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Scope of The QMS

The document discusses determining the scope of a quality management system (QMS) according to ISO 9001:2015. The QMS scope includes the processes and locations included in the system. Elements to consider include external/internal issues, requirements of interested parties, and organizational products/services. Some ISO 9001:2015 requirements may be deemed not applicable if the organization justifies how customer satisfaction and requirements are still met. Auditors should verify the documented QMS scope and justifications for any excluded requirements.

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752 views2 pages

Scope of The QMS

The document discusses determining the scope of a quality management system (QMS) according to ISO 9001:2015. The QMS scope includes the processes and locations included in the system. Elements to consider include external/internal issues, requirements of interested parties, and organizational products/services. Some ISO 9001:2015 requirements may be deemed not applicable if the organization justifies how customer satisfaction and requirements are still met. Auditors should verify the documented QMS scope and justifications for any excluded requirements.

Uploaded by

Victor
Copyright
© © All Rights Reserved
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ISO 9001:2015 Quality Management System Auditor

- Determining the scope of the QMS -

QMS Scope = what processes and locations from the organization are included in the
Quality management system

Elements to take into consideration when determining the


QMS Scope:
- The external and internal issues
- The requirements of the interested parties
- The products and services of the organization
ISO 9001:2015 Quality Management System Auditor
- Determining the scope of the QMS -

Some requirements of ISO 9001:2015 may be considered not applicable

- Those requirements considered not applicable shall not affect the organization’s ability
to provide products and services that meet requirements or enhance customer
satisfaction
- There has to be a justification for considered some requirements not applicable

AUDITING

- QMS scope should be maintained as documented information (may be


included in a document like a quality manual or may be a stand alone
document)
- Look at the justification of requirements considered not applicable

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