding of the organizations context is required
one size doesnt fit all
 Process approach strengthened/more explicit
 Concept of preventive action now addressed throughout the
standard by risk identification and mitigation
 The term documented information replaces the terms document
and record
 Control of externally provided products and services replaces
purchasing/outsourcing
 Increased emphasis on seeking opportunities for improvement
4
Date:

Beneficial changes
to 9001
 Enhanced leadership involvement in the
management system
 Risk-based thinking

ISO/TC 176/SC 2/ N1267

 Simplified language, common structure and


terms
 Aligning QMS policy and objectives with the
strategy of the organization

5
Date:

ISO/TC 176/SC 2/ N1267

Potential benefits
to the user
 Focus on achieving planned results
 Flexibility for documented information
 Improved risk control
 Better process control leading to improved
results
 Improved customer satisfaction
 Customer retention and loyalty
 Improved image and reputation
 Greater credibility
6
Date:

Key benefits of the


common clause structure
A new common format has been developed
 All ISO management systems standards will look
the same with the same structure (some deviations)

ISO/TC 176/SC 2/ N1267

 More efficient to address multiple management


system requirements
 Provides the option of integrating management
systems
 Standardized core definitions
7
Date:

Structure of ISO 9001:2015


(1/3)

ISO/TC 176/SC 2/ N1267

1 Scope 2 Normative references 3 Terms and definitions


4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested
parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
8
Date:

ISO/TC 176/SC 2/ N1267

Structure of ISO 9001:2015


(2/3)
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and
services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
9
Date:

Structure of ISO 9001:2015


(3/3)
9 Performance evaluation
9.1 Monitoring, measurement, analysis and
evaluation
9.2 Internal audit
9.3 Management review

ISO/TC 176/SC 2/ N1267

10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

10
Date: 10

The common structure and ISO 9001:2015 additions


4 Context of
organization

5 Leadership

6 Planning

7 Support

8 Operation

9 Performance
Evaluation

4.1
Understanding
context

5.1
Leadership and
commitment

6.1
Risks and
opportunities

7.1
Resources

8.1
Operational
planning and
control

9.1 Monitoring,
measurement,
analysis and
evaluation

4.2
Interested
parties

5.2
Policy

6.2
Planning

4.3
Scope

5.3
Organizational
roles,
responsibilities
and authorities

7.2
Competence

7.3
Awareness

10 Improvement

10.1
General

9.2
Internal audit

10.2
Nonconformity
and corrective
action

9.3
Management
review

10.3
Continual
improvement

7.4
Communication

4.4
QMS

ISO/TC 176/SC 2/ N1267

7.5
Documented
information

11
Date: 11

The common structure and ISO 9001:2015 additions


8 Operation

ISO/TC 176/SC 2/ N1267

8.1 Operational planning and


control

12
Date: 12

Plan
4
Context of
organization
4.1
Understanding
context
4.2
Interested parties

4.3
Scope

4.4
QMS

Check

Act
10
Improvement

5
Leadership

6
Planning

7
Support

8
Operation

9
Performance
and Evaluation

5.1
Leadership and
commitment

6.1
Actions to
address risks and
opportunities

7.1
Resources

8.1
Operational
planning and
control

9.1
Monitoring,
measurement,
analysis and
evaluation

5.2
Policy
5.3
Organizational
roles,
responsibilities
and authorities

7.1.2
People

See next slide

6.2
Quality objectives
and planning

7.1.3
Infrastructure

9.1.2
Customer
satisfaction

6.3
Planning of
changes

7.1.4
Environment for the
operation of
processes

9.1.3
Analysis and
evaluation

7.1.5
Monitoring and
measuring
resources

ISO/TC 176/SC 2/ N1267

Do

7.1.6
Organizational
knowledge

10.1
General

10.2
Nonconformity
and corrective
action

10.3
Continual
improvement

9.2
Internal audit
9.3
Management
review

7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented
information

13
Date: 13

4
Context of
organization
4.1
Understanding
context

Clause 4.1
Determine what the relevant external and internal issues
are for your organization, and that are relevant to its
strategic direction

