Can an organization exclude design from their Quality Management System?
Yes. If you do not do design and development then you may exclude it. You do this by writing a “permissible exclusion” in your Quality Manual. This means you would write in the design section of the manual that you do not do design and you are excluding it from your quality management system. You may do this for any requirement in section 7 that is not applicable to your company. You may only exclude things that do not apply to your organization. If you do design, it must be included.
