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 ...

7.3 Awareness

Persons doing work under the organization’s control shall be aware of:

1. a)  the quality policy;
2. b)  relevant objectives;
3. c)  their contribution to the effectiveness of the quality m
...

7.2 Competence

Last week’s discussion was about “organizational knowledge” as a required resource.  We defined what sort of knowledge was required to successfully perform our processes and create a g...

7.1.6 Organizational knowledge

Well, here we are at week 19 already!  I hope you’re enjoying the discussion thus far.  I have really enjoyed hearing everyone’s input (and on topics OTHER than risk ba...