Delta Checklist ISO 9001:2015

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Remarks for using this checklist:

- This checklist is created to check the essential additional requirements of ISO 9001:2015 in relation
to ISO 9001:2008. It don’t mention the substantially unchanged requirements. Therefore it is
applicable in case of already certified companies with conformity to ISO 9001:2008.
- The reference to chapter / subchapter of the standard should make it easy to have a quick link to the
complete text of the requirement.
- Requirements concerning documented information are listed at the end of the checklist. There are all
chapters listed, where “documented information” are required explicit.
- The left column “Requirement” should not be used for input by the user.
- The column “Notes / Documents” can be used by the organization for preparation as well as by the
auditor during the audit. It is indended for documentation of the check and has to document
evidences for conformity / nonconformity of the respective requirement.

* Evaluation: 1 = conform; 2 = conform opportunities for improvement; 3 = not conform/nonconformity

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Chapter 4:
Context of the organization
4.1 Understanding the organization and its
context
The organization shall determine::
- external issues
- internal issues,
that are relevant to its purpose and ist strategic
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
Widening the view from „client“ to „interested
parties“

The organization shall determine:

a) the interested parties that are relevant to
the quality management system;
b) the requirements of these interested parties,
which are relevant to the QM-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 scope must be:

• determined and maintained
• documented

Clarificaton of the basic ideas for “exclusions”:

If a requirement of this internatinalen standard

within the agreed range of application can be
applied, than it must be applied by the organization.

If a requirement of this international standard

* Evaluation: 1 = conform; 2 = conform opportunities for improvement; 3 = not conform/nonconformity

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cannot be applied, this fact may not the ability or
the responsibility of the organisation affect to
guarantee the conformance of products and
services.
4.4 Quality management system and its
processes
Additonal requirements concerning process
approach.
- Demand to determine the processes inclusive
Input and Output
- Demand to determine the responsibilities
and authorities of these processes (process
responsible person)
- Demand to determine risks
- Demand to improve the processesdetermine
to improve the chances
Chapter 5: Leadership
5. Leadership
Additional requirements regarding customer focus

In addition to the existing requirement to

communicate the relevance of customer, statutory
and regulatory requirements, it must be ensured,
that
- applicable statutory and regulatory
requirements are determined
- risks that can affect the conformity of
products and services, and the ability to
enhance customer satisfaction, are
determined and addressed
- focus on enhancing customer satisfaction
is maintained

Additional requirements regarding quality policy

The quality policy must now also

- appropriate to the purpose and context of
the organization
- supports the strategic direction of the
organization
- be understood and applied
- be available to relevant interested parties

* Evaluation: 1 = conform; 2 = conform opportunities for improvement; 3 = not conform/nonconformity

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Chapter 6: Planning

Actions to address risks

NOTE: Requirements were partially included, in a

weaker form, in ISO 9001:2008, Chapter 8.5.3 –
Preventative measures
Risks to be addressed shouldshall be determined
to
- ensure that the quality management system
can achieve its intended results Formatted: Font: Not Bold, English (United States)
- enhance desirable effects
- prevent or reduce undesired effects Formatted: English (United States)
- achieve continual improvement

Planning is required with regard to

- which actions will address these risks and
opportunities
- how these actions will be integrated into
QM system processes
- how the effectiveness of these actions will
be evaluated
Quality objectives must be defined more precisely

When planning the actions to achieve these

objectives the organization shall determine:
- what will be done
- which resources are required
- who is responsible
- when an action is completed
- how the results will be evaluated

Changes must be made in a planned and

systematic manner

The organisation must take into account:

- the objective of the change
- potential consequences of the change
(risks)
- the integrity of the QM system
- the availability of resources

* Evaluation: 1 = conform; 2 = conform opportunities for improvement; 3 = not conform/nonconformity

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- the allocation of responsibilities and
authority

Chapter 7: Support
Related to the knowledge necessary for the
operation of its processes and to achieve
conformity of products and services the
organization shall the knowledge
- determine
- make available to the extend necessary

When addressing changing needs and trends, the

organization shall
- consider its current knowledge
- determine how to acquire or access the
necessary additional knowledge.
The organization must determine relevant internal
and external communications
.

The organisation must determine:

- what is communicated
- when it is communicated
- to whom it is communicated
- how it is communicated
- who communicated

Chapter 8: Operation
Check whether the organisation has to carry out
development of products and services.
(Chapter 8.3)

The Organization must a development process:

- establishimplement
- implementcarry out
- maintain
which is appropriate to ensure the subsequent
provision likely to guarantee the supply of products
and services

*********************************************************
Where requirements regarding products and
services are not defined by the customer or other
interested parties in a manner suitable for
* Evaluation: 1 = conform; 2 = conform opportunities for improvement; 3 = not conform/nonconformity
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subsequent production or the provision of services,
the organisation must establish a development
process. (ISO / DIS 9001:2014 Chapter 8.3.1)
*********************************************************

Controls of externally provided products and

services (8.4)

The organization must have criteria for the

evaluation, selection, monitoring of performance
and re-evaluation of external providers. (Chapter
8.4.1)

NOTE: Equal treatment of “externally provided

goods” and “externally provided services”. (Chapter
8.4)

Chapter 9:
Performance evaluation
Clarification of the requirements for analysis and
evalutation (Chap. 9.1.3)

The organization schall analyse and evaluate

appropriate data and information.

