Many people believe ISO 9001:2015 is solely intended to manage the quality management system. However, if you examine the standard requirements, you will be surprised to learn that much more is included than just the responsibilities of the quality department. Organisations introducing a quality management system strive for sustainable success!
This is why ISO 9001:2015 is not just a sound tool for quality management. ISO 9001:2015 has proven to be an ideal business management tool as well, naturally with focus on quality. ISO 9001:2015 is therefore not a ‘necessary evil’: each investment in the standard offers advantages for the entire organisation.
ISO 9001:2015: the basis for business management
If you examine the requirements of the standard ISO 9001:2015 in detail, you will see a strong focus on various aspects and domains:
factors of influence on the goal, objectives and sustainability of the organisation are determined by the context analysis;
internal factors, such as values, culture, knowledge and performances of the organisation, are taken into account;
external factors, such as the legal, technological, competitive, market, cultural, social and economic environment, are taken into consideration;
the process approach defines and manages the processes and their interactions in order to realise the intended results in accordance with the organisation’s quality policy and strategic orientation;
internal processes as well as the external parties’ requirements are taken into account;
the quality manager is no longer solely responsible, but the entire management is responsible; this means the organisation as a whole is involved in the quality of your business;
clear objectives and planning are the drivers for changes in your system;
a high level of interest is given to analysing and managing your risks; this involves the positive as well as the negative impact thereof;
optimisation of the use of resources, whereby the effects on the long term as well as on the short term are taken into account;
the Plan-Do-Check-Act structure represents the basis for continuous improvements.
Therefore, the standard ISO 9001:2015 is much more than just a quality management tool: the requirements stipulated in ISO 9001:2015 create the practical basis for business management, including all resource and top management processes.
The ISO 9001:2015 management system is thus applicable to each and every aspect of your organisation: from sales and planning to delivery and post-delivery activities. Practice has proven that some businesses have already evolved to the point where ISO 9001 is no longer simply used as a ‘quality management system’. ISO 9001:2015 is then the standard manner of conducting business.
The importance of the management for ISO 9001:2015
If you consider the ISO 9001:2015 system as the manner in which you conduct business (and not solely as the work performed by the quality department), it is essential that the management is closely involved with:
how the ISO 9001:2015 system functions;
how the resources are applied;
where improvements could be introduced, which will benefit the business.
The ISO 9001:2015 system provides structure with which the management can manage the resources and output of its business, while also monitoring the quality. In this manner, the organisation’s efficiency, output and quality are aligned and executed optimally. It is self-explanatory that the top management must (should) be willing to be involved in this.
ISO 9001:2015: a flexible, non-binding standard
I can hear you think:
“We do not need ISO 9001:2015 to tell us how to run our business.”
True, and that is also the reason why ISO 9001:2015 is non-binding. After all, the ISO 9001:2015 requirements are stipulated as such that they can be approached in many ways.
According to the ISO 9001:2015 requirements, production and services must be planned and executed under controlled circumstances. ISO 9001:2015 provides several conditions which could apply, but does not state which conditions must be applied.
Naturally, this is only meaningful if you do not want your employees to adopt the design and then do what they want to do. Your employees should adopt the design and produce as specified! Meaning: in a controlled manner. How you check this? That is up to you!
The ISO 9001:2015 requirements are not intended to tell you how to work, but to ensure that you do not miss any inspections required to supply products and services which meet the client’s requirements.
ISO 9001:2015: an interesting business management tool
ISO 9001 is so much more than just a quality management system standard. ISO 9001:2015 is a fully fledged business management tool to optimise various aspects of your organisation (strategy, implementation and business processes) and to simultaneously monitor the quality.
ISO 9001:2015 is not a ‘necessary evil’, neither is it a ‘binding standard’: each investment in the standard offers advantages for the entire organisation, on the condition that everyone, from the work floor up to the top management, fully supports the system and acts accordingly.
Luc Marivoet is a Senior Consultant Engineering Services at Pauwels Consulting. He has more than 25 years of experience in Quality Management functions, providing support and supervising in an international context (Europe and Asia). Luc uses his experience today to set up, implement, monitor and maintain ISO 9001 certified Quality Management Systems and Supplier Quality Assurance activities. Currently, Luc is mainly active for The Belgian railway infrastructure manager and in specific subprojects for Life Sciences organizations (companies).