ISO 9001

2015 1

8 Operation

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ISO 9001
2015 2

8 Operation
8.1 Operation planning and control
 Organization shall plan, implement and control the processes by
 Determining the requirements for the products and services, t ion
r ma
 Establishing criteria for e ep n fo
K dI
 Processes, n te
me
c u
 Acceptance of products and services, Do
 Determining the resources needed,
 Implementing control of the processes,
 Determining and keeping documented information.
 “Keeping” implies both maintaining and retaining.

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ISO 9001
2015 3

8 Operation
8.1 Operation planning and control
 Control planned changes and review
 The consequences of unintended changes.
 Take action to mitigate and adverse effects.
 Organization shall ensure – outsourced processes are controlled (controlled
methods to be identified).

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ISO 9001
2015 4

8 Operation
8.2 Requirements for products and services
8.2.1 Customer communication
 Communication with customers includes
 Products and services information
 Handling enquiries, contracts or orders, including changes,
 Obtaining customer feedback, including complaints,
 Handling or controlling customer property,
 Establishing specific requirements for contingency actions.

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ISO 9001
2015 5

8 Operation
8.2 Requirements for products and services
8.2.2 Determining the requirements related to products and services
 When determining the requirements offered to customers, ensure
 The requirements for the Products and services are defined, including
 Any applicable statutory and regulatory requirements
 Those considered necessary by the organization.
 Meets the claims for the products and services offer.

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ISO 9001
2015 6

8 Operation
8.2 Requirements for products and services
8.2.3 Review of requirements related to products and services
8.2.3.1
 Organization shall ensure ability to meet requirements offered to customers.
 Organization shall conduct review before committing to supply products and
services include
 Requirements specified by the customer,
 Requirements not stated by the customer, but necessary for intended use,
 Requirements specified by the organization,
 Applicable statutory and regulatory requirements, and
 Order / contract requirements differing from those previously expressed.
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ISO 9001
2015 7

8 Operation
8.2 Requirements for products and services
8.2.3 Review of requirements related to products and services
8.2.3.1
 Organization shall resolve differing requirements from those previously expressed.
 Customer’s requirements shall be confirmed before acceptance, when customer
does not provide documented statement.
t ion
8.2.3.2 in r ma
e ta Info
R d
 Organization shall retain documented information for
n te
me
 On the results of the review ocu
D
 On any new requirements for the products and services.

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ISO 9001
2015 8

8 Operation
8.2 Requirements for products and services
8.2.4 Changes to requirements for products and services
 Organization shall ensure the below, when changes in requirements
 Relevant documented information is amended.
 Relevant persons are made aware of changed requirements. t ion
ma
ep nfor
e
K dI
e
e nt
c um
Do

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ISO 9001
2015 9

8 Operation
8.3 Design and Development of products and services
8.3.1 General
 Organization shall establish, implement and maintain a design and development
process.

Applicable to all Organizations

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ISO 9001
2015 10

8 Operation
8.3 Design and Development of products and services
8.3.2 Design and Development Planning (DD Plan)
 Organization shall consider during determining stages and control for DD Plan.
 Nature, duration and complexity,
 Required process stages, including DD Reviews,
 t ion
Verification and Validation activities,
ma
 ep nfor
Responsibilities and Authorities for involved persons, e
K dI
e
nt
 Need of Internal and External Resources,
e
 Need to control interfaces between persons involved, c um
 Need for involvement of customers and users, Do
 Requirements for subsequent provision of products and services,
 Level of control expected,
 Documented information needed.
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ISO 9001
2015 11

8 Operation
8.3 Design and Development of products and services
8.3.3 Design and Development Inputs
 Organization shall determine essential requirements for products and services.
 Consider DD Inputs:
 Functional and performance requirements, t ion
ma
 n
ai nfor
Information derived from previous similar DD activities, t
Re d I
e
 Statutory and regulatory requirements,
e nt
 Standards or codes of practices, and c um
Do
 Potential consequences of failure due to nature of products and services.
 Conflicting DD inputs shall be resolved.
 Retain documented information on DD inputs.

www.harshatech.com November 12, 2024

ISO 9001
2015 12

8 Operation
8.3 Design and Development of products and services n
io
mat
8.3.4 Design and Development Controls
t ain nfor
Re d I
 Organization shall apply controls to ensure
n te
 me
Results to be achieved are defined,
ocu
D
 Conduct review to evaluate the ability of results,
 Conduct DD output verification to meet DD input requirements,
 Conduct validation to ensure specified application or intended use,
 Necessary actions on problems during reviews, verification and validation,
 Retain documented information for reviews, verification and validation.