4.2
Interested parties
4.3
Scope

ISO/TC 176/SC 2/ N1267

4.4
QMS

14
Date: 14

4
Context of
organization

Clause 4.2
Identify the relevant interested parties and their relevant
requirements

4.1
Understanding
context
4.2
Interested parties
4.3
Scope

ISO/TC 176/SC 2/ N1267

4.4
QMS

15
Date: 15

4
Context of
organization
4.1
Understanding
context
4.2
Interested parties
4.3
Scope
4.4
QMS

Clause 4.3 and 4.4


The requirement for the scope is now better defined, must
be documented and consider:
 external and internal issues
 requirements of relevant interested parties
 the products and services covered (must also be
stated in scope)
 allowing applicability of specific requirements

ISO/TC 176/SC 2/ N1267

 justification for any case where a requirement


cannot be applied (exclusion)

16
Date: 16

4
Context of
organization
4.1
Understanding
context
4.2
Interested parties

4.3
Scope

4.4
QMS

5
Leadership

6
Planning

7
Support

8
Operation

9
Performance
and Evaluation

5.1
Leadership and
commitment

6.1
Actions to
address risks and
opportunities

7.1
Resources

8.1
Operational
planning and
control

9.1
Monitoring,
measurement,
analysis and
evaluation

5.2
Policy
5.3
Organizational
roles,
responsibilities
and authorities

7.1.2
People

See next slide

6.2
Objectives and
planning

7.1.3
Infrastructure

9.1.2
Customer
satisfaction

6.3
Planning of
changes

7.1.4
Environment for the
operation of
processes

9.1.3
Analysis and
evaluation

ISO/TC 176/SC 2/ N1267

7.1.5
Monitoring and
measuring
resources
7.1.6
Organizational
knowledge

10
Improvement

10.1
General

10.2
Nonconformity
and corrective
action

10.3
Continual
improvement

9.2
Internal audit
9.3
Management
review

7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented
information

17
Date: 17

5
Leadership

5.1
Leadership and
commitment
5.2
Policy

ISO/TC 176/SC 2/ N1267

5.3
Organizational roles,
responsibilities and
authorities

Clause 5.1.1
Leadership is required to ensure:
 take accountability for the effectiveness of the quality
management system
 ensure the quality policy and quality objectives are compatible
with the context and strategic direction of the organization
 ensure the integration of the QMS requirements into the
organizations business processes
 promote the use of the process approach and risk-based
thinking
 ensure that the QMS achieves its intended results
 engage, direct and support persons to contribute to the
effectiveness of the QMS
 supporting relevant management roles
 promotion of improvement
Clause 5.1.2
Top management needs to ensure customer satisfaction through:
 customer and applicable statutory and regulatory
requirements being determined and met
 risk and opportunities are being addressed
 the focus on products and services meeting customers and
other requirements
18
Date:

18

5
Leadership

Clause 5.2
Explicit requirement to apply the policy

5.1
Leadership and
commitment
5.2
Policy

ISO/TC 176/SC 2/ N1267

5.3
Organizational roles,
responsibilities and
authorities

19
Date: 19

5
Leadership

5.1
Leadership and
commitment
5.2
Policy

ISO/TC 176/SC 2/ N1267

5.3
Organizational roles,
responsibilities and
authorities

Clause 5.2
 Explicit requirement to apply the policy
Clause 5.3
 Explicit requirement for relevant roles to be assigned,
communicated and understood
 No requirement for a specific management
representative and the responsibility now resides with
top management to assign and manage
 Requirement for defining responsibility and authority
for ensuring processes are delivering their intended
outputs

