Exclusions to ISO9001:2015

Hari Varma

Registered
I am currently developing procedures for a startup company who have developed a prototype but no customers. What option do I have for exclusion of clauses in ISO 9001:2015.
They have no plans for commercialisation at the moment. They would provide a consultancy service
 

Thee Bouyyy

Multiple Personalities
Hi @Hari Varma Welcome to the Cove!

ISO 9001:2015 standard no longer makes specific reference to “exclusions,” but does recognize that an organization might need to review how the requirements apply to them. This may be due to the size of the organization, the management model, the activities that the organization does, or the nature of the risks and opportunities that the organization encounters.

When a requirement can be applied within the scope of the QMS, the organization cannot just decide that it is not applicable. Further, when a requirement is determined to be not applicable, this cannot be allowed to result in failures to achieve conformity of products and services to enhance customer satisfaction.

e.g. Often excluded are the requirements for design and development (8.3). If your organization does not do any design work, but strictly work from designs given to you by a customer, then these requirements can rightly be determined to be not applicable to your organization. This could be in the case of a machine shop that only takes the drawings and CAD programming files from customers, and uses these to machine the parts on a CNC machine. In doing so, the customer is in charge of the design and any design changes, and for the machine shop these requirements are not applicable.

Use the ISO 9001 standard as a guide and carefully consider if you would benefit from including the processes that the standard requires. You owe it to yourself to make your QMS the most useful for your company.

EDIT : Added link reference
Attaching FAQ available at ISO commitee.

Exclusions to ISO9001:2015
 
Last edited:

AMIT BALLAL

Super Moderator
I am currently developing procedures for a startup company who have developed a prototype but no customers. What option do I have for exclusion of clauses in ISO 9001:2015.
They have no plans for commercialisation at the moment. They would provide a consultancy service

It is difficult to comment which clauses this organization can exclude without understanding the organization, its operations & system.

You can do a gap assessment to understand this organization and then determine which clauses can be excluded.
 
Let's be clear. Exclusions are sections of the standard that an organization is not required to do based on regulatory requirements. There are no exclusions for ISO 9001 because it can be applicable to every business. On the other hand, non-applications are sections of the standard that do not apply because of the nature of the business or product.

Even if you don't have customers yet, you still have potential customers in mind. It is normal for quality systems to have some processes that are not yet fully implemented. It is wise to create procedures that show intent to comply and readiness to do so when the required time comes.
 

Hari Varma

Registered
I wish to to thank those who have contributed to my query. I guess i may have chosen the wrong word "exclusions". It would be better to state what clauses of the Standard are applicable to the core processes of this business. In this way the business would have a "buy-in" in the quality management system.
 

Dhaval Chitre

On Holiday
It would be better to state what clauses of the Standard are applicable to the core processes of this business.

What your organization is doing ? What are the operations ? Without this details, difficult to speak about the core processes of the business. It's the only you who can define the core processes of your business first.
 

Hari Varma

Registered
How is the Scope of QMS for ISO9001:2015 defined? Can it be listed as bullet points? I understand in my case the customer is " internal" ( no external customers) and we have a product already developed by the organisation based on Market Research. Hence no external design and development requirements were needed. The Organisation will be offering consultancy service based on the product developed. Any thoughts?
 
Here is an example.

Quality System Scope and References
Company Location
This quality manual applies to the following company and location:
address
address
address
website
phone #

Products and Services
Company manufactures the following products according to the requirements of this quality system:
Category 1
Category 2

Company manufactures the following products that are excluded from the requirements of this quality system:
Category 1
Category 2

Quality System and Regulatory References
The quality management system incorporates standard requirements from the following:
ISO 9001:2015 - Quality management systems — Requirements
other standard

Per Code of Federal Regulations, Title 21 Part 807.65(a), Company is not required to register with the US Food and Drug Administration.

Quality System Nonapplications
Company does not currently perform xxxxxx activities; therefore, the following sections are excluded from the quality management system:
Section
Section
 
Hence no external design and development requirements were needed.
The standard does not make a distinction between external and internal design requirements. There is either an actual customer or a potential customer, and you are designing the product for them. Customer requirements do not have to come from the actual customer.
 
Top Bottom