kwaliteitsmanagement software iso90012015

Role quality management software tools since ISO9001:2015

What changes does ISO 9001:2015 introduce with regard to the use of software tools in quality management according to quality standard ISO 9001? (And naturally this also applies to ISO 14001:2015, ISO 27001:2013 with regard to the document management aspect.) Several important elements will be discussed below.

Firstly, the new and mandatory process of risk management. This is a cyclical process, which needs to be repeated periodically (often annually): re-evaluate risks, establish measures, update the risk treatment plan, and establish the residual risk. In order to secure this system within the organisation, more is needed than just a simple spreadsheet. Even more so when multiple stakeholders are concerned, which all have their own actions. In Proware, the cycles of documentation and risk management have been integrated within the software module RiskManagement. Watch the video for a clarification.

Accessibility of documentation (policy, process descriptions, procedures, instructions, ..) has become increasingly important within quality management. With the new ISO 9001:2015 standard a shift has occurred towards organisation-wide policies and familiarity with relevant (process) documentation, also known as ‘documented information’. Top management plays an important role within this process. An insight into the lifecycles of the various (quality) documents can be extremely valuable. Supplemented with operational data concerning the use of documents, management can encourage employees to improve their knowledge on quality-based attitudes.

The six mandatory procedures from ISO 9001:2008 have disappeared, but have been replaced by the aforementioned ‘documented information’.. As such, documentation remains a necessity within quality management, in the following aspects:

PDCA circle Paragraph ISO 9001:2015
Plan 4.3 Determing the scope of the quality management system
4.4 Quality management system and its processes
5.2.2a Quality policy
6.2.1 Quality objectives and planning to achieve them
7.1.5 Monitoring and measuring resources
7.1.5 Control of monitoring and measuring equipment
7.2 Competence
Do 8.1e Operationel planning and control
8.2.3 Review of the requirements for products and services
8.3.2 Design and development planning
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4.1 Control of externally provided processes, products and services
8.5.1 Control of production and service provision
8.5.2 Identification and tracebility
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming outputs
Check 9.1. Monitoring, measurement, analysis and evaluation
9.2 Internal audits
9.3 Management review
Act 10.2.2 Nonconformity and corrective action
PDCA circle Paragraph ISO 9001:2015


To summarize, you will experience more freedom with regard to arranging all documentation, but control of the necessary documentation remains important. And risk management is part of that.

For whoever still ‘fights’ with random loose documents, has structured version control, or has to ‘fish’ procedures out of mailboxes… Set up our cloud solution Proware within 60 seconds, our software tool for quality management, and search for the differences.