ISO 9001 – A Beginner’s Guide

Manufacturing companies, regardless of product, usually have a quality assurance department or program.  The company sets quality standards based on customer needs and then inspects product before delivery to make sure it meets those standards.  While these programs may have been effective, they relied on inspection of the completed product to determine quality.  Quality standards were often subjective, with the company determining its own criteria apart from the customer.  

With a variety of customers and different quality standards, there was little or no consistency.  Finding the right product or vendor that could deliver consistent, reliable quality was “hit or miss” at best.

ISO 9000 has its roots in the British Standards Institute’s first quality standards, BS 9000, designed for the electronics industry and published in 1971.  In 1979, the standard became to BS 5750.  Suppliers dropped their individual standards and agreed to adopt BS 5750.  In 1982, the standards received government backing. 

When the British government transferred administration of BS 5750 to the International Organization for Standards in Geneva, Switzerland in 1987, it became ISO 9000.  There have been several variations and revisions, with ISO 9001:2008 as the latest version.

With ISO 9000 and the current revision, ISO 9001:2008, companies now have a recognized global quality standard that applies to service organizations as well.  Many companies, like General Motors or Boeing require their vendors to be ISO 9000 registered.  They are assured those vendors meet the ISO 9001 requirements and have established a consistent quality management system.   ISO 9000 registration is often part of a company’s Total Quality Management system, setting standards for both products and services.  The registration process can be lengthy, requiring input from all levels of the organization:

  1. Companies develop a quality manual, which outlines the quality management system.  They also must develop a quality plan with goals and objectives.  
  2. There are six required quality policies and procedures:  Document Control, Control of Quality Records, Control of Non-Conforming Product, Corrective Action, Preventive Action and Internal Audits.  These form the core of the quality management system.  
  3. Clear and specific documentation of policies, procedures and work instructions—step-by-step instructions for doing the work at each stage in a process–are essential to establishing and auditing an ISO 9001 quality management system.  This documentation acts as a control to manage conformance to standards, processes and internal audits.  The company must constantly revise documentation to reflect changes in policies and work processes.
  4. The company will test the quality system before undergoing an audit by an approved ISO 9001 registrar.  Periodic audits by the registrar confirm the company is operating under ISO standards. 

ISO 9000 clarifies and standardizes business processes, exposes variation and non-conformance, and eliminates the need for constant inspection. With an established, globally recognized quality management system, quality assurance is everyone’s job.

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