Quality Documentation - "or everything you don't know and need to know about documentation."

The documentation standards: S-0001-00; S-0001-01; S0011-00 detail how to "do" documentation. These documents explain everything about the control of documentation and the standard for creating documents. These standards are operating procedures for the control of documentation and establish the company standards according to the ISO Quality System and ISO 2000 Standard. Another reference for our Quality System is the Quality Manual, which is now available to users using the Intranet. Section 4 addresses the Quality System and specifically Control of Documentation. The quality manual and the related documentation references are tools in the ISO Program and users of documentation can reference these tools to become more familiar with both the ISO Standard (ISO 2000) and the QS (Quality System).

On the page Managing the Work Flow the process for documentation flow and process steps were explored. These tasks have been illustrated previously and are not referenced below. Please refer to Managing the Work Flow if you have questions about the process of documentation. S-0011-00 is the standard for the process of documentation.

This section of the documentation will focus on what a finished quality document looks like and how to get from what you have (or don't have) to what you need to get released. There are some interesting resources provided like the checklist, examples of documents out of revision and documents in revision. These are provided as resources to provide visual examples of the documentation.

Most users will have a general knowledge of ISO and the requirements for quality. Since the business of quality is reflected in our processes, the dynamic nature of change is present in the departmental documentation. While the procedures and quality manual provide direct evidence of the standards for control of documentation, quick reference guides are more useful for the day - to - day tasks of managing documentation. For this reason several job aids have been created to support the developers of documentation.

Format Check List

A checklist has been created to help users with the format. The Check List is available on the ISO Web Site under Quality Documentation. The template format for documentation does not change frequently, but it does change. When this happens the template is updated and the departments are required to keep the revised documentation in lockstep with these changes. (We "grandfathers - in" documents, which means departments update to the current template or standard when the document is under the two year review or revision.)

New Documentation - Quality Standard & Documentation Template.

The template is a utility tool for making sure all new documents are set- up in the proper format and use all of the standard format for documentation. This template is available in the word format and is a formatted document for you to add your content. The current fields and requirements for documentation are in the template.

If you don't have a copy of the template and are responsible for making new documents, you will need a current copy of this document. The template is a controlled document and does change. Departments are advised to check with ISO Documentation to assure the document template being used is the correct version.

Updating Documentation - Documentation Checklist

Documentation is and will always be an area that departments will need to stay current and continuously improve and revise. Documentation is never done and even when it is, it will change because the business is dynamic and therefore the processes and the procedures are dynamic.

When the ISO program was launched in 1999 the system did not include all of the ISO standard requirements: Quality Records, Authorities, Training, Safety, Related Documentation. The system continues to evolve and with this evolution is the change in format to address inconsistencies or gaps in the quality system. Just like departments get reviewed for appropriate use of the standard, documentation for the company changes to meet the criteria and updates required by continuous improvement and auditing corrective / preventive actions. These updates often occur in the procedures and processes, and of course flow charts.

Documentation updates are completed due to two reasons: (1) A business process changes and the procedure requires an update. (2) If the document has not been reviewed/ changed / or updated in past two years. Management has identified that all documents both internal and external are required to be reviewed minimally every two years. These two events will be the key reasons why a document will need an update. During the revision the format will also be updated to bring the documentation into conformance with the standard for documentation.

Revising the Format for the Standard.

There are several ways you could approach updating to the current standard. The first approach is to review your document against the standard (S-0001-00). The second approach is to use the check list and review your document against the list of changes in the format. This review is the most efficient as the check list has been created to shorten the amount of time for the department to conduct a formal review of the document and assure the document ascribes to the current standard.

Documentation has changed quite a bit since 1999. Most existing documents have been through one revision since the implementation of ISO. Below is one document from 1999 and the existing document from 2003. Both documents provide a visual to what is wrong (1999) and what is right (2003). These examples are provided to give you an idea of what documentation is reviewing and why documents may not meet the current approved standard for format compliance.

Documentation is an evolving process. When we are audited internally and externally we identify gaps in the system and as a result updates process, procedures, forms, flow - charts and documentation. In 2002 - over 250 documents were released. This does not count documents processed, but unreleased. The quantity of documents (over 600) and the number of requests for change/ review/ edits/ updates are substantial. The documentation change process is provided to control documents and assure the documents conform to the ISO standards for control in process.

The tools for ISO Documentation are available to support documentation developers and users to keep updated with the current knowledge base for ISO Documentation and control.

Managing The Work Flow

Documentation Tools

Quality Documents

Prioritizing Documentation