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