Finding out the extent of the Quality Management System (QMS) has been a part of the ISO 9001 prerequisites  (basic requirements) for quite a while. This degree is an essential part of the quality manual or related document, as it characterizes how far the QMS reaches out inside the organization’s activities and subtleties any rejection from the ISO 9001 prerequisites and the support for these. You describe what your Quality Management System covers inside your company or organization, or institute through the extension.

After the arrival of the new update to the ISO 9001 prerequisites, ISO 9001:2015, there is some extra explanation on characterizing the scope of the QMS. These explanations will assist with normalizing how organizations illustrate the extent of QMS, regardless of whether they decide not to have a quality manual, which is not generally an expressed prerequisite in the norm.

The sub-clause 4.3 Scope of the Organization of the standards ISO 9001:2015 Main clause 4.0 Context of the organization identifies the requirement of the standard for setting, deciding and planning the scope of the organization by:

• Determining the boundaries of the organization following the business processes.
• The interest of interested parties.
• Internal and external environment. i.e. internal and external issues.
• Following the supply chain and organizational future goals of extensions (backward or forward integration).

In a note about the QMS, it is expressed that the QMS can incorporate the entire organization, explicitly distinguished elements of the association, explicitly recognized areas of the association, or at least one capacity across a meeting of organizations.

Also, the degree incorporates any prerequisites of the ISO 9001 standard that can be applied. Assuming a not set in stone to not make a difference, the organization won’t utilize this to justify not guaranteeing similarity of item and administration. The degree is to express the items and administrations covered by the QMS and defence for any cases where the ISO 9001 standard can’t be applied.

Few repeated and famous questions may also arise in the mind of organizations stakeholders while setting the scope for the organization and certification. They both are quite different from each other.

Why is determining the scope of business necessary for any organization?

Because it is the fundamental condition to finalize the boundaries of any organization to adopt the ISO 9001 requirements whether they apply for the certificate or not, it is still mandatory to do so. By determining the scope, an organization can easily control its:

• Internal issues
• External issues
• Interested parties and their matters
• Fewer risks and greater the opportunities
• Better focus on customers and external providers (suppliers)

How can an organization set its scope of processes and certification?

The organization must identify their ultimate scope in a written form applicable to the QMS, including design and development, laboratory works, manufacturing activities, post-delivery services. 

For example:

• JK Corp manufactures cellular phones following the designs of its customer and ensures the quality controller given from the main customer with the services of deliveries in which the services after sales are covered by the main customer. (In this case, we can see that JJ Corp does not cover the main area of design and development for the sub-clause 8.3 of the ISO 9001:2015 standard and also does not cover the software sector). Similarly, the scope of the certification on the certificate can be used as “Manufacturing the hardware of cellular phones”.
• PFJ Pharmaceuticals deals in R & D, manufacturing, QA/ QC, post-delivery services of its patent/ licensed products in the market/ industry of medicine; therefore, scope shall be narrated differently in their manuals and certification. i.e. “designs, manufactures, control controls and post-delivery services for the pharmaceutical products.”

It is very important to note that your statement of the scope must not be vague at all. It must be:

• Specific
• Clear
• Concise
• Identifying all the processes including (departments) and to those which are not covered in processes. i.e. excluded part of ISO 9001 standard .i.e. 8.3 or other sub-clauses.

Most of the time, the ambiguity arises during or middle of the audit where two different processes are being run in the same organization with varying departments under the same title of the organization.

In this case, the organization failed to document other functions in the section of the scope statement in its quality manual or standard operating procedure.

The above-highlighted points help the organization set their scope of business to avoid such major non-conformances during the certification audit.

This is how organizations have to decide their business processes before setting their scope for the ISO certification with the help of this topic. It is technical enough; therefore, top management should ensure the availability of a senior member of the management and the team of experts or third-party experts to help the organization set their scope of business and certification.