Shall indicates requirements, when determining this scope, the organization shall consider 4.1 & 4.2, I think in this context the required in 4.1 & 4.2 should be maintained as documented information.
Thanks! We have Clause 4.4, we have just broken it into 3 parts. 1. ISO 9001 - Quality Management Systems | Understanding Clause 4.4 PART 1 - ruclips.net/video/WkFI5tQW0Ac/видео.html 2. ISO 9001 - Quality Management Systems | Understanding Clause 4.4 PART 2 - ruclips.net/video/sOyvTKjSYaw/видео.html 3. ISO 9001 - Quality Management Systems | Understanding Clause 4.4 PART 3 - ruclips.net/video/M9U0Ji12HvQ/видео.html
Great question sarhan32. It is possible to set the scope only for procurement, therefore, deeming any other areas as not applicable WITH justification for this. HOWEVER, this depends on what was identified during your process for Understanding the context of your organization (external and internal issues) as well as what you have understood as the needs and expectations of your Interested Parties (4.2). If you identified factors and influences, needs and expectations that are outside of just procurement then restricting your scope to just this would not really be seen as applicable boundaries. You also have to consider your products and services as a whole for your organization. If you are just a business that provides procurement services then yes, however if your business is much broader than this it may not be able to be justified. Take note of the last line in this clause - it states 'conformity to this International Standard may only be claimed if the requirements determined as not being applicable DO NOT AFFECT the organization's ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction'. So I would ask the question 'By having just procurement as the scope of my quality management system does this impact the ability to provide products and services to our customer and meet their requirements'? Hope this helps :) All the best - Jackie
What a great question! I can see why you are asking this and it shows you are putting a lot of thought into the process. There is no specific clause that asks us to 'define' our products and services. There are a few clauses where they influence us to determine how we control, review and provide these products and services. The clauses that will help you are: 4.1 Understanding the organization and its context and 4.2 Understanding the needs and expectations of interested parties. By understanding the internal and external issues to the business, as well as what these associated interested parties (stakeholders) expect from you or want from your business you will understand the risks and opportunities, and therefore you might be able to define more what products and services you can/should/will provide to your customer. For example, here at ATOL, we might identify that there is an external influence regarding the provision of Virtual Instructor-led training (outside of our online-only platform). We see that our interested parties (our customers) have a need and expectation that we not only have online training but also have virtual training options. Due to identifying this, our product offering would increase to include Virtual training. Therefore the scope of our system would now also include Virtual training. 8.1 Operational planning and control - then in this clause it is more about implementing those products and services and figuring out what these look like and how you will deliver them. 8.2 Requirements for products and services - this will help you to determine how you will communicate your products and services as well as ensure what you say you can provide to customers you can actually provide. This is important to your Scope (4.3) to ensure that any areas determined as customer requirements are included in your scope (where needed). 8.3 Design and development of products and services - if your business is responsible for design and development of your products and services, you will need to include this in your scope. If they are not responsible for D&D then a specific statement saying that this clause is not applicable is required including justification for why it isn't applicable. So for example, if here at ATOL we just purchased our courses and put them up for sale like that (no internal design or development of content) then we would state that Clause 8.3 Design and Development is not applicable to our quality management system as our course content is developed externally and delivered without modification. I hope this has helped you Nitheesh? All the best - Jackie 🙂
Great question Anette. Your company website could be 'one' of the areas that could be considered documentation for your quality management system. For example, you might have the scope of your quality management system documented on your website, so this covers the requirement in clause 4.3. Now, I'm just thinking front facing website when I refer to this, however I just thought that possibly you might have a website where staff/suppliers/customers can log in and there is a back end to the website where they can access relevant documentation. So if this is the case, it is quite possible that this could be satisfactory. Does this help at all Anette?
Hi @AnetteMekvik, Since you commented on this video (and Jackie shared a great response) we have published a new video touching on ISO 9001 Clause 7.5.1 Documented Information which may also be of interest to you. You can check it out here: ruclips.net/video/xykLIPDq-bM/видео.html
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Shall indicates requirements,
when determining this scope, the organization shall consider 4.1 & 4.2,
I think in this context the required in 4.1 & 4.2 should be maintained as documented information.
Thank you so much 🍃
is it necessary to consider 4.1 and 4.2 when the organization is going to document its scope?