20
Date: 20

4
Context of
organization
4.1
Understanding
context
4.2
Interested parties

4.3
Scope

4.4
QMS

5
Leadership

6
Planning

7
Support

8
Operation

9
Performance
and Evaluation

5.1
Leadership and
commitment

6.1
Actions to
address risks and
opportunities

7.1
Resources

8.1
Operational
planning and
control

9.1
Monitoring,
measurement,
analysis and
evaluation

5.2
Policy
5.3
Organizational
roles,
responsibilities
and authorities

7.1.2
People

See next slide

6.2
Quality objectives
and planning

7.1.3
Infrastructure

9.1.2
Customer
satisfaction

6.3
Planning of
changes

7.1.4
Environment for the
operation of
processes

9.1.3
Analysis and
evaluation

ISO/TC 176/SC 2/ N1267

7.1.5
Monitoring and
measuring
resources
7.1.6
Organizational
knowledge

10
Improvement

10.1
General

10.2
Nonconformity
and corrective
action

10.3
Continual
improvement

9.2
Internal audit
9.3
Management
review

7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented
information

21
Date: 21

6
Planning

6.1
Actions to address risks
and opportunities

6.2
Objectives and planning

Clause 6.1
 Considering the issues raised and relevant interested
parties requirements identified (4.1 and 4.2), this clause
requires the determination of risks and opportunities
which need to be addressed, actions to be taken and
evaluation of the effectiveness of these actions

ISO/TC 176/SC 2/ N1267

6.3
Planning of changes

22
Date: 22

6
Planning

Clause 6.2
Objectives should be:

6.1
Actions to address risks
and opportunities

6.2
Objectives and planning

 established for processes relevant to the QMS


 in line with customer requirements
 in line with products and services conformity

ISO/TC 176/SC 2/ N1267

6.3
Planning of changes

 monitored, communicated & updated

23
Date: 23

6
Planning

6.1
Actions to address risk
and opportunity

6.2
Objectives and planning

6.3
Planning of changes

Clause 6.3
Changes to the QMS should be carried out in a planned
manner
The standard has evolved to enable organizations to
adapt to changing environments or circumstances
Note: It is important to know that change is addressed in
the following clauses:
 Clause 6.3 - Planning/implementing changes to the
QMS

ISO/TC 176/SC 2/ N1267

 Clause 7.1.6 - Organizational knowledge - for addressing


changing needs and trends, with respect to knowledge
 Clause 8.1 - Controlling operational changes, planned
and unintentional
 Clause 8.5.6 - Addressing changes affecting products &
services

24
Date: 24

4
Context of
organization
4.1
Understanding
context
4.2
Interested parties

4.3
Scope

4.4
QMS

5
Leadership

6
Planning

7
Support

8
Operation

9
Performance
and Evaluation

5.1
Leadership and
commitment

6.1
Actions to
address risks and
opportunities

7.1
Resources

8.1
Operational
planning and
control

9.1
Monitoring,
measurement,
analysis and
evaluation

5.2
Policy
5.3
Organizational
roles,
responsibilities
and authorities

7.1.2
People

See next slide

6.2
Objectives and
planning

7.1.3
Infrastructure

9.1.2
Customer
satisfaction

6.3
Planning of
changes

7.1.4
Environment for the
operation of
processes

9.1.3
Analysis and
evaluation

ISO/TC 176/SC 2/ N1267

7.1.5
Monitoring and
measuring
resources
7.1.6
Organizational
knowledge

10
Improvement

10.1
General

10.2
Nonconformity
and corrective
action

10.3
Continual
improvement

9.2
Internal audit
9.3
Management
review

7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented
information

25
Date: 25

7
Support
7.1
Resources
7.1.2
People
7.1.3
Infrastructure

Clause 7.1
There should be adequate resources to ensure
effectiveness of the QMS. Resource considerations now
include:
 internal resources
 external providers

7.1.4
Environment for the
operation of processes

ISO/TC 176/SC 2/ N1267

7.1.5
Monitoring and
measuring resources

7.1.6
Organizational
knowledge

 people
 monitoring and measuring resources
 organizational knowledge required to ensure the
processes provide conforming products and services
 external communication

7.2
Competence
7.3
Awareness
7.4
Communication

7.5
Documented information
26
Date: 26

7
Support
7.1
Resources
7.1.2
People

Clause 7.3 and 7.4


Relevant persons doing work under the organizations
control need to have awareness and communication
(internal and external) of the QMS and benefits of improving
performance

