Clause 8 Download File

8.
7 Control of 8 Operation
nonconforming
outputs 8.1 Operational
planning and control
8.6 Release of Nonconformance

Planning
products and 8.2 Requirements
services for products
and services
Requirements
Release OPERATION
Design
Production Development
8.3 Design and development
8.5 Production
External
of products and services
and service provision
providers
8.4 Control of externally provided

processes, products and services
8.1 Operational planning and control
The organization shall plan, implement

and control
the processes needed to meet the

requirements for the provision of
products and services, and
to implement the actions determined in

Clause 6 (Planning)
8.1 Operational planning and control
a) Requirements b) Criteria c) Resources d) Controls e) Documentation

determining the establishing determining the implementing determining, maintaining
requirements criteria resources needed control of the and retaining
processes documented information
to the extent necessary
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for

products and services
8.2.3 Review of the requirements for

8.2.4 Changes to requirements for

CUSTOMER COMMUNICATION
8.2.1 Customer DETERMINE REQUIREMENTS

communication
8.2.2 Determining REVIEW REQUIREMENTS
the requirements
for products and 8.2.3 Review of the CHANGES
services requirements for
products and 8.2.4 Changes to
services requirements for
products and
services
Communication with customers shall

include:
a) providing information relating to

products and services;
b) handling enquiries, contracts or

orders, including changes;
c) obtaining customer feedback relating

to products and services, including
customer complaints;
Communication with customers shall

include:
d) handling or controlling customer

property;
e) establishing specific requirements

for contingency actions, when
relevant.
8.2.2 Determining the requirements for products and services
ORGANIZATIONAL
Requirements considered necessary by the
organization
Requirement ABILITY TO
MEET
s
LEGAL
Applicable statutory and regulatory Organization can meet
requirements the claims
8.2.3 Review of the requirements for products and services
8.3.2.1
The organization shall ensure that it has

the ability to meet the requirements for
products and services to be offered to
customers.
The organization shall conduct a review

before committing to supply products and
services to a customer
CUSTOMER NECESSARY ORGANIZATION LEGAL CHANGES

specified by the not stated by the specified by the statutory and contract or order
customer customer, but organization regulatory requirements
necessary requirements differing from
those previously
expressed.
The organization shall ensure that contract

or order requirements differing from those
previously defined are resolved.
The customer’s requirements shall be

confirmed by the organization before
acceptance, when the customer does not
provide a documented statement of their
requirements.
8.2.3.2
The organization shall retain documented

information, as applicable:
a) on the results of the review;
b) on any new requirements for the

products and services.
8.2.4 Changes to requirements for products and services
When the requirements for products and

services are changed:
ensure that relevant documented

information is amended,
relevant persons are made aware of the

changed requirements,
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes.

8.3.1 General
Establish, implement and maintain a

design and development process -
that is appropriate to ensure the

subsequent provision of products and
services.
In determining the stages and controls for

design and development, consider:
a) the nature, duration and complexity of

the activities;
b) the required process stages, including

applicable reviews;
c) the required verification and validation

activities;
d) the responsibilities and authorities

involved in the process;
e) the internal and external resource

needs
f) the need to control interfaces between

persons involved in the process;
g) the need for involvement of customers

and users in the process;
h) the requirements for subsequent

provision of products and services;
i) the level of control expected for

process by customers and other
relevant interested parties;
j) the documented information needed

to demonstrate that design and
development requirements have been
met.
Determine the requirements essential for

the specific types of products and services
to be designed and developed.
Functional LEGAL FAILURE

functional and statutory and regulatory potential consequences
performance requirements of failure due to the
requirements nature of the
SIMILAR CODES Products/
Services
information derived from standards or codes of
previous similar design practice that the
and development organization has
activities; committed
Inputs shall be adequate, complete and

unambiguous
Conflicting inputs shall be resolved
Retain documented information on design

and development inputs.
definition
REVIEW
determination of the suitability, adequacy or

