ISO-DIS 9001-2026附录A
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ISO/DIS 9001:2026 附录部分
Annex A
附录A
(informative)
(资料性)
Clarification of structure,terminology and clauses
结构、术语和条款的说明
A.1 General
A.1 总则
The information given in this annex is intended to provide clarification and to prevent
misunderstanding of the requirements contained in this document.This information
addresses and is consistent with these requirements,and does not add to,subtract from,or
in any way modify them.
本附录中给出的信息旨在对本文件所含要求进行澄清并防止误解。这些信息针对并符合这些
要求，但不对其进行任何增加、删减或修改。
This annex does not provide guidance for the implementation of requirements;for guidance
on the application of requirements see ISO/TS 9002[1],ISO handbook ISO 9001 for small
enterprises-What to do?Advice from ISO/TC176[5]or the other standards referred to in
the notes to the relevant paragraphs of this annex.
本附录不为要求的实施提供指南；有关要求应用指南，请参见 ISO/TS 9002[1]、ISO手册《ISO
9001小型企业指南-如何做?来自ISO/TC176 的建议》[5]或本附录相关段落注释中引用的其
他标准。
The requirements in this document are better viewed from a systems perspective and not in
isolation,i.e.there can be an interrelationship between the requirements in one clause with
the requirements in other clauses.
本文件的要求最好从系统角度而非孤立地看待，即一个条款中的要求可能与其它条款中的要
求存在相互关系。
A.2 Structure and terminology
A.2 结构和术语
The clause structure (i.e.clause sequence)and some of the terminology of this document,
have been changed in comparison with the previous edition (ISO 9001:2015),to improve
alignment with the Harmonized Structure(HS)for management system standards(MSS).
与上一版(ISO 9001:2015)相比，本文件的条款结构(即条款顺序)和一些术语已作更改，以
改进与管理体系标准(MSS) 的协调结构(HS) 的一致性。
There is no requirement in this document for its structure and terminology to be applied to
the documented information of an organization's quality management system.
本文件并未要求组织的质量管理体系形成文件的信息必须采用本文件的结构和术语。
The structure of clauses is intended to provide a coherent presentation of requirements,
rather than a model for documenting an organization's policies,objectives,and processes.
The structure and content of documented information related to a quality management
system can often be more relevant to its users if it relates to both the processes operated
by the organization and information maintained for other purposes.
条款的结构旨在连贯地呈现要求，而非为组织记录其方针、目标和过程提供一个模型。如果
与质量管理体系相关的形成文件的信息的结构和内容，既关联到组织运作的过程，也关联到
为其他目的而维护的信息，那么它对使用者通常更具相关性。
To prevent misunderstanding,the meanings of the following words are clarified:
为防止误解，对以下词语的含义予以澄清：
a)The words“appropriate”and“applicable”are not interchangeable.“Appropriate”means
suitable(for,to)and implies some degree of freedom,while "applicable"means relevant or
possible to apply and implies that if it can be done,it needs to be done.
a)“适当的(appropriate)”和“适用的(applicable)”不可互换。“适当的”意为适合(于),并暗示
一定程度的自由度；而“适用的”意为相关或可应用，并暗示如果能做到，就必须做到。
b)The word "consider"means it is necessary to think about the topic,but it can be excluded;
whereas "take into account"means it is necessary to think about the topic,but it cannot be
excluded.
b)“考虑(consider)”一词意为有必要思考该议题，但可以排除；而“考虑到(take into account)”
意为有必要思考该议题，且不能排除。
c)The word “continual”indicates duration that occurs over a period of time,but with
intervals of interruption (unlike "continuous"which indicates duration without interruption).
"Continual"is therefore the appropriate word to use when referring to improvement.
c)“持续的(continual)” 一词表示在一段时间内发生，但有间断(不同于“连续的(continuous)”
表示不间断)。因此，在提及改进时，使用“持续的”是恰当的。
d)The word "ensure"means the responsibility to do an activity can be delegated,but not
the accountability for the results of the activity.
d)“确保(ensure)” 一词意为执行一项活动的责任可以被委托，但对活动结果的问责性不能被委
托。
e)To align the use of the term "documented information"to the Harmonized Structure,two
changes have been made.First,the phrase "shall be available as documented information"
replaces "maintain documented information"which previously referred to documentation
other than records.Second,"documented information shall be available as evidence of"
replaces "retain documented information as evidence of"which previously referred to
records.It is worth noting that the phrase "as evidence of"is not a requirement to meet
legal evidential requirements;its intent is only to indicate objective evidence needs to be
retained.
e)为使术语“形成文件的信息”的使用与协调结构保持一致，作了两处更改。首先，用短语“应
作为形成文件的信息予以保持(shall be available as documented information)”取代了“保持
形成文件的信息(maintain documented information)”, 后者以前指记录以外的文件。其次，
用“应提供形成文件的信息作为……的证据(documented information shall be available as
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ISO/DIS9001:2026附录部分AnnexA附录A(informative)(资料性)Clarificationofstructure,terminologyandclauses结构、术语和条款的说明A.1GeneralA.1总则Theinformationgiveninthisannexisintendedtoprovideclarificationandtopreventmisunderstandingoftherequirementscontainedinthisdocument.Thisinformationaddressesandisconsistentwiththesere...
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时间：2026-04-08
