What Is The QMS Scope For ISO 9001?
The scope of the QMS should be based on the nature of the organization’s products and their realization processes, the result of risk assessment, commercial considerations, and contractual, statutory and regulatory requirements.
While ISO 9001 is generic and is applicable to all organizations (regardless of their type, size or product category), under certain circumstances, an organization may exclude complying with some specific ISO 9001 requirements (from clause 7), while being permitted to claim conformity to the standard. This is because it has been recognized that not all the requirements in this clause of the standard are relevant to all organizations.
To enable identification of what has been registered/certified, the scope of registration/certification should clearly define:
*the scope of the quality management system (including details of the product lines and related sites, departments, divisions etc. that are covered by it)
*the organization’s main processes for its product realisation or service delivery activities (such as design, manufacture and delivery), for the product lines that are covered
*any ISO 9001 requirement that has been excluded