effectiveness of an object to achieve established
objectives
definition
VERIFICATION
confirmation, through the provision of objective

evidence, that specified requirements have been
fulfilled
definition
VALIDATION
confirmation, through the provision of objective

evidence, that the requirements for a specific
intended use or application have been fulfilled
apply controls to ensure that:
a) the results to be achieved are defined;
b) reviews are conducted to evaluate the

ability of the results of design and
development to meet requirements;
c) verification activities are conducted to

ensure that the design and
development outputs meet the input
requirements;
d) validation activities to ensure that the

resulting products and services meet
the requirements for the specified
application or intended use;
e) any necessary actions are taken on

problems determined during the
reviews, or verification and validation
activities;
f) documented information of these

activities is retained.
ensure that outputs:
a) meet the input requirements;
b) are adequate for the subsequent

processes
c) include or reference monitoring and

measuring requirements, as
appropriate, and acceptance criteria;
d) specify the characteristics of the

products and services that are
essential for their intended purpose
and their safe and proper provision.

information on design and development
outputs.
8.3.6 Design and development changes
identify, review and control changes made
during, or subsequent to, the design and

development of products and services, to
the extent necessary to ensure that there
is no adverse impact on conformity to
requirements.
8.3.6 Design and development changes
Retain documented information on:
a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse

impacts.
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers

definition
EXTERNAL PROVIDER
provider that is not part of the organization

8.4.1 General
ensure that externally provided processes,

products and services conform to
requirements.
8.4.1 General
determine the controls when:
a) products and services are intended for

incorporation into the organization’s
own products and services;
b) products and services are provided

directly to the customer(s) by external
providers on behalf of the organization
c) a process, or part of a process, is

provided by an external provider as a
result of a decision by the organization.
8.4.1 General
The organization shall determine and apply

criteria for the
evaluation, selection, monitoring of

performance, and re-evaluation of external
providers, based on their ability to provide
processes or products and services in
accordance with requirements.

information of these activities and any
necessary actions arising from the
evaluations.
Ensure that externally provided processes,

products and services do not adversely
affect the organization’s ability to
consistently deliver conforming products
and services to its customers.
a) ensure that externally provided

processes remain within the control of
its quality management system;
b) define both the controls that it intends

to apply to an external provider and
those it intends to apply to the
resulting output
c) take into consideration:

1) the potential impact on the
organization’s ability to consistently
meet requirements;
2) the effectiveness of the controls
applied by the external provider;
d) determine the verification, or other

activities, necessary to ensure that the
externally provided processes,
products and services meet
requirements.
ensure the adequacy of requirements prior

to their communication to the external
provider.
Communicate requirements for:
a) products/services to be provided;
b) approvals
c) competence
d) interactions with the organization
e) control and monitoring of performance
f) verification or validation activities

8.5 Production and service provision
8.5.1 Control of production and service

provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or

external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes

8.5.1 Control of production and service provision
The organization shall implement

production and service provision under
controlled conditions.
Controlled conditions, as applicable:
a) documented information on:

1) the characteristics
2) the results to be achieved;
b) Availability of monitoring and

measuring resources
c) implementation of monitoring and

measurement activities
d) infrastructure and environment
e) competent persons
f) validation, and revalidation, where

the resulting output cannot be
verified by subsequent monitoring or
measurement;
g) actions to prevent human error;
h) release, delivery and post-delivery

activities.
The organization shall use suitable

means to identify outputs when it is
necessary to ensure the conformity of
products and services.
The organization shall identify the status

of outputs with respect to monitoring
and measurement requirements
throughout production and service
provision.
The organization shall control the

unique identification of the outputs
when traceability is a requirement, and
shall retain the documented information
necessary to enable traceability.
definition
TRACEABILITY
ability to trace the history, application or location of an

object
8.5.3 Property belonging to customers or external providers
Exercise care with property belonging to

customers or external providers while it
is under the organization’s control or
being used by the organization.
Identify, verify, protect and safeguard

customers’ or external providers’
property provided for use or
incorporation into the products and
services.
8.5.3 Property belonging to customers or external providers
When the property of a customer or

external provider is:
- lost, damaged or otherwise found to be

unsuitable for use,
the organization shall :

