What is the ‘Scope’ referred to in ISO 9001?

The Quality Management System (QMS) scope, sets boundaries and applicability of your QMS and it is also included in the ISO 9001 certificate, so it’s very important to identify and must be documented. Try not to jump ahead with finalising your scope. Before defining your scope, you must take into consideration the following factors: The external and internal… Continue reading What is the ‘Scope’ referred to in ISO 9001?

When Does a Document Have to be Controlled?

Clause 7.5 Document Control In an ISO Management System, when does a document have to be controlled per the requirements of 7.5?  The standards say when the document is “necessary” or is “required documented information” per the ISO Management Standard.  “Necessary” documents are defined as those documents necessary to ensure the processes and services are controlled.  In… Continue reading When Does a Document Have to be Controlled?

ISO 9001 Annex A & B – What is it used for?

With the changes to the ISO 9001:2015 standard comes new terminology and requirements. Annex A and B are included in the ISO 9001 standard to explain structure, terminology, and concepts used in the standard. In this article, we will briefly review Annex A and B. Annex A Annex A includes an overview of: Structure and… Continue reading ISO 9001 Annex A & B – What is it used for?

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