Category Archives: ISO 9000

ISO 9001:2015 Non-Applicability

I’m starting to get asked this quite a bit just now, so maybe it’s time for an article to explain it and to point people at. Those people going through ISO 9001 transition now, and whose QMS has what ISO 9001:2008 calls “exclusions” will need to revisit the matter. In many ways the same rules apply, but there are a couple of differences. Continue reading

Posted in ISO 9000, ISO 9001:2015 | Tagged , , , , | 2 Comments

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

Posted in Auditing, ISO 9000, ISO 9001:2015 | Tagged , , , , , , | 10 Comments

ISO 9001:2015: A Dystopian Nightmare

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

Posted in ISO 9000, ISO 9001:2015 | Tagged , , , | 1 Comment

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

Posted in ISO 9000, ISO 9001:2015 | Tagged , , , , , , | 5 Comments

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

Posted in ISO 9000, ISO 9001:2015 | Tagged , , , , | 1 Comment