Scope Statement

Employees, Training, Working, Learning, Duties, Tasks, DFSS, Innovation, Audit, Auditing

Question

My company is late to transition from ISO 9001: 2008 to 2015 and we are just starting. I am already stumped. I need to answer “What is our your scope statement?  This should succinctly summarize your products and/or services. A single sentence is all that is required, as this will be shown your ISO 9001:2015 certificate.”

We are a commercial printing and bindery. Is the scope from receipt of order through final acceptance by the customer? I don’t know what this means.

Answer

Scope is a difficult concept for many. Accuracy is important; however, you encounter two types of scope that may confuse you.  The first is the Scope of the Standard.  It’s in the “introduction,” in clause 01.  It’s informational and is not auditable.  The second is clause 4.3.  Scope is the outcome of the work in 4.1 & 4.2.  There can be a number of ways to address scope: your range of products and services (XYZ company provides design and printing services); different sites (XYZ designs art work in its Chicago studio and our Cleveland plant does commercial printing) – each of these sites addresses their activities; outsourced services (XYZ company coordinates outsourced design and printing services for our customers).  You can slice and dice scope for a single plant (having others in the company), specific sections (within XYZ company, implantable medical devices are manufactured).

In your case, “XYZ provides commercial printing and bindery” is sufficient.

The scope must be documented and will be verified by your third party certification body.

Thanks for your question.

George Hummel

ISO Certification without Quality Dept?

Suppliers, supplier management

Question

There were some changes recently in the company where I work. Now, a quality manager or quality function does not exist in the our company; however, we do maintain the ISO certification.  Our ISO certification applies to our corporate office and it applies also to the manufacturing facility located in a different city.

Is acceptable to have an ISO certification and not have a quality function?

Answer

There is no requirement for a quality function in ISO 9001:2015. I believe that this can be a positive move for your organization as it puts the job of quality upon the process owners, especially top management.  This is where it should be.

It can be a little messy as these responsibilities are passed back to the process owners; but, it’s right!

George Hummel