- report this to the customer or external
provider and
- retain documented information on
what has occurred.
8.5.4 Preservation
The organization shall preserve the

outputs during production and service
provision, to the extent necessary to
ensure conformity to requirements.
8.5.5 Post-delivery activities
Meet requirements for post-delivery

activities.
In determining the extent of post-

delivery activities consider:
a) Legal requirements;
b) the potential undesired
consequences
c) the nature, use and intended lifetime
of its products and services;
d) customer requirements;
e) customer feedback.
8.5.6 Control of changes
Review and control changes, to the

extent necessary to ensure continuing
conformity with requirements.
Retain documented information

describing the
- results of the review of changes
- the person(s) authorizing the change,
- any necessary actions arising from the
review.
8.6 Release of products and services
The organization shall implement

planned arrangements, at appropriate
stages, to verify that the product and
service requirements have been met.
The release of products and services to

the customer shall not proceed until the
planned arrangements have been
satisfactorily completed, unless
otherwise approved by a relevant
authority and, as applicable, by the
customer.
8.6 Release of products and services
The organization shall retain

documented information on the release
of products and services. The
documented information shall include:
a) evidence of conformity with the

acceptance criteria;
b) traceability to the person(s)

authorizing the release.
8.7 Control of nonconforming outputs
8.7.1
Ensure that outputs that do not conform

to their requirements are:
- identified and
- controlled
to prevent
- their unintended use or

- delivery.
Take appropriate action based on:
- the nature of the nonconformity and

- its effect on the conformity of products
and services.
This shall also apply to nonconforming

products and services detected
- after delivery of products,

- during or after the provision of services.
Ways to deal with nonconforming outputs
a) correction (Conformity to the

requirements shall be verified )
b) segregation, containment, return or

suspension of provision of products
and services;
c) informing the customer;
d) obtaining authorization for acceptance

under concession.
8.7.2
Retain documented information that:
a) describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the

action in respect of the nonconformity.

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8.

8.6 Release of Nonconformance

8.4 Control of externally provided

The organization shall plan, implement

the processes needed to meet the

to implement the actions determined in

a) Requirements b) Criteria c) Resources d) Controls e) Documentation

8.2.1 Customer communication

8.2.2 Determining the requirements for

8.2.3 Review of the requirements for

8.2.4 Changes to requirements for

8.2.1 Customer DETERMINE REQUIREMENTS

Communication with customers shall

a) providing information relating to

b) handling enquiries, contracts or

c) obtaining customer feedback relating

Communication with customers shall

d) handling or controlling customer

e) establishing specific requirements

The organization shall ensure that it has

The organization shall conduct a review

CUSTOMER NECESSARY ORGANIZATION LEGAL CHANGES

The organization shall ensure that contract

The customer’s requirements shall be

The organization shall retain documented

a) on the results of the review;

b) on any new requirements for the

When the requirements for products and

ensure that relevant documented

relevant persons are made aware of the

8.3.2 Design and development planning

8.3.3 Design and development inputs

8.3.4 Design and development controls

8.3.5 Design and development outputs

8.3.6 Design and development changes.

Establish, implement and maintain a

that is appropriate to ensure the

In determining the stages and controls for

a) the nature, duration and complexity of

b) the required process stages, including

c) the required verification and validation

d) the responsibilities and authorities

e) the internal and external resource

f) the need to control interfaces between

g) the need for involvement of customers

h) the requirements for subsequent

i) the level of control expected for

j) the documented information needed

Determine the requirements essential for

Functional LEGAL FAILURE

Inputs shall be adequate, complete and

Conflicting inputs shall be resolved

Retain documented information on design

determination of the suitability, adequacy or

confirmation, through the provision of objective

confirmation, through the provision of objective

apply controls to ensure that:

a) the results to be achieved are defined;