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In accordance with the requirements of the ISO 9001:2015 standard, an organization should analyze and evaluate its internal and external environment. The organization must fully identify these factors and analyze them in order to understand the impact of the internal and external conditions on its business operations. By using the SWOT analysis method, it can identify the organization’s opportunities and threats, and then develop appropriate measures accordingly. The specific contents and analysis methods for analyzing the internal and external environments of an organization are as follows: 2. Analysis of the internal environment (I) Analysis of organizational resources and capabilities 1. Resource analysis Organizational resources refer to the sum of all effective factors that an organization possesses or controls, including tangible and intangible assets as well as human resources. The purpose of this analysis is to identify the organization’s resource situation, as well as its strengths and weaknesses, and to understand their impact on the formulation of the organization’s strategic goals. (1) Resource classification: tangible, intangible, human resources (2) Organizational resources that determine competitive advantage a) Scarcity of resources ； b) Unimitability of resources: ① Physically unique resources ； ② Resources with path dependence (acquired through long-term accumulation) ； ③ Resources with causal ambiguity ； ④ Resources with economic constraints. c) Irreplaceability of resources ； d) Sustainability of resources. 2. Analysis of organizational capabilities: An organization’s capabilities refer to its ability to allocate resources and leverage them for production and competitive purposes; they are the result of combining various organizational resources. Such capabilities include research and development, production management, marketing, finance, and organizational management. a) R&D capability: measured from R&D planning, R&D organization, R&D process, and R&D outcomes ； b) Production management capabilities: including production processes, production capacity, inventory management, human resource management, quality management, etc ； c) Marketing management: Analysis is conducted from aspects such as product competitiveness, sales capability, and market decision-making ability: ① Product competitiveness analysis: Market position, profitability, and growth potential. Market position — market share, coverage rate ； Profitability – profit margins, cost-volume-profit analysis ； Growth potential – sales growth rate, market expansion rate, etc. ② Sales activity capability: includes the assessment of basic data such as sales organizations, personnel, and management. Sales Performance Analysis — Sales Plan Completion Rate ； Sales channel analysis — Sales channel structure, intermediary evaluation, channel management ； ③Market decision-making capability: is analyzed based on product competitiveness and sales activity capabilities. d) Capacity: the ability to raise funds, as well as the ability to use and manage funds. Fund-raising capacity – debt-to-asset ratio, current ratio, interest coverage ratio, etc ； The ability to use and manage funds – return on assets, profit margin on sales, asset turnover, etc. e) Organizational management capability: ① Task allocation in the functional management system ； ② Job responsibilities ； ③ Centralization and decentralization status ； ④ Organizational structure (functional, divisional) ； ⑤ The alignment between management levels and scope of management. The concept of an organization’s core competitiveness: Management combines the technical and production skills across the company to create the ability for its various business units to quickly adapt to changing opportunities. Identification methods: functional analysis, resource analysis, process system analysis ； Evaluation methods: self-evaluation, industry comparison, benchmark analysis, cost drivers and activity-based costing, and gathering information on competitors. (II) Value chain analysis 1. Two types of activities in the value chain: Basic activities: a) Internal logistics: Activities related to the input of products, including purchasing, storage, logistics, and distribution, such as the loading and unloading of raw materials, their storage, transportation, and returns ； b) Production and operation: Activities that convert inputs into final products, such as machining, assembly, equipment maintenance, testing, etc ； c) External logistics: Activities related to product inventory and distribution to consumers, such as product receipt, order processing, delivery, etc ； d) Market sales: Activities aimed at promoting and encouraging consumers to purchase the organization’s products, such as advertising, pricing, and sales tactics ； e) Services: Activities related to maintaining and enhancing the value of products, such as training, etc. Supporting activities: f) Procurement management: This includes both the procurement of raw materials and the management of resource allocation ； g) Technology development: A series of activities aimed at improving organizational products and processes, including both productive and non-productive technologies. These technology development activities are not only directly related to the final products but also support all aspects of the organization’s operations, and they constitute an important factor in determining an organization’s competitiveness ； h) Human resource management: It is an important activity for motivating employees ； i) Infrastructure: This refers to an organization’s institutional control systems and culture, among other elements; unlike other support activities, it is used to underpin the operation of the entire value chain. 