ISO 9001:2000
7. 產品實現 (Product realization)
7.1 產品實現之規劃 (Planning of product realization)
7.2 顧客相關過程 (Customer-related processes)
7.3 設計與發展 (Design and development)
7.3.1 設計與發展規劃 (Design and development planning)
7.3.2 設計與發展輸入 (Design and development inputs)
7.3.3 設計與發展輸出 (Design and development outputs)
7.3.4 設計與發展審查 (Design and development review)
7.3.5 設計與發展查證 (Design and development verification)
7.3.6 設計與發展確認 (Design and development validation)
7.3.7 設計與發展變更之控制 (Control of design and development changes)
7.4 採購 (Purchasing)
7.5 生產與服務供應 (Production and service provision)
7.6 監視與量測設備之控制 (Control of monitoring and measuring equipment)
ISO 9004:2000
7.3 設計與發展 (design and development)
7.3.1 一般指引 (general guide)
Top management should ensure that the organization has defined, implemented and maintained the necessary design and development processes to respond effectively and efficiently to the needs and expectations of its customers and interested parties.
When designing and developing products and processes, management should ensure that the organization is not only capable of considering their basic performance and function, but all factors that contribute to meeting the product and process performance expected by customers and other interested parties. For example, the organization should consider life cycle, safety and health, testability, usability, user-friendliness, dependability, durability, ergonomics, the environment, product disposal and identified risks.
Management also has the responsibility to ensure that steps are taken to identify and mitigate potential risk to the users of the products and processes of the organization. Risk assessment should be undertaken to assess the potential for, and their effect of, possible failures or fault in products or processes. The results of the assessment should be used to define and implement preventive actions to mitigate the identified risks. Example of tools for risk assessment of design and development include:
- 設計故障模式與效應分析 (design fault modes and effects analysis, FMEA) ⇒ 故障模式 (Fault Modes) 不是失效模式 (Failure Modes) ；
- 故障樹分析 (fault tree analysis, FTA) ；
- 可靠度預估 (reliability prediction)；
- 關係圖 (relationship diagrams)；
- 排序技法 (ranking techniques) ；及
- 模擬技法 (simulation techniques) 。
7.3.2 設計與發展輸入與輸出 (Design and development input and output)
The organization should identify process inputs that affect the design and development of products and facilitate effective and efficient process performance in order to satisfy the needs and expectations of customers, and those of other interested parties. These external needs and expectations, coupled with those internal to the organization, should be suitable for translation into input requirements for the design and development processes.
Examples are as follows:
a) external inputs such as:
- customer or marketplace needs and expectations,
- needs and expectations of other interested parties,
- supplier's contributions,
- user input to achieve robust design and development,
- changes in relevant statutory and regulatory requirements,
- international or national standards, and
- industry codes of practice.
b) internal inputs such as:
- policies and objectives,
- needs and expectations of people in the organization, including those receiving the output of the process,
- technological developments,
- competence requirements for people performing design and development,
- feedback information from past experience,
- records and data on existing processes and products, and
- outputs from other processes.
c) inputs that identify those characteristics of processes or products that are crucial to safe and proper functioning and maintenance, such as,
- operation, installation and application,
- storage, handling and delivery,
- physical parameters and the environment, and
- requirements for disposal of the products.
Product-related inputs based on an appreciation of the needs and expectations of end users, as well as those of the direct customer, can be important Such inputs should be formulated in a way that permits the product to be verified and validated effectively and efficiently.
The output should includes information to enable verification and validation to planned requirements. Examples of the output of design and development include:
- 展示過程輸入和過程輸出比較值的資料 (data demonstrating the comparison of process inputs to the process outputs)，
- 包括允收準則的產品規範 (product specifications, including acceptance criteria)，
- 過程規範 (process specifications)，相當於美軍標準 MIL-STD-490 的 D 規範，
- 材料規範 (material specifications)，相當於美軍標準 MIL-STD-490 的 E 規範，
- 測試規範 (testing specifications)，
- 訓練要求 (training requirements)，
- 使用者與顧客資訊 (user and customer information)，
- 採購要求 (purchase requirements)，及
- 鑑定試驗報告 (reports of qualification tests)。
Design and development outputs should be reviewed against inputs to provide objective evidence that outputs have effectively and efficiently met the requirements for the process and product.