How do we create a Quality Management System (QMS)?

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Regardless of the standard to be used, a QMS is needed in the organization. Generally a QMS has 2-4 levels. The top level is always the quality policy where the company states what their aims are for quality of their products. This may be a four-liner with “political words” (i.e. impressive words and no substance) or it may be a selection of more detailed goals for the quality. One company that I recently audited had one full binder with very detailed quality policies.

The next level is the quality manual. In some cases this is a more detailed policy document, in other cases this is a collection of SOPs, and in other cases again it may not even exist.

The next mandatory level is the SOPs, the detailed procedures for how to do things in a quality way.

Some companies add a sub-level to the SOPs for “work instructions” that will cover other work in the company that does not relate to the products. This may for example cover how to order paper and PCs, how to clean the coffee machines, and how to handle sponsor work.

Table 04x01: QMS

Table 04x01: QMS