Of course, the goals and implementation of different management systems are different, and some minor adjustments are allowed. In addition to the main structure of the 10 clauses can not be changed, allow different MSS to make some necessary additions to the clause, or make some modifications in the title of the clause. For example, the 4.4 management system can be adjusted to a quality management system or an environmental management system; for example, “8. Operation” is a process that needs to be controlled in a key way for QMS, so in fact, QMS has added a lot of sub-clauses here.
Such a high-level structure enhances the compatibility and compliance of different management system standards. For organizations that implement multiple systems, it provides a convenient opportunity for effective integration of systems. Because each standard's structural framework and direction of discussion are consistent, integration is very easy.
For the majority of standard users, whether it is the system management personnel of the organization that implements ISO9001, or the auditors of the certification body, it is undoubtedly good news. The learning, memory, understanding and implementation of different management system standards will be easier and more effective.
In addition, this MSS high-level structure is also a more open structure, providing facilities for organizations that need a more complex management system, including the integration of other specific industry-specific requirements.
It is particularly important to state that the MSS high-level structure is not a mandatory requirement for the organization. In other words, the organization's own file architecture, title, and terminology are not mandatory to conform to the higher-order structures used in ISO9001. The organization can decide whether to adopt the structure, title and terminology of the new standard. For example, the new version of the standard now uses "documented information" to replace the past "files" and "records", the organization does not need to be just to be consistent with the standard, the "documents" and "records" in the existing documents The statements were all changed to “documentized information”, so that all documents and forms were revised. If the organization is willing to do this, of course. However, if the cost is taken into account and no modification is made, there is no problem at all. As long as the organization is in internal and external communication, there is no problem in understanding.
This arrangement of the new version of the standard is actually concerned with the actual results of QMS, rather than focusing on the specific performance of the form. With the subsequent revision of other MSS standards, as well as the familiarity and wide application of the organization, MSS high-level structure will gradually show its influence, even beyond the scope of ISO, becoming a new benchmark for international technical standards and norms and trade exchanges.
In the process of revision of ISO9001, a very important idea is to strengthen the role of top management in QMS and resolve to give top management a more active role. Undoubtedly, the participation and support of top management is crucial for QMS to achieve the expected results and achieve QMS effectiveness, and the real contradiction is that the level of participation of top management actually decreases. Therefore, the new version of the standard attempts to strengthen the role of leadership in QMS in several ways:
a) The standard now emphasizes the expected outcome of the QMS and is in line with the strategic direction of the organization. This is both an inevitable pursuit of QMS and an inducement to encourage top management to participate and support QMS;
b) Standard 5.1.1 a) Directly indicate that the top management is responsible for the effectiveness of the quality management system; and remove the requirements for the management representative.
c) Standard 5.1.1 c) explicitly requires QMS to be integrated with the organization's operational processes and indicates that this is a requirement for top management. I hope to embed QMS into the organization's day-to-day operations, not two skins. This means that the expected results of achieving QMS are a powerful boost to the organization's overall business objectives and the organization's business strategy;
d) In fact, Standard Clause 5 is all a requirement for top management and is mandatory, including 5.1, 5.2, and 5.3. Top management certainly does not necessarily perform and operate each matter personally, but needs to arrange, participate in and support related activities, and listen to reports of results, especially QMS performance reports. Top management needs to demonstrate leadership and commitment in all aspects of Article 5, not just to get things done.
e) Standards now emphasize the application of the quality policy. The top management determines the policy not only to specify a direction, which is consistent with the strategic direction of the organization and the organization's environment, and this direction has practical guiding significance in the daily operation of the organization, and is committed to the ultimate goal.
f) The quality management system model in Figure 2 above shows the core position of leadership in the entire QMS.
It is worth noting that the leadership in the new version of the standard is more focused on “leadership” than on the day-to-day role of the leader, such as “management”. The title of the relevant standard "Article 5" has been changed from "Management responsibility" of the 2008 version to "Leadership". Leadership means that managers need to be oriented toward the organization based on the organizational environment, and understand and form a consensus within the organization to motivate employees to create value for the organization.
