ISO 9001:2008 to

ISO 9001:2015
Summary of Changes

ISO/TC 176/SC 2/N1282

 Purpose of presentation

The intention of this presentation is to:

Provide a summary of notable changes
from ISO 9001:2008 to ISO 9001:2015
ISO/TC 176/SC 2/ N1282

2
Date:
 Key perspectives

ISO 9001 needs to change, to:

adapt to a changing world
reflect the increasingly complex environments in which
organizations operate
provide a consistent foundation for the future
reflect the increasingly complex environments in which
ISO/TC 176/SC 2/ N1282

organizations operate
ensure the new standard reflects the needs of all relevant
interested parties
Ensure alignment with other management system
standards 3
Date:
 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
ISO/TC 176/SC 2/ N1282

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
ISO 9001
Enhanced leadership involvement in the
management system
Risk-based thinking
Simplified language, common structure and
terms
ISO/TC 176/SC 2/ N1282

Aligning QMS policy and objectives with the

strategy of the organization

5
Date:
 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
ISO/TC 176/SC 2/ N1282

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)
More efficient to address multiple management
system requirements
ISO/TC 176/SC 2/ N1282

Provides the option of integrating management

systems
Standardized core definitions
7
Date:
 Structure of ISO 9001:2015
(1/3)
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
ISO/TC 176/SC 2/ N1282

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:
 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
ISO/TC 176/SC 2/ N1282

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
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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
10 Improvement
10.1 General
ISO/TC 176/SC 2/ N1282

10.2 Nonconformity and corrective action

10.3 Continual improvement

10
Date:
 The common structure and ISO 9001:2015 additions
4 Context of 9 Performance
5 Leadership 6 Planning 7 Support 8 Operation 10 Improvement
organization Evaluation

4.1 5.1 6.1 7.1 8.1

8.1 9.1
9.1 Monitoring,
Monitoring,
4.1 5.1 6.1 7.1 10.1
Understanding Leadership Operational measurement,
measurement, 10.1
Understanding Leadership and
and Risks
Risks and
and Resources
Resources Operational General
context commitment opportunities planning
planning and
and control
control analysis
analysis and
and General
context commitment opportunities
evaluation
evaluation

7.2
7.2
4.2
4.2 10.2
10.2
5.2 6.2
6.2 Competence
Competence 9.2
Interested
Interested 5.2 9.2 Nonconformity
Nonconformity
Policy Planning
Planning Internal
Internal audit and
parties
parties Policy audit and corrective
corrective
action
action
7.3
7.3
5.3 Awareness
Awareness
4.3
4.3 5.3 9.3
9.3 10.3
10.3
Scope Organizational
Organizational Management Continual
Scope Management Continual
roles,
roles, review improvement
review improvement
responsibilities
responsibilities
and
and authorities
authorities 7.4
7.4 Communication
Communication
4.4
4.4
QMS
QMS
7.5
7.5
Documented
Documented
information
information
ISO/TC 176/SC 2/ N1282

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Date:
 The common structure and ISO 9001:2015 additions

8 Operation

8.1
8.1 Operational
Operational planning
planning and
and
control
control
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 Plan Do Check Act
4 9
5 6 7 8 10
Context of Leadership Planning Support Operation Performance Improvement
organization and Evaluation

4.1 6.1 7.1 8.1 9.1 10.1

5.1
Understanding Actions to Resources Operational Monitoring, General
Leadership and planning and measurement,
context address risks and
commitment control analysis and
opportunities 7.1.2
4.2 evaluation 10.2
5.2 People
Interested parties Nonconformity
Policy 6.2 See next slide 9.1.2 and corrective
Quality objectives 7.1.3 Customer action
4.3 and planning Infrastructure satisfaction
5.3
Scope
Organizational 7.1.4 10.3
roles, 6.3 9.1.3
responsibilities Environment for the Continual
4.4 Planning of operation of Analysis and improvement
and authorities changes evaluation
QMS processes

7.1.5 9.2
Monitoring and Internal audit
measuring
resources
9.3
Management
ISO/TC 176/SC 2/ N1282

7.1.6
Organizational review
knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented 13
information Date:
 4 Clause 4.1
Context of
organization Determine what the relevant external and internal issues
are for your organization, and that are relevant to its
4.1
Understanding strategic direction
context

4.2
Interested parties

4.3
Scope

4.4
QMS
ISO/TC 176/SC 2/ N1282

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Date:
 4 Clause 4.2
Context of
organization Identify the relevant interested parties and their relevant
requirements
4.1
Understanding
context

