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Interpretation of the new edition of ISO 9001-2015 Part I


Interpretation of the new edition of ISO 9001-2015 Part I

2017/08/12 15:37
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On September 23, 2015, the highly anticipated ISO 9001:2015 was released, marking a new beginning for global quality management. Dr. Nigel, Chairman of the ISO/TC 176 Working Committee responsible for standard revision work, said: The new ISO 9001 version is ready for the next 25 years of quality management standards. Quality people have been paying attention to their changes. Recently, experts and scholars have comprehensively and systematically interpreted the significant changes in the new standards and the roadmap for their transition. As the content of the article is detailed and the length is long, it will be divided into two parts, so stay tuned.


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The ISO 9001 quality management system is currently the most widely used and most widely certified international standard system. Since its inception in 1987, it has undergone three transitions in 1994, 2000 and 2008. The reason why it is so popular is also due to the fact that the standard provides a common quality management framework and ideas for organizations, and also provides the organization with the basic confidence to provide products and services that meet customer and legal requirements. As with all other ISO standards, ISO 9001 is reviewed every five years to ensure that it is up to date and up to date.


The era of informationization that we are facing is an increasingly complex and changing social environment. Information technology has completely subverted people's communication and communication modes. B2B, B2C, C2C, P2C... various business models and concepts have taken turns. In the technical field, the Internet of Things, cloud computing, and 3D technologies are rapidly coming to the forefront. Some people call it The third industrial revolution; in the field of management, there are also many new management techniques and good practices emerging; at the organizational level, quality, environment, safety, occupational health, social responsibility... many requirements require organizations to respond at the same time.


So the first requirement of the new version of the standard is to determine the "organizational environment" for a reason. The revision of ISO9001 is to expect to face and effectively deal with such reality. The new version of the standard introduces many new elements in structure, concept and thinking. It not only asks for requirements, but also expects to change concepts and thinking, so as to more effectively cope with this complex and ever-changing social reality and help the organization to achieve continuous success.


This article will analyze and share some changes in the new standards from the two major directions of significant changes in standards and roadmaps. I hope to provide useful reference for organizations and personnel who are implementing and preparing to implement the reorganization activities.


Digital interpretation of the new standard


1 Purpose


2 Models


3 Pillars


7 Principles


8 Rhetoric


68 Requirements


Below we will make a brief analysis and explanation of some significant changes in the new standard around the changes represented by these numbers and their meanings.


1 purpose


Now ISO9001 is more focused on a core purpose, which is "the expected result of the quality management system (QMS)."


As early as December 8, 2006, the ISO published an APG (Audit Practice Guide), the title of which directly pointed out: "The important thing is the result!". Whether the organization is implementing ISO 9001 or the auditor is performing a certification audit, it is not just a matter of focusing on the compliance of each single clause of the standard. More important is to focus on the overall results of QMS.


So, what is the expected result of QMS? In fact, in the beginning of the standard clause "1. Scope", 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, this should be the organization's continuous and constant pursuit.


The requirements for the expected results of QMS have been passed through the entire process of the new standard. The direct manifestation is mainly in the planning part of QMS (P of the PDCA cycle), ie the standard clause 4-6; and the inspection and disposal part of the QMS (C, A of the PDCA cycle), ie part 9-10 of the standard. These parts belong to the top-level design part of the system and are also the part of top management that needs to be actively involved. 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 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, and 10.3, and indirect expressions are 4.3, 5.2, 6.2, 6.3, and 9.2. 10.2. That is to say, standard clauses 4, 5, 6, and 9, 10, in each clause and its sub-clauses are concerned about how and if the expected outcome of QMS is reached.


3) Further, the new standard also emphasizes that 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 will also be in line 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 good the QMS documentation is, no matter how well the records are, or even how well each of the terms meets the requirements, is the product and service meeting the requirements? Has customer satisfaction been enhanced? In the end, is it moving towards achieving the strategic direction of the organization? This is the ultimate sign of evaluating the effectiveness of QMS.


Achieving the expected results of QMS and ultimately meeting the strategic direction of the organization is a core purpose of the new standard and the ultimate standard for determining whether QMS is effective.


2 models

The new version of the standard updates two models, the process model and the QMS structural model.

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Figure 1: Schematic diagram of a single process element:


Traditional process models focus only on inputs, activities, and outputs, as well as monitoring these three process steps. The new process model is further extended to both ends of the process to enhance and ensure the efficiency and effectiveness of the process. include:


1) In terms of input, further consideration needs to be given to the source of the input. It can be a process or a few processes, or it can be an object or several related parties. Based on the results of the inputs and the effectiveness of the process, the organization also needs to consider monitoring the input source.


2) In terms of output, the recipient of the output needs to be further considered. It can be a process or a few processes, or it can be an object or several related parties. In order to ensure the output of the results and the effectiveness of the process, the organization also needs to consider the monitoring of the recipient of the output.

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Figure 2: Schematic diagram of the QMS structure model based on the PDCA cycle:


This new QMS model contains a lot of new ideas, including the following:


1) QMS is now a PDCA cycle driven by leadership. This means that managers, especially top managers, need to be more active in supporting and supporting QMS activities. The standards also explicitly require top management to be responsible for the effectiveness of QMS.


2) The input of QMS still comes from the customer's requirements, but further consideration needs to be made in the organization environment and related parties. Considering the organizational environment and the needs and expectations of relevant parties is an indispensable part of the organization's continued success.


3) The output of QMS directly focuses on the results of QMS. This result includes whether the products and services meet the requirements and whether they lead to increased customer satisfaction. And consider whether it ultimately meets the strategic direction of the organization.


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


3 pillars


In 2012, when ISO decided to revise the ISO 9001 standard, Dr. Nigel. H. Croft, Chairman of ISO/TC176/SC2 (ISO Sub-Committee, which is responsible for the preparation of the ISO 9001 standard), published an article entitled “Quality for the next 25 years”. Management System Standards." The article reviews the extensive application and success of ISO9001 since its first release in 1987, and is determined to be future-oriented and to create a robust and effective framework for ISO9001.


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

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


Compared with ISO9001:2008, the 2015 version is now the structure of the following 10 terms:








Normative reference

Normative reference


Terms and definitions

Terms and definitions


Organizational environment

Quality management system



Management responsibility





Stand by

Resource management



Product realization


Performance Evaluation

Measurement, analysis and improvement





The reason for adopting such a structure is mainly due to the requirements of ISO/IEC Guide 2012. In particular, the “Additional SL” (Annex SL) requires all future management system standards (MSS) to use common structures, titles and terminology in principle.


This common structure is the structural form of the aforementioned ten clauses. Not only that, but the sub-clauses that must be included in these 10 articles, as well as the basic directions that each clause needs to be discussed, also have specific provisions. And the headings of these main clauses and their sub-clauses are also consistent. In addition, Annex SL has a unified interpretation of 22 commonly used terms, which are common to all MSS in the future. This is the high-order structure of MSS. The main part of its common structure is shown below:


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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.


2) Leadership

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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