Example of system scope according to ISO 9001: 2015
I have noticed that many of you have difficulties in defining the scope of the quality management system. For this, I show you this article, where I am going to present an example, and also I will make the comments in each of the sections, with the purpose that you can contemplate the different possibilities, and answer, so your doubts about this Requirement of ISO 9001: 2015.
As I showed you in an earlier article, the standard describes the requirements that must be met by the scope of the management system (see link).
If you need to know, or expand information, of each requirement of the standard, I recommend that you consult the following link where I present an index of each requirement of the standard (showing the specific section of the standard), and where if you click on each Title, you will have the link to the article where each concept is developed. (See link).
If we return to the subject of this article, the management of the company should consider the scope, taking into account the following three concepts, which I show you in the following image:
What does it mean and how do we take into account the three previous blocks?
Step 1: Look at all the products and services of the organization
First of all, we must consider all those productive processes that the organization has, shown in the process map.
Step 2: Decide which processes are included or not based on the internal or external issues of the organization.
Once we are clear what productive processes we have and where each one of them is performed, we must by analyzing the internal and external factors, consider whether it is necessary or if the scope of the system is required to contemplate all processes.
I explain myself by a somewhat exaggerated example. We consider an organization, which has several factories of production at an international level. Where you have different production lines, for example, the line of manufacture of televisions is made in the headquarters of China, the line of manufacture of soaps is realized in Chile … the Direction, must decide if it interests, or wants to contribute The resources needed to implement the management system, and certified, in some or all processes, depending on internal and external factors of the company. Certification of the Chinese product line could be considered an opportunity (depending on the context of the organization) in order to be able to sell these products to other countries. Or, the fact of certifying the production system in the headquarters of china, would suppose such cost, that could be considered a threat for the company, by its sobrecoste …
Step 3: decide on stakeholder requirements
This is the simplest, usually the purpose of companies to decide to invest and become certified in a quality management system. One of the requirements that a client requires us to be able to offer is to present our company’s certificate in ISO 9001: 2015. Many public administrations are demanding it, especially to construction companies. If the company wants to offer and have possibilities to be hired, it must have, and the scope must include those processes for which they are going to hire us.
Once decided and analyzed How and where do we do it?
As you all know at this point, ISO 9001: 2015 does not require the elaboration of a Quality Manual, but you can have it without problems.
In the case that you do not have a quality manual, you must enable a document format for it, where it describes the scope by processes, the geographical scope and the non applicability of the requirements (exclusions). In case your organization has a quality manual, it should be included in it.
I give you a general example:
In your document or manual you must describe the scope by processes, the geographic scope and justify the applicability or not of the requirements.
Scope by processes: commercialization, production of products X and execution of services Y (3 production processes)
Geographical scope: you must indicate where each of the previous processes is carried out.
Marketing – Headquarters A – Complete address
Product manufacturing X – Headquarters B – Full address
Execution of services Y – Headquarters C – Complete address
Non applicability of the requirements (exclusions): here you must justify if any requirement of the standard is not applicable and why, usually usually the design and management of measurement equipment, depending on the activity.
Example of design exclusion: The organization is excluded from requirement 8.3 of ISO 9001: 2015 because it does not design and develop any new product, and product requirements are regulated according to technical specifications and Contractual requirements established by the client and product quality.
Does the scope of the certificate be the same as that described in the management system?
There is no reason why the auditor of the certifier will ask us what the scope of the certificate will be, and We will have to say what processes we want the certificate to include, and that will be what we are audited. Therefore, the management system that we are going to audit must include in the scope those processes, there may be more, of course … but in the end we will audit what we mark on the certificate.NOTE IMPORTANT NOTICE: We are setting the scope With the productive processes of the company, therefore, all productive processes have their corresponding strategic and support processes.
Therefore, if we decide that the scope will only be of a production line, we have to consider all the processes that help the production line to be realized. I explain better, when we audit the production process, they will also do it Of the training process, of nonconformities, claims, HR, commercial, equipment management, risk management, system review minutes, customer satisfaction, purchases and subcontracting … That are not all requirements of the rule.