4.2
Interested parties

4.3
Scope

4.4
QMS
ISO/TC 176/SC 2/ N1282

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Date:
 4 Clause 4.3 and 4.4
Context of
organization
The requirement for the scope is now better defined, must
4.1
Understanding
be documented and consider:
context
external and internal issues
4.2
Interested parties requirements of relevant interested parties
4.3 the products and services covered (must also be
Scope
stated in scope)
4.4
QMS allowing applicability of specific requirements
justification for any case where a requirement
cannot be applied (exclusion)
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 4 9
5 6 7 8 10
Context of Leadership Planning Support Operation Performance Improvement
organization and Evaluation

4.1 6.1 7.1 8.1 9.1 10.1

5.1
Understanding Actions to Resources Operational Monitoring, General
Leadership and planning and measurement,
context address risks and
commitment control analysis and
opportunities 7.1.2
4.2 evaluation 10.2
5.2 People
Interested parties Nonconformity
Policy 6.2 See next slide 9.1.2 and corrective
Objectives and 7.1.3 Customer action
4.3 planning Infrastructure satisfaction
Scope 5.3
Organizational 7.1.4 10.3
roles, 6.3 9.1.3
responsibilities Environment for the Continual
4.4 Planning of operation of Analysis and improvement
QMS and authorities changes evaluation
processes

7.1.5 9.2
Monitoring and Internal audit
measuring
resources
9.3
Management
ISO/TC 176/SC 2/ N1282

7.1.6
Organizational review
knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented 17
information Date:
 5 Clause 5.1.1
Leadership
Leadership is required to ensure:
take accountability for the effectiveness of the quality
5.1 management system
Leadership and
commitment ensure the quality policy and quality objectives are compatible
5.2 with the context and strategic direction of the organization
Policy
ensure the integration of the QMS requirements into the
5.3 organizations business processes
Organizational roles,
responsibilities and promote the use of the process approach and risk-based
authorities
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
ISO/TC 176/SC 2/ N1282

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:
 5 Clause 5.2
Leadership
Explicit requirement to apply the policy
5.1
Leadership and
commitment

5.2
Policy

5.3
Organizational roles,
responsibilities and
authorities
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Date:
 5 Clause 5.2
Leadership
Explicit requirement to apply the policy
5.1
Leadership and
commitment Clause 5.3
5.2
Policy Explicit requirement for relevant roles to be assigned,
5.3 communicated and understood
Organizational roles,
responsibilities and
authorities
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
ISO/TC 176/SC 2/ N1282

outputs

20
Date:
 4 9
5 6 7 8 10
Context of Leadership Planning Support Operation Performance Improvement
organization and Evaluation

4.1 6.1 7.1 8.1 9.1 10.1

5.1
Understanding Actions to Resources Operational Monitoring, General
Leadership and planning and measurement,
context address risks and
commitment control analysis and
opportunities 7.1.2
4.2 evaluation 10.2
5.2 People
Interested parties Nonconformity
Policy 6.2 See next slide 9.1.2 and corrective
Quality objectives 7.1.3 Customer action
4.3 and planning Infrastructure satisfaction
5.3
Scope
Organizational 7.1.4 10.3
roles, 6.3 9.1.3
responsibilities Environment for the Continual
4.4 Planning of operation of Analysis and improvement
and authorities changes evaluation
QMS processes

7.1.5 9.2
Monitoring and Internal audit
measuring
resources
9.3
Management
ISO/TC 176/SC 2/ N1282

7.1.6
Organizational review
knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented 21
information Date:
 6 Clause 6.1
Planning
Considering the issues raised and relevant interested
6.1 parties requirements identified (4.1 and 4.2), this clause
Actions to address risks
and opportunities requires the determination of risks and opportunities
which need to be addressed, actions to be taken and
6.2
Objectives and planning
evaluation of the effectiveness of these actions

6.3
Planning of changes
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Date:
 6 Clause 6.2
Planning
Objectives should be:
6.1
Actions to address risks
established for processes relevant to the QMS
and opportunities
in line with customer requirements
6.2
Objectives and planning in line with products and services conformity
6.3
monitored, communicated & updated
Planning of changes
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Date:
 6 Clause 6.3
Planning
Changes to the QMS should be carried out in a planned
manner
6.1
Actions to address risk
and opportunity The standard has evolved to enable organizations to
adapt to changing environments or circumstances
6.2
Objectives and planning
Note: It is important to know that change is addressed in
6.3
the following clauses:
Planning of changes
Clause 6.3 - Planning/implementing changes to the
QMS
Clause 7.1.6 - Organizational knowledge - for addressing
changing needs and trends, with respect to knowledge
ISO/TC 176/SC 2/ N1282