7.1.3
Infrastructure

7.1.4
Environment for the
operation of processes

ISO/TC 176/SC 2/ N1267

7.1.5
Monitoring and
measuring resources

7.1.6
Organizational
knowledge
7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented
information
27
Date: 27

7
Support
7.1
Resources
7.1.2
People

Clause 7.5.1
Requirements that used to be required for a quality
manual have been enhanced and made more flexible to
allow for the use of documented information needed for
the quality management system

7.1.3
Infrastructure

7.1.4
Environment for
operation of processes

ISO/TC 176/SC 2/ N1267

7.1.5
Monitoring and
measuring resources

Clause 7.5.2
Enhanced requirement for the creation and updating of
documented information, e.g. description, format &
suitability

7.1.6
Organizational
knowledge
7.2
Competence
7.3
Awareness

Clause 7.5.3
Control of documented information now explicitly
includes confidentiality, integrity and access

7.4
Communication

7.5
Documented information
28
Date: 28

4
Context of
organization
4.1
Understanding
context
4.2
Interested parties

4.3
Scope

4.4
QMS

5
Leadership

6
Planning

7
Support

8
Operation

9
Performance
and Evaluation

5.1
Leadership and
commitment

6.1
Actions to
address risks and
opportunities

7.1
Resources

8.1
Operational
planning and
control

9.1
Monitoring,
measurement,
analysis and
evaluation

5.2
Policy
5.3
Organizational
roles,
responsibilities
and authorities

7.1.2
People

See next slide

6.2
Objectives and
planning

7.1.3
Infrastructure

9.1.2
Customer
satisfaction

6.3
Planning of
changes

7.1.4
Environment for
operation of
processes

9.1.3
Analysis and
evaluation

ISO/TC 176/SC 2/ N1267

7.1.5
Monitoring and
measuring
resources
7.1.6
Organizational
knowledge

10
Improvement

10.1
General

10.2
Nonconformity
and corrective
action

10.3
Continual
improvement

9.2
Internal audit
9.3
Management
review

7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented
information

29
Date: 29

ISO/TC 176/SC 2/ N1267

4
Context of
organization

5
Leadership

6
Planning

7
Support

8
Operation

9
Performance and
Evaluation

8.1 Operational planning


and control

8.3 Design and


development of
products and services

8.4 Control of externally


provided processes,
products and services

8.5 Production and


service provision

8.2 Requirements for


products and services

8.3.1 General

8.4.1 General

8.5.1 Control of
production and service
provision

8.2.1 Customer
communication

8.3.2 Design and


development planning

8.4.2 Type and extent of


control

8.5.2 Identification and


traceability

8.2.2 Determination of
requirements related to
products and services

8.3.3 Design and


development Inputs

8.4.3 Information for


external providers

8.5.3 Property
belonging to customers
or external providers

8.2.3 Review of
requirements related to
products and services

8.3.4 Design and


development controls

8.2.4 Changes to
requirements for products
and services

8.3.5 Design and


development outputs

8.3.6 Design and


development changes

10
Improvement

8.6 Release of products and


services

8.7 Control of
nonconforming process
outputs

8.5.4 Preservation

8.5.5 Post-delivery
activities
8.5.6 Control of
changes

30
Date: 30

8 Operation

Clause 8.1.b
 explicit requirement for establishing criteria for
processes

8.1 Operational planning


and control

8.2 Requirements for


products and services

8.2.1 Customer
communication

ISO/TC 176/SC 2/ N1267

8.2.2 Determination of
requirements related to
products and services
8.2.3 Review of
requirements related to
products and services

Clause 8.2.1
 explicit considerations are now linked to: customer
communications; customer property, and contingency
actions
Clause 8.2.2
 Determination of requirements; this requires a process
and is explicit with regard to substantiating claims for
products and services being offered

8.2.4 Changes to
requirements for
products and services

31
Date: 31

8 Operation

Clause 8.3
This section on design and development of products and
services has substantively changed and simplified:

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

ISO/TC 176/SC 2/ N1267

8.3.4 Design and


development controls

8.3.5 Design and


development outputs

8.3.6 Design and


development changes

Clause 8.3.2
 Design and development has been restructured to allow
for a more process orientated approach
 Involvement of customers and users as part of design
planning to be considered
Clause 8.3.3
 Design and development inputs explicit requirements
for internal and external resource needs, potential
consequences of failure, level of control expected by
customers
Clause 8.3.4
 Design and development controls new clause
combining Reviews, Verification & Validation
32
Date: 32

