2024年3月9日发(作者：lol手游官网最新公告)

ISO 9001:2015

1 Scope

This International Standard specifies

requirements for a quality management

system when an organization:

a) needs to demonstrate its ability to

consistently provide product or service

that meets customer and applicable

statutory and regulatory requirements,

and

b) aims to enhance customer satisfaction

through the effective application of the

system, including processes for

improvement of the system and the

assurance of conformity to customer and

applicable statutory and regulatory

requirements.

All requirements of this International

Standard are generic and are intended to be

applicable to all organizations, regardless of

type, size and product and service provided.

NOTE 1 In this International Standard, the terms

“product” or “service” only apply to products

and services intended for, or required by, a

customer.

NOTE 2 Statutory and regulatory requirements

can be expressed as legal requirements.

2 Normative references

The following documents, in whole or in part,

are normatively referenced in this document

and are indispensable for its application. For

dated references, only the edition cited

1範圍

本國際標準所訂的品質管理系統要求，當一個組

織：

a) 必須展現其提供一致地符合顧客要求和符合

適用法令和法規要求之產品或服務的能力。

及

b) 藉由對系統的有效應用，包含對系統改善的

過程和對顧客要求及適用法令和法規要求之

符合的保證，以增進顧客滿意。

本標準的所有要求是通用的，並意圖適用於所有

的組織，不論其類型、規模大小和所提供的產品

及服務。

註1：本國際標準內｢產品｣或｢服務｣一詞只用於顧客

想要的或要求的產品及服務。

註2：法令和法規要求可以統稱為法規要求。

2引用標準

下列文件的全部或部分，對本標準的應用是不可

缺的。對有日期的參考標準，只有該引用到的版

本適用。對沒有日期的參考標準，最新版本的參

考文件(包含任何變更)適用。

Page 2 of 40

applies. For undated references, the latest

edition of the referenced document

(including any amendments) applies.

ISO 9000:2015, Quality management systems

ISO9000：2015，品質管理系統-原則和辭彙

— Fundamentals and vocabulary

3 Terms and definitions

For the purposes of this document, the terms

and definitions given in ISO 9000:2015 apply.

4 Context of the organization

4.1 Understanding the organization and its

context

The organization shall determine external

and internal issues that are relevant to its

purpose and its strategic direction and that

affect its ability to achieve the intended

result(s) of its quality management system.

The organization shall monitor and review

information about these external and internal

issues.

NOTE 1 Issues can include positive and negative

factors or conditions for consideration.

NOTE 2 Understanding the external context can

be facilitated by considering issues arising from

legal, technological, competitive, market, cultural,

social and economic environments, whether

international, national, regional or local.

NOTE 3 Understanding the internal context can

3用詞和定義

作為本文件的目的，ISO9000：2015所列的名

詞與定義適用於本標準。

4組織的內涵

4.1瞭解組織及其內涵

組織應決定與其宗旨及其策略方向和影響其達成

品質管理系統預期輸出相關的外部及內部議題。

組織應監督與審查這些外部與內部議題的資訊。

註一：議題可能包含正面或反面的因子和考量條件

註二：藉由考量來自法規、技術、競爭、市場、文

化、社會和經濟環境的議題，不管是國際上的、國家

的、地區的或當地的，可以去瞭解外部的內涵。

註三：考量與組織的價值觀，文化知識與績效有關者

的議題，可以去瞭解內部的內涵。