On September 23, the much-anticipated ISO 9001:2015 was released, which marked the arrival of a new beginning for global quality management. Dr. Nigel, chairman of the ISO/TC 176 working committee responsible for the revision of the standard, said: The new version of ISO 9001 is ready for the next 25 years of quality management standards. The ISO 9001 standard, since the first edition was promulgated in 1987, has gone through 28 years and has been revised five times, especially this year's revision, which has undergone relatively large changes. Welcome to inquire: Miss Luo 13798904733

The ISO 9001 quality management system is currently the most widely used and certified international standard system. Since its inception in 1987, the reason why it has become so popular is that it provides a common quality management system for various organizations. Framework and thinking, but also establish basic confidence for the organization to provide products and services that meet customer and legal and regulatory requirements.

The new version of the standard has introduced many new elements in terms of structure, concept and thinking. It not only puts forward requirements, but also expects to change concepts and thinking, so as to more effectively cope with this complex and changing social reality and effectively help organizations achieve sustainable success. This article will analyze and share some changes in the new version of the standard from two main directions, the significant changes of the standard and the transition roadmap, hoping to provide a useful reference for organizations and personnel who are implementing and preparing to implement transition activities.

1. A core idea of standard focus

Regarding the new version of ISO 9001, it focuses more on a core purpose, which is "the expected results of the quality management system". As early as December 8, 2006, ISO published an APG (Audit Practice Guide), the title of which directly states: "It is the results that matter!". Whether an organization is implementing ISO9001 or an auditor is performing a certification audit, it is not just the means to focus on compliance with each single clause of the standard. It is more important to focus on the results of the QMS as a whole.

So, what exactly are the expected outcomes of QMS? In fact, it is in the clause "1. Scope" at the beginning of the standard, namely:

1) meet the requirements. Including customer requirements, applicable legal and regulatory requirements.

2) Enhance customer satisfaction.

Customer satisfaction is not the best, only better, which should be the continuous and constant pursuit of the organization. The requirements for the expected results of the QMS have been throughout the entire process of the new version of the standard. The direct manifestation is mainly in the planning part of the QMS (P of the PDCA cycle), that is, parts 4-6 of the standard clauses; and the inspection and disposal part of the QMS (C, A of the PDCA cycle), that is, the standard clauses 9-10 Parts. These parts belong to the top-level design part of the system, and are also the parts that top management needs to actively participate in. Such as:

1) In the quality management architecture model shown in Figure 2 below. Now, the direct output of the entire quality management system is the "result of the QMS". The validity of the evaluation results includes whether the products and services meet the requirements and whether the customers are satisfied.

2) In the standard clauses, the requirements for directly expressing the expected results of QMS are 4.1, 4.2, 4.4, 5.1, 5.3, 6.1, and 9.1, 9.3, 10.1, 10.3, and the indirect expressions are 4.3, 5.2, 6.2, 6.3, 9.2 , 10.2. That is, standard clauses 4, 5, 6, and 9, 10, in each clause and its sub-clauses, focus on how and whether the expected results of the QMS are achieved.

3) Further, the new version of the standard also emphasizes that the QMS should be in line with the strategic direction of the organization. Directly reflected in the standard clauses 4.1, 5.1.1, 5.2.1, 9.3.1.

Ultimately, the results of this QMS must also be aligned with the strategic direction of the organization. This is also directly reflected in the standard clauses 4.1, 5.1.1, 5.2.1, 9.3.1.

No matter how well the QMS documentation is prepared, no matter how complete the records are, and no matter how well each clause meets the requirements, the key is whether the products and services meet the requirements? Has customer satisfaction increased? Ultimately, is progress toward achieving the organization's strategic direction? This is the ultimate mark of evaluating the effectiveness of a QMS.

Achieving the expected results of the QMS and ultimately meeting the strategic direction of the organization has become a core purpose of the new version of the standard and the ultimate criterion for judging whether the QMS is effective.

2. Two quality management system models established by the standard Welcome to inquire: Miss Luo 13798904733

The new version of the standard has updated two models, namely the process model and the QMS structural model.

The traditional process model is only concerned with input, activity and output, and the monitoring of these three process links. The new process model extends further to both ends of the process, thereby enhancing and ensuring the efficiency and effectiveness of the process. include:

1) In terms of input, the source of the input needs to be further considered. It may be a process or several processes, or it may be an object or several related parties. Organizations also need to consider monitoring of input sources based on the results of the input and the effectiveness of the process.

2) In terms of output, the recipient of the output needs to be further considered. It may be a process or several processes, or it may be an object or several related parties. To ensure the effectiveness of outputs and processes, organizations also need to consider monitoring the recipients of outputs.

