Document Control: Definition, Standards & Tools

1. What is meant by document control?
2. What is the objective of document control?
3. These are the areas of document control
4. Why is document control important?
5. What are documents in the sense of DIN EN ISO 9001?
6. Which documents must be controlled according to ISO 9001?
7. How does document control work?
8. What forms of document control are there?
9. What tools can be used for document control? 
10. Document control: guiding documents through the lifecycle

Hundreds of documents, both analog and digital, are moved back and forth in a company every day to enable smooth workflow. These documents are guided through their life cycle - they are created, edited and archived. All these processes are referred to as document control. Read on to discover more about document control, the relevance of the DIN ISO 9001 standard, and the tools that can support you with document control.

What is meant by document control?

Document control, or 'control of documented information' according to DIN EN ISO 9001:2015, is an essential component of quality management. It describes a series of practices ensuring enterprise documents are discernibly and systematically created, reviewed, distributed and disposed of. In simple terms, document control involves the overall organization of documents. This covers the entire life cycle of documents - from creation to revision and ultimately, secure document archiving.

What is the objective of document control?

The main goal of document control is reliable, consistent documentation and storage of important information. This is to prevent certain data and work instructions from being altered and safety notices from not being found.

Here are the goals of document control at a glance:

• relevant documents in their current version at the right place at the right time

• responsibilities for processes and approval workflows are clearly regulated  

• supporting of employees

• traceable, standard-compliant documentation facilitates successful auditing

• important information is distributed more efficiently
  

These are the areas of document control

The term document control generally arises in relation to quality management and its documentation. However, it also applies to all areas where documents are used and distributed. Besides quality management, the following other areas of application arise:

• Data protection

• Risk management

• Project management

• Document Compliance

• Contract management

• Complaint management

• specific areas in production, marketing and sales and many more

• all management systems orientated towards standards – from ISO 14001 to IFS

Why is document control important?

Document control is essential for the smooth running of enterprise processes. It ensures the accuracy and actuality of documents and records, thereby reducing errors. It also simplifies access to needed information and helps achieve compliance requirements.

Furthermore, only thorough documentation can retain know-how. Otherwise, the departure of individual employees will automatically result in a loss of knowledge and certain information.

What are documents in the sense of DIN EN ISO 9001?

According to ISO 9001:2015, all information to be documented in a DMS is termed 'documented information'. This collective term covers internal and external documents, data, forms, records, checklists, as well as work instructions and process descriptions. The documented information can be stored on paper or digitally, and can be controlled.

The definition of a document has continually evolved with the advent of technological innovations and increased information density. Before digitalization, documents mostly referred to paper documents. However, we have now reached the age of digital documentation.

In general, a document is defined as follows:

• it contains information and data

• an analog (paper) or digital medium (hard drive, DMS) may be used

• document can be modified

• there can be different versions of a document (different revision statuses)

Typical examples of documents include process descriptions and work instructions.

Distinction between document and record

The ISO 9001 standard makes no distinctions between the two terms. Instead, they are grouped together under the term 'documented information'. However, ISO 13485, the international standard for quality management systems for medical products, uses the terms separately.

In practice, documents and records differ in some factors. A significant distinguishing feature is the ability to modify. While documents can be adapted and thus may have different revision statuses, records do not change after their creation. They serve to provide proof of actions, events, and results, whereas documents contain requirements and instructions. Moreover, records are often filled-out templates, which can also be documents.

Which documents must be controlled according to ISO 9001?

The DIN ISO 9001:2015 defines which types of documents must be controlled. It is based on the principles of quality management written in DIN ISO 9000. These include leadership, involvement of people, customer focus, and relationship management.

According to ISO 9001, the following documents and records must be controlled:

Recorded audits, meetings, and management reviews

• Inspection protocols

• Training proofs

• Procedure and process instructions

• Quality management manuals and outsourced documents such as organization charts

However, the DIN standard does not answer all questions. For example, it does not stipulate who is allowed to create the documents and ultimately approve them. Additionally, the timeframe for document review is flexible and determined by the company. Moreover, the standard does not specify in detail which documents must be controlled. While the aforementioned requirements apply, all documents relevant to the company and its operations must be controlled.

How does document control work?

The document control process always follows the same concept:

1. The documents are created.

2. They are approved and documented.

3. Approval process

4. The documents are added to a list of documented information through a DMS.

5. Documents are updated or adjusted.

6. New approval process

7. Document archiving takes place.

8. Following the preservation period, documents are then destroyed.

Aside from the Implementation of a document management system these process steps can also be covered via network drives, cloud storage, and wiki systems.

What forms of document control are there?

Originally, documents were managed and controlled in paper form. Nowadays, however, it is more common to turn to a network drive or document control software in the form of a DMS. Let's take a look at the pros and cons of the different forms of document control:

In paper form

File system on network drive

Document management system

What tools can be used for document control? 

In document control, you can resort to various solutions – including cloud storage, workflow tools, and document management systems. You should always make your selection dependent on your company's requirements. Below you will find an overview of the currently best DMS software:

Microsoft OneDrive for Business

Caya

Dropbox Business

Filestage

heyData

enaio® by OPTIMAL SYSTEMS

Adobe Document Cloud

Sawayo by Infoniqa

empower

DocuWare

Document control: guiding documents through the lifecycle

The basis of document control is the DIN ISO 9001 standard. It states that companies must control all important documents, such as process descriptions. This refers to the control of records and documents throughout the complete life cycle, which includes the production, editing, approval, review, and archiving of documents.

As document control greatly affects a company's effectiveness and productivity, it is important to avoid mistakes. For this reason, most companies use document management systems to manage their documents safely and in compliance with standards.