2. Value chain analysis of resource capabilities: a) Identifying the key activities that support the organization’s competitive advantage ； b) Clarify the connections between various activities within the value chain ； c) Clarify the relationships between various value activities within the value system. (III) Business portfolio analysis: a) For organizations with diversified operations, it is also necessary to consider the organization’s resources as a whole; therefore, it is essential to analyze the business portfolio in order to ensure its optimization. b) Methods: Boston Matrix, General Matrix. Application of the 3SWOT method: The SWOT analysis method is a systematic evaluation that takes into account various factors within an organization’s internal conditions as well as its external environment, in order to select the best business strategy. An organization’s internal competitive advantages and disadvantages are relative to its competitors, and they are generally reflected in aspects such as the organization’s funds, technology, equipment, employee competence, products, market position, and management skills. The criteria for assessment include both individual advantages and disadvantages as well as overall advantages and disadvantages. Opportunities in an organization’s external environment refer to factors in that environment that are favorable to the organization, while threats refer to factors that are unfavorable to it. The most crucial part of a SWOT analysis is evaluating an organization’s strengths and weaknesses, identifying the opportunities and threats it faces, and making decisions accordingly. The following is an example of analyzing the internal and external environments using the SWOT analysis method: Analysis of internal and external environments: n% @! j- b- k. j 5 S. Internal environment % K1 V, K, ~" I . D3 {- ~6 J! S+ k+ %> i3 l / _, g* D# H6 j& x External environment S (Strengths) W (Weaknesses) Strong brand presence with significant brand advantages ； Leading quality with stable quality control ； Technological leadership, advanced equipment, and high technical content of products ； Leading in sales, with a high market share and a wide marketing network ； Clear advantages in the industrial chain ； Strong R&D capabilities and a sufficient pool of technical personnel ； Good organizational culture ； There are information systems for rapid response ； ……The product is not well-known ； The product has a narrow range of coverage ； Insufficient capability to develop high-end products ； …… During the O (opportunity) economic crisis, some organizations withdrew from market competition, giving better-performing organizations more market space ； Resources are accelerating their concentration in top organizations ； Residents’ income continues to grow ； Urbanization is accelerating ； Environmental awareness creates opportunities for the production of related products ； **Exploiting the opportunities brought about by clean energy and the Belt and Road Initiative: (I) Uncovering market potential, expanding into niche markets, and entering high-end markets ； Accelerate the research and development of new products ； Enhance brand value and pursue brand diversification ； Strengthen the development and design of environmentally friendly products ； ……WO: (Ⅲ) Consolidate market position and maintain existing competitive advantages ； Optimize internal resources ； Improve product quality ； Control production costs ； …… T (Threat) comes from competition from other brands ； The quality of employees is low ； Insufficient talent reserve ； The costs of labor and materials are rising rapidly……ST: (II) Expand upstream in the industrial chain to enhance control over it ； Transfer of production base ； Improvement in labor efficiency ； ……WT: (IV) Improve design capabilities ； Strategic contraction or withdrawal ； …… 8 H1 C2 A& u1 `; W & ?/ ^/ \% b$ m' X, n ; n, y- q# c9 R; L, j7 I% V Based on the internal and external environmental factors that have a significant impact on market operations and development, as listed, these factors are evaluated using established criteria. This evaluation helps identify strengths and weaknesses, as well as opportunities and threats, thereby identifying risks and opportunities; measures are then taken to address those risks. A SWOT analysis helps organizations truly understand what adjustments to their resources are necessary in order to respond better to emerging industries and competitive environments ； Whether it is necessary to address the resource gap, and which opportunities should be given priority when allocating resources. As can be seen from the table above, Category I organizations possess strong internal advantages and external opportunities, and should adopt a growth strategy such as expanding into new markets and increasing production ； Organizations in Category II face significant external opportunities but are constrained by internal weaknesses; they should adopt a turnaround strategy ； Organizations in Category III possess internal advantages but face threats from the external environment; they should adopt a diversified strategy to utilize their strengths to counter these external threats ； Category IV organizations have internal weaknesses and face external threats; they should adjust their business operations and adopt a defensive strategy. In the ISO9001:2015 standard, organizations are required to analyze their internal and external environments, determine the scope of their quality management system, and identify the processes necessary for its operation. Organizations adopt different strategies, which determines the focus of their work; the scope of quality management systems as well as the control requirements for various processes also vary. Organizations should identify the key requirements outlined in the ISO 9001:2015 standard that require attention. For example, organizations that follow a diversified strategy may need to adjust their product portfolio, develop new products, and invest more in hiring technical talent as well as in infrastructure ； For organizations pursuing a growth strategy, emphasis should be placed on increasing production capacity, investing in resources, and developing markets. It should be noted that adopting a quality management system is an important strategic decision for an organization. Achieving certification under such a quality management system requires significant effort. Although the management systems of most organizations are currently merely formalities, this does not diminish the role and importance of the ISO 9001:2015 standard on “Quality Management Systems – Requirements” in helping organizations improve their quality management.