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Clause 6 Download File

The document discusses planning for a quality management system (QMS). It outlines that organizations should: 1) determine risks/opportunities that could impact the QMS and plan actions to address them; 2) establish quality objectives that are measurable and consistent with policies; and 3) plan any changes to the QMS in a manner that considers consequences and maintains integrity.

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Keny Maddy
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46 views14 pages

Clause 6 Download File

The document discusses planning for a quality management system (QMS). It outlines that organizations should: 1) determine risks/opportunities that could impact the QMS and plan actions to address them; 2) establish quality objectives that are measurable and consistent with policies; and 3) plan any changes to the QMS in a manner that considers consequences and maintains integrity.

Uploaded by

Keny Maddy
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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6.

1 Actions to address risks and


opportunities

6.2 Quality objectives and planning to


achieve them

6.3 Planning of changes.

6. PLANNING
Planning for the Quality Management System
6.1 Actions to address risks and opportunities

6.1.1
When planning for the QMS determine
the risks and opportunities that need to
be addressed to:

a) give assurance that the QMS can


achieve its intended result(s);

b) enhance desirable effects;

c) prevent, or reduce, undesired effects

d) achieve improvement.
definition

RISK

effect of uncertainty
6.1 Actions to address risks and opportunities

6.1.1
When planning for the QMS determine
the risks and opportunities that need to
be addressed to:

a) give assurance that the QMS can


achieve its intended result(s);

b) enhance desirable effects;

c) prevent, or reduce, undesired effects

d) achieve improvement.
6.1 Actions to address risks and opportunities

6.1.2
The organization shall plan:

a) actions to address these risks and


opportunities
b) how to:
1) integrate and implement the
actions into its QMS processes
2) evaluate the effectiveness of these
actions.

Actions shall be proportionate to the


potential impact on the conformity
6.2 Quality objectives and planning to achieve them

6.2.1

The organization shall establish quality


objectives at relevant functions, levels
and processes needed for the quality
management system.

The organization shall maintain


documented information on the quality
objectives.
6.2 Quality objectives and planning to achieve them

The quality objectives shall:

a) be consistent with the quality policy;


b) be measurable;
c) take into account applicable
requirements;
d) be relevant to conformity of products
and services and to enhancement of
customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
definition

POLICY

intentions and direction of an organization as formally


expressed by its top management
definition

QUALITY POLICY

policy related to quality


definition

OBJECTIVE

result to be achieved
definition

QUALITY OBJECTIVE

objective related to quality


6.2 Quality objectives and planning to achieve them

The quality objectives shall:

a) be consistent with the quality policy;


b) be measurable;
c) take into account applicable
requirements;
d) be relevant to conformity of products
and services and to enhancement of
customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
6.2 Quality objectives and planning to achieve them

6.2.2

When planning how to achieve its


quality objectives, the organization shall
determine:

a) what will be done;


b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
6.3 Planning of changes

When the organization determines the


need for changes to the QMS, the
changes shall be carried out in a planned
manner

The organization shall consider:


a) the purpose of the changes and their
potential consequences
b) the integrity of the QMS
c) the availability of resources
d) the allocation or reallocation of
responsibilities and authorities.

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