What is the ISO 9001 Quality Management System (QMS)?

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iso 9001 quality management system qms

The ISO 9001 Quality Management System (QMS) is a versatile, flexible management tool that an organization uses to dramatically improve the day to day operations, the financial health of the business, the continuous improvement process and customer satisfaction. In recent years, the ISO 9001 QMS has become the defacto baseline or benchmark for minimally acceptable Quality Management Systems throughout the world.

  • The standard defines, outlines and categorizes all the “good business practices” that are normally necessary to help a business become more profitable and competitive
  • Companies need to approach this new business methodology with a completely different attitude. What may have been acceptable business practices a few years ago are no longer going to work for small to mid-sized organizations
  • Whenever we look at the quality management system we should look at it as though the title was the “Operational Management System” for it to have any value from a business perspective
  • The ISO 9001 Quality Management System process must be fully integrated with the Operational System process and be absolutely transparent. The two processes are a single management process and must be perceived as such
  • The ISO 9001 Quality Management System is a means of preventing non-conformities which add non-value cost to the overall price of our goods / services. The goal is to reduce cost and expenses. Corrective action activities are expensive since they are part of the non-value cost of our end result
  • If we do not fully and completely understand our processes, we will never make the transition from “business as usual” to becoming a “world-class organization”
  • Successful implementation is a process that leads to a cultural change that significantly and positively impacts the way an organization conducts its business

Background and History

Objective – Facilitate worldwide coordination & unification of industrial standards (level the playing field)

  • ISO organization was created in 1947 and is headquartered in Geneva, Switzerland
  • ISO 9000 quality standard first issued in 1987
  • Based in part on U.S. MIL-Q-9858 (See evolution below)

ISO 9001 Evolution

  • 1959, MIL – Q – 9858 released – first significant attempt by military procurement to standardize purchasing / quality process
  • 1968, NATO develops Allied Quality Publications to assist in military procurement
  • 1973, The United Kingdom developed their defense standard from the previous standards
  • 1979, Revised to a British Standard to include non-military activities
  • 1987, Initial release of the ISO quality management system standards
  • 1994, First revision of the standards – minor changes to text and clarifications
  • 2000, Major revision to the standards – revised to incorporate process management philosophy
  • 2008, Minor revision to the standard – clarifications and note expansions
  • 2015, Major revision to the standard – added risk management, business context, leadership and completely reformatted

What are the goals of the ISO 9001 Quality Management System?

The goals of the ISO 9001 QMS are many and well-focused. These goals assist an organization in building a stronger, more functional, better-organized operational system that will potentially lead to a world-class operation. The major goals of the ISO 9001 are listed as follows:

  • Ensure customer needs and expectations as well as their requirements are continuously met
  • Ensure that a continuous improvement process is established and maintained
  • Provide a comprehensive model for quality management systems
  • Eliminate the proliferation of organizational unique quality management systems
  • Change the typical current detection / reaction culture into a preventive thinking culture

Why bother to implement an ISO 9001 QMS?

There are a variety of reasons for an organization to implement the ISO 9001 QMS. The most popular reasons are:

  • We want to build a better organization
  • We want to compete in a larger marketplace
  • We want more market share
  • We need to be more profitable - see Quality for Profit
  • Our customers want our organization ISO 9001 certified

All are reasons enough to begin the task of ISO 9001 implementation. This is not normally an easy decision to arrive at. Consider the external implementation cost, the registration cost, the annual surveillance costs and finally the hidden cost which is the cost of the organizations staff during implementation and afterwards for maintenance efforts. There are also many, many benefits that will offset these costs, but only after a successful implementation.

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ISO Quality Consulting, Inc, Management Consultant, Fort Lauderdale, FL