Tag Archives: shaun sayers

ISO 9001:2015 Non-Applicability

A post on ISO 9001:2015 by Shaun Sayers. 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

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ISO 9001:2015 Organisational Context

There has been a lot of chatter this past year about this new section 4 requirement of ISO 9001. Not all of it, in my opinion, either informed or particularly helpful. In essence, the whole concept of ISO 9001 Organisational Context is something we can summarise in very simple terms. Continue reading

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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 45001 Update

The development of ISO 45001 has been beset by delays as consensus amongst participating national bodies has been difficult to achieve. This led to the aim that ISO 45001 would be issued in October 2016 and that the FDIS stage would be omitted from the process (that is, it was hoped that comments The volume of comments and concerns raised by participating national bodies was very high and consequently ISO 45001 and the process of further consultation, will require a significant amount of work, meaning that, at this stage, the very earliest we can expect the standard to be issued in February 2017.
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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

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