8 Operation

8.4 Control of externally


provided processes
products and services

Clause 8.4
 The terms which previously referred to purchasing and
outsourcing is now Control of externally provided
processes, products and services
Clause 8.4.1

8.4.1 General

8.4.2 Type and extent of


control

8.4.3 Information for


external providers

 Conditions are applied when controls are required for


externally provided processes, products and service
 Terminology has changed from supplier to external
provider

ISO/TC 176/SC 2/ N1267

Clause 8.4.2
 Type and extent of control of external provision
previous notes in 4.1 (ISO 9001:2008) now turned into
requirements
Clause 8.4.3
 Information for external providers are now more
detailed and explicit
33
Date: 33

8 Operation

Clause 8.5.1
This clause specifically considers:

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

ISO/TC 176/SC 2/ N1267

8.5.4 Preservation

 monitoring and measurement activities will ensure the


control of processes and output (clauses 8.2.3 and
8.2.4 of ISO 9001:2008 have been moved to 8.5.1)
 acceptance criteria for products and services are met
 the use, and control of suitable infrastructure and
process environment
 suitable monitoring and measuring resources
 Requires competent persons

8.5.5 Post-delivery
activities
8.5.6 Control of
changes

34
Date: 34

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

ISO/TC 176/SC 2/ N1267

8.5.4 Preservation

8.5.5 Post-delivery
activities
8.5.6 Control of
changes

Clause 8.5.2
 The identification and traceability now focus on
outputs rather than on product (includes intermediate
products and services) rather than on product
Clause 8.5.3
 Customer property has been expanded to include
external providers property
Clause 8.5.4
 Preservation of product has been changed to
preservation of the output
Clause 8.5.5
 Post-delivery activities is a new clause
Clause 8.5.6
 A new requirement for the control of changes is
addressed in the slide introducing the concept of
change
35
Date: 35

8 Operation

Clause 8.6
 The release of products and services is now part of the
operational requirements

8.6 Release of products


and services

8.7 Control of
nonconforming outputs

Clause 8.7
 The control of nonconforming output is more explicit; it
now considers the options to apply correction and
corrective action

ISO/TC 176/SC 2/ N1267

 Nonconforming product changed to nonconforming


output

36
Date: 36

4
Context of
organization
4.1
Understanding
context
4.2
Interested parties

4.3
Scope

4.4
QMS

5
Leadership

6
Planning

7
Support

8
Operation

9
Performance
evaluation

5.1
Leadership and
commitment

6.1
Actions to
address risks and
opportunities

7.1
Resources

8.1
Operational
planning and
control

9.1
Monitoring,
measurement,
analysis and
evaluation

5.2
Policy
5.3
Organizational
roles,
responsibilities
and authorities

7.1.2
People

See next slide

6.2
Quality objectives
and planning

7.1.3
Infrastructure

9.1.2
Customer
satisfaction

6.3
Planning of
changes

7.1.4
Environment for the
operation of
processes

9.1.3
Analysis and
evaluation

ISO/TC 176/SC 2/ N1267

7.1.5
Monitoring and
measuring
resources
7.1.6
Organizational
knowledge

10
Improvement

10.1
General

10.2
Nonconformity
and corrective
action

10.3
Continual
improvement

9.2
Internal audit
9.3
Management
review

7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented
information

37
Date: 37

9
Performance
evaluation
9.1
Monitoring,
measurement, analysis
and evaluation

9.1.1
General

9.1.2
Customer satisfaction

ISO/TC 176/SC 2/ N1267

9.1.3
Analysis and evaluation

9.2
Internal audit

Clause 9.1.1
 In 8.1 ISO 9001:2008 (clause 8.1) there was a
requirement for planning. This is replaced with
identifying what needs monitoring and measuring, and
the methods to be used
Clause 9.1.3
 There are specific requirements for analysis and
evaluation when using results as inputs to
management review
 Effective implementation of planning and actions to
address risks and opportunities are new requirements
in this clause

