What a QMS is not?

QMS is not a reactionary initiative to put out fires such as writing a procedure or a work instruction without evaluating its need/purpose/benefit. QMS used to be very prescriptive until ISO 9001:2008 version.

In the 2009:2015 version, the concept of process approach and risk-based thinking was formally introduced for the design, implementation, and evaluation of a QMS. This concept requires organizations to identify the processes within the scope of QMS with defined inputs, outputs, sequence, interaction, checks & balances, acceptance criteria, and resources.

Once the processes have been identified, then a risk assessment approach on the identified processes is required to prioritize identified processes. Based upon the priority methodology used by an organization, it can decide what documented information to maintain and retain. In addition to documented information decided by the organization, ISO 9001 standard defines limited prescribed documented information.