ISO 9000 Documentation and Documentation Hierarchy

Documentation and Documentation Hierarchy

ISO 9000 DOCUMENTATION

STRUCTURE

The documentation created for ISO 9000 registration is submitted to the company’s 3rd-party registrar prior to them visiting the site to conduct the actual audit. In fact, one type of documentation is used by the registrar to develop the audit plan for your company. Structuring your ISO 9000 documentation to facilitate the audit process only serves to enhance the potential for a successful audit. This structuring will also make it easy for you to plan and monitor your documentation efforts, both for the registration audit and all subsequent maintenance audits.

DOCUMENT CONTROL AND ISO 9000

Once the documentation structure has been defined and the documentation written, a strategy for controlling it must be put in place. ISO 9000 requires that documentation must be readily available to those who need it, be of current issue, and that all obsolete material be completely removed from the system. The control of documentation, from creation of new material through to the destruction of obsolete material, presents one of ISO 9000’s biggest challenges. It is also one of the elements audited by your 3rd-party registrar.

DOCUMENTING ISO 9000

A thorough analysis of each element prior to writing ensures the resulting documentation will meet ISO 9000’s criteria. Specific characteristics exist for robust Quality Systems, and these must be clearly established within the organization. Since ISO 9000 registration is not a one-time occurrence, clearly documented procedures for maintaining a compliant Quality System must be in place. Historically, companies have produced policy and procedure manuals which, because they contained corporate policies, where often not made available to all employees. As a result, the procedures were also not readily available. ISO 9000’s requirement that procedures be readily available to all persons performing the work usually necessitate the separation of these procedures from the policy manual Perhaps the biggest stumbling block for North American businesses is the requirement to clearly define and document the processes that it uses. Developing documentation that tells HOW we do something is not new to us, but accurately describing WHAT it is we do is far less common. Most of our existing documentation is product or department based. ISO looks only at the processes used to create products, and these generally run across many areas of an organization. We can no longer write documentation in isolation, the whole organization must be considered when writing ISO compliant documentation.

WHEN IS ENOUGH, ENOUGH?

One of the complaints often heard about ISO 9000 refers to the large amount of documentation that is perceived to be required. While procedural documentation is important to the proper functioning of an effective Quality System, many companies tend to over document. First and foremost, you must remember that it is your company and the documentation must fit the company, not the standard.

The ISO 9000 series of Quality Standards does indicate key characteristics of a properly functioning Quality System, but how they are implemented is the responsibility of the organization. ISO documentation must reflect what the company does, not what it thinks the ISO auditor will want to hear. In determining whether procedural documentation is required, look at the skill sets of the people performing the task as well as any unique requirements the company may have for completing the task. In many cases, documentation will not be required because there is no unique process and/or the person has been trained in how to complete the task.