ISO 9001:2015

Clause 8: Operation
Liibaan Cali Afrax
&
Mohamed Hashi Mohamed
31 March, 2015
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Operation
ISO 9001:2008

ISO 9001:2015

Clause 7: Product realization Clause 8: Operation

ISO 9001:2015 clause 8

includes
planning & control, determine market needs,
interaction with customers, planning process,
control of external provisions of
products/services, production of product,
provision of services, release of
products/services, control of non-conforming
products/services
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8.1 operational planning and control

ISO 9001:2008

ISO 9001:2015

7.1 Planning of product realization

8.1 Operational Planning and control

The organization shall plan, implement and control those

processes that it has previously identified in clause 4.4 to meet
product or service requirements.

ISO 9001:2015 clause 8

Planning process
Establishing products and service requirements
Organization must consider its processes
For each process must establish
o Criterial
o How it control the process
o The acceptance criteria output for each process
o Recourse necessary to support each process

Create and keep documented information

It must additionally plan how to address any risks and opportunities

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8.2 Determination of requirements for products and

services
ISO 9001:2008

ISO 9001:2015

7.2 Customer-related processes

8.2 Determination of requirements for

7.2.3 Customer communication

products and services

8.2.1 Customer communication

8.2.1 Customer communication

ISO 9001:2015 clause 8

The organization is requires to ensure that it has processes

in place for effective customer communications channels,
to allow dialogue regarding:
product and service information,
enquiries, contracts, order handling, changes, and
receiving customer views and perceptions, including
complaints.
Handling or treatment of customer property if applicable
Specific requirement for contingency action when relevant
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8.2.2 Determination of requirements related to the

products and services
ISO 9001:2008

ISO 9001:2015

7.2.1 Determination of requirements

related to the products

8.2.2 Determination of requirements

related to the products and services

ISO 9001:2015 clause 8

The Standard requires the organization to stablish

implement and maintain process to ensure product and
service requirements have been defined.
These requirements can come from the customer, may
be mandated by laws or regulations, and include
generally accepted standards within industry or market.
The organization must then ensure that it has the ability
to meet the defined requirements.
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8.2.3 Review of requirements related to the products

and services
ISO 9001:2008

ISO 9001:2015

7.2.2 Review of requirements related

to the products

8.2.3 Review of requirements related

to the products and services

The organization is required to review requirements relating

to its products and services. This review needs to consider:

ISO 9001:2015 clause 8

That requirements set by the customer including once relating

to delivery and post-delivery.
The requirements not stated by the customer but that are
known to be necessary for the product or service to be suitable
for the customers intended use,
The review also must consider any statutory or regulatory
requirement, and any new or changed requirements.
Documented information describing the results of the review
shall be retained.

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8.3 Design and Development of products and services

ISO 9001:2008

ISO 9001:2015

7.3 Design and Development

8.3 Design and Development of products

and services

8.3.1 General

ISO 9001:2015 clause 8

Before the organization establish a detailed requirements for

the products and services the organization must implement
and maintain a design and development process.

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8.3.2 Design and Development planning

ISO 9001:2008

ISO 9001:2015

7.3.1 Design and Development planning

8.3.2 Design and Development planning

To effectively plan the design and development process, the

organization must:

ISO 9001:2015 clause 8

Clearly define the stages involved in the design and

development process.
Identify the design and development verification and
validation that is required for each stage.
Describe clear responsibility and authority for the people
doing this work.
See that design information flows effectively among the
various groups having a role in designing, selling, managing,
manufacturing, and servicing the products.
Keep design and development plans up to date.

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8.3.3 Design and Development inputs

ISO 9001:2008

ISO 9001:2015

7.3.2 Design and Development inputs

8.3.3 Design and Development inputs

The organization is required to determine product

and service input requirements, including:
what it does and how well it must perform,

ISO 9001:2015 clause 8

legal and regulatory requirements,

internal and external resources needs,
Potential consequences of design and development failure,
The customers and other interested parties expected level
of control of the design and development process

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8.3.4 Design and Development controls

ISO 9001:2008

ISO 9001:2015

7.3.4, 7.3.5, 7.3.6 Design and

Development review, verification and
validation

8.3.4 Design and Development controls

The organization is required to apply controls to its

design and development process in order to ensure
that:

ISO 9001:2015 clause 8

The results from undertaking the design and development

process are clearly defined;
Design and development reviews take place in accordance
with planned arrangements;
The design and development outputs meet the design and
development inputs (verification);
The resulting products and services are fit for their intended
use or specified application where this is known to the
organization (validation).

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8.3.5 Design and Development output

ISO 9001:2008

ISO 9001:2015

7.3.3 Design and Development outputs

8.3.5 Design and Development outputs

ISO 9001:2015 clause 8

The output of design and development must include

sufficient information to verify that design output meets
design input requirements.
Design outputs must include or reference any related
monitoring or measuring requirements and acceptance
criteria.

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8.3.6 Design and Development changes

ISO 9001:2008

ISO 9001:2015

7.3.7 Control of Design and

Development changes

8.3.6 Design and Development changes

If change are made to either design input or design

output the organization must Identify, review and control
to ensure that conformity to requirements is maintained.

ISO 9001:2015 clause 8

Documented information is required.

