Standards

Context of the Organization 4.0, there are no exclusions- if it is functional within the company, working towards a quality product/service (the ISO uses "relevant"), it has to be addressed within the context of the Org. You mentioned Project Management and Sales, those have a direct impact to the product/service and on ISO (Project: Planning: 6.0, 8.1) (Sales: deals with the customer 8.5.5, 8.6, 8.7.2). 


The ISO does not state any exclusions (that was left behind with the 2008), but why would you want to withhold a part of the organization from the benefits of the ISO? ISO is a tool to help a company. Would you want to have sections of the company on the same page, while others were not? The process of information would not flow the same if all of the departments are not held to the same standard. It would be more beneficial to keep all aspects of the business on the same page.

May I get help/clarification for the questions regarding ISO9001:2015 scope?
 
To certify an organization for ISO9001:2015, should the entire organization (all business activities, all products and services) be covered?
If it is OK to have some activities (such as Project Management, Sales) out of the QMS scope, what are the exception rules for ISO9001?

 

If those processes are part of the normal operation they should be in the scope. They can be support processes if the organization does not define them under Clause 4.4.1.

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John Vandenbemden
Principal consultant Q-Met.Tech
Mobile: 859-240-1739

Hi John,

Thank you for your insights.
Is there any exception to have some operations out of the scope?

Thanks,
Hugh

 

If you have a separate operating business not part of the processes required for the sellable product, it could be a candidate. Without more information it is difficult to assess the question properly.

Sent from my iPhone
John Vandenbemden
Principal consultant Q-Met.Tech
Mobile: 859-240-1739

Thanks again.
Our company is in financial technology industry which sales POS terminals and also provides managed service.
POS terminals: we design the terminal hardware and software and sale to the customers. Manufacturing of the terminal is outsourced to Contract Manufacturer.
Managed service: It’s value added service to the POS terminals. It’s optional/conditional for customers to purchase, such as Terminal estate management, POS transaction gateway service… etc.
Is that acceptable if we only certify POS terminals business for ISO9001:2015?

Thanks,
Hugh

 

Hello Hongjiang Wang‍,


I'm ASQ's research librarian and wanted to offer an information source to you.  Are you familiar with ASQ's Ask the Standards Experts blog?  You'll find it here: https://asqasktheexperts.com/. The blog fields questions about the application of standards developed, supported, or facilitated by ASQ.  As you may imagine, many questions (and answers) about ISO 9001: 2015 have been submitted and posted.  Perhaps you will find some of the posts helpful to you!


Best, 

Gretchen Peterson

Hi Gretchen Peterson,


Thank you for the info.

I'll check the Standards Experts blog.


Thanks,

Hugh

Normally the processes which have any impact on final quality of product or service of an organisation must be part of the scope in ISO 9001 Quality Management system

While those items cannot be excluded anymore, the standard allows for requirements to be justified as "not applicable". It clearly states, however, in 4.3 (last paragraph) that conformity to the Standard can 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. You cannot say that specific processes are not applicable. You can only claim specific requirements are not applicable and only under that rule so "excluding" sales / project management will not work. Hope that helps. If you have 

"Not applicable" is pretty obvious if it exists for your organization. For example, we do not use measuring equipment that is calibrated, thus clause 7.1.5 does not apply. Our products are verified by editors, people, so they are covered under other clauses, such as: 7.1.2, people, 7.1.6 organizational knowledge, and 7.2 competence. While we in one sense calibrate people with training, 7.1.5 still does not apply here.