What do they mean by quality procedures? What is so qualitative about them? Ah! Good question. These quality procedures are the heart and soul of your quality management system. These procedures make sure everything is performed according to the ISO 9001 Standard requirements.

But first, let's make a short review and understand what a procedure is.

WORKING PROCEDURES

One of the most important principles of the ISO 9001 Standard applies simply:
"say what you do, do what you say"
That actually means that you must define first what you are required to perform and then do it! You can also explain it differently; you will define in which cage you want to spend your time.
How to achieve? Working processes and working instructions.

The purpose of the working instructions is to explain, very simply, what is required to do by your employees in their everyday tasks. The instructions are highly important! Why? Who asked that? You are not serious! The explanation is very simple;
When you define a working procedure you define a frame. This frame defines what has to be done and leave much less possibilities for nonconformities and faults. Your employees need guidance. Naturally people would try to break the frame they are living and working in, in order to maintain more comfort for themselves or to promote interests that are no conformed to the organization's objectives. This comes on behalf of efficiency and effectiveness. And when efficiency and effectiveness are declining, you can be pretty much sure that, in the not so long term, your profitability would decline as well.

Procedures give you the ability to examine where your employee asked for short cuts. Straying of the procedures brings nonconformities. Nonconformities harm your profitability, even if you cannot sense it within the short term. In this case, it is highly important, when you define a procedure, to define the control over it as well.
This issue is enforced by the ISO 9001 Standard almost fanatically. One of the means to eliminate nonconformities and defects is a clear procedure.

A procedure must include:

The purpose of the process - what is the outcome of the process.

• Who is responsible for maintaining and performing the procedure – in order for you to know exactly who is responsible for what had been done.
• What is the method – you must specify the steps, or phases for performing the procedure. We recommend being generous with details, to specify within the most detailed level and to explain with the simplest language what should be done.
• What are the tools one needs to perform the procedure: forms, software etc. – This is actually the documentation and control over the procedure. By examining this tools we can decide whether the procedure was maintained and how well.
• The procedure outputs (nonobligatory) – what are the outputs expected at the end of the process (a price quote documented, a certificate of calibration, records of any kind, any form, etc).

QUALITY PROCEDURES

O.K. Is it clear enough? Now let's turn to the quality procedures.
In order to maintain a quality management system, the ISO 9001 Standard places requirements. One of these requirements is to maintain documented procedures. The goal of these procedures is to make sure that the organization performs the minimum requirements of the ISO 9001 Standard that suit all kinds of organizations – from the low tech to the high-tech companies. The procedures required are called "quality procedures". The procedures include the next:

• The quality manual – a document defining the scope of the quality management system, a general presentation of the organization activities, its organizational structure, a general description of the main process, a description of the relation between the working process and the quality management system (as shown below), a list of all procedures in the organization and list of exclusions – which of the ISO 9001 Standard requirements are not applicable for the organization's activity. The quality manual is, in fact, not a procedure. It describes no activities at all but it is required to maintain it documented as specified. Need more information? Well, you got it right here. As far for the description of the relation between the working process and the quality management system, we present you with this diagram for example:

• Control of documents – specifying the process of controlling your documents within the quality management system. The requirements are specified in this article. In the procedure you must define how to achieve the requirements.
• Control of records – specifying the process of controlling your records within the quality management system. The requirements are specified in this article. In the procedure you must define how to achieve the requirements. In this procedure you must include a list of all documentation which is under the quality management scope as well.
• Internal audits – a procedure specifying how the internal audit should be performed within the organization. You may refer to this article for the requirements. In the procedure you are required to define how to achieve.
• Control of nonconformity – a procedure specifying how one should handle nonconformity when he detects it.
• Corrective action - a procedure specifying how one should take and perform a corrective action. Read this article to learn about the ISO 9001 Standard requirements for corrective action.
• Preventive action - a procedure specifying how one should take and perform a preventive action.

This is the list of the required quality procedures. You must document them and maintain them – that means that it's not enough to document the procedure, you must also prove that you follow what you  had defined and actually perform it  day by day – perform quality management activities. You might be in need of help to define the procedure. Try this solution: Qualitymanualtemplates.com provides you with templates of quality procedure that are easy to customize and use for your own quality management system. They provide you with documented quality procedures that achieve the ISO 9001:2008 Standard requirements.

SUMMERY

• The quality procedures are the heart and soul of your quality management system.
• These quality procedures ensure that you maintain a quality management system according to the ISO 9001 Standard.
• Say what you do, do what you say - One of the most important principles of the ISO 9001 Standard.
• The purpose of working procedures is to explain, very simply, what is required to do in order to reach a specified result.
• A procedure must include: purpose of the process, who is responsible, what is the method, what are the tools and the process outputs
• The purpose of quality procedures is to make sure that the organization performs the minimum requirements of the ISO 9001 Standard
• Quality procedure must include: the quality manual, control of documents, control of records, internal audits, control of nonconformity, corrective action and preventive action.
• The quality procedure must be documented and maintained – that means that you would have to prove that you are performing the activities you had defined. 

aaa