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 organization’s context is required
“one size doesn’t 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
 Aligning QMS policy and objectives with the
ISO/TC 176/SC 2/ N1282

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
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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

8.1 9.1 Monitoring,

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

7.2 10.2
4.2 Competence
Interested 5.2 6.2 9.2 Nonconformity
parties Policy Planning Internal audit and corrective
action

7.3
5.3 Awareness
4.3 Organizational 9.3 10.3
Scope roles, Management Continual
responsibilities review improvement
and authorities
7.4 Communication
4.4
QMS
7.5
Documented
information
ISO/TC 176/SC 2/ N1282

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Date:
 The common structure and ISO 9001:2015 additions

8 Operation

8.1 Operational planning and

control
ISO/TC 176/SC 2/ N1282

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

4.1 7.1 8.1 9.1 10.1

5.1 6.1 Monitoring,
Understanding Resources Operational General
Leadership and Actions to measurement,
context planning and
commitment address risks and analysis and
opportunities control
7.1.2 evaluation
4.2 People 10.2
Interested parties 5.2
Nonconformity
Policy See next slide 9.1.2
6.2 and corrective
Quality objectives 7.1.3 Customer action
and planning Infrastructure satisfaction
4.3 5.3
Scope Organizational
roles, 7.1.4 10.3
responsibilities 6.3 Environment for the 9.1.3 Continual
4.4 and authorities Planning of operation of Analysis and improvement
QMS changes processes evaluation

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 be documented and consider:
Understanding
context  external and internal issues
4.2  requirements of relevant interested parties
Interested parties

 the products and services covered (must also be

4.3
Scope stated in scope)
4.4  allowing applicability of specific requirements
QMS
 justification for any case where a requirement
cannot be applied (exclusion)
ISO/TC 176/SC 2/ N1282

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

4.1 7.1 8.1 9.1 10.1

5.1 6.1 Monitoring,
Understanding Resources Operational General
Leadership and Actions to measurement,
context planning and
commitment address risks and analysis and
opportunities control
7.1.2 evaluation
4.2 People 10.2
Interested parties 5.2
Nonconformity
Policy See next slide 9.1.2
6.2 and corrective
Objectives and 7.1.3 Customer action
planning Infrastructure satisfaction
4.3 5.3
Scope Organizational
roles, 7.1.4 10.3
6.3 Environment for the 9.1.3 Continual
responsibilities
4.4 Planning of operation of Analysis and improvement
and authorities
QMS changes processes evaluation

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
Leadership and
management system
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 organization’s 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

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

4.1 7.1 8.1 9.1 10.1

5.1 6.1 Monitoring,
Understanding Resources Operational General
Leadership and Actions to measurement,
context planning and
commitment address risks and analysis and
opportunities control
7.1.2 evaluation
4.2 People 10.2
Interested parties 5.2
Nonconformity
Policy See next slide 9.1.2
6.2 and corrective
Quality objectives 7.1.3 Customer action
and planning Infrastructure satisfaction
4.3 5.3
Scope Organizational
roles, 7.1.4 10.3
responsibilities 6.3 Environment for the 9.1.3 Continual
4.4 and authorities Planning of operation of Analysis and improvement
QMS changes processes evaluation

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
Actions to address risks
parties’ requirements identified (4.1 and 4.2), this clause
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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 6 Clause 6.2
Planning

Objectives should be:

6.1
Actions to address risks
and opportunities  established for processes relevant to the QMS

6.2
 in line with customer requirements
Objectives and planning

 in line with products and services conformity

6.3
Planning of changes
 monitored, communicated & updated
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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
the following clauses:
6.3
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

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

4.1 7.1 8.1 9.1 10.1

5.1 6.1 Monitoring,
Understanding Resources Operational General
Leadership and Actions to measurement,
context planning and
commitment address risks and analysis and
opportunities control
7.1.2 evaluation
4.2 People 10.2
Interested parties 5.2
Nonconformity
Policy See next slide 9.1.2
6.2 and corrective
Objectives and 7.1.3 Customer action
planning Infrastructure satisfaction
4.3 5.3
Scope Organizational
roles, 7.1.4 10.3
responsibilities 6.3 Environment for the 9.1.3 Continual
4.4 and authorities Planning of operation of Analysis and improvement
QMS changes processes evaluation

