ISO 9001 clause 8.2.3 and 8.4

Q: Our quality management department, of which I am the lead internal auditor, has a question that we have been debating for some time:

How do we apply ISO 9001:2008 Quality Management systems-Requirements, clause 8.2.3 Monitoring and measurement of processes and 8.4 Analysis of data, in a non manufacturing organization?

Our organization is primarily software, software modification of COTS that is implemented into our products, and applications modified for our business unit’s use.

My specific questions are:

1. How is the effectiveness of process improvements measured.

2. What methods of measurement do we use to capture the effectiveness?

3. Is there a check sheet or report form available that would guide us on how to apply these two requirements?

Thank you for your assistance in this matter. We want to implement a methodology for capturing measurement and effectiveness of process improvement data, but are at a loss as to how and where to start.

A: You posed several questions about ISO 9001 compliance.

1. How is the effectiveness of process improvements measured?

In a service environment there are typically many process characteristics that can be monitored or measured to assess whether the process has been planned and is being carried out under controlled conditions. Without knowing details of your service offering, it is difficult to comment explicitly.

Possible examples of metrics that may be appropriate include on time completion of a project, after-release detected “bugs,” time required to maintain “released” software modules, and etc.

Also, such metrics can be graphed and cost can be tied to each metric so that when process improvements are made, the benefits can be presented to management in management review in terms of the financial benefits of aggressive measuring and monitoring initiatives.

2. What methods of measurement do we use to capture the effectiveness?

See #1 above.

3. Is there a check sheet or report form available that would guide us on how to apply these two requirements?

Any check sheet or form would have to be developed by you to suit your processes.

A few references that would be helpful to you are ISO 9001:2008 Explained, Third Edition and How to Audit the Process-Based QMS.

Charlie Cianfrani
Consulting Engineer
Green Lane Quality Management Services
Green Lane, PA
ASQ Fellow; ASQ CQE, CRE, CQA, RABQSA Certified QMS-Auditor (Q3558)
ASQ Quality Press Author

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