The Scope Statement describes your products and services, the regulatory requirements, activities, remote locations, and facilities supported and documented by your company's quality management system.
In essence, your scope identifies precisely what your business does.
Make sure your Scope details are fully documented in your QMS. Remember to keep it short and simple. Your customers should be able to read and understand it easily.
Considering the nature of your business, the scope of ISO 9001 should be evident by the range of controls and processes that have already been established.
Usually, the scope covers the entire organization. However, there are exceptions for companies with multi-location sites, such as national and international offices. It can also be limited where a business has two sides, and the QMS (Quality Management System) only applies to one.
The scope includes the ISO requirements that apply. A justification should be provided for the standards that do not apply. It covers the organization's physical location, products and services, and relevant industries.
Yes, there may be. The second part of the scope can include exclusions; in most cases, it will identify none. However, a common exclusion is the ‘Design & Development standard,’ which applies to companies such as machining shops. Such businesses do not design any product but work exclusively from drawings of their clients.
Focus on short-term external factors only. You may not be able to reap the long-term benefits of internal motivators such as the quest for higher efficiency and productivity.
Some reasons may be valid, but if considered alone, they cannot get you the best results. Examples of wrong reasons for pursuing ISO 9001 certification include marketing purposes and just because competitors have acquired it.
After determining the right reasons for seeking the certificate, it’s time to seek support from Top Management. This could be the business owner, the board of directors, or the CEO.
These people should give insights necessary for a Quality Management System to successfully acquire the ISO certificate and its potential benefits.
When leaders demonstrate commitment, they are taking accountability for QMS. Thus, they must emphasize the significance of ISO 9001's requirements. If Top Management is not involved in the process, ISO 9001 may not be sustainable in the long run.
The personnel involved in creating the scope must be conversant with ISO 9001. If they don’t understand the requirements, they could make a huge mistake. The key personnel, in this case, are people involved in the decision-making process.
Everyone needs training in 1SO certification. The importance of quality and how to achieve it should be communicated appropriately. The training should match the personnel's responsibilities and duties.
Your scope statement should not be limited to a particular size. However, it must stay clear and concise.
You need to gather sufficient information to determine what is covered by the QMS process. But be clear about what’s covered and what’s excluded.
You must stipulate what processes your QMS covers. Otherwise, how will the interested parties and the auditor understand the scope?
By making the statement simple and legible, you can focus on your QMS efforts and prevent unnecessary activities or questions that do not apply to your ISO 9001 certification.
One of the most important elements of the ISO scope is describing how processes interact in your organization. To make this easier, use flow charts to identify those processes and how they are interrelated.
Consider a simple, top-level flow chat to expound on the basics of the Quality Manual rather than an in-depth flow chat, which might confuse people.
You might wonder, ‘How does the scope apply to your business? Most probably, the ISO scope will cover your organization in its entirety. But if your service is split between two industries, some exemptions will exist.
Another exemption is when your QMS covers a single physical location of your international company, and you want only one location to be ISO certified.
If all business areas are applicable, specify which parts are.
