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What is a Quality Management System?

For more and more companies, implementing a Quality Management System based on ISO 9001, AS9100D, ISO 13485 or TS 16949 is becoming a necessity! It will help you win new customers and retain existing ones!

Implementing one of the Quality Management System standards may seem daunting, especially for the smaller businesses, fortunately the standards are flexible, they mandate requirements for an organization to follow but allow you to fulfill the requirements any way you choose.

This allows a wide range of manufacturing and service companies, both large and small, to create a Quality Management Systems that meets the specific needs of your business. Developed and published by the International Organization for Standardization, ISO 9000 is the international standard for quality management. It comprises a set of requirements that reflect time-proven, universally accepted good business practices, the majority of which are mandatory. The aim of ISO 9000 is to assure that an organization consistently meets customer needs by controlling the core processes that affect them such as sales orders, design, production, inspection, delivery, etc. ISO 9000 requirements also go beyond these “core” processes to address support processes like purchasing, training, calibration, maintenance, and performance metrics.

One important aspect of ISO 9000 is its process-oriented approach. Instead of looking at departments and individual processes, ISO 9000 requires an organization to look at how processes interact and if they can be integrated with one another. This makes the standard applicable to service organizations as well. The actual requirements of ISO 9000 are intentionally generic and can be applied to any organization that provides a product or service. Basically, requirements fall under four categories:

  • Requirements that help assure that the organization’s products and/or services meet customer specifications.
  • Requirements that assure the quality system is consistently implemented and verifiable.
  • Requirements for measuring the effectiveness of the various components of the system.
  • Requirements that support the continual improvement of the company’s ability to meet customer needs.

Nothing in the ISO 9000 requirements is new. Published in 1987, the first version was drawn almost word for word from the British Standards Institute, which evolved from various quality system specifications that had their ultimate origin in the defense industry. Most of the practices required by ISO 9000 have been in use for decades.

ISO 9000 strives to harmonize the sometimes conflicting “quality programs” that have been required by major corporations from their suppliers in the past, although ISO 9000 does not supersede customer, legal, or regulatory requirements.

Bottom line: ISO 9001 is more than a comprehensive set of rules. It is a management system that will help manage your business and improve the performance of your organization on an ongoing basis.

Get Started with Quality Management Systems

If you would like more information on how ETI Group can help you with your Quality Management Systems needs, we would welcome the opportunity to discuss this with you. Please contact us today!