What do you think of when asked if you do design--engineers? Original concept development? What about processes development? Or reverse engineering? While this is always a hotly disputed and needlessly feared area of ISO 9001 requirements, it has a much wider application than most of us initially assume.  Here is the definition of design found in ISO 9000:2005:3.4.4: design and development is a set of processes (3.4.1) that transforms requirements (3.1.2) into specified characteristics (3.5.1) or into the specification (3.7.3) of a product (3.4.2), process (3.4.1) or system (3.2.1)

NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development process.

NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product design and development or process design and development).

There are a lot of nuances in there. Many different types of engineers are all involved in design (not only mechanical, electrical and software but also, by ISO’s definition, process engineers and system engineers).
Corrective action is when I fix a problem and the customer is happy, right?  While this may be the way most folks view it, actually there’s a lot more to it. In 2005, ISO added an additional word into their vocabulary list to help clarify it: “Correction” as opposed to “Corrective action.” In 2008, they added this clarification into the ISO 9001 standard. So, what’s the difference? A Correction is when you fix the thing that went wrong (the nonconformity) This is the immediate action to keep customers or management happy: rework the product, replace the thing that’s not working right with one that does, or edit the document requiring accurate information. A Corrective Action, then, is described in 8.5.2 of the ISO 9001 standard as something done to “prevent recurrence.” This is the thing you do to ensure the nonconformity never happens again. It also requires some strategic thinking. Therefore, it is crucial to always identify causes of nonconformities before defining and implementing a Corrective Action.
Saturday, 07 September 2013 16:43

How SMART are Your Quality Objectives?

Written by

S.M.A.R.T. Quality Objectives.

I recently watched Robert Alvarez provide an excellent description of Quality Objectives, and I share this concept with his permission.

ISO 9001:2008, 5.4.1 requires that management set measurable quality objectives. In over 13 years of auditing, I have seen many stated objectives—of which about only 20% are measurable and 10% are measured effectively.
Wednesday, 22 January 2014 16:40

Your QMS Truly CAN Help You Reach Your Strategic Goals

Written by
What one thing in your QMS seems arduous but can help your company take a leap forward this year? For some, the answer would be finding ways to collect and analyze needed data. For others, it’s employee engagement in the company’s objectives. Or, resolving vendor relationships that remain painful despite effort.  For many, it’s finding new customers and new ways to serve old customers. What if I told you that all of these could be helped by the effective use of one tool?  In over 20 years of auditing, the one tool we’ve seen that has the greatest potential for change (but remains the most dreaded and least used) is Causal Analysis or Root Cause Analysis.  Most avoid it because it’s not fast and it can’t be done effectively by solely one person.
Page 5 of 7