Clause 8.1 - Controlling operational changes, planned

and unintentional
Clause 8.5.6 - Addressing changes affecting products &
services

24
Date:
 4 9
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Context of Leadership Planning Support Operation Performance Improvement
organization and Evaluation

4.1 6.1 7.1 8.1 9.1 10.1

5.1
Understanding Actions to Resources Operational Monitoring, General
Leadership and planning and measurement,
context address risks and
commitment control analysis and
opportunities 7.1.2
4.2 evaluation 10.2
5.2 People
Interested parties Nonconformity
Policy 6.2 See next slide 9.1.2 and corrective
Objectives and 7.1.3 Customer action
4.3 planning Infrastructure satisfaction
5.3
Scope
Organizational 7.1.4 10.3
roles, 6.3 9.1.3
responsibilities Environment for the Continual
4.4 Planning of operation of Analysis and improvement
and authorities changes evaluation
QMS processes

7.1.5 9.2
Monitoring and Internal audit
measuring
resources
9.3
Management
ISO/TC 176/SC 2/ N1282

7.1.6
Organizational review
knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented 25
information Date:
 7
Support Clause 7.1
7.1 There should be adequate resources to ensure
Resources
effectiveness of the QMS. Resource considerations now
7.1.2
People
include:
7.1.3
Infrastructure
internal resources
7.1.4 external providers
Environment for the
operation of processes
people
7.1.5
Monitoring and monitoring and measuring resources
measuring resources

7.1.6
organizational knowledge required to ensure the
Organizational
processes provide conforming products and services
ISO/TC 176/SC 2/ N1282

knowledge

7.2 external communication

Competence

7.3
Awareness

7.4
Communication

7.5 .
Documented
information
26
Date:
 7
Support Clause 7.3 and 7.4
7.1 Relevant persons doing work under the organizations
Resources
control need to have awareness and communication
7.1.2
People
(internal and external) of the QMS and benefits of improving
7.1.3 performance
Infrastructure

7.1.4
Environment for the
operation of processes

7.1.5
Monitoring and
measuring resources

7.1.6
Organizational
ISO/TC 176/SC 2/ N1282

knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented
information
27
Date:
 7
Support Clause 7.5.1
7.1 Requirements that used to be required for a quality
Resources
manual have been enhanced and made more flexible to
7.1.2
People allow for the use of documented information needed for
7.1.3 the quality management system
Infrastructure

7.1.4
Environment for
operation of processes
Clause 7.5.2
7.1.5
Monitoring and
Enhanced requirement for the creation and updating of
measuring resources
documented information, e.g. description, format &
7.1.6 suitability
Organizational
ISO/TC 176/SC 2/ N1282

knowledge

7.2
Competence
Clause 7.5.3
7.3
Awareness
Control of documented information now explicitly
7.4
Communication includes confidentiality, integrity and access
7.5
Documented information
28
Date:
 4 9
5 6 7 8 10
Context of Leadership Planning Support Operation Performance Improvement
organization and Evaluation

4.1 6.1 7.1 8.1 9.1 10.1

5.1
Understanding Actions to Resources Operational Monitoring, General
Leadership and planning and measurement,
context address risks and
commitment control analysis and
opportunities 7.1.2
4.2 evaluation 10.2
5.2 People
Interested parties Nonconformity
Policy 6.2 See next slide 9.1.2 and corrective
Objectives and 7.1.3 Customer action
4.3 planning Infrastructure satisfaction
5.3
Scope
Organizational 7.1.4 10.3
roles, 6.3 9.1.3
responsibilities Environment for Continual
4.4 Planning of operation of Analysis and improvement
and authorities changes evaluation
QMS processes

7.1.5 9.2
Monitoring and Internal audit
measuring
resources
9.3
Management
ISO/TC 176/SC 2/ N1282

7.1.6
Organizational review
knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented 29
information Date:
 4 9
5 6 7 8 10
Context of Leadership Planning Support Operation Performance and Improvement
organization Evaluation