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8.4 Control of externally provided products and

services
ISO 9001:2008

ISO 9001:2015

7.4 Purchasing

8.4 Control of externally provided

products and services

8.4.1 General
The organization must ensure that externally provided processes,
products or services meet the organizations specified requirements.
When:

ISO 9001:2015 clause 8

products and services are provided by the external providers for

incorporation into the organizations own products and services;
products and services are provided directly to the customer by the
external provider on behalf of the organization.
The organization must establish criteria for how they evaluate and
choose external providers. These criteria must be based on the external
providers ability to provide products and services that meet product
and service quality requirements.
Finally, the organization must retain appropriate documented
information of the result of the evaluations.

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8.4.2 Type and extent of control of external provision

ISO 9001:2008

ISO 9001:2015

7.4.3 Verification of purchased product.

8.4.2 Type and extent of control of

external provision

ISO 9001:2015 clause 8

The organization is required to determine the type

and extent of controls to apply to external providers
The extent of the controls depend on the
importance of the externally provided processes,
products and services.

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8.4.3 Information for external providers

ISO 9001:2008

ISO 9001:2015

7.4.2 Verification of purchased product.

. 8.4.3 Information for external providers

The organization is required to communicate to

external providers of processes, products and
services. This information must include
how products, services and processes are approved for
external provision,
ISO 9001:2015 clause 8

required competencies for contracted personnel,

Requirements for the external providers quality management
system.

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8.5 Production and service provision

ISO 9001:2008

ISO 9001:2015

7.5 Production and service provision

. 8.5 Production and service provision

ISO 9001:2015 clause 8

8.5.1 Control of production and

service provision
Organizations are required to control the way in which they
provide their products and services. These controlled
conditions may include:
Documented information regarding product and service
specifications,
written instructions for carrying out the work,
suitable equipment,
adequate tools for monitoring and measuring process and
product characteristics,
activities for monitoring and measuring process and product
characteristics,
criteria for product release,

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8.5.2 Identification and traceability

ISO 9001:2008

ISO 9001:2015

7.5.3 Identification and traceability

. 8.5.2 Identification and traceability

ISO 9001:2015 clause 8

To ensure conformity product and service, the organization

must establish procedures to identify process output pertain
throughout production and service provision.
Individual process outputs must have unique identification,
and retain any documented information necessary to maintain
traceability.

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8.5.3 Property belonging to customers or external

providers
ISO 9001:2008

ISO 9001:2015

7.5.4 Customer property

. 8.5.3 Property belonging to customers

or external providers

ISO 9001:2015 clause 8

Special care must be taken when a customer provides their

property for use or incorporation into the product or service.
Identify, verify, and protect customer property provided and
maintain records of lost, damaged or unsuitable customer
property.

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8.5.4 Preservation
ISO 9001:2008

ISO 9001:2015

7.5.5 Preservation of product

. 8.5.4 Preservation

ISO 9001:2015 clause 8

The organization is required to take appropriate measures

during production and service provision to safeguard process
outputs, in order to maintain their conformity to requirements.
Preservation include identification, handling, storage,
packaging, protection, and delivery of products or service
provision throughout all processes.

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8.5.5 Post-delivery activities

ISO 9001:2008

ISO 9001:2015

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. 8.5.5 Post-delivery activities

ISO 9001:2015 clause 8

The organization shall determine the nature and extent of any

post-delivery activities it needs to undertake.
When making this decision, the organization must consider
the risks associated with the particular product or service, the
nature of the product or service, how the product or service
will be used and what the product or services intended
lifetime is.

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8.5.6 Control of changes

ISO 9001:2008

ISO 9001:2015

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. 8.5.6 Control of changes

ISO 9001:2015 clause 8

The organization is required to control any unplanned

changes that are considered essential in order to ensure that
products or services continue to meet their specified
requirements.
The organization must retain documented information
describing the results of the review of the changes, the
person(s) authorizing the changes and any necessary actions.

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8.6 Release of products and services

ISO 9001:2008

ISO 9001:2015

8.2.4 Monitoring and measurement of

product

. 8.6 Release of products and services

The organization must verify that products and services

requirements have been met.

ISO 9001:2015 clause 8

Evidence that the product or service meets the acceptance

criteria needs to be retained.
The release of product and delivery of service to the customer
shall not proceed until the planned tests and checks have
been satisfactorily completed, unless otherwise approved by
a relevant authority.
Documented information that allows the individual
authorizing any early releases to be identified must be
retained.
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8.7 Control of nonconforming process outputs,

products and services
ISO 9001:2008

ISO 9001:2015

8.3 Control of nonconforming product

. 8.7 Control of nonconforming process

outputs, products and services

The organization is required to identify any process outputs,

products or services that do not conform to their intended
requirements.

ISO 9001:2015 clause 8

Controls need to be established and implemented to ensure that

these nonconforming process outputs, products or services are
not delivered to the customer or used unintentionally.
Where nonconforming process outputs, products or services are
identified, the organization is required to take action to correct the
fault.
This corrective action must be proportionate, reflecting both the
nature of the nonconformity and its ability to impact the
organizations intended product or service. This requirement also
applies to nonconforming products or services that are identified
after delivery to the customer.

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The End!

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