DMS software meets ISO 9001: your guarantee for secure document management

No matter whether you work in a small business or a global company: You deal with many documents every day that are part of your work and business processes. You have to create, read, check, release, pass on, archive or delete documents. In technical jargon, these tasks are referred to as “document control”.

All of these tasks are anything but trivial: Systematic and effective document control is crucial to a company's success, and there is even an internationally recognized quality standard for it: Companies that are ISO 9001:2015 certified or want to be certified must ensure that they control relevant documents in their company according to the specified standard.

Discover how to achieve effective document control according to ISO 9001 and what advantages high-quality DMS software offers.

Document control according to ISO 9001

The “control of documented information” in accordance with ISO 9001:2015 is part of a structured quality management system (QMS). It is used to effectively control processes in your company and to continuously improve the quality of products or services and satisfy your customers.

Managing documents relevant to quality management covers the entire life cycle of a document from creation, review, approval, distribution, updating to storage and destruction of documents.

“Documented information” that must be controlled in accordance with ISO 9001 is:

• Test protocols
• Checklists
• Training certificates
• Work instructions
• Process descriptions
• Quality management manuals
• Records, meetings, audits, etc.

Documents can be in paper or digital form.

To ensure that all basic documents can be properly created, reviewed, approved, updated and checked, ISO 9001 defines clear guidelines for document control and specifies how and with what objectives you must organize documents. After all, what good is a safety instruction if nobody knows it? How effective is an important manual that is out of date?

Expert knowledge: The ISO 9001:2015 standard regulates legal requirements as well as customer requirements - which are relevant even if a company is not (yet) certified. Companies must therefore ensure that employees have the latest version of the relevant guideline for their work process at their disposal.

Document control in accordance with ISO 9001 ensures that ...

... responsibilities and workflows are clearly defined for all employees concerned.

... it is clear who created and approved the document .

... all authorized employees can use important documents and (re)read information at any time.

... documents are clearly named and clearly labeled.

... the documents are up-to-date.

... different versions are clearly marked and can be traced without gaps.

... documents with confidential content are protected.

... the documents are protected against loss.

... employees cannot arbitrarily change or accidentally delete documents.

... documents are stored, properly destroyed or deleted in accordance with legal archiving regulations.

To ensure that document control is carried out in accordance with the standards, companies must create clear structures and develop reliable business processes. For example: Who is responsible for what? How are employees trained? How are document changes managed? The document control requirements in accordance with ISO 9001:2015 are checked in internal and external audits. Companies must ensure that their document control procedures are effective and continuously improved, as they learn from mistakes.

Document control with the help of DMS software

Depending on the size of the company and the complexity of the products and processes, hundreds of documents can be created in a single day. Manually managing large volumes of (printed) documents is time-consuming and error-prone. A document cannot be processed by several people at the same time. In the worst case scenario, information ends up in a personal pile of paper or on a local desktop. Manual document control is therefore simply neither feasible nor up-to-date.

The more standard documents there are, the more important it is for your company to work with smart DMS software in order to comply with the ISO 9001:2015 guideline in a secure and traceable manner. Intelligent document management software (DMS) as a cloud solution effectively supports you in managing your documents digitally and meeting the ISO 9001 requirements. This makes your company faster and more efficient, improves products and customer relationships - and gives you a decisive advantage over your competitors.

DMS software as a cloud solution offers you these 10 advantages for document management:

1. Central storage and fast access
   
   Document management software allows you to store all relevant documents and files in one place and manage large volumes of documents in a clear and organized way. Authorized users can quickly and easily access the information they need without wasting time searching for scattered data.

2. Location-independent access
   
   With DMS software as a cloud solution, employees can access documents from any location. This is particularly advantageous for companies with teams at different locations or employees who work remotely.

3. Improved cooperation

   DMS software supports collaboration and the exchange of documents between team members in real time. Users can simultaneously work on documents, leave comments and track changes, which increases their efficiency and productivity.

4. Versioning and revision security

   DMS software allows you to save different versions so that changes to documents can be tracked and documented. This ensures audit compliance and is particularly important to meet compliance requirements and minimize the risk of errors.

5. Workflow management

   DMS software allows you to intelligently manage document control workflows, including automatic notifications, multi-level approval processes and task assignments. Document creation, -review and approval is more efficient.

6. Security and access control

   By defining access controls and authorizations, DMS software ensures that documents can only be viewed or edited by authorized users. This function contributes to the security of confidential information and minimizes the risk of data leaks.

7. Search functions and metadata management

   Efficient document management software includes search functions and the ability to add metadata to documents. This makes it much easier to find and organize documents and comply with documentation standards.

8. Auditing and reporting

   With high-quality DMS software, you can track all activities related to documents, including changes, access and approvals. This also simplifies ISO 9001 audits, allowing you to generate reports on document processes and activities that prove ISO-compliant document control during an audit.

9. Integration with other systems

   Document management software offers integrations with other company systems such as Enterprise Resource Planning (ERP) or Customer Relationship Management (CRM). This enables seamless data transfer, improves the efficiency of business processes or prevents unpublished local copies.

10. Automatic updates and maintenance

    Good DMS software is managed by the cloud provider. This means that updates and maintenance work are carried out automatically. Companies do not have to worry about installing patches or updating the software, which saves time and resources.

Expert knowledge: A QM officer or compliance officer manages all relevant documents in accordance with ISO 9001 and ensures that authorized employees in the company have access to the appropriate and up-to-date specification documents for their area.

Conclusion

Regardless of size and industry, documents are created, read, forwarded, archived and deleted every day in every company. The nationally and internationally recognized quality standard ISO 9001:2015 specifies how these processes, known as document control, are to be regulated. Companies that are certified or wish to be certified must adhere to the specifications for the “control of documented information”. DMS software helps companies to effectively and reliably comply with the guidelines, increase the quality of their products or services, meet customer requirements and avoid errors. This pays off, improves collaboration between your employees - and makes your company more successful.