1. Introduction

In recent years, terms like “customer needs,” “PDCA cycle,” and “management system” have become commonplace in not only the manufacturing industry, but the service industry (restaurants, hotels, etc.), the retail industry (supermarkets, convenience stores, etc.), and fields as diverse as energy, telecommunications, transportation, healthcare, welfare, education, and finance. One reason for this is the international quality management systems standard ISO 9001^[1] and the QMS (Quality Management System) certification scheme based on it. The number of certified organizations worldwide has already passed the one million mark, and the standard’s principles and methods have been applied to environmental management, information security, food safety, energy management, road traffic safety, occupational health, medical safety, and educational quality assurance. This powerful standard is being revised this year.

2. The Purpose and Challenges of QMS Certification

The purpose of QMS certification is to ensure customers can confidently buy and use products and services whose quality cannot be judged from appearance alone by evaluating the quality management systems (QMS for short, ways of performing work) of the organizations offering products and services to determine whether or not the QMS meet certain requirements and providing certificates to the organizations whose QMS do. As the international trade of products and services has expanded, it has become increasingly difficult to evaluate the other party in each transaction. If neutral third parties evaluate organizations to determine whether or not they meet standardized requirements, and customers place confidence in the certificates in individual transactions, there is a substantial increase in efficiency. And if the certificate is recognized by society at large as evidence of an organization’s excellence, it provides a strong incentive for organizations to improve the way they perform work.

There are cases, however, in which certified organization cause accidents and other problems, undermining confidence in the QMS certification^[2]. When examined, the causes of these accidents and problems can be divided into four major categories:

• (1) Lack of technology: Organizations need to establish processes for providing products and services that meet customers’ needs in an economical way. They accumulate technology through existing experience and plan and manage the processes based on that technology. Normally, an organization must compare the technology it has with the technology needed for products and services, and, if there is a big gap, decide not to deal in the products or services or try to acquire the needed technology from outside. There are cases, however, in which these decisions or efforts are not carried out adequately.
• (2) Deviation from rules: No matter how much technology an organization has, accidents and problems occur when it cannot be used appropriately. For this reason, organizations establish rules based on known technology and implement the education and training needed to follow those rules. Deviations from the rules sporadically occur, however, when newcomers or replacements lack the needed knowledge and skills, veterans dismiss the importance of rules and intentionally break them, employees unintentionally forget to do something or make mistakes, and the like.
• (3) Insufficient management of suppliers: Organizations need to procure materials, equipment, information, services, and the like from other organizations to produce and provide their own products and services. Accidents and problems occur when suppliers do not make adequate efforts to prevent Causes (1) and (2) from occurring. A close inspection of supplies when they are received is fine for simple products and services. As complexity increases, however, managing supplies at the source becomes more desirable.
• (4) Disconnect between top management and persons in charge on the work floor: The difficulty in preventing Causes (1) to (3) lies in the fact that the problems remain undetected as long as persons in charge do not re-examine their own ways to perform work on these perspectives. Top management (the company president, general manager, etc.) pursues the profits of the organization (this in itself is not a bad thing), while persons in charge try to follow its instructions. As a result, the problems faced by persons in charge are not communicated to top management and remain undetected until big accidents and problems occur. To prevent this, problems on the work floor should be communicated to top management, but a vicious cycle arises in which top management takes no interest in problems because they are not communicated, the instructions it gives and efforts based on those instructions address areas unrelated to existing problems, and the problems become easier to overlook.

3. 2015 Revision of ISO 9001

With the 2015 revision of ISO 9001, the common structure for all management system requirements (see Annex SL^[3], Figure 1) will be adopted, and the requirements will be strengthened to prevent the causes described above and increase society’s confidence in QMS certification:

• (1) Top management will be required to integrate the management system with business processes, taking into consideration the context of the organization (business environment, actual state of the organization, etc.). (Addresses Cause (4))
• (2) The organization will be required to determine risks and opportunities based on its context, and incorporate actions to address them into the management system (addresses Cause (4)). Here, “risks” refers to the effect of uncertainty, such as changes in the business environment, equipment failure, and deviations from rules, to the achievement of objectives. On the other hand, “opportunities” indicates good times or places for the organization to do something to achieve objectives, based on its present situation—for example, switching over to more efficient equipment when existing equipment gets old, or reviewing existing work practices when legal regulations are tightened.
• (3) The organization will be required to evaluate “performance” of product and services, processes, and QMS and make improvements when results are unsatisfactory. (Addresses Cause (4))
• (4) The organization will be required to determine the technology needed to ensure the operation of the QMS and its processes, the conformity of products and services, and customer satisfaction; the methods for considering the technological level of the organization and acquiring any additional technology needed when actions are taken to address changing needs and circumstances. (Addresses Cause (1))
• (5) The organization will be required to make efforts to prevent human-caused deviation from rules like unintentional human errors in its processes for producing and providing products and services. (Addresses Cause (2))
• (6) The organization will be required to determine the type and extent of control to be applied to its suppliers, taking into account the influence of suppliers on the ability of the organization to satisfy requirements. (Addresses Cause (3))

• 1. Scope
• 2. Normative references
• 3. Terms and definitions
• 4. Context of the organization
• 　4.1 Understanding the organization and its context
• 　4.2 Understanding the needs and expectations of interested parties
• 　4.3 Determining the scope of the quality management system
• 　4.4 Quality management system
• 5. Leadership
• 　5.1 Leadership and commitment
• 　5.2 Policy
• 　5.3 Organizational roles, responsibilities and authorities
• 6. Planning
• 　6.1 Actions to address risks and opportunities
• 　6.2 Quality objectives and planning to achieve them
• 7. Support
• 　7.1 Resources
• 　7.2 Competence
• 　7.3 Awareness
• 　7.4 Communication
• 　7.5 Documented information
• 8. Operation
• 　8.1 Operational planning and control
• 9. Performance evaluation
• 　9.1 Monitoring, measurement, analysis and evaluation
• 　9.2 Internal audit
• 　9.3 Management review
• 10. Improvement
• 　10.1 Nonconformity and corrective action
• 　10.2 Continual improvement

Figure 1: ISO 9001: 2015 Structure

4. Conclusion

While the content of the 2015 revision of ISO 9001 holds no surprises for the organizations that have been actively engaged in quality management, it will push the organizations that have just gone through the motions of QMS certification to make big changes. The organizations that are certified or seeking certification and the institutions that examine the organizations for certification will need to seriously consider their stance. The revision of ISO 9001 is expected to foster lively discussion about what needs to be done to guide society in a better direction and to encourage everyone concerned to take a step or two in the right direction.