15. QUESTIONS/TIPS ON UPGRADING OF ISO 9001 :2008

1. 4.1 Quality Management System (General Requirements)

Are all outsourced processes identified? Is there a need to revise the system for type and extent of control over outsourced processes?


2. 5.5.2 Management Representative
Is the Management Representative a member of the organization's own management?

3. 6.2.1
Human Resources (General)
Did the new Note for this clause expand your view of the personnel expected to be competent based on their direct or indirect effect on conformity to product requirements?

4.)6 .3 Infrastructure
Has the new example of supporting services resulted in information systems being added to the internal audit schedule?

5.) 6.4 Work Environment
Did the new Note for this clause result in the consideration of more conditions (physical, environmental, noise, temperature, humidity, lighting or weather) that might affect the work environment?

6.) 7.2.1 Determination of Requirements Related to the Product
Did the new Note for this clause expand the view of what should be considered as a post-delivery activity?

7. ) 7.3.3
Design and Development Outputs
Did the new Note for this clause result in product preservation requirements, e.g., packaging, being considered as part of the design and development output?

8.) 7.5.4
Customer Property
Did the revised Note for this clause cause client to expand the category of customer property to include personal data?



9. ) 7.6
Control of Monitoring and Measuring Equipment
Has the new Note for this clause clarified how to confirm the ability of computer software for the intended application?


10.) 8.2.1
Customer Satisfaction
Has the new Note for this clause identified more input sources for monitoring the customer's perception as to how well client are meeting their requirements?

11. ) 8.2.2
Internal Audit
Has the revised requirement to ensure any necessary "corrections and corrective actions" are taken resulted in the revision of the audit procedure?

12. )
8.2.3
Monitoring and Measurement of Processes
Has the new Note for this clause resulted in a consideration of the impact of monitoring and measurement methods on conformity to product requirements and the effectiveness of the quality management system?

13.
8.5.2
Corrective Action
Has the revised requirement to review the effectiveness of the action taken resulted in an update of the corrective action process?

14.
8.5.3
Preventive Action
Has the revised requirement to review the effectiveness of the action taken resulted in an update of the preventive action process?


15.
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Conclusion
Has the QMS documentation been fully updated to address the requirements of ISO 9001: 2008?