• Bureaucratic • Top-heavy • Rigid • Paperwork-driven • Limited to manufacturing • Limited to products • Relegated to the Quality department • Expensive

ISO 9001:2008 (intermediate definition)

It is an internationally-recognized standard designed to specify requirements for quality management systems where an organization:

• Aims to enhance customer satisfaction through the effective application of the system, including processes for continual business improvement, and
• Needs to demonstrate its ability to provide products and services that constantly meet customer and applicable regulatory requirements

ISO 9001:2008 (advanced definition)

ISO 9001:2008 is a standard that provides a set of standardized requirements for a quality management system.  Let's dig deeper.  It’s a short statement but it packs quite a punch. 

ISO 9001: This is the same thing as ISO 9001:2008.  The “2008” portion represents the version of the standard.  The previous version was ISO 9001:2000 and the version before that was ISO 9001:1994.  For the sake of brevity, it’s easier to say ‘ISO 9001’.  ISO has a formal process whereby the revision of standards must be initiated within 3 years of the publication of a standard in order to keep them up to date. 

Standard: for comparison; a reference point against which other things can be evaluated.  In ISO terms, a standard is a listing of criterion outlining the recommended guidelines that need to be adhered to in order for a business to be considered compliant to that standard.  Better yet, a standard is a recipe.  Follow the recipe to get the desired results.

Standardized: This means when you look at the ISO 9001 standard, what you see has been approved by ISO through international consensus and the involvement of Technical Committee no. 176, sub-committee no. 2 (ISO/TC 176/SC 2) and several quality and industry experts, ISO Member bodies and any other interested parties.

Quality Management System: It is a common sense, documented, business management system that can be applied to all business sectors (i.e. public and private) and all sizes of companies.  It identifies the key process areas that need to be addressed to ensure quality is managed effectively.  The QMS addresses what the organization needs to do to:

• Fulfill the customer’s quality requirements
• Fulfill Applicable regulatory requirements
• Enhance customer satisfaction
• Achieve continual improvement of its performance in its pursuit of these objectives