TIP SHEET

Quality Standard Standards

Writing standards compliance documentation is actually quite simple because the governing body is usually very specific in telling you what it wants. You, the writer, just need to follow their rules. The tough part is working with the subject matter experts to assure that all of the relevant supporting details are available and complete.

The whole purpose for employing standards is to provide consistent quality in a product or service to a customer. The purpose of the standards compliance documentation is to prove that the producer of that product or service is doing just that. Regardless of which standards you are using, most employ similar practices, such as:

Let's look at each of these elements a little closer.

Uniform Content and Format

This means that, in order to be compliant, the documentation is expected to present the reader with the following document characteristics:

This does not mean that you need to reformat every piece of documentation; it means that only the documents showing proof of compliance need to follow these rules.

Typically, for the compliance documents, you will follow an established format provided by the governing body, either on their Web site or in their documentation. Additionally, there are several examples available on the Web. Just search for documents either by the name of the standard you are using or by the governing organization's name.

As for the supporting documents (charts, tables, data lists, disk files, photos, etc.), unless their format is specifically defined by the standard you are using, they need only be uniquely identifiable and readily available to satisfy the compliance audit requirement. Remember that the purpose of this mound of documentation is to prove that the company follows consistent, accepted, verifiable, and repeatable methods, practices, and processes, not to prove that you can generate one thousand pages that look the same (unless, of course, it's the company's business to produce identical-looking pages).

Standards organizations publish a glossary of terminology that they use. Get a copy of it and use it, because consistency is the key to success in compliance documentation. Even if you're wrong, if you're consistently wrong, the error can easily be detected and corrected.

Finally, if any of the company's methods or processes happens to be inconsistent with a published standard for valid business reasons, all you need to do is document why the company will not adhere to that particular standard. Auditors will usually accept such documented justification.

Unique Document Identification

This means that every document you provide (either the compliance document or any of the supporting materials) must somehow stand out from the rest. Typically, this includes using titles (document, process, procedure, etc.), page numbers, dates (effective and update), control numbers, owners, authority, etc. As the writer, it is up to you to determine what the standard requires and to present that information consistently throughout your document through the use of headers and footers.

If the format for such identification is not provided for you, after you develop an appropriate header/footer layout, take the time to identify and document the layout in your introductory pages.

When referring to supporting documentation, where you may not be able to change the document ID, be sure to include sufficient information in your reference description so that the auditors can readily associate the supporting document with the compliance document.

Also remember that your graphics must be legible. If you can't get a graphic properly sized to fit in your compliance document and still be effective, then leave it with the supporting documentation in a larger size and simply refer to it in the compliance document.

Document Linkage

This element is used in conjunction with document identification. In order to be both effective and compliant, a clear reference path between the compliance document and supporting documentation is a must. As long as the auditor is satisfied that the information required to prove compliance is readily available, you should have no trouble getting your certification (assuming, of course, that your supporting documentation meets the standard requirements).

Once again, remember that the key to compliance certification is to prove that the company follows consistent, accepted, verifiable, and repeatable methods, practices, and processes.

Change Control

All standards programs require some sort of change control, in the form of version numbering or change log entry recording, or something of that nature. Avoid having to either continuously republish documents or display a multi-page change log at the beginning of the document by establishing and then adhering to routine editing habits.

This method can tie up some resources for a while, but it can also prevent tying up more resources to recover from a catastrophic error later in the process. Once the change is published, you can delete the interim documents.

Controlled Distribution

Many standards programs follow the practice that the electronic version of the documentation is considered to be the current version in effect. The purpose for this is to prevent conflicts that may arise from individuals following two different hardcopy versions of the documentation. If you adopt this practice, make sure that you archive every published electronic version of the documentation, and keep it apart from the current production version.

I hope you find these tips useful in your next standards compliance documentation project. Please use the contact form to send any questions or comments and remember to include the title of this tip sheet.