8.4.3 Information for external providers Readers, I appreciate your patience as we work carefully through this section.  It is one of the most detailed, which is a plus because it is clearly defined so it can be easily understood.  However, the section is wordy and can be somewhat redundant.  I’m happy to continue, though, because…

Read More

8.4.2 Type and extent of control of external provision Last week, we reviewed 8.4.1 where the requirements of how the standard applies.  This week, we begin to peel back the layers, so to speak, about what must actually be done to be compliant. Before we get down to business, I’d like to point out the…

Read More

8.4.1 Control of externally provided products and services Make it or buy it?  That is the question. Organizations with a focus on core competencies often choose to outsource rather than try to do themselves those things that fall outside of their “wheelhouse”.  When making this choice, the organization is relying on an outside provider to provide…

Read More

8.3.6 Design and development changes One thing is for certain, change happens! This week, we’ll look at the final section of 8.3 Design and development of products and services.  8.3.6 Design and development changes.  Along with a very specific and disciplined list of required inputs, controls and outputs, we must always consider the importance of…

Read More

8.3.4 Design and development controls Hello Readers!  It’s been a very busy summer and last week, an on site client project consumed the week before I knew it had gotten away from me!  So, this week, we have a double edition, talking about 2 sections, “8.3.4 Design and development controls” and “8.3.5 Design and development…

Read More

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