Companies can be ISO9001 compliant without PDM [product data management] or PLM [product lifecycle management] software, but it requires a whole new level of discipline and increases risk.
Processes are a key component of ISO compliance as is documentation. ISO9001 compliance requires control and visibility.
Documents follow procedures that are tuned to document types. A change request will move through a process that is different than a work instruction package. Software can make sure that procedures are followed. In a paper based environment, people will need to make sure procedures are followed and prove that they were followed– this can be error prone.
Different document types will have their own business rules that must be followed.
Basic rules for documents require that they must not be deleted or over written, they must be versioned, approved and released. There must be document histories.
There are many components to visibility.
Security – Users will need to see documentation. They will need permission to access a document or documents. Users may not be able to view a document because they don’t have proper access.
They will need permission to change a document. Changes will need to be approved, released and tracked.
Search – Users need to be able to search for and find documents. Many software solutions allow you to search using meta-data. This makes it easier to find information.
Users need to know if there are changes pending to a document. They may want to know who has it now so that they can collaborate on changes.
Management will need to know where documents are within their process.
As you can see, managing documents for ISO9001 compliance is not a simple task. If you are not using software, your users will need to make sure that all of these activities take place and they need to document everything to show that they are compliant.
If your company plans on taking on ISO9001 compliance, it is a great idea to cultivate a culture of compliance.
Contact me if you would like to explore this further…