8.3.3 Design and development inputs Ah yes, and now we get to the section so many companies previously chose to “exclude” from their quality management systems.  This is some tough content and these are some tough requirements to meet.  Many companies rely on their customers for the design of their products and services, and therefore,…

Read More

8.3.2 Design and development planning When tackling this clause, it is important to clearly identify how and where it is applicable within your organization to avoid confusion.  For example, last week we discussed how many organizations do not actually do any type of design or development of their product/service, but may defer to their customer’s…

Read More

8.3 Design and development of products and services I’d like to start this week’s discussion with a big thank you to one of my readers who brought to my attention a mistake I made last week.  Somehow, as I wrapped up week 27 with 8.2.1, and began week 28 with 8.2.3, I skipped over 8.2.2. …

Read More

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:…

Read More

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…

Read More

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…

Read More

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,…

Read More

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…

Read More