ISO9001:2015 52-Wk Challenge (Week 6)

This is a 52 week discussion of the proposed 2015 revision of ISO9001. We challenge you to follow us each week, and review your QMS from top to bottom with us. By year end 2015, you can have your QMS upgraded and ready for the 2015 revision!

Do you know your boundaries?  This week, we put together our previous discussions about why our organization exists (its mission and strategy) and what our context is (where and how we fit into our industry and community).

Now, it is time to put pen to paper (or other media, as it were) and to establish as “documented information” the scope of the quality management system.  Clause 4.3 specifically defines what “shall” be considered.  This includes “internal and external issues” as we discussed in Week 4 for 4.1, “requirements of relevant interested parties” as we discussed in Week 5 for 4.2 and the “products and services of the organization” as we discussed in Week 3 for 4.0.

As we create this scope statement “as documented information”, we must specifically identify the products and services covered by the QMS and justification where anything in the ISO standard may not apply.  This was formerly referred to as “exclusions” and most companies who are currently registered to ISO9001 have had help with their scope and exclusions statements, because this is the first order of business in the registration process.

The subtle changes in language, IMHO (in my humble opinion), are helpful in further defining the intent of this clause.  Further, the language bridges the gap that many quality professionals have had to manage in that a quality management system MUST include participation by management and an intimate inclusion in the business management system overall.  The expansion of definitions in this area also guide the organization to consider their business strategy as a whole when creating their QMS, (rather than just making the scope and exclusions strictly for the use of the certification body).

THIS WEEK’S HOMEWORK

Describe the scope of your quality management system with specific definition of your organization’s products and services, relevant interested parties (both internal and external) and the REQUIREMENTS of those interested parties.  After all, the whole reason for having a QMS is to create a system for ensuring the organization can meet those requirements.

Please feel free to share your scope with the group for discussion.  If you are currently registered to ISO9001:2008, did you make any changes to your scope?  Thank you in advance for sharing your work!

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