What Is Scope In ISO 9001?
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.
Contents
- What Is Scope In ISO 9001?
- What Precise Elements Should The Scope Include? (4.3)
- Are The Any Exclusions In The Scope?
- How To Write Your Scope For ISO 9001
- 7 Examples Of ISO 9001 Scope Statements
- Tips For Writing Your Scope
- Writing ISO 9001 Scope: Common Mistakes To Avoid
- Why Is Scope Important?
- QMS Scope & Processes Procedure
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.
What Precise Elements Should The Scope Include? (4.3)
- The organization as a whole
- The support offered by centralized functions
- Processes, site-specific instructions, and procedures
- Specific sections of the organization
- Specific functions of the business
- Various functions across a group of entities
When Establishing The Scope, There Are Three Factors You Must Consider
- Requirements of relevant parties: directors, investors, suppliers, and employees
- The internal and external issues affecting the organization
- Products and services
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.
Are There Any Exclusions In The Scope?
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.
Start with Expert Templates, then Make Them Yours
How To Write Your Scope For ISO 9001
- Please do it for the right reasons
- Engage the top leadership commitment
- Train the personnel involved
- Make it simple and precise
- Determine what is applicable and what is not
- Avoid being sales-y
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.
Don’t Try to Manage It All Alone!
7 Examples Of ISO 9001 Scope Statements
(The company names mentioned below are entirely fictional. The scope statements are for illustrative purposes only):
- Empreza manufacturing company located in Cleveland, Ohio, produces automotive machines and their components within the USA
- Amaco consultants with offices in Atlantic City, Camden, and Jersey City, NJ, offer professional IT services to companies and individuals from all industries
- Find Justice consultants provide legal advice and attorney services to organizations in the real estate sector within South America
- Quala, a part of Express International that operates in Canada in the Pharmaceutical industry, provides traditional medicinal drugs
- Digital Computing provides web development services to companies across the globe
- PendoLa Inc. is an affiliate company of Pendo that operates in Japan and produces kitchen appliances in America, Europe, and the Middle East
- Illuminac specializes in manufacturing, marketing, and sales of furniture and lighting accessories, located in Utica, New York
Finally, stating you are the best or industry-leading company in the country is not necessary. Save such overhyped adjectives for marketing materials. When writing the scope, you are only supposed to explain the management system's applicability and boundaries. You are not trying to make a sale here.
However, do not be scanty. For instance, ‘Machine Shop in Colorado produces precision machines’ would sound better as:
‘Located in Denver, Colorado, Machine Shop is a high-volume producer of precision machines for suspension systems, aluminum brakes, and steering according to OEM standards for automotive applications.’
The latter version is much better because it covers the products, though limited, and specifies one compliance that most clients would be interested in. A good statement addresses all the requirements of the ISO 9001 certification.
It may not be possible to include all the internal and external factors, products and services, interested parties, etc., but you should at least try to summarize the major considerations.
Remember that ISO 9001:2015 policy requires you to maintain the scope as documented data. Note again that this information should be accessible to the relevant parties.
Too much documentation (or documented information) is not necessary. You don’t need to record everything your company does, as the statement will end up looking like a policy, not a sales pitch.
The key to creating a non-complex document is to define the need for the ISO 9001 scope.
Tips For Writing Your Scope Statement
Ask Yourself These Questions After Your First Draft
- Is the information relevant?
- How will it help the people who need our products or services?
- What are the other compliance requirements mandating the scope?
- Does the Scope Statement support the business operations?
If not, then you should re-evaluate and revise or ditch the Scope Statement.
Writing ISO 9001 Scope: Common Mistakes To Avoid
Complicating The System
Is your business trying to keep the system alive? Perhaps your system is too complex, and documenting procedures and filling out forms does not add any value. How about you simplify the system and keep it practical? The best idea is to focus on improvements and results rather than on the documents.
Rushing Into Writing The Scope
Developing a concrete ISO scope takes time. Trying to draft the statement quickly will be counterproductive.
Therefore, it is important that your company takes time to plan, write, and revise. This also helps to implement a system that can actually improve your products and services.
I Do Not Understand The Clients
ISO 9001 aims to improve customer satisfaction. You must know what your customers want before writing the scope. This begs the question: Do you take the time to listen to clients? If yes, you will be able to achieve this goal.
You don’t need to take a complex customer survey. You can ask a few questions to gather sufficient information to determine the changes that will satisfy this objective.
Not Having The Right Resources
Without the necessary resources to assure quality, quality problems are more likely to occur. When incompetent personnel create the scope, something can go wrong.
Are working spaces and equipment reliable? Does the working environment hinder the process of creating the scope? Does it degrade or promote the products?
Failure To Correctly Use The Corrective Action Process
Your organization should evaluate the underlying problems and engage the right people in the process. Some problems are recurrent; hence, correctly applying the corrective action process can eliminate redundancy.
Lack Of An Experienced Auditor
In most cases, internal auditors lack the right training or experience to differentiate big issues from small ones in the ISO requirements. Auditors must focus on issues that help organizations improve their systems and processes.
Not Having A Unique Plan
What works for one company may not work for another. Every entity is unique, so it must focus on its specific context to develop a proper ISO scope.
Leaving It To One Individual
The entire organization must be involved in creating the scope of ISO 9001. For the quality management system to work, every stakeholder must take ownership of it.
No outsider will help the workers incorporate quality unless they incorporate it themselves. That is why training is essential for the process to add value to your company.
Why Is Scope Important?
The scope helps the registrar determine what areas require auditing. Within the scope, you should state the products and services you offer.
Don’t forget to justify non-applicable requirements.
If you do not design your products, state this exclusion in the scope. If your company has several facilities, list all the locations included in or excluded from the QMS scope.
If you manufacture toys, the scope should include all the primary functions of producing toys in your business's specific location and the distribution of toys to kids of all ages.
One of the companies' most significant mistakes is implementing an ISO scope without a valid reason. You cannot just create a bureaucratic statement based on mere compliance or create one.
Understanding the process of developing the ISO scope from beginning to end and what the registrars are looking for is key to developing a useful and compliant Scope statement.
Related Information You Might Find Useful
- 1 Scope of the EMS [ISO 14001]
- 4.3 Determining the Scope of the EMS [ISO 14001]
- 4.3 Determining the Scope of the OH&S Management System [ISO 45001]
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