7.5.2 Creating and Updating Documented Information [ISO 9001 Template]

Creating and Updating Documented Information Requirements

1. Identifications and descriptions should be clearly defined
2. Appropriate formatting must be followed for each type of document
3. Suitable media should be maintained for each type of document
4. All documented information must be reviewed and approved before being considered adequate (creating and updating)

You should seek to confirm that when documented information is created or updated, that it is appropriately identified and described (include credentials such as date, time, title, author, reference number, etc.).

It must be in an appropriate format (e.g. language, software version, images) and suitable media (e.g. paper, electronic).

Confirm that documented information is reviewed and approved for suitability and adequacy.

Before any documented information can be considered adequate along ISO 9001 guidelines, it must be properly checked and reviewed. This reviewing process should go over the clarity of the document, the formatting, media, and contents of the actual record itself.

Once this has been reviewed by someone of the proper authority to make the decision, the document can be approved and considered adequate documentation.

Keep Up-to-Date

When a document is created following all of the specified ISO 9001 guidelines in terms of detail, format, and approval, the documentation process is not over.

Although documentation and records are an important part of any business that should be accurately and efficiently kept, these documents must also be frequently updated to maintain the accuracy that they were created with.

For instance, if a business has created a document in relation to a product that they are developing, there should be detailed information within that document that describes the progress and current standing of the product in question.

However, if there are any changes made during the design and development process, the initial documentation will no longer be accurate. Take, for example, the design and development of a functional product.

During the design and development stages, there is a step toward the end of the process that includes creating the first prototype of the product. This step, also referred to as “verification” in terms of ISO 9001, will give the organization the chance to test the product and make any necessary changes.

So, if the initial prototype of the product in this stage is not carrying out the function that it is supposed to, the company will be forced to take necessary action to make sure that the problem has been solved. This, of course, will involve making changes to something on the product.

With these changes taking place, the documentation that was first created about the design of the product will not be accurate anymore, and must be updated.