How Document Control Software Helps You Meet the Requirements for ISO 9001:2015

ISO 9001:2015 eliminates the distinction between records, processes, and manuals. Intelex Document Control Software helps you meet ISO 9001:2015 requirements
ISO 9001:2015 eliminates the distinction between records, processes, and manuals by using the category documented information to describe all of them. Intelex Document Control Software can help you meet the requirements of ISO 9001:2015.

Unlike previous iterations of ISO 9001, ISO 9001:2015 does not prescribe specific approaches to document governance. Instead, it is up to each organization to determine its approach to the maintenance, retention, and disposition of documentation.

ISO 9001:2015 eliminates the distinction between records, processes and manuals by using the category “documented information” to describe all of them. The phrase maintain documented information describes working documentation that requires regular updates, such as procedures and work instructions. The phrase retain documented information refers to document types such as records that provide evidence of past conformity with requirements.

ISO 9001:2015 has requirements for documented information throughout the standard. The table below collects all the references to required documented information.


The Hidden Benefits of Document Control Software

There are a multitude of hidden benefits that an organization can enjoy when document management becomes a part of their operations.

A knock on the door from an OSHA or FDA official is usually enough to send the average EHS manager into at least a mild panic. That sound usually means a dreaded regulatory inspection is upon them, bringing with it nightmarish visions of hefty fines, shutdown orders or costly reputational damages to the organization. 

Some of these managers, however, tend to accept the predicament with considerably more calm and confidence than others. That’s because they know that when their uninvited guests inevitably ask to see documented proof that procedures were properly followed and regulations were adhered to, they will be able to produce that documentation in a quick and efficient manner. 

They will be able to do so because they will have been using document control software as part … Read more...

Document Control Software Simplifies Compliance

Regulated industries face unique challenges regarding risk management and compliance, making document control software a crucial component in managing key documents such as permits, reports and forms.

There is a lot of confusion about what digitization, digitalization and digital transformation are, how they are different and what this means for document control. Many people use them interchangeably, but when you dig deeper, you will find that there are significant differences regarding their goals, scope and benefits. In the long run, they share a common goal of transforming legacy processes and operations to fully digital analogs that increase efficiency, transparency and customer satisfaction while reducing costs.

With benefits like these, it’s no wonder that companies are aggressively adopting these changes. The global digital transformation is expected to reach almost $3.3 trillion by 2025 as companies increase their spending on mobile technology, IoT and SaaS.

COVID-19 accelerated this trend and turned …