The introduction of the concept of “leadership” is considered by many to be one of the most important changes in the standard revision, with far-reaching implications. Of course, the actual effect depends on the organization's cognition and proactive practice.
3) Risk-based thinking
Before discussing risk-based thinking, it is necessary to understand and understand in depth what is risk. The definition of risk is one of the 22 common terms and definitions provided by Annex SL, which is interpreted as “risk: the impact of uncertainty”.
To better understand the term, you can focus on the characteristics of the risk. There are three characteristics of risk, namely:
a) Potential “incidents”. If there is no incident, the world is too peaceful, there is usually no risk. The so-called potential event means that it does not necessarily happen (whether in the past or in the future), and as long as it is possible, it constitutes an event.
b) “Consequences”. If there is a cause, the occurrence of an event will always have an impact. If it affects the achievement of the expected result, it is the consequence that needs attention. If it is a positive impact, it is an opportunity and needs to be considered for reinforcement; if the impact is negative, it is a risk and needs to be considered for elimination.
c) “Combination” of events and their consequences. Also consider the likelihood of an event occurring and its impact on the expected outcome. This is actually a complete expression of risk.
When people cross the road, they usually always subconsciously "look and see," and they will cross the road without danger. We can simply understand it as risk awareness, which is actually a primitive form of risk-based thinking. Therefore, risk-based thinking is a mature performance.
In the planning of the quality management system and the review of the quality management system, risk-based thinking should be applied proactively. For example, we plan a production assembly process. In the simplest case, for example, a work process for assembling gaskets, we can apply risk-based thinking to plan. We need to ask some questions, such as:
a) What happens to this assembly gasket process? Will it be missing, multi-loaded, reversed, and misplaced...?
b) What are the consequences of each incident? For example, if there is a "reverse" situation, if there is no adverse effect, then we can do nothing. If this happens, it has no effect on the function and application, but it will affect the appearance, the user may feel bad, affecting the sales of the product, then this may be the risk of control.
c) Risk control can be considered to reduce or even eliminate the possibility of an event occurring, or to mitigate its adverse effects, or both. For example, if the above gasket is reversed, we can consider:
— Is there any way to reduce the likelihood of occurrence? For example, training employees and using appropriate installation tools to prevent mistakes can reduce the possibility. It is also possible to consider improving the design or processing method so that the two sides of the gasket are the same, which completely eliminates the possibility.
— However, there may be no effective way to reduce the likelihood of an event occurring, or the cost is too high to be viable. At this time, we can start from the consequences of the incident and consider alleviating its adverse effects. For example, in the subsequent process setting inspection position, to avoid the assembly of the wrong product out.
— It is often necessary to consider both aspects simultaneously to select the most cost-effective option.
It can be seen that the application of risk-based thinking begins with consideration of three characteristics of risk: potential events, their consequences, and their combinations.
Using risk-based thinking to consider the assembly process of this gasket can help us identify risks and opportunities, allowing us to use the most appropriate assembly methods and optimal process design. If we apply this method to all production processes, not only can each production process achieve an optimized and balanced operation, but the coordination and coordination of integrated production is also improved, and the capacity of the entire production process is enhanced. Bad, improve production efficiency, thereby improving the effectiveness of the organization's production process. In fact, this risk-based thinking can and should be applied to all processes of the quality management system, including management processes and supporting processes, to help us improve the performance and effectiveness of the entire quality management system.
Risk-based thinking is now an important part of the process approach along with the PDCA cycle. Risk-based thinking has been fully integrated into every clause of the new standard, and is reflected in a more direct way, such as the terms of the requirements to consider "the impact of ...", "the potential impact of ...", "the consequences of ..." and so on.
Risk-based thinking is now integrated into the entire process of the new standards, and risk-based thinking should be actively applied during the QMS planning and review process. To enhance customer confidence and satisfaction, ensure continuous delivery of qualified products and services, and build a positive culture of prevention and improvement within the organization for continued success.
to be continued
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