You're just great! Thank you!
Thank you so much. I'm glad you are getting something out of the videos. Regards Jackie
Hi, thank you for explaining in such simple terms. Kindly explain ISO 9001 2015
clause 4.4
Thanks!
We have Clause 4.4, we have just broken it into 3 parts.
1. ISO 9001 - Quality Management Systems | Understanding Clause 4.4 PART 1 - ruclips.net/video/WkFI5tQW0Ac/видео.html
2. ISO 9001 - Quality Management Systems | Understanding Clause 4.4 PART 2 - ruclips.net/video/sOyvTKjSYaw/видео.html
3. ISO 9001 - Quality Management Systems | Understanding Clause 4.4 PART 3 - ruclips.net/video/M9U0Ji12HvQ/видео.html
Really helpful
Glad you think so!
Is it possible to let the scope only for procurement
Great question sarhan32. It is possible to set the scope only for procurement, therefore, deeming any other areas as not applicable WITH justification for this. HOWEVER, this depends on what was identified during your process for Understanding the context of your organization (external and internal issues) as well as what you have understood as the needs and expectations of your Interested Parties (4.2). If you identified factors and influences, needs and expectations that are outside of just procurement then restricting your scope to just this would not really be seen as applicable boundaries. You also have to consider your products and services as a whole for your organization. If you are just a business that provides procurement services then yes, however if your business is much broader than this it may not be able to be justified. Take note of the last line in this clause - it states 'conformity to this International Standard may only be claimed if the requirements determined as not being applicable DO NOT AFFECT the organization's ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction'. So I would ask the question 'By having just procurement as the scope of my quality management system does this impact the ability to provide products and services to our customer and meet their requirements'? Hope this helps :) All the best - Jackie
Could you please explain while documenting the scope of the QMS, which clause is relevant to the point C?
What a great question! I can see why you are asking this and it shows you are putting a lot of thought into the process.
There is no specific clause that asks us to 'define' our products and services. There are a few clauses where they influence us to determine how we control, review and provide these products and services.
The clauses that will help you are:
4.1 Understanding the organization and its context and 4.2 Understanding the needs and expectations of interested parties. By understanding the internal and external issues to the business, as well as what these associated interested parties (stakeholders) expect from you or want from your business you will understand the risks and opportunities, and therefore you might be able to define more what products and services you can/should/will provide to your customer. For example, here at ATOL, we might identify that there is an external influence regarding the provision of Virtual Instructor-led training (outside of our online-only platform). We see that our interested parties (our customers) have a need and expectation that we not only have online training but also have virtual training options. Due to identifying this, our product offering would increase to include Virtual training. Therefore the scope of our system would now also include Virtual training.
8.1 Operational planning and control - then in this clause it is more about implementing those products and services and figuring out what these look like and how you will deliver them.
8.2 Requirements for products and services - this will help you to determine how you will communicate your products and services as well as ensure what you say you can provide to customers you can actually provide. This is important to your Scope (4.3) to ensure that any areas determined as customer requirements are included in your scope (where needed).
8.3 Design and development of products and services - if your business is responsible for design and development of your products and services, you will need to include this in your scope. If they are not responsible for D&D then a specific statement saying that this clause is not applicable is required including justification for why it isn't applicable. So for example, if here at ATOL we just purchased our courses and put them up for sale like that (no internal design or development of content) then we would state that Clause 8.3 Design and Development is not applicable to our quality management system as our course content is developed externally and delivered without modification.
I hope this has helped you Nitheesh? All the best - Jackie 🙂
Can our company website be enough for documentation?
Great question Anette. Your company website could be 'one' of the areas that could be considered documentation for your quality management system. For example, you might have the scope of your quality management system documented on your website, so this covers the requirement in clause 4.3. Now, I'm just thinking front facing website when I refer to this, however I just thought that possibly you might have a website where staff/suppliers/customers can log in and there is a back end to the website where they can access relevant documentation. So if this is the case, it is quite possible that this could be satisfactory. Does this help at all Anette?
Hi @AnetteMekvik, Since you commented on this video (and Jackie shared a great response) we have published a new video touching on ISO 9001 Clause 7.5.1 Documented Information which may also be of interest to you. You can check it out here: ruclips.net/video/xykLIPDq-bM/видео.html