External Documents in Management Systems | How to Correct Documents in Management System | ISO 9001
Today, we will discuss external documents in management systems in clause 7.5.3/2 of the ISO 9001 standard. The clause requires that documented information of external origin necessary for the planning and operation of the QMS shall be identified as appropriate and controlled. Let’s start with what is the documentation of external origin. These may be:
• Standards like ISO 9001,
• Any industry-specific standards like API 1104 Welding of Pipelines and Related Facilities,
• Laws like FDA Quality System Regulation 21 CFR Part 820,
• Customer specifications and drawings,
• Any other documents that the organization does not control.
Let’s start with the management of external documents in general. As a rule, companies create an External document list on their SharePoint, Excel, or network. Such lists may indicate the title, the current revision, media: electronic or hard copy, location, and other info. For this purpose, you may choose to use our Business Management System Structure that we discussed in previous videos. The link is below – check it out; it is a very helpful tool. And you can use it for external documents in management systems.
The following requirement is the control of changes. Since these are external documents, we cannot control their revisions; we can only ensure that the documents we use are recent revisions. If you are a small company and have just a handful of external documents, it is easy. Nobody will miss revisions of the standard, and your customer quality agreements, I hope, include requirements for your customer to notify you of revision changes. For big companies, the system is the same for the customer specifications and drawings. But what if you are a large international company with hundreds or even thousands of standards your system must comply with? Keeping track of the changes in your standard revisions may become a full-time job. Don’t panic; there is a simple solution. There are companies specializing in providing such services for you. Don’t be sorry for them; they do it electronically and charge you quite good money for their services.
The next requirement is unintended alterations. We need to talk about both unintended and intended modifications here. Unintended alterations are easy to control. Your records are safe if they are in PDF format or are password-protected. Intentional alterations are those when a record has been discovered to contain an error, and the record shall be corrected. In this case, a record can be amended per an established process. There is a simple rule in regulated industries that any business may use. Print a PDF file, cross out an error, correct the entry, and initial and date the change. Just make sure that the original content is still readable. Scan the corrected record and file it as the next record revision. Simple!
Let's summarize our discussion today:
• Identify external documents.
• Establish a system to manage them.
• Choose internal or external tracking options.
• Document the process for correcting records.
These steps will help you to manage external documents in management systems.
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