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  internal resources
Infrastructure
 external providers
7.1.4
Environment for the
operation of processes  people

7.1.5
 monitoring and measuring resources
Monitoring and
measuring resources  organizational knowledge required to ensure the
7.1.6
processes provide conforming products and services
Organizational
 external communication
ISO/TC 176/SC 2/ N1282

knowledge

7.2
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 organization’s
Resources
control need to have awareness and communication
7.1.2
People
(internal and external) of the QMS and benefits of improving
performance
7.1.3
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
Enhanced requirement for the creation and updating of
7.1.5
Monitoring and documented information, e.g. description, format &
measuring resources
suitability
7.1.6
Organizational
ISO/TC 176/SC 2/ N1282

knowledge

7.2 Clause 7.5.3

Competence

7.3
Control of documented information – now explicitly
Awareness
includes confidentiality, integrity and access
7.4
Communication

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

4.1 7.1 8.1 9.1 10.1

5.1 6.1 Monitoring,
Understanding Resources Operational General
Leadership and Actions to measurement,
context planning and
commitment address risks and analysis and
opportunities control
7.1.2 evaluation
4.2 People 10.2
Interested parties 5.2
Nonconformity
Policy See next slide 9.1.2
6.2 and corrective
Objectives and 7.1.3 Customer action
planning Infrastructure satisfaction
4.3 5.3
Scope Organizational
roles, 7.1.4 10.3
responsibilities 6.3 Environment for 9.1.3 Continual
4.4 and authorities Planning of operation of Analysis and improvement
QMS changes processes evaluation

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 Performance and
Leadership Planning Support Operation Improvement
organization Evaluation

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

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 8.5.3 Property

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

8.2.3 Review of 8.3.4 Design and

requirements related to development controls 8.5.4 Preservation
products and services

8.2.4 Changes to 8.5.5 Post-delivery

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

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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  explicit considerations are now linked to: customer
products and services
communications; customer property, and contingency
8.2.1 Customer
actions
communication
Clause 8.2.2
8.2.2 Determination of
requirements related to
products and services  Determination of requirements; this requires a process
8.2.3 Review of
and is explicit with regard to substantiating claims for
requirements related to
products and services
products and services being offered
ISO/TC 176/SC 2/ N1282

8.2.4 Changes to
requirements for
products and services

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Date:
 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 Clause 8.3.2
8.3.1 General
 Design and development has been restructured to allow
for a more process orientated approach
8.3.2 Design and
development planning  Involvement of customers and users as part of design
planning to be considered
8.3.3 Design and
development inputs
Clause 8.3.3
8.3.4 Design and
development controls
 Design and development inputs – explicit requirements
for internal and external resource needs, potential
ISO/TC 176/SC 2/ N1282

8.3.5 Design and

development outputs
consequences of failure, level of control expected by
customers
8.3.6 Design and
development changes 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
‘outsourcing’ is now ‘Control of externally provided
8.4 Control of externally
provided processes processes, products and services’
products and services

Clause 8.4.1
8.4.1 General
 Conditions are applied when controls are required for
8.4.2 Type and extent of externally provided processes, products and service
control

 Terminology has changed from ‘supplier’ to ‘external

8.4.3 Information for
external providers provider’
Clause 8.4.2
 Type and extent of control of external provision
ISO/TC 176/SC 2/ N1282

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:
 monitoring and measurement activities will ensure the
8.5 Production and
service provision control of processes and output (clauses 8.2.3 and
8.5.1 Control of
8.2.4 of ISO 9001:2008 have been moved to 8.5.1)
production and service
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
process environment
belonging to
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

