Chuck Richardson of Performance Quality Systems, Inc. (www.performancequalitysystems.com) reminds us of the precise interpretation of ISO 9001 requirements associated with documentation.

Required Documents Fewer Than Folk Tales Dictate

Documentation is information and the medium used to convey the information; it can take various forms such as paper, electronic, photographs, or samples. Records are a special type of document that provides evidence of what has been done. This article focuses on documentation that communicates to the organization what is to be done, how it is to be done, or the required standards. Documentation applies to all levels of the organization and is really the written plan for how objectives will be met

How much documentation does ISO 9001 specifically require? Not much. The required documents are: a quality policy, quality objectives, quality manual, and six procedures. The six procedures are control of documents, control of records, internal audits, control of nonconforming product, corrective action, and preventive action. Additionally ISO 9001 requires your organization to have the documents that are needed to effectively plan, operate, and control your quality management system. Your organization determines what documents are needed based on the needs of the organization, customer requirements, and relevant statutory and regulatory requirements.

My clients are often surprised that ISO 9001 doesnt require more documents. Many of us have heard the stories of companies that write a huge number of complex procedures many of which are ignored, hinder effective operations, or make vital information hard to find. Most companies will need more procedures than the six mentioned above, but there is no need to create documents that add no value or which include unnecessary details.

Appropriate Documents, Appropriate Content

When you create documents think about the information that a trained and qualified employee would need to do the job correctly. Consider the size of your organization, its activities, the complexity and criticality of the processes, the skills and experience of the people you hire, and the training you provide. Companies sometimes seem to use the assumption that the documents are for someone they have just randomly pulled off the street and stuck in front of a work station. The result is more detail than a trained and qualified person would need.

I suggest your organization review its current documentation in light of current and potential problems and then decide what would make the documentation more effective. You might decide to add documents or to increase the level of detail or you might discover that you can reduce the amount of documentation and improve effectiveness.

Documents must be controlled. This means they must be approved, current, and available to the people who need the information. Documents that originate outside the organization also must be controlled. For example, customer drawings used on the shop floor to communicate part specifications should be reviewed and approved by someone within the organization prior to use. Documents must have some type of revision indication typically a revision number, letter, or date so you can determine that the document is current. Obsolete documents can be retained, but they must be identified as obsolete and removed from use.

Documentation is vital to an effective and efficient quality management system, and it should fit the needs of the organization and be as concise and easy to use as possible.