ISO 9001:2015 clause 4 (Context of the organization ... · Presenter: Carlos Pereira da Cruz ISO...
Transcript of ISO 9001:2015 clause 4 (Context of the organization ... · Presenter: Carlos Pereira da Cruz ISO...
Presenter: Carlos Pereira da Cruz
ISO 9001:2015 clause 4 (Context of the organization, interested parties and scope)
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How to deal with the context of the organization, interested parties and scope of the QMS
If you’re starting to implement a QMS…
… these issues need to be addressed before you start implementing the rest.
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An organization determines: what is
relevant in the context, who the
interested parties are, what their
relevant requirements are, and the
scope of the QMS.
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Agenda
•Context – external issues •Context – internal issues •Relevant interested parties •Relevant requirements of interested parties
•Scope of the QMS •Exclusions
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Environment
Context - external
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Organization
Legislation Business models
Competition
Economy
Politics Technology
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Environment
Context – internal
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Organization
Employees Product portfolio
getting old
Breakdowns Quality
problems
Performance
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• Determine the relevant issues
• Determination of relevant issues is a never ending activity
4.1 Understanding the organization and its context
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Potential interested parties
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Organization
Customers
Regulators
Suppliers
Employees Influencers
Prescribers
Customers'
customers NGO’s
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Relationships between interested parties
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Company
University
Builders Architects
Regulators
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Requirements from interested parties
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Builders
Architects
A tool to help me run
away from engineering
and materials constraints
I can trust on
their know-how
They deliver
on time Quality OK
They deliver
support during
installation
They train
users
They give
guaranties of
service
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4.2 Understanding the needs and expectations of interested parties
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• Determination of relevant interested parties and their relevant requirements is a never ending activity
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ISO 9001 clause 4.3 requirements for the scope
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• An organization must determine the scope of the quality management system
• No exclusions are allowed, if a clause is applicable it must be considered in the QMS
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Exclusions from the QMS scope
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• An organization has the flexibility to apply the QMS to all products and services or part of it, to all locations or parts, provided that everything is very clear, and not misleading.
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Example of making a scope decision and exclusion
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Only Private
Label
Only Own
Brand 25% Own
Brand
Applicable? NO YES ?
Is clause 8.3 Design and development of products
and services applicable to a company?
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Main challenges
• Find the appropriate level of detail for internal and external factors
• Design an ecosystem of relevant interested parties
• Using the scope as a management decision
• Live without mandatory documentation
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Conclusion
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Determine the context of your organization and the relevant
interested parties
Determine the scope of your QMS that best suits your activity
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Q & A
Presenter: Carlos Pereira da Cruz
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