What is ISO 9000-2008?

Fundamental Quality Management: The ISO 9000 family is focused "quality management". This means what the organization does to fulfill:

• the customer's quality requirements,
  
• and  applicable regulatory requirements,while aiming to
  
• enhance customer satisfaction,
  
• and  achieve continual improvement of its performance in pursuit of these objectives.

This document is not an actual standard with requirements. It is a description of what a fundamental quality management system is, as well as including the vocabulary used in the standard. Since it is an international standard, and words can have different meanings in different languages, it is necessary to define the words to have a common meaning.

The following information is in the ISO 9000 guideline:

• Vocabulary 

• Fundamentals of quality management systems 

• Rationale for quality management systems 

• Requirements for quality management systems and requirements for products 

• Quality management system approach 

• The process approach 

• Quality policy and quality objectives  

• Role of top management within the quality management system 

• Documentation 

• Evaluating quality management systems 

• Continual improvement 

• Role of statistical techniques 

• Quality management systems and other management system focuses 

• Relationship between quality management systems and excellence models

The most recent edition of ISO 9000 is dated 2008. This is a crucial document for companies to read and understand. It is especially important for top management because it clearly sets forth the focus and intent of the ISO 9000 requirements.

Unfortunately, at last count, less than 10% of certified companies possessed a copy of ISO 9000:2008. Even worse, none of top management in those companies had actually read it.

Whether you are an old hand or new to ISO 9000 this is a valuable document to have and read if you are truly going to understand the principles of quality management systems.

The Requirements for Quality Management Systems

This document sets forth the actual things a quality management system needs to address. This is the "standard" and as such, it has the requirements that must be fulfilled to get your certification/registration.

The 1987 and 1994 editions of the standard were focused on standardizing processes primarily through extensive documentation. Although the intent was to provide customer satisfaction and improvement those terms never actually appeared in the standard.

The 1994 edition that immediately preceded the current edition had one clause with 20 sub-clauses. Each of the sub-clauses focused itself on a specific type of operation in companies. For example, there was a clause (4.3) titled "Contract Review" that focused on customer order review.

Another one was a clause titled "Process Control" (4.9). However, it focused on production processes, not all processes. Each was considered a separate entity and was treated that way when documenting and implementing as well as being audited.

The 2000 edition was completely reformatted and re-focused. This edition contains only five clauses, they are reflective of the processes most companies have. The new formatting is geared toward the interaction of the processes in companies. All processes in companies rely on each other for their input and output.

The Process Approach

ISO 9001:2000 requires companies to identify the processes in their organization as well as the interaction of these processes in order to enhance customer satisfaction through continual improvement.

The process approach starts with customer requirements as the initial input and customer satisfaction and continual improvement as the output. The phrases "customer satisfaction" and "continual improvement" actually appear in the standard and requirements have been set for measuring and monitoring activities based on objective measurements.

The sections are numbered and titled...

• Quality management system 

• Management responsibility 

• Resource management 

• Product realization 

• Measurement, analysis and improvement

Another of the significant changes from previous editions is there is only one standard opposed to three. The 2000 edition includes everything from product design or development to servicing the product after the sale.

Speaking of design and development, under the previous edition of the standard companies could simply choose not to include specific operations or processes in the scope of their quality management system and certification.

For example, if they didn’t want to include product design engineering, sometimes referred to as "wild cards" because of the lack of standardization between engineers, they chose certification to ISO 9002, which didn’t include design control. This is no longer possible.

You can only exclude a process by justifying that it doesn’t affect customer or regulatory requirements. That's tough to prove when you design and/or develop the product or service that customers buy.

This initially resulted in many companies not transitioning from the 1994 edition to the 2000 standard and therefore eventually losing their certification. And that says a lot in itself. I won’t go into that in detail here, but those companies evidently never received any return from their certification efforts.