Quality Management System - Section 4

4.1 General Requirements

The important tasks in your company must be identified and then the sequence they occur. This must include those tasks that you farmed out to other companies (sub-contractors).

When you can perform all these tasks correctly the first time you have an effective quality management system.

You will also need to monitor and measure these operations and record the information from time to time. This tells you how the operation is doing.
If things aren’t going according to plan, action is needed to fix it.

4.2 Documentation Requirements
4.2.1 General Requirements
4.2.2 Quality Manual

The general basis of a quality management system is the quality manual. It describes the important tasks and how they work together. You don’t want repeat the wording of the standard. This doesn’t provide anyone with helpful information about your management system. And, they probably wouldn’t read it anyway.
The quality manual can have the six (6) required procedures included in it. Most companies don’t include them, so they just list the procedures in the manual. This tells people they exist and what they are about.

4.2.3 Control of Documents
4.2.4 Control of Records

Make instructions available for as long as they are needed to help people do their job. Keep these instructions up-to-date. Keep records of the controlled documents including the document title, revision date and/or level. The list can be used by anyone who needs to determine if the document they have is the current and correct one.

Determine what records are needed to prove what was done and it was done correctly. Records are a critical part of the QMS. They are the hard evidence that the required activities have been completed.

See Quality Managment System - Section 4 (top of page)

See Management Responsibility - Section 5

See Resource Management - Section 6

See Product Realization - Section 7

See Measurement, Analysis and Improvement - Section 8