This new QMS model contains a lot of new ideas, which simply include the following aspects:

1) QMS is now a PDCA cycle driven by leadership. This means that managers, especially top management, need to be more actively involved in and support the activities of the QMS, and the standard also clearly requires the top management to be responsible for the effectiveness of the QMS.

2) The input to the QMS still comes from customer requirements, but further consideration of the organizational environment and the requirements of interested parties is required. Consideration of the organizational environment, and the needs and expectations of interested parties, is an integral part of an organization's continued success.

3) The output of the QMS is directly concerned with the result of the QMS. This outcome includes whether products and services meet requirements and lead to enhanced customer satisfaction. And consider whether it ultimately aligns with the strategic direction of the organization.

In fact, the above-mentioned aspects are mutually reinforcing and mutually stimulating relationships, thereby promoting the effectiveness of the QMS.

3. Establish the 2015 version of the standard structure from three major directions, based on the next 25 years

In 2012, when ISO decided to revise the ISO9001 standard, Dr. Nigel. H.Croft, chairman of ISO/TC176/SC2 (the ISO subcommittee responsible for the preparation of the ISO9001 standard), once published an article with the title of "Quality for the Next 25 Years". Management System Standards". The article reviews the extensive application and great success of ISO9001 in the 25 years since its first release in 1987, and is determined to face the future and build a robust and effective framework for ISO9001.

The new version of the standard has indeed created a good framework for us from the three aspects of MSS high-level structure, risk-based thinking, and leadership, and from different aspects of entity structure and thinking structure, which actually constitute the three pillars of ISO9001. They represent different directions, but all have a global impact on the application and effectiveness of QMS.

1) MSS (Management System Standard) high-level structure

Compared to ISO9001:2008, the 2015 edition is now a 10-clause structure. The reason for this structure is mainly due to the requirements of ISO/IEC Guide 2012. In particular, the "Annex SL (Annex SL)" of the guideline requires that all future management system standards (MSS) should in principle use a common structure, title and terminology.

This common structure is the structure of the aforementioned 10 clauses. Not only that, there are also specific provisions on which sub-clauses must be included in these 10 clauses, as well as the basic direction that each clause needs to discuss. Also, the titles of these main clauses and their sub-clauses are the same. In addition, Annex SL has made a unified interpretation of 22 commonly used terms, and these interpretations will also be common to all MSSs in the future. This is the higher order structure of MSS. The main parts of its common structure are shown in the following figure:

Of course, different management systems have different goals and approaches, and some minor adjustments are allowed. Except that the main structure of the 10 clauses cannot be changed, different MSSs are allowed to make some necessary supplements to the sub-clauses, or make some modifications to the title of the clauses. For example, 4.4 management system can be adjusted to quality management system or environmental management system; for example, "8. Operation" is a process that requires key control for QMS, so in fact, QMS has added a lot of sub-clauses here; etc.

Such a high-level structure enhances compatibility and compliance with different management system standards. For organizations implementing multiple systems, this provides a convenient opportunity for the effective integration of systems. Since the structural framework and discussion direction of each standard are consistent, it is very easy to integrate.

For the majority of standard users, whether it is the system management personnel of the organization implementing ISO9001, or the auditors of the certification body, it is undoubtedly good news. It will be easier to learn, memorize, understand and implement the various management system standards, and it will be easier to achieve effectiveness.

In addition, this MSS high-level structure is also a more open structure, providing convenience for organizations that need a more complex management system, including the integration of some other industry-specific special requirements on this basis.

It is particularly important to state that the MSS higher order structure is not a mandatory requirement for the organization. That is, the organization's own document architecture, titles, and terminology are not mandated to align with the higher-order structure adopted by ISO 9001. Organizations can decide whether to adopt the new version of the standard's structure, titles and terminology. For example, the new version of the standard now uses "documented information" to replace the previous expressions of "document" and "record". In fact, organizations do not need to change the "document" and "record" in existing documents just to be consistent with the standard. The expressions were all changed to "documented information", resulting in a revision of all documents and tables. If the organization is willing to do so, 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 has no problem in understanding in internal and external communication.

This arrangement of the new version of the standard actually focuses on the actual results of the QMS, rather than on the specific performance of the form. With the successive revision of other MSS standards, as well as the familiarity and wide application of organizations, the MSS high-level structure will gradually show its influence, even beyond the scope of ISO, and become a new benchmark for international technical standards and norms and trade exchanges.

