Quality Management


Resource Management
Product Realization
Analysis and


4.1 General Requirements
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 achieved.

4.2 Documentation requirements

4.2.1 General

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 contracts, etc.)
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 doesn’t. 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.

Section: 1 of 5

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