What are the ISO 9001 requirements of the quality management standard?
The ISO 9001 standard sets requirements that serve as the basis for the certification of quality management systems. What comes to your mind first when you hear the term “mother of all norms”? Is it currently the DIN EN ISO 9001? The designation DIN EN ISO makes it clear that this set of standards is important on a national level (DIN), European level (EN) and worldwide (ISO). If you look at the best-known ISO family of standards, this is the 9000 family.
In principle, nobody can be forced to adhere to an ISO standard for a management system. In spite of everything, some norms are stronger than laws: Those who do not follow them will be punished by the market (or the customer). The quality management standard DIN EN ISO 9001 has finally developed into such a weighty standard. Many large companies only accept suppliers who meet the ISO 9001 requirements and specifications. So the ISO has a lot of power in its hands. The ISO shares this with the two other large international standards organizations, ITU and IEC. The International Telecommunication Union (ITU), as its name suggests, deals with telecommunications, the International Electrotechnical Commission (IEC) with electrical engineering and information technology.
The standard in quality management ISO 9001 – from pretender to follow-up
Few people realize that without these international norms and norms the world would be instantly chaotic. For example, you could not fill up in Spain or make calls abroad. However, you would only have a problem with it if you had not already died in a fire in your favorite pub because you mistakenly believed the emergency exit sign (ISO 7001) to be the guide to the toilet. So the ISO specifications are reasonable and justified in a comprehensible manner. Since the ISO, like so many other organizations of this type, does not need to fear direct competition, customer focus has sometimes been neglected. That means that the users of the standard often got left in the rain with their user problems.
How do the quality management standards DIN EN ISO 9000 ff interact?
The family of standards consists of the three individual standards ISO 9000, 9001 and 9004. The principles and terms of a quality management system are named and explained in ISO 9000. The standard describes the individual requirements of the ISO 9001 standard that are placed on a QM system. It serves as the basis for the certification of companies. This also includes requirements for the standard-compliant documentation of a QM system described. ISO 9004 represents an additional guide to improving performance through management and control for sustainable success. This standard provides additions and interpretations to ISO 9001. The QM series of standards ISO 9000 ff. Shows much more clearly than before that the introduction of a quality management system is not only means fulfilling the requirements of the ISO 9001 standard on paper, but above all represents a strategic decision of the company management.
These basic pillars naturally apply across all industries, for example also for quality management ISO 9001 in hospitals or quality management ISO 9001 in nursing! Guidelines for the action of the organization. These are made up of:
What are the guidelines of the ISO 9001 standard?
As previously stated on this page, DIN EN ISO 9001 is based on four guidelines or pillars that guide the actions of a company. These guidelines are explained in more detail below.
Orientation towards the context of the organization
According to ISO 9001, the organization must “monitor and review” external and internal issues that are relevant to its purpose and strategic direction. It is therefore necessary to constantly pay attention to whether and where significant changes occur. In the case of relevant changes, their consequences must be incorporated into the design of the quality management system and its processes. The analysis of external and internal influencing factors can therefore not be a one-off task! The context or the requirements of interested parties are relevant if there are effects on the quality management system.
The principle of process orientation in quality management ISO 9001
The focus is not on the “divisions”, but on the procedural connection between activities. The advancing process orientation is forcing the bundling of activities and resources into processes and their management and control. ISO 9001 explicitly requires the representation of the “interactions” of processes. A process-oriented QM system accompanies and examines all essential operational processes; Even with good organization, this leads to opportunities for optimization. Management processes and the tasks of the supporting areas are expressly included. There are for all functions …
- clearly formulate the tasks to be performed,
- to define the responsibility and competence as well as the interfaces,
- to provide the funds necessary for their fulfillment,
- to monitor the implementation of the processes and to evaluate their success and
- systematically identify and deal with risks and opportunities.
The principle of continuous improvement in quality management ISO 9001
The aim of continuous improvement is to increase customer satisfaction. With the help of the quality policy, this must be internalized as a mindset in all employees. The improvement process is defined by a step-by-step procedure in the sense of the Plan-Do-Check and Act cycle. Improvement suggestions from employees or dedicated work groups are requested in the Kaizen. The suggestions are checked for usability and evaluated in order to incorporate them into the company processes if the overall assessment is positive. There is a constant cycle of planning, activity, control and improvement: the PDCA cycle (Plan-Do-Check-Act). As a result, all processes in the company are to be constantly analyzed and improved. When an improvement has been implemented, this is set as a standard and thus permanently integrated into the company’s process model. Only when the standardization has been fully completed will a further improvement be sought.
The principle of risk-based thinking in ISO 9001 quality management
The QM standard ISO 9000 defines the term “risk” as the “effect of uncertainty”. According to note 1, an impact is a deviation from the expected in a positive (opportunity) or negative (risk) regard. The standard clarifies the importance of risks and opportunities in connection with the context (environment, framework conditions), the company’s goals and the process-oriented approach. Risks and opportunities should be taken into account in an increasingly dynamic and complex environment when creating, introducing, maintaining and continuously improving the quality management system and its processes. The risk-based thinking, with the consideration of as well as the handling of risks and opportunities, is understood as a prevention against the occurrence of undesired events.
Why do you need ISO 9001 quality management in practice?
Quality management in practice is often designed according to ISO 9001. But what is it used for in practice?
At the same price, the customer decides on the product that meets most of the quality features he prefers, e.g. product and processing quality, equipment, brand image, customer advice and service after the sale. Instead of taking the initiative for a comprehensive ISO 9001 quality management system at an early stage and trimming their company on a quality course, many companies have waited until the external pressure (competitive pressure or pressure from customers) was so great that they had to react under pressure, so as not to be shipwrecked.
The companies, on the other hand, which have developed a high level of quality on their own initiative, were able to face this situation calmly. For them, the quality management ISO 9001 certification is associated with significantly less effort and, due to the internal quality awareness, also with greater benefits. Quality capability of a company means the ability to manufacture and offer a high-quality product at a price that is acceptable for the customer and profitable for the company. The quality capability does not come by itself, however, it is the result of the joint efforts for quality at all levels and in all areas of the company.
Against this background, it is no longer enough just to be good, but the company must constantly improve. You can only improve what you can measure. Companies have to constantly adapt to new market and customer requirements. Therefore, you have to optimize products and services, efficiency of the processes, as well as the QM system and the organization itself through constant improvement! Analyzes must be carried out on the basis of data, facts and information and the basis for decision-making must be prepared.
What are the advantages of a quality management system according to the requirements of the ISO 9001 standard?
By introducing a QM system, you or your company can benefit from numerous advantages. You will find a listing of these below:
- Increase in profitability.
- Customer satisfaction as well as improved customer loyalty.
- Improvement of the rating of banks, suppliers, customers, etc.
- Cost savings and continuous improvement
- Competitive advantage and optimization of work processes
- Flexibility and transparent operational processes
- Improved product quality and avoidance of errors (minimization of error costs)
- Worldwide recognition and high level of awareness of the quality management system in accordance with ISO 9001.
- Detection and correction of weak points as well as communication improvement
- Legal compliance and occupational safety