Category Archives: 9001 Lead Auditor Study Group

ISO 9001:2015 External Issues

In this post I will explore what (external issues) actually means and offer some suggestions and examples of how an organisation might demonstrate conformance to this requirement, focussing in this post specifically on external issues. For more background information on the wider requirement and on internal issues, you might find some useful guidance in this earlier post. Continue reading

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ISO 9001:2015: A Word on “Written Procedures”

There was a time, years ago, when “controls” and “procedures” were tantamount the same thing. Documented procedures were BY FAR the most widely applied control, so asking for “the procedure” was a reasonable request. Those days are gone, and ISO 9001:2015 has tried to reflect that. It has tried to reflect the way organisations manage their affairs in the 21st Century and, unfortunately for the lazier auditor, this will involve “documented procedures” to a lesser and lesser extent. They do things differently Continue reading

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ISO 9001:2015 Human Factors

Most people that know anything about management systems understand that human factors have to be accounted for. You can’t simply write a procedure or implement a control and then assume that it will be adhered to. People are not like that. People can be lazy, selfish, tired, distracted, hacked off … all of which can reduce the chance that a procedure, no matter how correct and communicated, may not be followed all of the time. Continue reading

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ISO 9001:2015 Revised Quality Management Principles

The principles of quality management can be considered “threads” of good business practice that should focus the application and intent of the ISO 9000 series. ISO 9000:2015 provides guidance on the way that these principles should be applied Continue reading

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ISO 9001:2015: Internal and External Issues

All management systems adopting the Annex SL format are required to identify and manage as appropriate, the management system’s internal and external issues. This will initially require an organisation to determine the scope of the management system, then to understand the processes within its scope, and then to further understand how they inter-relate both internally and externally. Continue reading

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