Monday, March 14, 2005

What's ISO 9001 anyway?

What is ISO 9001?

ISO 9001 is an international Standard. It's one of the most widely known and internationally accepted models for a quality system, and the basis of many highly effective quality systems.

The Standard can be applied to any size of company or organisation, any industry and any country, for both services and products.

It consists of a set of 'requirements'. They require (ie, specify) what you must do, but not how. For example, one set of requirements applies to people: it says that people who perform work that affects the quality of your products (or services) must be competent, which you'd agree is a good idea. It doesn't say what qualifications, skills, experience or training they must have - you decide that in your company.

Another requirement is for planning: it requires you to plan how you intend to achieve quality, but it does not say specifically how you must plan, nor specify a format for your planning. And contrary to very widespread belief to the contrary, it does NOT say anywhere that you must have or produce a document called a 'quality plan'!

The Standard is based on these 8 principles, which underpin all the requirements:
  • Customer focus
  • Leadership
  • Involvement of people
  • A process approach
  • A systems approach to management
  • Continual improvement
  • A factual approach to decision making
  • Mutually beneficial supplier relationships.

It's worth understanding that the Standard was written by a committee, and that it has the inherent weaknesses of multiple authorship. It can be difficult to understand in places - particularly because some of the language is formally expressed, and also because certain terms may be used that you haven't come across before, or often, such as 'nonconformance' and 'corrective action'.

Because it states generic requirements, and is intended to apply to all kinds of businesses, some interpretation and experience is required to apply it to your particular business. But it's sets a standard, it has international acceptance, and thus it's been widely adopted across so many countries.