2) Leadership

In the revision process of ISO9001, a very important idea is to strengthen the role of top management in QMS and to give top management a more active role. Undoubtedly, the involvement and support of top management is crucial for the QMS to achieve the desired results and achieve the effectiveness of the QMS, and the paradox of reality is that the level of involvement of top management has actually declined. Therefore, the new version of the standard attempts to strengthen the role of leadership in QMS in several ways:

a) The standard now emphasizes achieving the expected results of the QMS and is in line with the strategic direction of the organization. This is not only the inevitable pursuit of QMS, but also an inducement factor to motivate top management to participate in and support QMS;

b) Standard 5.1.1 a) directly states that top management is responsible for the effectiveness of the quality management system; at the same time, the requirement for management representatives is eliminated.

c) Standard 5.1.1 c) explicitly requires that the QMS be integrated with the organization's operational processes and indicates that this is a requirement for top management. Looking to embed QMS into the day-to-day operational processes of an organization, not just two skins. This means that achieving the expected results of QMS is a powerful promotion for the organization to achieve the overall business objectives and realize the organization's business strategy;

d) In fact, Standard Clause 5 is all requirements for top management and is mandatory, including 5.1, 5.2, 5.3. Of course, the top management does not have to personally implement and operate every matter, but needs to arrange, participate in and support related activities, and listen to the report of the results, especially the report of the performance of the QMS. Top management needs to demonstrate leadership and commitment in all aspects of Clause 5, not just getting those things done.

e) The standard now emphasizes the application of the quality policy. Top management establishing a policy requires more than a direction that is consistent with the strategic direction of the organization, matches the environment of the organization, and has practical guiding significance in the day-to-day operations of the organization, and is committed to achieving the ultimate goal. .

f) The quality management system model in Figure 2 above vividly shows the core position of leadership in the entire QMS.

It is worth noting that the leadership in the new version of the standard focuses more on "leadership ability" rather than the daily role of a leader, such as "management". The title of "Clause 5" of the relevant standard has been changed from "Management responsibility" in the 2008 edition to "leadership". Leadership means that managers need to point out the direction for the organization based on the organizational environment, gain understanding and form a consensus within the organization, and then stimulate the willingness of 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 this revision of the standard, with far-reaching effects. Of course, the actual effect also depends on the organization's cognition and proactive practice.

3) Risk-Based Thinking

Before exploring risk-based thinking, it is necessary to have a specific and in-depth understanding of what risk is. The definition of risk is one of 22 common terms and definitions provided by Annex SL, which is interpreted as "Risk: The Effects of Uncertainty".

To better understand the term, focus on the characteristics of risk. Risk has three characteristics, namely:

a) Potential "Events". If nothing happens, the world is at peace, and 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), as long as it is likely to happen, it constitutes an event.

b) "Consequences". If there is a cause, there must be an effect. 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 enhanced; if the impact is negative, it is a risk and needs to be considered for elimination.

c) the "combination" of events and their consequences. Also consider the likelihood of events and their impact on expected outcomes. This is really a complete expression of risk.

When people cross the road, they usually "look left and right" subconsciously, and they will cross the road when there is no danger. We can simply understand it as risk awareness, which is actually a primitive form of risk-based thinking. So, risk-based thinking is a sign of maturity.

Risk-based thinking should be actively applied in the planning of the quality management system and in the auditing process of the quality management system. For example, if we plan a production and assembly process, in the simplest terms, such as an operation process of assembling gaskets, we can use risk-based thinking for planning. We need to ask questions such as:

a) What will happen to this process of assembling gaskets? Will it be missing, multi-installed, reversed, wrong model...?

b) What are the consequences of each event? For example, if there is a "reverse" situation, if there is no adverse effect, then we can do nothing. If this happens, there is no impact on the function and application, but it will affect the appearance, the user may not feel good, and the sales of the product may be affected, then this may be a risk that needs to be controlled.

c) Controlling risks can consider reducing or even eliminating the possibility of events, or mitigating their adverse effects, or both. For example, in the case where the above gaskets are installed backwards, we can consider:

— Is there any way to reduce the likelihood of it happening? For example, training staff and using proper installation tools to prevent mistakes can reduce the likelihood. Consider also improving the design or machining method so that both 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, or the cost is too high to be feasible. At this time, we can start from the consequences of the event and consider mitigating its adverse effects. For example, setting up inspection posts in subsequent processes to avoid the flow of wrongly assembled products.

— It is usually necessary to consider both aspects to select the best economical solution.

As you can see, applying risk-based thinking begins by considering 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, so that the most appropriate assembly method and optimal process design can be adopted. If we apply this method to all production processes, not only can each production process achieve an optimally balanced operation plan, but also the coordination and coordination of integrated production will be improved, and the capacity of the entire production process will be enhanced. Defects, 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 quality management system processes, including management processes, supporting processes, to help us improve the performance and effectiveness of the overall 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 each clause of the new version of the standard, and it is reflected in a more direct way, such as clauses requiring consideration of "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 version of the standard, and risk-based thinking should be actively applied in the QMS planning and auditing process. To enhance customer confidence and satisfaction, ensure the continuous delivery of qualified products and services, and establish a positive prevention and improvement culture within the organization to achieve sustained success.

Welcome to inquire: Miss Luo 13798904733