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…
Blog Archives
ISO9001:2015 52-Wk Challenge (Wk 29) 8.3 Design and development of products and services
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…
ISO9001:2015 52-Wk Challenge (Wk 28) 8.2.3 Review of requirements related to products and services
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…
ISO9001:2015 52-Wk Challenge (Wk 27) 8.2.1 Customer communication
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…
ISO9001:2015 52-Wk Challenge (Wk 26) 8.1 Operational planning and control
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…
ISO9001:2015 52-Wk Challenge (Wk 25) 7.5.3 Control of documented information
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…
ISO9001:2015 52-Wk Challenge (Wk 24) 7.5.2 Creating and updating (documented information)
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…
ISO9001:2015 52-Wk Challenge (Wk 23) 7.5 Documented information
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…
ISO9001:2015 52-Wk Challenge (Wk 22) 7.4 Communication
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…
ISO9001:2015 52-Wk Challenge (Wk 21) 7.3 Awareness
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…
