About  ISO 9001
Documentation and Compliance with Requirements


About the standard ISO 9001:2008

The standard ISO 9001 Quality Management System is issued by ISO (International Organization for Standardization) in Switzerland. The ISO standards are developed with international participation of more then 150 countries. ISO 9001 with its latest revision ISO 9001:2008 is the most popular standard and is used by more than 500,000 organizations worldwide.  

Organizations with an implemented ISO 9001 quality management system can obtain certification - also called registration - of their implemented quality management system through a third party certification body called Registrar. It is important to note that ISO 9001 does not certify the quality of products or services regarding functionality, lifecycle or other applicable characteristics. The certification only confirms that manufactured products or provided services are in compliance with defined specifications and requirements of the organization's quality management system, and that this implemented quality system meets the requirements of ISO 9001. Any organization, with manufacturing or service activities, large, medium size or small, can implement an ISO 9001:2008 quality management system and obtain certification.  

Over 500,000 certificates have been issued worldwide in over 150 countries. The growing number of organizations with certified ISO 9001:2008 quality management systems confirms the increasing popularity of ISO 9001.  

In addition to the assurance that defined quality requirements are met, the organization with an implemented ISO 9001:2008 quality management system has usually a competitive advantage over non-certified competitors. 


Implementation of ISO 9001:2008
How to get started
One of the first steps is usually the purchase of the current and fourth edition of ISO 9001, usually referred to as ISO 9001:2008. This standard contains the requirements of an ISO 9001:2008 quality management system

Unless you are familiar with specified requirements, activities and methodologies, and with writing manuals and procedures, the content of the ISO 9001:2008 standard will most likely bring up many questions. An easy and fast way to get answers to most of these questions is to look at a quality management system overview in an applied environment. Browsing through the model will give you a much better understanding of the requirements of the standard ISO 9001:2008. The model will also help you later with the development of documents and activities that are an important part of the implementation process. Keep always in mind that the standard specifies requirements that must be met by your organization. This includes the creation of records to demonstrate evidence of compliance with the requirements of ISO 9001:2008. Using a requirements checklist helps to ensure that all requirements have been met by the quality management system. 

With an understanding of ISO 9001 and its requirements, and based on the content and samples contained in a quality management system model, you can estimate what would be involved with the implementation of ISO 9001 in your organization. Now you can make the decision to initiate (or not) the implementation process. The initial steps are to inform all employees about the implementation of ISO 9001:2008, followed by the development of required documentation such as a quality manual, procedures and forms as well as certain activities like auditing, quality control, monitoring customer satisfaction, etc.   

Once the quality management system is implemented, it can be certified by a recognized third party certification body, called Registrar. A certification confirms that the requirements of ISO 9001 are met. The ISO representative in your country can provide you with a list of Registrars who will inform details of the certification process, including costs. 
After initial certification, the Registrar will perform periodic compliance audits to verify if requirements of the standard have been and are being met.  

If necessary, you can hire the services of a consultant who will help you with the implementation process. Try to find a consultant with some experience in your industry.