opffirm.blogg.se - How to determine the scope of the qms

This leaves far less freedom for the organization when defining the scope, and the aim is to ensure that all operations that affect the quality of products and services and/or customer satisfaction are included in the QMS scope. Supporting functions can be design centers, corporate headquarters, and distribution centers. What are the supplemental requirements to be met?Īlthough ISO 9001 allows organizations to decide which functions or sections will be included in the scope, IATF 16949 requires supporting functions, whether on-site or remote, to be included in the scope of the QMS. In addition, the scope must state the products and services covered by the QMS, and justification for any instances where the ISO 9001 standard cannot be applied-but this requirement is further limited by IATF 16949, as you will see below.

the product and service of the organization.

requirements of relevant interested parties.

external and internal issues that are relevant to the purpose of the organization, the strategic direction, and the ability to achieve intended results.

To start, there are three considerations to be included when determining the scope: In a note about the QMS, it is stated that the QMS can include the whole organization, specifically identified functions of the organization, specifically identified sections of the organization, or one or more functions across a group of organizations. Section 4.3 of the ISO 9001:2015 standard details the requirements for determining the scope of the Quality Management System. What are the basic requirements for defining the scope?

Since ISO 9001 requirements are the first we need to meet in the implementation, and are not stated in the text of the IATF 16949 standard, let’s examine them first. Requirements for the scope in IATF 16949 are based mostly on ISO 9001, but as with many other requirements, the automotive industry goes a bit further. You will basically define to what processes, locations, products, and services your QMS applies, and this will provide an input for the certification body and auditors. Although it seems like just a formality, defining the scope is one of the crucial steps in the implementation and ongoing maintenance of the QMS. This requirement is nothing new to quality standards, or any other management system standard, for that matter. In order to establish a QMS (Quality Management System) according to IATF 16949, you first need to define everything the QMS will apply to.