The results of analysis shall be used to evaluate:

- conformity of products and services
- improve the customer satisfaction
- the performance and effectiveness of the
quality management system
- if planning has been implemented
effectively
- process performance
- the performance of external providers
- the need and opportunity for improvements

Additional issues to be taken into consideration in

the management review (Chapter 9.3)

The management review shall be planned and

carried out considering

- information regarding quality performance

including trends and indicators relating to:

* Evaluation: 1 = conform; 2 = conform opportunities for improvement; 3 = not conform/nonconformity

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 the results of monitoring and
measurement
 issues concerning external
providers and other relevant
interested parties
 the adequacy of resources for the
maintenance of an effective quality
management system
 the effectiveness of activity to
address risks

Chapter 10:
Improvement
Continual improvement of the QM system is
required

Concerning the QM system, the organization shall

improve
- suitability
- adequacy
- effectiveness

Documented information:

(Note: All required „documented information“

are listed, not only changes against ISO
9001:2008)
(1) The scope of the quality system (chapter
4.3 - „Determining the scope of the quality
available and be maintained as
documented management system“)
(maintain information)
(2) The organization shall maintain
documented information to the extent
necessary to support the operation of
processes (chapter 4.4.2 a –„ Quality
management system and its processes“)
(maintain information)
(3) The organization shall retain documented
information to the extent necessary to have
confidence that the processes are being
carried out as planned (chapter 4.4.2 b)–„
Quality management system and its
processes“)
(retain information)
(4) Quality policy (chapter 5.2.2 a) – „Quality
policy“)
* Evaluation: 1 = conform; 2 = conform opportunities for improvement; 3 = not conform/nonconformity
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(maintain information)
(5) Quality objectives (chapter. 6.2 – „Quality
objectives and planning to achieve them“)
(maintain information)
(6) The organization shall retain appropriate
documented information as evidence of
fitness for purpose of monitoring and
measurement resources (chapter 7.1.5.1 –
„Monitoring and measuring resources“)
(retain information)
(7) Measuring instruments shall be verified or
calibrated at specified intervals or prior to
use against measurement standards
traceable to international or national
measurement standards. Where no such
standards exist, the basis used for
calibration or verification shall be retained
as documented information (chapter 7.1.5.2
– „Measurement traceability“)
(retain information)
(8) Evidences of competence of the personell
(chapter. 7.2 - „Competence“)
(retain information)
(9) 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.
(chapter 8.1- „Operational planning and
control“)
(Maintain and retain information)
(10)Documented information describing the
results of the review, including any new or
changed requirements for the products and
services, shall be retained. (chapter 8.2.3.2
- „Review of requirements related to
products and services“)
(retain information)
(11) Information about design and
developmend (Chapter 8.3.3 –“Design and
development inputs”)
(retain information)
(12) Information about design and controls
(Chapter 8.3.4 – Design and development
controls”)
(retain information)

(13)The organization shall retain the

documented information resulting from the
design and development process (chapter
8.3.5 - „Design and development outputs“)

* Evaluation: 1 = conform; 2 = conform opportunities for improvement; 3 = not conform/nonconformity

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(retain information)
(14)Documented information on design and
development changes shall be retained.
(chapter. 8.3.6 - „Design and development
changes”)
(retain information)
(15)The organization shall retain appropriate
documented information of the results of
the evaluations, monitoring of the
performance and re-evaluations of the
external providers. (chapter. 8.4 – „Control
of externally provided processes, products
and services“).
(retain information)
(16)Where traceability is a requirement, the
organization shall control the unique
identification of the process outputs, and
retain any documented information
necessary to maintain traceability. (chapter.
8.5.2 – „Identification and traceability“)
(retain information)
(17) Information to the customers and external
providers in case of their property is lost,
damage or otherwise unsuitable for use
(Chapter 8.5.3 – “Property belonging to
customers or external providers
(retain information)
(18)The organization shall retain documented
information describing the results of the
review of changes, the personnel
authorizing the change, and any necessary
actions. (chapter. 8.5.6 - “Control of
changes”)
(retain information)
(19)The information shall include:
– evidence of conformity with the
accetance criteriea
– traceability to the person(s) authorizing
rhe relase.(chapter. 8.6 – “Release of
products and services”). (retain
information)
(20)The organization shall retain documented
information of actions taken on
nonconforming process outputs, products
and services, including on any concessions
obtained and on the person or authority that
made the decision regarding dealing with
the nonconformity. (chapter. 8.7.2 -
“Control of nonconforming process outputs,
products and services”)
(retain information)

* Evaluation: 1 = conform; 2 = conform opportunities for improvement; 3 = not conform/nonconformity

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(21)The organization shall ensure that
monitoring and measurement activities are
implemented in accordance with the
determined requirements and shall retain
appropriate documented information as
evidence of the results (chapter. 9.1.1 –
„Monitoring, measurement, analysis and
evaluation“)
(retain information)
(22)The organization shall retain documented
information as evidence of the
implementation of the audit programme and
the audit results.(chapter. 9.2.2 - „Internal
audit“)
(retain information)
(23)The organization shall retain documented
information as evidence of the results of
management reviews. (chapter 9.3 -
„Management review“)
(retain information)
(24)The organization shall retain documented
information as evidence of the nature of the
nonconformities and any subsequent
actions taken. (chapter 10.2.2
„Nonconformity and corrective action“)
(retain information)
(25)The organization shall retain documented
information as evidence of the results of
any corrective action (chapter 10.2.2 -
„Nonconformity and corrective action“)
(retain information)

* Evaluation: 1 = conform; 2 = conform opportunities for improvement; 3 = not conform/nonconformity

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