To be able to set up that a QMS (Quality Management System) based on IATF 16949, first you must specify everything the QMS will employ to. This condition is not anything new to quality criteria, or some other management system standard, for this matter. Even though it feels like only a formality, specifying the extent is just one of the significant steps in the implementation and ongoing maintenance of the QMS. You will essentially specify to what procedures, places, goods, and solutions your QMS uses, and this may give an input to the certificate body and auditors.Prerequisites for the range at IATF 16949 are based largely on ISO 9001, but as with several different prerequisites, the automotive sector goes somewhat farther. Since ISO 9001 needs will be the very first we will need to satisfy from the execution, and aren't mentioned in the text of this IATF 16949 standard, let us analyze them.
What are the fundamental prerequisites for defining the extent?
Section 4.3 of the ISO 9001:2015 standard details the requirement for specifying the range of this Quality Management System. In a note concerning the QMS, it's said that the QMS can incorporate the entire organization, especially identified purposes of their organization, especially identified segments of their business, or a couple of functions across a bunch of associations. To Begin, there are three factors to be included when deciding the extent:Internal and external Problems That are relevant to the purpose of the business, the strategic leadership, and the capability to Attain planned results needs of relevant interested parties that the Goods and support of their organization.Additionally, the scope has to say the services and products covered by the QMS, and justification for any cases where the ISO 9001 standard can't be implemented--but this condition is further confined by IATF 16949, as you'll see below.
Which will be the supplemental needs to be fulfilled?
Though ISO 9001 enables organizations to choose which works or segments will be contained in the extent, IATF 16949 requires supportive purposes, whether onsite or distant, to be contained in the scope of the QMS. Supporting functions may be layout facilities, corporate headquarters, and distribution facilities. This leaves much less liberty for your business when defining the extent, and the purpose is to make sure that all operations which influence the quality of merchandise and customer or services satisfaction are contained in the QMS scope. This is likely to make the implementation much more difficult for several organizations, particularly for large businesses which have many places on many continents.Customer-specific requirements also have to be assessed and included in the scope of the QMS.
In practice, this usually means that the company is going to need to think about these conditions, and determine how they reflect about the QMS and behave appropriately. For many organizations, this will not bring anything fresh; nonetheless, for businesses in their clients specify procedures, goods, or services that it usually means they might need to incorporate all this from the scope of the QMS.What's more, the standard in this section defines the exceptions. IATF 16949 permits exceptions just from clause 8.3, and here, with lots of constraints. Basically, the only requirements which may be excluded are linked to development and design of services and products. Permitted exceptions don't include manufacturing process layout. Obviously, the company will also need to provide and record justifications for exceptions.In the end, there's a need to record the extent; unlike ISO 9001, that does not define exactly where and the way IATF 16949 necessitates the Quality Manual to incorporate the info regarding the range and justifications for any exceptions.
How can this apply to my business?
Normally, the range of the QMS covers the whole organization. Some documented exceptions are if your QMS merely covers a single physical place of a multi-location business, or any time your production or support is obviously split between businesses (e.g., in a plant with three assembly lines in which assembly lines 1 and 2 are for automotive, and also will need to get a QMS licensed into the ISO/TS 16949 QMS benchmark for automotive, however you need line 3 to become certified to ISO 9001 because most of those automotive requirements don't apply).So, your extent should determine the physical places of their QMS, services or products that are made inside the QMS procedures, as well as the businesses which are pertinent, if that is applicable. It needs to be obvious enough to identify exactly what your company does, and should not all areas of the company are related, it needs to be recognized clearly that parts are.