DIN EN ISO 9001 ff. & Documentation Toolkit

What is DIN EN ISO 9001?

The norm DIN EN ISO 9001 is part of the norm family DIN EN ISO 9000. They describe possibilities, measures and regulations regarding quality management in manufacturing companies. The norms relevant in practice are the ISO 9001:2000 and ISO 9001:2008. At the same time, these norms are certifiable via external audits and thus make quality management measurable in the industry. From this basis many more special (branch) norms were developed that defined the requirements to quality management, e.g. also for service providers.

Realisation of DIN EN ISO 9001 within a company

A quality management handbook (QMH) has to be written for the realisation of the norm within a company, which documents all relevant processes. The working on documents is also subject to the guidelines of the norm.

An essential component of DIN EN ISO 9001 ff. when it comes to working with documents is the so-called dual control principle. This means that a document created or edited by one employee must first be checked by another suitably competent employee before publication. The latter can approve or reject the document, with appropriate instructions for revision.

With an acceptable effort electronic Document Management can help implement the requirements to the Document Control with the required transparency.

Enterprise Content Management

An enterprise content management system like bitfarm-Archiv Document Management can help to implement this, because the users are given a certain way of working. Documents in ECM get a fixed workflow, depending on the document type and department there are other involved persons who edit, check and publish documents.

Exceptions are not permitted. If such a system is introduced in the company and established as a filing / processing system for documents, the requirements of DIN EN ISO 9001 ff. and many other standards are mandatorily implemented. This is also where the statement comes from that compliance requirements are automatically met with an ECM system.

In this context, the term document control is also used. An ECM system also ensures the traceability of a process at any time, also an important requirement of the standard, which is also implemented at bitfarm-Archiv as an open source DMS / ECM for medium-sized businesses. Do you have more questions around the topic of document compliance?

ISO 9001 Documentation Toolkit 

For many companies, the requirements can seem demanding at first glance. This is precisely why it is advisable to acquire an ISO 9001 documentation toolkit. Our document management system already fulfills many requirements out-of-the-box. The creation of a so-called quality management handbook is without a doubt the most significant task of a toolkit. This type of handbook, which is essentially a collection of documented processes, is not only required for ISO 9001 certification, but also essential for quality management. It contains all of the procedures you've already standardized, whether in the form of a flow chart, a checklist, or just continuous text. In this case, bitfarm-Archiv can assist you with the following: 

• Create a centrally managed digital manual with all relevant processes. This way, you'll always have access to the most crucial records - and something to show auditors if certification is on the way.
• To modify the process flows at a later time, such as if you come up with a superior solution or if you acquire new resources or work materials. The changes are versioned, which means you can see all previous versions of a document even after it has been modified.
• Send the manual's documents to the persons who need them. Not every employee needs to be aware of every process flow. Your marketing team, for example, doesn't need to know how the factory floor workers put a component together. As a result, individual process strategies should always end up in the right place.

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