Database Reference
In-Depth Information
Section 4 is a great place to start an internal audit because it addresses the "big
picture" items. If there are any non-conformances from a Section 4 audit, fix
the problems before auditing Sections 5 through 8. This will save a lot of effort
documenting the same problem over and over.
Questions
1. General quality system requirements
Has the organization established, documented, implemented, and maintained a
quality management system in accordance with the ISO 9001 Requirements?
Is the Quality Management System (QMS) continually improving?
Has the organization:
1) Identified the process needed for the QMS throughout ISO 9001 organization?
2) Determined the proper interaction between the process ISO 9001. Is there a flow
chart that shows the process flow for the entire organization?
3) Determined and documented criteria and methods to ensure that the ISO 9001
operations and process control are effective?
4) Got resources and information necessary to support ISO 9001 operations and
maintenance of their process?
5) Got resources to measure, monitor, and analyze their processes?
6) Implement corrective and preventive actions needed to achieve the planned
results as documented in the quality plans?
7) Does the company have documentation to show continuous improvement in
their process?
Does the organization have documentation in accordance with the requirements
of the ISO 9001 Standard?
How does the company control quality processes that are performed outside of
the ISO approved facility?
2.Documentation requirements
2.1 General
Does the QMS documentation system include:
1) Quality Manual?
2) Documented company quality policy and quality objectives?
3) Documented level 1 and level 2 procedures as required by ISO 9001?
4) Documentation on how the company can effectively plan, operate, and control
its processes?
5) Creation and management of records that demonstrate compliance with the
ISO standard?
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