The Quality Management System (QMS) needs to address some basic
areas. You need to consider who will have ultimate responsibility
for the system, look at what kinds of resources will be needed,
figure out how to measure the quality of your processes and output,
and put actions in place to ensure that desired results will be
4.2 Documentation requirements
You need to document either electronically or on paper
your quality policy, manual, and objectives. The types of areas
that need to be looked at specifically are procedures, planning,
and operations. You need to describe what you do to control quality
in these areas. You also need to retain quality records, which are
documents that would prove to someone that a procedure was followed.
(i.e. inventory control listings, travelers, work orders, signed
There are no specific requirements on the form or volume of the
documentation. It can differ from one organization to another depending
on size, type of activities, or complexity of processes.
4.2.2 Quality manual
Your quality manual should document what your QMS deals with, and
what it doesnt. You can identify all of the quality procedures
or make reference to them here. You should describe how procedures
interact with your QMS, how do they achieve the desired results
and who are the responsible parties.
4.2.3 Control of documents
The proper control of documents means that you need to ensure that
all of the documents in your QMS have been appropriately identified,
reviewed, authorized, issued and distributed. You need to take care
that old, obsolete documents are not being used, and that they are
stored in a secure location if they are needed for reference. You
also need to make sure that any external documents that you use
in your QMS are identified in your system and that the access to
these documents is controlled somehow.
4.2.4 Control of quality records
You need to make sure that the documents that you keep prove that
your QMS is doing what you say it should. These documents must be
legible and easily retrievable. You must have a consistent policy
for retaining both active and inactive documents.