Controlling quality documents is fundamental to ISO 9001 and is common to all other management standards.
This specification was inserted from ISO 9001: 2008. In the 2015 version, there is no longer a requirement to document this process. In return, the control requirements are practically the same.
Another difference is that the category of documents has been expanded to documented information, which includes what used to be called records.
Recording each action at each stage facilitates the training of new employees and the audits of the process. Therefore, even if it is no longer a required procedure in the ISO 9001: 2015 standard, we recommend that you continue to document the process.
So, what do you need to do, in a practical sense, to control documents? We have listed 3 practices that will help you in this process.
1. Put some information from the document itself, in each controlled document
Some information will go on the cover of the document and some need to be on each page, usually in the footer.
Generally, header and footer data show what will be found in that document. They also answer questions about how the document was approved (Released), the version (Date), who is responsible for its approval (Management Representative) and where to find it (Quality Systems).
2. Appoint a single location to maintain master copies and a record of documents
This is where end users will go to check if the version they have is the most recent one. It can also be the place where they can access documents they need.
The document register is simply a list for you to control quality documents of all types. You will need one to be able to keep track of your management system documents and to identify what needs to be reviewed.
Ideally, the record will include the title, review information (date, number or both), status (project, launched, etc.) and who is responsible for the document (name and / or title).
3. Establish the process
Here’s where you answer these other questions:
The process of releasing a new document or updating it can be as simple as making the document available at the designated exchange. Notifying this release to relevant people is always a good idea. But be very careful about sending any new document notifications to everyone in your organization. An excess of them can mean that they will be ignored.
You need to review documents regularly to make sure they are valid, that they are adequate and that reflect your practices. If the practice has changed, then the document must be updated. Your comment should include checking for changes to standards, regulations, specifications and other external documents.
In management systems based on paper files, changes are usually controlled in the document itself placed on a table. This can sometimes be stored outside the document in the register.
Document management software will usually store change information in the database and a multidisciplinary verification table is not required.
These days, access is usually through login to the file server or online document manager. However, do not assume that this is enough for all situations.
The practicalities of computer access can be difficult for some locations or for some people and you may have to distribute copies in these cases. Keep track of hard copies for future reference when updates need to go elsewhere and you will need to remove obsolete versions.
Maintaining a distribution list of printed copies will help you to track the old copies that should be removed. Also, it is common to leave the task of controlling quality documents to the end user. This way, he can check his new version, in contrast to the version shown in the registration document or the current version of the central manager.
We hope this topic has become clearer for you! Share your comment by telling us what this process is like in your company or any questions that are still left!