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Clause 7 Support
Clause 7 Support
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7.1.1 Resources - General
• Organisations must identify and provide the
resources needed for the establishment,
implementation, maintenance and continual
improvement of the QMS, taking into account:
• the capabilities of, and constraints on,
existing internal resources
• what needs to be obtained from external
providers
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7.1.2 Resources - People
• Organisations must determine and provide
the staff necessary for the effective
implementation of your quality
management system and for the operation
and control of its processes.
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7.1.3 Resources - Infrastructure
• Organisations must determine,
provide and maintain the
infrastructure necessary for the
operation of their processes and to
achieve conformity of products and
services, including:
• buildings and associated
utilities
• equipment, including
hardware and software
• transportation resources
• information and
communication technology
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• Organisations must determine, provide and maintain the environment necessary for the
operation of their processes and to achieve conformity of products and services.
• A suitable environment can be a combination of human and physical factors, such as:
Resources -
• physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise)
• These factors can differ substantially depending on the products and services provided.
Environment
for the
operation of
processes
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• Organisations must determine and
provide the resources needed to
ensure valid and reliable results when
monitoring or measuring is used to
verify the conformity of products and
services to requirements.
• They need to ensure that the
resources provided:
• are suitable for the specific type
of monitoring and measurement
activities being undertaken
• are maintained to ensure their
continuing fitness for their
purpose
• The oganisation must also retain
appropriate documented information
(i.e. records) as evidence of fitness
for purpose of the monitoring and
7.1.5 Resources - measurement resources.
Continued …
Monitoring and measuring
resources v
Proprietary document of AUSPICE MANAGEMENT SOLUTIONS W.L.L. Unauthorized copying is strictly prohibited
7.1.5 Resources - Monitoring and measuring
resources
Proprietary document of AUSPICE MANAGEMENT SOLUTIONS W.L.L. Unauthorized copying is strictly prohibited
7.1.5 Resources - Monitoring and
measuring resources
• When measuring equipment is found to be unfit for its intended
purpose, Organisations must determine if the validity of
previous measurement results has been adversely affected.
• Where the validity of previous measurement results have been
adversely affected, the organisation must take appropriate
action as necessary.
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7.1.6 Resources - organisational knowledge
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7.2 Competence
• Organisations must:
• determine the necessary competence of person(s) 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 (such as the provision of training to, the
mentoring of, or the reassignment of currently employed persons; or the hiring
or contracting of competent persons) to acquire the necessary competence,
and evaluate the effectiveness of the actions taken
• retain appropriate documented information as evidence of competence
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7.3 Awareness
• Organisations must ensure that those doing work
under their control are aware of:
• the quality policy
• relevant quality objectives
• their contribution to the effectiveness of the
QMS, including the benefits of improved
performance
• the implications of not conforming with QMS
requirements
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7.4 Communication
• Organisations needs to determine and undertake the internal
and external communications relevant to the QMS, including:
• what you will communicate
• when to communicate
• with whom to communicate
• how to communicate
• who communicates
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7.5.1 Documented information –
General
• The QMS must include:
• documented information required by the
ISO9001:2015 standard
• documented information determined by the
organisation as being necessary for the
effectiveness of the QMS
• The extent of documented information for a QMS can
differ from one organisation to another due to:
• the size of organisation and its type of activities,
processes, products and services
• the complexity of processes and their interactions
• the competence of persons
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7.5.2 Documented information -
Creating and updating
• When creating and updating
documented information,
Organisations must 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
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7.5.3 Documented information - Control
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7.5.3 Documented information - Control
• For the control of documented information, Organisations must address the following activities,
as applicable:
• distribution, access, retrieval and use
• storage and preservation, including preservation of legibility
• control of changes (e.g. version control)
• retention and disposition.
• Access as referred to above, can imply a decision regarding the permission to view the
documented information only, or the permission and authority to view and change the
documented information.
• Documented information of external origin, that you determine to be necessary for the
planning and operation of the QMS, must be identified as appropriate, and be controlled.
• Documented information (i.e. records) retained as evidence of conformity must be protected
from unintended alterations.
Proprietary document of AUSPICE MANAGEMENT SOLUTIONS W.L.L. Unauthorized copying is strictly prohibited