What is ISO 9001, AS9100 and ISO 13485?

ISO 9001; AS9100; and ISO 13485 are the internationally recognised standards for quality management systems.

 

ISO 9001 is the most popular of these standards for quality management systems with over 1.1M certificates issue in over 200 countries.  It is designed for businesses of all types and sizes to help them operate effectively by reducing “quality” waste (rework, scrap, customer returns etc), getting things right first time and consistently meeting customer requirements. AS9100 which is designed for businesses working in the aerospace/defence sector and ISO 13485 which is designed for businesses in the medical device world are also “quality” standards that are based on ISO 9001 but with some extra sector specific requirements added.  Regardless of which ISO Standard is chosen the benefits are very similar.

 

ISO 9001 / AS9100 / ISO 13485

Research carried out on 250 UK SME’s found that companies with formal business certification such as ISO 9001 were better placed to ride out economic downturns than those without any formal systems in place. Benefits can include;

 

  • access to trade restricted to ISO 9001 (AS9100 / ISO 13485) registered companies
  • more credibility with potential customers
  • a marketing edge over companies who are not ISO 9001 certified
  • working practices consistently and correctly followed
  • reduced rework and replacement costs
  • improved competitiveness
  • increased staff confidence and moral
  • increased customer satisfaction and loyalty

 

A BSI customer survey has revealed that since achieving ISO 9001 certification:

  • 75% improved customer satisfaction levels
  • 77% boosted their operational performance
  • 74% acquired new customers and retained existing customers
  • 44% achieved cost savings