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,...

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 ...

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 wee...

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...

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 ...

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 de...

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 ...

7.5.2 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...

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 anymo...

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 ...