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Date:
 8 Operation
Clause 8.5.2
 The identification and traceability now focus on
8.5 Production and ‘outputs’ rather than on ‘product’ (includes intermediate
service provision
products and services) rather than on ‘product’
8.5.1 Control of
production and service Clause 8.5.3
provision

 Customer property has been expanded to include

8.5.2 Identification and
traceability external providers’ property
8.5.3 Property
belonging to Clause 8.5.4
customers or external
providers
 Preservation of product has been changed to
8.5.4 Preservation 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
 Post-delivery activities is a new clause
changes
Clause 8.5.6
 A new requirement for the control of changes is
addressed in the slide introducing the concept of
change
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 Performance
Leadership Planning Support Operation Improvement
organization evaluation

4.1 7.1 8.1 9.1 10.1

5.1 6.1 Monitoring,
Understanding Resources Operational General
Leadership and Actions to measurement,
context planning and
commitment address risks and analysis and
opportunities control
7.1.2 evaluation
4.2 People 10.2
Interested parties 5.2
Nonconformity
Policy See next slide 9.1.2
6.2 and corrective
Quality objectives 7.1.3 Customer action
and planning Infrastructure satisfaction
4.3 5.3
Scope Organizational
roles, 7.1.4 10.3
responsibilities 6.3 Environment for the 9.1.3 Continual
4.4 and authorities Planning of operation of Analysis and improvement
QMS changes processes evaluation

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
requirement for planning. This is replaced with
Monitoring,
measurement, analysis identifying what needs monitoring and measuring, and
and evaluation
the methods to be used
9.1.1 Clause 9.1.3
General
 There are specific requirements for analysis and
9.1.2 evaluation when using results as inputs to
Customer satisfaction
management review
9.1.3
 Effective implementation of planning and actions to
Analysis and evaluation
address risks and opportunities are new requirements
in this clause
ISO/TC 176/SC 2/ N1282

9.2
Internal audit

9.3
Management review

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Date:
 9
Performance
Clause 9.2
Evaluation  Internal audit program now has explicit considerations for:
quality objectives, customer feedback and changes impacting
9.1
Monitoring, the organization; management responsibility for action is now
measurement, analysis
and evaluation implicit whereas previously this was explicit
 An auditor is now required to be impartial versus in the
9.1.2
Customer satisfaction
previous version they could not audit their own work
Clause 9.3
9.1.3
 There are now additional requirements for management
Analysis and evaluation
review. These include:
 changes in external and internal issues (such as strategic
9.2
Internal audit direction)
 performance concerning external providers
9.3
 adequacy of resources for effective QMS and effectiveness of
ISO/TC 176/SC 2/ N1282

Management review

actions taken addressing risks & opportunities

9.3.1
General Clause 9.3.1
 Management reviews should be aligned to the strategic
9.3 .2
Management review direction of the organization
input
Clause 9.3.3
9.3.3
Management review  Management review outputs have been enhanced to include
output
many of the new areas of focus
39
Date:
 4 9
5 6 7 8 10
Context of Performance
Leadership Planning Support Operation Improvement
organization Evaluation

4.1 7.1 8.1 9.1

5.1 6.1 Monitoring,
Understanding Resources Operational 10.1 General
Leadership and Actions to measurement,
context planning and
commitment address risks and analysis and
opportunities control
7.1.2 evaluation
4.2 People
Interested parties 5.2 10.2
Policy See next slide 9.1.2 Nonconformity
6.2
Objectives and 7.1.3 Customer and corrective
planning Infrastructure satisfaction action
4.3 5.3
Scope Organizational
roles, 7.1.4
responsibilities 6.3 Environment for the 9.1.3 10.3
4.4 and authorities Planning of operation of Analysis and Continual
QMS changes processes evaluation improvement

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
nonconformities and improving products and services
corrective action Clause 10.2
 The nonconformity referred to in this clause concerns the entire
QMS and not specifically the products or services which are
10.3
Continual improvement 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
ISO/TC 176/SC 2/ N1282

 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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 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 organization’s business processes
 Determining risks and opportunities increase the effectiveness
of the organization’s 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

2015 2016 2017 2018

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

44
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