8.2.3 Review of requirements related to products and services Last week, we established our methods of communication with customers and soliciting input regarding their needs.  Now it’s time to talk about understanding and reviewing those needs in order to fulfill them. Let’s have a look at each requirement individually. “The organization shall review, as applicable:…

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8.2 Determination of requirements for products and services 8.2.1 Customer communication This week’s discussion is about customer communication, and the requirement is that first, there must be a defined process for how the organization will communicate with a customer.  Once again, I must point out the awkwardness of the structure of ISO9001:2015.  This section jumps…

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8.1 Operational planning and control This week, we change gears from higher level planning of the quality management system overall, to the nitty gritty of operational planning and control.  In Week 7 of this challenge, we identified the processes necessary to maintain full control of the quality (or business) management system.  There is some overlap…

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7.5.3 Control of documented information Well, well, well.  We’ve finally arrived at the control part of document control.  Last week, we talked about what documents are.  They’re not just paper anymore.  We talked about having a system for creating them with a standard minimum of information which must be included – date, author, revision number,…

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7.5.2 Creating and updating (documented information) ISO9001:2015 changes terminology from “documents” to “documented information” in an attempt to clarify to the last remaining users who have yet to pry their paper documents out of their hands, the wide assortment of other media available for use in support of a quality management system.  Most all organizations…

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7.5 Documented information, 7.5.1 General “Say what you do and do what you say”?  That’s the old adage, I suppose.  But what does it mean, really?  Does the ISO9001 standard require that we document everything we do?  Has it ever required that? The 2015 revision changes “documentation” into “documented information” for clarification.  And it still…

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7.4 Communication In the immortal words of both Strother Martin and Paul Newman in the movie “Cool Hand Luke”, “What we have here is a failure to communicate!”. Communication is perhaps the absolute bedrock of every organization.  Poor communication leads to chaos, poor performance, poor morale and other bad things.  Good communication can foster a sense…

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7.3 Awareness Persons doing work under the organization’s control shall be aware of: a)  the quality policy; b)  relevant objectives; c)  their contribution to the effectiveness of the quality management system, including the benefits of improved quality performance; d)  the implications of not conforming with the quality management system requirements. This is one of my…

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