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ISO 9001
2015 13

8 Operation
8.3 Design and Development of products and services
ion
8.3.5 Design and Development Outputs mat
t ain nfor
 Organization shall ensure DD outputs Re d I
n te
 Meet the input requirements, me
ocu
 Are adequate for the subsequent processes, D
 Include Monitoring and Measuring Requirements and Acceptance Criteria,
 Specify the characteristics for intended purpose and safe usage.
 Retain documented information for DD Outputs.

www.harshatech.com November 12, 2024

ISO 9001
2015 14

8 Operation
8.3 Design and Development of products and services
8.3.6 Design and Development Changes
 Organization shall identify, review and control changes.
ion
 Organization shall retain documented information on, mat
t ain nfor
 DD Changes, Re d I
n te
 Results of reviews,
u me
c
 Authorization of changes, and Do
 Actions taken to prevent adverse impacts.

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ISO 9001
2015 15

8 Operation
8.4 Control of externally provided processes, products and services
8.4.1 General
 Organization shall determine the controls to be applied to when
 External providers are intended for incorporation into the organization’s own
products and services.
 Provided directly to the customer by external provider on behalf of the
organization.
 Provided by an external provider as a result of a decision by the organization.

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ISO 9001
2015 16

8 Operation
8.4 Control of externally provided processes, products and services
8.4.1 General
 Organization shall determine and apply criteria for
 t ion
Evaluation,
ma
n
ai nfor
t
 Selection, Re d I
e
 Monitoring of performance, and e nt
c um
 Re-evaluation of external providers. Do
 Organization shall retain documented information on above activities.

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ISO 9001
2015 17

8 Operation
8.4 Control of externally provided processes, products and services
8.4.2 Types and extent of control
 Organization shall
 Ensure that externally provided processes remain within the control of its
QMS,
 Define control for external provider and resulting output.
 Take into considerations
 Customer requirements, statutory and regulatory requirements
 Effectiveness of the controls applied by the external provider.
 Determine the verification or other activities.

www.harshatech.com November 12, 2024

ISO 9001
2015 18

8 Operation
8.4 Control of externally provided processes, products and services
8.4.3 Information for External Providers
 Organization shall ensure adequacy of requirements prior to communication.
 Requirements includes the
 Processes, products and services
 Approval of
 Products and services,
 Methods, processes and equipment,
 Release of products and services.

www.harshatech.com November 12, 2024

ISO 9001
2015 19

8 Operation
8.4 Control of externally provided processes, products and services
8.4.3 Information for External Providers
 Requirements includes the
 Competence of persons
 Interactions with organization.
 Control and monitoring the performance of external providers.
 Verification or validation activities at premises of external providers.

www.harshatech.com November 12, 2024

ISO 9001
2015 20

8 Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
 Controlled conditions shall include, as applicable
 Availability of documented information
 Products, services or activities.
 The results to be achieved.
 Availability and use of suitable M&M Resources.
 Acceptance criteria for products and services.
 Use of suitable infrastructure and environment for the operation of processes.

www.harshatech.com November 12, 2024

ISO 9001
2015 21

8 Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
 Controlled conditions shall include, as applicable
 Appointment of competent persons.
 Validation and periodic revalidation of special processes.
 Actions to prevent human errors.
 Implementation of release, delivery and post-delivery activities.

www.harshatech.com November 12, 2024

ISO 9001
2015 22

8 Operation
8.5 Production and service provision
8.5.2 Identification and Traceability
t ion
 in r ma
Organization shall
e ta Info
R
 t ed
Use suitable means to identify outputs. e n
c um
 Identify the status of outputs. Do
 Control the unique identification of the outputs.