8.1 Operational planning
and control
8.3 Design and 8.4 Control of externally 8.6 Release of products and
provided processes, 8.5 Production and
development of services
products and services service provision
products and services

8.5.1 Control of 8.7 Control of

8.2 Requirements for 8.3.1 General nonconforming process
8.4.1 General production and service
products and services outputs
provision

8.2.1 Customer 8.3.2 Design and 8.4.2 Type and extent of 8.5.2 Identification and
communication development planning control traceability

8.2.2 Determination of 8.3.3 Design and 8.4.3 Information for 8.5.3 Property
requirements related to development Inputs external providers belonging to
products and services customers or external
providers
ISO/TC 176/SC 2/ N1282

8.2.3 Review of 8.3.4 Design and

requirements related to development controls 8.5.4 Preservation
products and services

8.5.5 Post-delivery
8.2.4 Changes to 8.3.5 Design and activities
requirements for development outputs
products and services
8.5.6 Control of
8.3.6 Design and changes
development changes

30
Date:
 8 Operation
Clause 8.1.b
explicit requirement for establishing criteria for
processes
8.1 Operational planning
and control
Clause 8.2.1
8.2 Requirements for
products and services explicit considerations are now linked to: customer
communications; customer property, and contingency
8.2.1 Customer
communication actions
8.2.2 Determination of
requirements related to
Clause 8.2.2
products and services
Determination of requirements; this requires a process
8.2.3 Review of
requirements related to
products and services and is explicit with regard to substantiating claims for
ISO/TC 176/SC 2/ N1282

8.2.4 Changes to
products and services being offered
requirements for
products and services

31
Date:
 8 Operation
Clause 8.3
This section on design and development of products and
8.3 Design and
services has substantively changed and simplified:
development of
products and services
Clause 8.3.2
8.3.1 General
Design and development has been restructured to allow
8.3.2 Design and
for a more process orientated approach
development planning
Involvement of customers and users as part of design
8.3.3 Design and
development inputs
planning to be considered

8.3.4 Design and

Clause 8.3.3
development controls
Design and development inputs explicit requirements
ISO/TC 176/SC 2/ N1282

8.3.5 Design and

development outputs
for internal and external resource needs, potential
consequences of failure, level of control expected by
8.3.6 Design and
development changes customers
Clause 8.3.4
Design and development controls new clause
combining Reviews, Verification & Validation 32
Date:
 8 Operation
Clause 8.4
The terms which previously referred to purchasing and
8.4 Control of externally
outsourcing is now Control of externally provided
provided processes
products and services processes, products and services
8.4.1 General Clause 8.4.1
Conditions are applied when controls are required for
8.4.2 Type and extent of
control
externally provided processes, products and service
8.4.3 Information for
external providers
Terminology has changed from supplier to external
provider
Clause 8.4.2
ISO/TC 176/SC 2/ N1282

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:
 8 Operation
Clause 8.5.1
This clause specifically considers:
8.5 Production and
monitoring and measurement activities will ensure the
service provision
control of processes and output (clauses 8.2.3 and
8.5.1 Control of
production and service
8.2.4 of ISO 9001:2008 have been moved to 8.5.1)
provision
acceptance criteria for products and services are met
8.5.2 Identification and
traceability
the use, and control of suitable infrastructure and
8.5.3 Property
belonging to
process environment
customers or external
providers
suitable monitoring and measuring resources
8.5.4 Preservation

Requires competent persons

ISO/TC 176/SC 2/ N1282

8.5.5 Post-delivery
activities

8.5.6 Control of
changes

34
Date:
 8 Operation
Clause 8.5.2
The identification and traceability now focus on
8.5 Production and
service provision
outputs rather than on product (includes intermediate
products and services) rather than on product
8.5.1 Control of
production and service
provision Clause 8.5.3
8.5.2 Identification and
traceability
Customer property has been expanded to include
external providers property
8.5.3 Property
belonging to
customers or external
providers
Clause 8.5.4
8.5.4 Preservation Preservation of product has been changed to
preservation of the output
ISO/TC 176/SC 2/ N1282

8.5.5 Post-delivery
activities

Clause 8.5.5
8.5.6 Control of
changes
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 35
Date:
 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
Clause 8.7
8.7 Control of
nonconforming outputs The control of nonconforming output is more explicit; it
now considers the options to apply correction and
corrective action
Nonconforming product changed to nonconforming
output
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Date:
 4 9
5 6 7 8 10
Context of Leadership Planning Support Operation Performance Improvement
organization evaluation

