Preparing to be ISO Compliant

As I said last week, ISO calls for your company to have a quality manual that includes documentation of all of your procedures.  As you write your quality manual, you will uncover your requirements for any needed software.

Managing Documents

A basic user needs the ability to store documents and to retrieve them.

Beyond that, your requirements for document management should include:

A Secure Vault – Documentation will need to be stored securely.  Only people with proper access will be allowed to ‘check in’ or ‘check out’ any documents.

Version Controls – Unlike MSWord, the software will not allow you to write one file over another.  It should assign a new version or revision number to the file while keeping the original.  A user needs to know that they have the latest released version of a document.

Metadata – It is best that your software provides for metadata [information about the file] so that searching for the document does not require you to know the exact name of the file.

Managing Processes

Documents within a company go through some kind of authoring process to create the initial version of a document.  After that, documents go through a change process.

These processes need to be documented and followed.

During an ISO audit, you will be required to show them your documented processes.  Additionally, you will be required to show [prove] that you follow those processes.

When asked about the history of a document, you will need to show how a document changed through all of the process steps.  For example, you will be asked how a document went from version 1 to version 5.  You will be asked to show all of the versions.  You will be asked who made the changes [and if they had the proper access].  You will be asked to show approval signatures [electronic or otherwise].

Finding a Solution

The better your requirements document, the easier it will be for you to select a software solution.  A thorough requirements document will also make it easier for the solution to be implemented.

As I said last week, most of the PLM [product lifecycle management] software packages have all of the tools listed above and more that are needed to help you be ISO9001 compliant.

Selecting the right software for your company is not a simple task.  Contact me if you would like some help…

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