 Retain the documented information to enable traceability.

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ISO 9001
2015 23

8 Operation
8.5 Production and service provision t ion
in r ma
8.5.3 Property belonging to customers or external providers e ta Info
R
t ed
 Organization shall e n
c um
o
 Identify, verify, protect and safeguard customer’s Dor external providers
property.
 Report to customer or external provider and retain documented information
when the customer property is
 Lost,
 Damaged or otherwise found to be unsuitable for use.

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ISO 9001
2015 24

8 Operation
8.5 Production and service provision
8.5.3 Property belonging to customers or external providers
 Customer’s or external provider’s property can include
 Material,
 Components,
 Tools and equipments,
 Premises,
 Intellectual property and personal data.

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ISO 9001
2015 25

8 Operation
8.5 Production and service provision
8.5.4 Preservation
 Organization shall preserve the outputs during production and service provision.
 Preservation includes
 Identification
 Handling
 Contamination control
 Packaging
 Storage
 Transmission or transportation , and
 Protection.

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ISO 9001
2015 26

8 Operation
8.5 Production and service provision
8.5.5 Post-delivery Activities
 Organization shall meet requirements for post-delivery activities associated with
products and services.
 In determining Post-delivery activities shall consider:
 Statutory and regulatory requirements.
 Potential undesired consequences associated with its products and services.
 Nature, use and intended lifetime of its products and services.
 Customer requirements.
 Customer feedback.

www.harshatech.com November 12, 2024

ISO 9001
2015 27

8 Operation
8.5 Production and service provision
8.5.5 Post-delivery Activities
 Post-delivery activities includes:
 Actions under warranty provisions,
 Contractual obligations,
 Maintenance services,
 Supplementary services such as
o Recycling or final disposal .

www.harshatech.com November 12, 2024

ISO 9001
2015 28

8 Operation
8.5 Production and service provision
8.5.6 Control of Changes
 Organization shall
 Review and control changes for production or service provision. t ion
ma
 Retain documented information describing the
n
ai nfor
t
Re d I
e
o Results of the review,
e nt
o c um
Person(s) authorizing the change, and
Do
o Necessary actions arising from the review.

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ISO 9001
2015 29

8 Operation
8.6 Release of Products and Services
 Organization shall implement planned arrangements, at appropriate stages.
 The release of products and services to the customer
 Shall not proceed until the planned arrangements completed,
 Unless other wise approved by a relevant authority (or customer)
 Retain documented information on the release of products and services
includes:
t ion
o Evidence of conformity with the acceptance criteria,
ma
n
ai nfor
o t
Traceability to the person(s) authorising the release. Re d I
e
e nt
c um
Do
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ISO 9001
2015 30

8 Operation
8.7 Control of nonconforming outputs
8.7.1
 Nonconforming outputs shall be identified and controlled to prevent their
unintended use or delivery.
 Organization shall
 Take appropriate action based on nature of nonconformity,
 Apply to detected after delivery of products,
 During or after the provision of services.

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ISO 9001
2015 31

8 Operation
8.7 Control of nonconforming outputs
8.7.1
 Organization shall deal with nonconforming outputs in one or more of the following:
 Correction,
 Segregation, containment, return or suspension of provision of products and
service,
 Informing the customer,
 Obtaining authorization for acceptance under concession.
 Conformity to the requirements shall be verified when nonconforming outputs are
corrected.

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ISO 9001
2015 32

8 Operation
8.7 Control of nonconforming outputs
8.7.2
t ion
 Organization shall retain documented information that in r ma
e ta Info
R
 Describes the nonconformity, t ed
e n
 Describes the actions taken, c um
Do
 Describes any concessions obtained,
 Identifies the authority deciding the action in respect of the nonconformity.

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ISO 9001
2015 33

November 12, 2024

ISO 9001
2015 34

November 12, 2024

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35
Chart

Harsha Technologies, Hyderabad November 12, 2024

ISO 9001
2015 36

www.harshatech.com November 12, 2024