Scope, not just for rifles anymore.
In the new 2016 version of AS9100, the word “shall” is mentioned 197 times, and as we all know, shall means that there is no gray area. All “shalls” are non-negoitable, which means the requirement is not just a suggestion, but a requirement. Continuing on with the “shall series”…
4.0 CONTEXT OF THE ORGANIZATION II
4.3 Determining the Scope of the Quality Management System
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
When determining this scope, the organization shall consider:
- the external and internal issues referred to in 4.1;
- the requirements of relevant interested parties referred to in 4.2;
- the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
Plain English Translation
The bottom line to this new requirement is that you need to define the internal and external influences on your organization before you can define the Scope of your QMS. While most of the world has long ago defined their QMS Scope, you have to back into this requirement by doing the analysis and making any necessary adjustments to the QMS and/or Scope.
Contact me to see how I can help you develop your Context of the Organization process for ISO 2015 or AS9100 2016 as painlessly as possible in your company.
920-841-3478
Steve@TheRightApproachConsulting.com