9.3
Management review

38
Date: 38

9
Performance
Evaluation
9.1
Monitoring,
measurement, analysis
and evaluation

9.1.2
Customer satisfaction

9.1.3
Analysis and evaluation

ISO/TC 176/SC 2/ N1267

9.2
Internal audit

9.3
Management review

9.3.1
General

9.3 .2
Management review
input
9.3.3
Management review
output

Clause 9.2
 Internal audit program now has explicit considerations for:
quality objectives, customer feedback and changes impacting
the organization; management responsibility for action is now
implicit whereas previously this was explicit
 An auditor is now required to be impartial versus in the
previous version they could not audit their own work

Clause 9.3
 There are now additional requirements for management
review. These include:
 changes in external and internal issues (such as strategic
direction)
 performance concerning external providers
 adequacy of resources for effective QMS and effectiveness of
actions taken addressing risks & opportunities

Clause 9.3.1
 Management reviews should be aligned to the strategic
direction of the organization

Clause 9.3.3
 Management review outputs have been enhanced to include
many of the new areas of focus
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Date: 39

4
Context of
organization
4.1
Understanding
context
4.2
Interested parties

4.3
Scope

4.4
QMS

5
Leadership

6
Planning

7
Support

8
Operation

9
Performance
Evaluation

5.1
Leadership and
commitment

6.1
Actions to
address risks and
opportunities

7.1
Resources

8.1
Operational
planning and
control

9.1
Monitoring,
measurement,
analysis and
evaluation

See next slide

10.2
Nonconformity
and corrective
action

10.3
Continual
improvement

5.2
Policy
5.3
Organizational
roles,
responsibilities
and authorities

7.1.2
People

6.2
Objectives and
planning

7.1.3
Infrastructure

9.1.2
Customer
satisfaction

6.3
Planning of
changes

7.1.4
Environment for the
operation of
processes

9.1.3
Analysis and
evaluation

ISO/TC 176/SC 2/ N1267

7.1.5
Monitoring and
measuring
resources
7.1.6
Organizational
knowledge

10
Improvement

10.1 General

9.2
Internal audit
9.3
Management
review

7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented
information

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Date: 40

10
Improvement

10.1
General

10.2 Nonconformity and


corrective action

ISO/TC 176/SC 2/ N1267

10.3
Continual improvement

Clause 10.1
 This clause is new, it addresses more comprehensive
opportunities for improvement; not only continual improvement
 Addresses improvement of products and services and future
needs and expectations
 Emphasis is now on improving processes to prevent
nonconformities and improving products and services
Clause 10.2
 The nonconformity referred to in this clause concerns the entire
QMS and not specifically the products or services which are
addressed under clause 8.7
Clause 10.2.1
 New emphasis is placed on nonconformity and corrective action
 Consequences are now included thus actions taken now
recognize the potential occurrence of a similar nonconformity
elsewhere
 Risks and opportunities now need to be updated when required
following a nonconformity
Clause 10.2.2
 Documented information is now required on the nature of the
nonconformity and subsequent actions taken
Clause 10.3
 Opportunities shall be addressed as part of continual
improvement
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Date: 41

Summary
 Determining the organizational context enables a more effective
implementation of the quality management system
 Greater emphasis on processes being managed to achieve
planned results
 Alignment with strategic direction
 Integration of the QMS into organizations business processes

ISO/TC 176/SC 2/ N1267

 Determining risks and opportunities increase the effectiveness


of the organizations QMS
 Change management has been expanded to add emphasis that
the QMS should be carried out in a planned manner
 The concept of organizational knowledge introduced to ensure
the organization acquires and maintains the necessary
knowledge
 Communication expanded to include external
42
Date: 42

ISO 9001:2015 Certification


Transition Timeline
2015

2016

2017

2018

ISO/TC 176/SC 2/ N1267

September 2015
Published International
Standard

September 2015 start of 3 years transition period


to September 2018
Certifications to ISO 9001:2008 will no longer be
valid after September 2018

43
Date: 43

More information

Further information is available at


ISO/TC 176/SC 2/ N1267

www.iso.org/tc176/sc02/public

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Date: 44