ISO 9001 Section 4
Quality Management System
ISO 9001 Section 4 - Quality Management System
4.1 General Requirements
The important tasks in your company must be identified and then the
sequence that they occur. This must include those tasks that you farmed out to other companies (sub-contractors)
that affect product quality or customer requirements.
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 and,
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. The procedures usually have their own manual separate from the quality
manual.
Most company procedures have proprietary information and shouldn't be released
outside of the company. However, many customers ask there suppliers and vendors for a copy of their quality manual.
If the procedures are in the quality manual they could be accidently released. Or, a customer only copy of the
quality manual is created. This is extra work and can be avoided by not including the procedures in the quality
manual.
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 if it
was done correctly. Records are a critical part of the QMS. They are the hard evidence that the required activities
have been completed.
A list, log or database of all the company's documents and records
must be kept. There can be separate lists for documents and records. The lists must be kept up-to-date to show the
current revision of the document or record.
A history of the documents life needs to be kept, also. The idea here
is to show that improvement has taken place and the documents were revised to reflect the new methods.
ISO 9001 Section 5: Management
Responsibility
ISO 9001 Section 6: Resource
Management
ISO 9001 Section 7: Product
Realization
ISO 9001 Section 8: Measurement,
Analysis and Improvement
Additional Information
Resources
What are Quality Management
Systems?
What is ISO 9000?
What is ISO 9001?
What is ISO 9004?
What is ISO 19011?
ISO 9000-2008 Changes
Online ISO
9000/9001 Overview Course
Auditor Training: Online
Auditor Training
Courseware
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