ISO 9001:2015 – Self Assessment Transition Checklist

This questionnaire is developed as a guide to give you an indication of your readiness for audit against ISO 9001:2015. Use this self-
assessment checklist to determine how close you are to compliance with the new ISO 9001:2015 requirements.

For support regarding your transition, please contact us:

+353 (0)1 6204121

ISO 9001:2015 Clause New Complies Evidence

requirement (Yes/No)
4 Context of the organization
4.1 Understanding the organization
and its context
The organization shall determine
external and internal issues that are
relevant to its purpose and its strategic Yes
direction and that affect its ability to
achieve the intended result(s) of its
quality management system. The
organization shall monitor and review
the information about these external
and internal issues

4.2 Understanding the needs and

expectations of interested parties
Due to their impact or potential impact
on the organizations ability to
consistently provide products and
services that meet customer and
applicable statutory and regulatory
requirements, the organization shall Yes
determine:
The interested parties that are relevant
to the quality management system
The requirements of these interested
parties that are relevant to the quality
management system; the organization
shall monitor and review the
information about these interested
parties and their relevant requirements

4.3 Determining the scope of the

quality management system
The organization shall determine the Yes
boundaries and applicability of the
quality management system to
establish its scope and conside
requirements as defined in clause 4.1 &
4.2 and its products & services.
4.4 Quality management system
The organization shall establish,
implement, maintain and continually Yes
improve a quality management system,
including the processes needed and
their interactions.

ISO 9001 Client Transition Checklist Page 1 of 8

ISO 9001:2015 Clause New Complies Evidence
requirement (Yes/No)
5 Leadership
5.1 Leadership and commitment

5.1.1 General
Top management shall demonstrate Yes
leadership and commitment with
respect to the quality management
system by:
Taking accountability of the
effectiveness of the QMS
Ensuring that the quality policy and
objectives are established for the QMS
and are compatible with the context
and strategic direction of organization
Ensuring the integration of the QMS
requirements into the organization’s
business processes
Promoting the use of the process
approach and risk based thinking
Ensuring that the resources needed for
the QMS are available
Communicating the importance of
effective quality management and of
conforming to the QMS requirements
Ensuring that the QMS achieves its
intended results
Engaging, directing and supporting
persons to contribute to the
effectiveness of the QMS
Promoting continual improvement
Supporting other relevant
management roles to demonstrate
their leadership as it applies to their
areas of responsibility

5.1.2 Customer Focus

Top management shall demonstrate
leadership and commitment with
respect to customer focus by ensuring:

a) Customer and applicable

statutory and regulatory
requirements are
determined, understood and
consistently met
b) The risks and opportunities
that can effect conformity of
products and services and
the ability to enhance
customer satisfaction are
determined and addressed
c) The focus on enhancing
customer satisfaction is
maintained
5.2 – Policy
5.2.1 Developing the Quality Policy
Top management shall establish, Yes
review and maintain a quality policy
that:
Is appropriate to the purpose and
context of the organization.
ISO 9001 Client Transition Checklist Page 2 of 8
Provides a framework for setting and
reviewing quality objectives
Includes a commitment to satisfy
applicable requirements

It should communicated and

understood and be available to
relevant interested parties as
appropriate

5.2.2 Communicating the Quality

Policy
The quality policy shall:
a) Be available and be
maintained as documented
information
b) Be communicated,
understood and applied
within the organisation
c) Be available to relevant
interested parties, as
appropriate
5.3 Organizational roles,
responsibilities and authorities
Top management shall ensure that the
responsibilities and authorities for
relevant roles are assigned, No
communicated and understood within
the organization

6 Planning
6.1 Actions to address risk and
opportunities
When planning for the QMS the
organization shall consider the issues Yes
referred to 4.1 and the requirements
referred to in 4.2 and determine the
risks and opportunities that need to be
addressed to:

a)give assurance that the QMS can

achieve the intended results
b) enhance desirable effects
c) prevent or reduce, undesired
effects
d) achieve improvement

6.1.2 The organization shall plan:

a) actions to address these risks and Yes

opportunities
b) how to:
1) Integrate and implement the
actions into its QMS
2) Evaluate the effectiveness of
these actions

6.2 Quality objectives and planning to

achieve them

6.2.1 The organisation shall establish Yes

quality objectives at relevant functions,

ISO 9001 Client Transition Checklist Page 3 of 8

levels and processes needed for the
QMS
ISO 9001:2015 Clause New Complies Evidence
requirement (Yes/No)
6.2.2 When planning actions to achieve
quality objectives the organization shall Yes
determine:

What will be done, what resources will

be required, who will be responsible,
when will it be completed, how will the
results be evaluated

6.3 Planning of changes

When the organisation determines the
need for changes to the QMS, the
changes shall be carried out in a
planned manner:
The purpose of the change and any
potential consequences, the integrity No
of the QMS, the availability of
resources, the allocation or re-
allocation of responsibilities and
authorities
7 Support
7.1 Resources
The organization shall determine and
provide the resources needed for the
establishment, implementation, No
maintenance and continual
improvement of the quality
management system

