Creating and updating documented information is the process of recording data in a defined and clear manner. In doing this, all specifications must be outlined and identified for monitoring and future reference.
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When documented information is created and updated, there are a few main points that must be considered and followed in order to be compliant with ISO 9001 guidelines.
You should seek to confirm that when documented information is created or updated, that it is appropriately identified and described (e.g. title, date, author, reference number).
It must be in an appropriate format (e.g. language, software version, images) and on appropriate media (e.g. paper, electronic). Confirm that documented information is reviewed and approved for suitability and adequacy.
Next, all documentation must follow the correct formatting requirements. Since there will be several different types of documents filled out and used throughout the course of any business, there will also be a corresponding format for each of these documents.
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.
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.
Our Documented Information Procedure is proven to work.
When a document is updated in ISO 9001, it must still adhere to the guidelines that are set in place for the creation of a document. All updated information must also be clearly defined and written, with specific dates, times, title, author, and reference number indicated within the document for future reference.
Basically, the updating of ISO 9001 documentation should be as detailed and thorough of a process as the first time the document was written.
Along with the creation of documentation in ISO 9001 as described in the previous section, these documents must also be identified. To be more specific, there must be some kind of written explanation of what the created document is and what it contains in order to be able to easily identify it.
All documents created against ISO 9001 guidelines must be identified with a name, identification number, or another unique way to tell it apart from other documents. As a result, all company personnel who have access to the document in question will know exactly what it is and what to do with it.
The identified documents listed above are very general, but will be sufficient to hold up during an ISO audit. Just for the purposes of an example, these are the most basic identifications of documentation for ISO 9001.
With the proper identification of ISO 9001 documentation, all documents and records that are kept within the organization will be organized and easily locatable when they are needed during business operations.
Our Documented Information Procedure is proven to work.
Updated: 26th April 2024
Author: Richard Keen
Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
Learn more about Richard
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EMS ISO 14001 |
OH&S ISO 45001 |
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Documented Information Procedure - view sample The purpose of this procedure is to ensure that all relevant documented information and organizational knowledge which forms an integral part of our quality management system is managed under controlled conditions and that all documented information is reviewed and approved by authorized personnel prior to issue.
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