A Brief Discussion on Innovative Concepts in Quality Management System Standards

1. Innovation is the primary driving force for development

At the Fifth Plenary Session of the 19th Central Committee of the Communist Party, adhering to the concept of innovative development was established as one of the principles that must be followed during the 14th Five-Year Plan period for economic and social development, clearly defining "insisting on innovation as the core position in the overall modernization of our country." Innovation is the primary driving force for development. Focusing on innovation means focusing on development; planning innovation means planning for the future.

From an economic perspective, innovation is the act of improving or creating new things (including but not limited to various methods, elements, paths, environments, etc.) based on existing knowledge and materials in a specific environment, which can achieve certain beneficial effects.

From a business perspective, innovation is seizing potential market profit opportunities or the potential commercial value of technology, aiming to gain profit by recombining production factors and conditions, establishing a new production and operation system with stronger effectiveness and higher efficiency, thereby launching new products, new production methods, opening new markets, obtaining new sources of raw materials, or establishing new organizations. It includes a comprehensive process of activities such as technology, organization, business, and finance.

Innovation is the soul of a nation's progress, the inexhaustible driving force for a country's prosperity and development, and the source of sustainable development for an enterprise.

2. The basic principles of quality management contain the concept of innovation

ISO 9000:2015 "Quality Management Systems — Fundamentals and Vocabulary" (3.6.15) defines innovation as: a new or changed object that realizes or reallocates value. Innovation gives new momentum to resources, can create more customer value, is the driving force for sustainable development of enterprises, and promotes social progress.

The concept of innovation is embedded in the basic principles of quality management.

ISO 9000:2015 lists "improvement" as one of the seven principles of quality management. Successful organizations are always committed to continuous improvement. Improvement is essential for organizations to maintain current performance levels, respond to changes in internal and external conditions, and create new opportunities. Improvement can enhance process performance, organizational capability, and customer satisfaction; increase focus on investigation and determination of root causes as well as subsequent preventive and corrective actions; improve the ability to anticipate and respond to internal and external risks and opportunities; increase consideration of incremental and breakthrough improvements; better utilize learning for improvement; and strengthen the motivation for reform.

The foreword of ISO 9001:2015 "Quality Management Systems — Requirements" also clearly points out: continuously meeting requirements in an increasingly complex and dynamic environment and taking appropriate actions for future needs and expectations is undoubtedly a challenge faced by organizations. To achieve this goal, organizations may find it necessary to take various forms of improvement beyond corrective and continuous improvement, such as breakthrough changes, innovation, and restructuring.

It is evident that the improvement requirements in the ISO 9001:2015 "Quality Management Systems — Requirements" standard contain the concept of innovation.

3. Innovation requirements are included in the quality management system standards

Many clauses in the ISO 9001:2015 standard propose improvement requirements, and improvement includes innovation. Innovation is a form of improvement based on inheritance. Therefore, strictly implementing these clause requirements helps promote the implementation of the innovation concept.

Clause 4.4.1 in Chapter 4 requires the organization to establish, implement, maintain, and continuously improve the quality management system according to the requirements of ISO 9001, including the necessary processes and their interactions. This section is the general requirement for the quality management system. A quality management system that meets ISO 9001 requirements must have a continuous improvement mechanism to constantly improve processes and the operation of the entire quality management system.

Clause 5.1.1 in Chapter 5 requires top management to promote improvement and demonstrate their leadership and commitment to the quality management system; Clause 5.2.1 requires the quality policy to include a commitment to continuous improvement of the quality management system; Clause 5.3 requires top management to assign responsibilities and authorities to report on the performance of the quality management system and improvement opportunities. Clearly, this requires establishing a mechanism to promote improvement within the governance structure.

Clause 6.1.1 in Chapter 6 requires identifying risks and opportunities to be addressed to achieve improvement, and also specifically notes (Note 2): opportunities may lead to adopting new practices, launching new products, opening new markets, winning new customers, establishing partnerships, utilizing new technologies, and other feasible actions to meet the needs of the organization or its customers; Clause 6.2.1 requires that the quality objectives established by the organization be consistent with the policy and updated in a timely manner. This requires quality objectives to reflect improvement and guide innovation.

Clause 7.1.1 in Chapter 7 requires the organization's resource allocation to ensure the needs for continuous improvement of the quality management system; Clause 7.1.6 requires the organization's knowledge management to consider intellectual property as well as the results of process, product, and service improvements, including innovation results; Clause 7.3 requires the organization to ensure that personnel under its control are aware of the commitment to improvement and the benefits of improvement performance, which requires employees to have an innovation mindset; Clause 7.5 sets control requirements for documented information changes caused by improvement and innovation.

Clause 8.1 in Chapter 8 requires the organization to control planned changes, including changes triggered by innovation; Clauses 8.2.3.2 and 8.2.4 set control requirements for new requirements of products and services. These new or changed requirements contain innovation opportunities; Clause 8.3 sets requirements for the design and development of products and services. Various organizations should proactively take responsibility for products and services, establish the capability to develop new products, and continuously meet customer requirements, which is the essential meaning of enterprise innovation; Clause 8.5.6 sets control requirements for changes in production and service provision.

Clause 9.1.3 in Chapter 9 requires the organization to use analysis results to evaluate the need for quality management system improvement; Clause 9.2 requires internal audits to provide information about quality management system improvements; Clause 9.3 requires management review inputs to consider improvement opportunities, and management review outputs to include decisions and actions related to improvement opportunities.

Chapter 10 is entirely about improvement requirements. Clause 10.1 clearly states that improvement should include improving products and services to meet requirements and respond to future needs and expectations, and specifically notes: examples of improvement may include correction, corrective actions, continuous improvement, breakthrough changes, innovation, and restructuring; Clause 10.3 requires the organization to consider the results of analysis and evaluation as well as management review outputs to determine if there are needs or opportunities, which should be addressed as part of continuous improvement.

4. Certification of the quality management system can promote the organization's innovation capability

As mentioned above, the improvement requirements in the ISO 9001 standard contain the concept of innovation, which auditors should fully understand. During the audit process, through in-depth communication with top management, it should be checked whether they actively promote improvement and innovation, whether the pursuit of improvement and innovation is incorporated into policies and objectives, and whether responsibilities related to improvement are clearly defined; through communication with employees, it should be checked whether they have an innovation mindset and forward-thinking, and actively carry out knowledge management; by collecting evidence of implementation of relevant requirements, it should be checked their actual practices in innovation. When an organization has not established a mechanism for continuous improvement of the quality management system, certification should not be granted. From this perspective, certification of the quality management system can promote Chinese enterprises to continuously enhance innovation awareness, practice the innovation concept, improve innovation capability, and achieve high-quality development.