7.2 Competence
The organisation shall:

Determine the necessary competence No

of persons doing work under its control
that affects the performance and
effectiveness of the QMS

Ensure that these persons are

competent on the basis of appropriate
education, training or experience

Where applicable take actions to

acquire the necessary competence and
evaluate the effectiveness of the
actions taken

Retain appropriate documented

information as evidence of competence

7. 3 Awareness
Persons doing work under the
organization’s control shall be aware
of:
The quality policy and relevant quality
objectives Yes

Their contribution to the effectiveness

of the QMS, including the benefits of
improved performance

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The implications of not conforming
with the QMS requirements
ISO 9001:2015 Clause New Complies Evidence
requirement (Yes/No)
7.4 Communication
The organization shall determine
internal and external communications
relevant to the QMS Yes
What it will communicate?
When to communicate?
With whom to communicate?
How to communicate?

7.5 Documented information

7.5.1 General
The organizations QMS shall include:
No
Documented information required by
this international standard and
determined by the organization as
being necessary for the effectiveness of
the QMS

7.5.2 Creating and updating

When creating and updating
documented information the
organization shall ensure appropriate:
Identification and description (e.g. a
title, date, author, or reference
number);
format (e.g. language, software
version, graphics) and media (e.g.
paper, electronic);
review and approval for suitability and
adequacy.

7.5.3 Control of documented

information
Documented information required by No
the QMS and by this International
Standard shall be controlled to ensure:
it is available and suitable for use,
where and when it is needed it is
adequately protected

7.5.3.2
For control of documented information
the organization shall address the
following activities where applicable:
Distribution, access, retrieval and use
Storage and preservation
Control of changes
Retention and disposition

Documented information of external

origin shall be identified as appropriate
and controlled

ISO 9001 Client Transition Checklist Page 5 of 8

ISO 9001:2015 Clause New Complies Evidence
requirement (Yes/No)
8 Operation
8.1 Operational planning and control
The organization shall plan, implement
and control the processes needed to
meet requirements for the provision Yes
of products and services, and to
implement the actions determined in
6.0 by:

Determining requirements for the

products and services

Establishing criteria for the processes

and for the acceptance of products and
services

Determining the resources needed to

achieve conformity to product and
service requirements

Implementing control of the processes

in accordance with the criteria

Determining and keeping documented

information to the extent necessary to
have confidence that the processes
have been carried out as planned and
to demonstrate conformity of products
and services to requirements

The organisation shall control planned

changes and review the consequences
of unintended changes taking action to
mitigate any adverse effects as
necessary

The organisation shall ensure that

outsourced processes are controlled in
accordance with 8.4

8.2 Requirements for products and

services

8.2.1 Customer communication

Communication with customers shall
include: No

Providing information relating to

products and services

Handling enquiries, contracts or orders

including changes

Obtaining customer feedback,

including customer complaints

The handling or controlling customer

property

ISO 9001 Client Transition Checklist Page 6 of 8

Establishing specific requirements for
contingency actions when relevant
ISO 9001:2015 Clause New Complies Evidence
requirement (Yes/No)
8.2.2 Determining requirements
related to products or services No

8.2.3 Review of requirements related No

to products and services
8.2.4 Changes to requirements for No
products and services No
8.3 Design and development No
8.3.1 General
The organisation shall establish,
implement and maintain a design and No
development process that is
appropriate to ensure the subsequent
provision of products and services

8.3.2 Design and development No

planning
8.3.3 Design and development inputs No
8.3.4 Design and development No
controls
8.3.5 Design and development outputs No
8.3.6 Design and development No
changes
8.4 Control of externally provided No
services
8.5 Production and service provision No
8.6 Release of products and services No
8.7 Control of nonconforming process No
outputs
9 Performance evaluation
9.1 Monitoring, measurement,
analysis and evaluation
9.1.1 General No
The organization shall determine:

what needs to be monitored and

measured, the methods of monitoring
measurement, analysis and evaluation
as applicable to ensure valid results

when monitoring and measuring will be

performed and when results from
monitoring and measurement shall be
analysed and evaluated

The organisation shall evaluate the

quality performance and effectiveness
of the QMS

9.1.2 Customer Satisfaction No

9.1.3 Analysis and evaluation No
9.2 Internal Audit
9.2.1 New clause
but not really
The organization shall conduct internal
any new
audits at planned intervals to provide
requirements
information on whether the QMS
conforms to the organisations own
ISO 9001 Client Transition Checklist Page 7 of 8
requirements for its QMS and to this
international standard and is
effectively implemented and
maintained
ISO 9001:2015 Clause New Complies Evidence
requirement (Yes/No)
9.3 Management Review
Top management shall review the
organization's QMS, at planned New clause
intervals, to ensure its continuing but not really
suitability, adequacy and effectiveness any new
requirements

10 Improvement
10.1 General
10.2 Nonconformity and corrective New clause
action but not really
When a nonconformity occurs, any new
including those arising from requirements
complaints, the organization shall react
to the nonconformity
10.3 Continual improvement
The organization shall continually New clause
improve the suitability, adequacy and but not really
effectiveness of the QMS any new
requirements

ISO 9001 Client Transition Checklist Page 8 of 8