4.1 6.1 7.1 8.1 9.1 10.1

5.1
Understanding Actions to Resources Operational Monitoring, General
Leadership and planning and measurement,
context address risks and
commitment control analysis and
opportunities 7.1.2
4.2 evaluation 10.2
5.2 People
Interested parties Nonconformity
Policy 6.2 See next slide 9.1.2 and corrective
Quality objectives 7.1.3 Customer action
4.3 and planning Infrastructure satisfaction
5.3
Scope
Organizational 7.1.4 10.3
roles, 6.3 9.1.3
responsibilities Environment for the Continual
4.4 Planning of operation of Analysis and improvement
and authorities changes evaluation
QMS processes

7.1.5 9.2
Monitoring and Internal audit
measuring
resources
9.3
Management
ISO/TC 176/SC 2/ N1282

7.1.6
Organizational review
knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented 37
information Date:
 9
Performance Clause 9.1.1
evaluation
In 8.1 ISO 9001:2008 (clause 8.1) there was a
9.1
Monitoring,
requirement for planning. This is replaced with
measurement, analysis
and evaluation
identifying what needs monitoring and measuring, and
the methods to be used
9.1.1
General Clause 9.1.3
There are specific requirements for analysis and
9.1.2
Customer satisfaction
evaluation when using results as inputs to
management review
9.1.3
Analysis and evaluation
Effective implementation of planning and actions to
address risks and opportunities are new requirements
ISO/TC 176/SC 2/ N1282

9.2
Internal audit
in this clause
9.3
Management review

38
Date:
 9
Performance
Clause 9.2
Evaluation Internal audit program now has explicit considerations for:
9.1
quality objectives, customer feedback and changes impacting
Monitoring,
measurement, analysis
the organization; management responsibility for action is now
and evaluation
implicit whereas previously this was explicit
9.1.2
An auditor is now required to be impartial versus in the
Customer satisfaction
previous version they could not audit their own work

9.1.3
Clause 9.3
Analysis and evaluation There are now additional requirements for management
review. These include:
9.2
Internal audit changes in external and internal issues (such as strategic
9.3
direction)
Management review performance concerning external providers
ISO/TC 176/SC 2/ N1282

9.3.1
adequacy of resources for effective QMS and effectiveness of
General actions taken addressing risks & opportunities
9.3 .2 Clause 9.3.1
Management review
input Management reviews should be aligned to the strategic
9.3.3 direction of the organization
Management review
output Clause 9.3.3
39
Management review outputs have been enhanced to includeDate:
 4 9
5 6 7 8 10
Context of Leadership Planning Support Operation Performance Improvement
organization Evaluation

4.1 6.1 7.1 8.1 9.1

5.1 10.1 General
Understanding Actions to Resources Operational Monitoring,
Leadership and planning and measurement,
context address risks and
commitment control analysis and
opportunities 7.1.2
4.2 evaluation
5.2 People 10.2
Interested parties
Policy 6.2 See next slide 9.1.2 Nonconformity
Objectives and 7.1.3 Customer and corrective
4.3 planning Infrastructure satisfaction action
5.3
Scope
Organizational 7.1.4
roles, 6.3 9.1.3 10.3
responsibilities Environment for the
4.4 Planning of operation of Analysis and Continual
QMS and authorities changes evaluation improvement
processes

7.1.5 9.2
Monitoring and Internal audit
measuring
resources
9.3
Management
ISO/TC 176/SC 2/ N1282

7.1.6
Organizational review
knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented 40
information Date:
 10
Clause 10.1
Improvement This clause is new, it addresses more comprehensive
opportunities for improvement; not only continual improvement
10.1 Addresses improvement of products and services and future
General
needs and expectations
Emphasis is now on improving processes to prevent
10.2 Nonconformity and
corrective action nonconformities and improving products and services
Clause 10.2
The nonconformity referred to in this clause concerns the entire
10.3
Continual improvement 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
ISO/TC 176/SC 2/ N1282

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 41
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 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
Determining risks and opportunities increase the effectiveness
of the organizations QMS
Change management has been expanded to add emphasis that
ISO/TC 176/SC 2/ N1282

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
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 ISO 9001:2015 Certification
Transition Timeline

September 2015
Published International
Standard
ISO/TC 176/SC 2/ N1282

September 2015 start of 3 years transition period

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

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 More information

Further information is available at

www.iso.org/tc176/sc02/public
ISO/TC 176/SC 2/ N1282

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