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Clause 7: Support

•This clause is sub-divided into the following:


• 7.1 Resources
• 7.1.1 General
• 7.1.2 People
• 7.1.3 Infrastructure
• 7.1.4 Environment for the operation of processes
• 7.1.5 Monitoring and measuring resources
• 7.1.6 organisational knowledge
• 7.2 Competence
• 7.3 Awareness
• 7.4 Communication
• 7.5 Documented information
•Let’s now look into each of these in detail …

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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:

• social (e.g. non-discriminatory, calm, non-confrontational)

7.1.4 • psychological (e.g. stress-reducing, burnout prevention, emotionally protective)

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
 
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7.1.5 Resources - Monitoring and measuring
resources

• 7.1.5.2: When measurement traceability is a requirement, or is considered by


the organisation to be an essential part of providing confidence in the validity of
measurement results, measuring equipment shall be:
• calibrated or verified, or both, at specified intervals, or prior to use, against
measurement standards traceable to national or international
measurement standards; when such standards do not exist, the basis
used for calibration or verification shall be retained as documented
information
• identified in order to determine their status
• safeguarded from adjustments, damage or deterioration that would
invalidate the calibration status and subsequent measurement results
Continued …

 
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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

• Organisations must determine the knowledge necessary for the operation of


their processes and to achieve conformity of products and services.
• This knowledge must be maintained and be made available as necessary.
• When addressing changing needs and trends, the organisation must consider
their current state of knowledge and determine how to acquire or access any
necessary additional knowledge and required updates.
• Note 1: organisational knowledge is knowledge specific to the organisation. It is
generally gained by experience. It is information that is used and shared to
achieve the organisation’s objectives.
• Note 2: organisational knowledge can be based on internal sources (e.g.
intellectual property) and/or external sources ( e.g., standards, academia).

 
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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

• Organisations must ensure that the documented


information required by the QMS and by 9001 is
controlled so that:
• it is available and suitable for use, where and
when it is needed
• it is adequately protected (e.g. from loss of
confidentiality, improper use, or loss of integrity)
Continued …

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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.

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