ISO 9001:2000/2008 is an outline for a Quality Management System
 

When you build your Quality Management System based on ISO 9001:2000/2008, you will be managing your organization as a system of interrelated processes.
 

You will plan these processes; identify how they relate to each other, set goals, measure the processes and make improvements.
 

ISO is the International Organization of Standardization
ISO is an organization that develops Standards for use worldwide to help companies plug into the world market.
 

ISO 9001:2000/2008 Outlines criteria for a good Quality Management System (QMS)
 

Quality Management System Criteria
 

An International Group of Business and Quality Professionals determined criteria.
 

These criteria are basics of good business practice. For example:
 

*	Set quality goals
*	Ensure customer requirements are understood and met
*	Train employees
*	Control your production processes
*	Purchase from suppliers that can provide quality product
*	Correct problems and make sure they do not happen again

Once the quality system is in place a Registrar will come and audit.
If all the criteria are being followed, the company will be ISO 9001 Registered.
 

Registered companies put their Registration mark in marketing materials.
Potential customers will know that you have a good Quality Management System in Place.
 

The ISO 9001 Standard
 

The standard outlines the requirements for the Quality Management System in sections 4 through 8 of ISO 9001. Take a look at the sections of the standard outlined below.
 

The ISO 9001 Standard

The requirements cover everything from how you plan your processes, to how you carry them out, measure them and improve them.
The standard calls your production processes "Product Realization". This is where you are actually making your product or delivering your service.
 

The Importance of ISO 9001

Having an effective Quality Management System, (QMS) in place leads to many improvements in an organization.
ISO 9001 is a proven foundation for an effective QMS. Whether you decide to Register your organization, or just build an ISO 9001 QMS for the internal benefits, you will improve your organization.
 

Internal Benefits include:
 

*	Increased productivity
*	Less scrap and rework
*	Increased employee satisfaction
*	Continual improvement
*	Increased profits

 

Marketing Benefits include:

*	An internationally recognized QMS
*	Increased opportunities in specific markets
*	Increased customer satisfaction

ISO 9001 Requirements
You must identify your Key Processes:
 

*	The processes that affect product or service quality.
*	These processes are included in the QMS.
*	This includes most of the processes in your organization.

And use a "Process Management Approach":
 

*	A process management approach is managing your organization as a system of interlinked processes.
*	The output of one process is the input for the next process.

4.1 General Requirements

The standard requires that your organization has a Quality Management System in place that meets the requirements of the standard.

Your organization must:
 

*	Establish a Quality Policy and Quality Goals, and
*	Design a Quality Management System to control how processes are performed

Documented Quality Management System

The Quality Management System (QMS) is documented in:
 

*	Quality Policy
*	Quality Manual
*	Procedures
*	Work Instructions
*	Records

 

Section 5: Management Responsibility
 

Once Management has established the Quality Policy and Objectives, they must continually improve the effectiveness of the QMS

Management will:
 

*	Review the Quality Policy
*	Collect and analyze data about the performance of QMS processes
*	Hold Management Review Meetings to assess opportunities for improvement and need for changes

Management and the Customer

Management must make sure that systems have been established to determine and meet customer requirements

It is up to each and every employee to work to meet customer requirements.  
 

The organization must continue to provide the resources necessary:

Employees are a resource

Employees must be qualified and trained for the job they are performing.
 

*	Qualifications and training requirements have been identified for your job.
*	You need to complete all required training. This may be on-the-job training, group training, or individual training.
*	Once you have completed training, the "effectiveness" of the training must be evaluated. This is in the form of a quiz, observation of your work, performing to specifications or other ways of evaluating your understanding.

The physical resources needed to make quality product are considered "infrastructure"
 

*	The facility
*	Equipment
*	Layout
*	Workspace
*	Support services

Work environment includes factors such as:
 

*	Heat
*	Vibration
*	Noise
*	Humidity
*	Light
*	Cleanliness

 

Product Realization:
The processes in your organization that actually result in the product or service that goes to your client.
 

*	Customer related processes
*	Purchasing
*	Production and Service

Product realization processes must be planned

There are things that need to be determined as you set up your quality management system and as you implement new processes.
 

*	How will the processes be controlled?
*	What are the Quality objectives?
*	What are the Documentation requirements?
*	What are the Records requirements?
*	What are acceptance criteria for the process?

 

Processes must be controlled
 

A well controlled process will be performed constantly day to day, employee to employee.

Consistency is achieved by:
 

*	Training or qualifying employees to perform the process
*	Documenting the process
*	Providing information on process characteristics or product characteristics.