品質的定義

hlperng

自從 1987 年國際標準化組織 (ISO) 推出 ISO 9000 品質管理系統系列國際標準之後，開啟了一般產業對於品質及相關議題統一與標準化的動力，品質概念也從一般製造業擴展到所有的產業。

ISO 對於品質所下的定義，依次為：
⇒ 1986 年：產品或服務的特徵與特性滿足明定或隱含需要的能力。
⇒ 1994 年：物品總體特性滿足明定及隱含需要的能力。
⇒ 2000 年：固有特性實現要求的程度；要求包括明定、通常隱含或義務的需要或期望。
⇒ 2015 年：物件固有特性實現要求的程度；要求包括明定、通常隱含或義務的需要或期望。
依此，目前對於品質的定義是：
→ 品質 = 物件的固有特性實現明定、通常隱含或義務的需要或期望等要求的程度。

組織對於品質的轉換過程：
需要與期望的供應 ⇒ 固有特性的要求
需要、期望與義務 (需求) ⇒ 要求 ⇒ 特性(固有的與指定的) ⇒ 能力 ⇒ 性能或績效 = 功能要求 + 非功能要求（限制條件）

品質討論的對象：
⇒ 1986年 (ISO 8402) 指以製造產業為主的「產品或服務」(product and/or service)。
⇒ 1994年 (ISO 8402) 改為涵蓋面較廣大的「事物」(entity, item)概念。
⇒ 2000年 (ISO 9000) 沒有明確定義特定對象。
⇒ 2013年 (ISO 2000) 定義對象為包括產品、過程、人員、組織與系統的通用名詞物件(object)。


國際標準化組織(ISO)對於品質的定義，以下列述ISO 8402:1986、ISO 8402:1994、ISO 9000:2000、ISO 9000:2005對於品質的定義原文：
ISO 8402_1986,
3.1 Quality

• The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.
• NOTE 1.  In a contractual environment, needs are specified, whereas in other environments, implied needs should be identified and defined.
• NOTE 2.  In many instances, needs can change with time; this implies periodic revision of specifications.
• NOTE 3.  Needs are usually translated into features and characteristics with specified criteria.  Needs may include include aspects of usability, safety, availability, reliability, maintainability, economics and environment.
• NOTE 4.  The term "quality" is not used to express a degree of excellence in a comparative sense nor is it used in a quantitative sense for technical evaluations.  In these cases a qualifying adjective shall be used.  For example, use can be made of the following terms: a) "relative quality" where products or services are ranked on a relative basis in the "degree of excellence" or "comparative" sense; b) "quality level" and "quality measure" where precise technical evaluations are carried out in a "quantitative sense".
• NOTE 5.  Product or service quality is influenced by many stages of interactive activities, such as design, production or service operation and maintenance.
• NOTE 6.  The economic achievement of satisfactory quality involves all stages of the quality loop (quality spiral) are sometimes identified separately for emphasis.  Two examples: "quality attributable to design", "quality attributable to implementation".
• NOTE 7.  In some reference sources, quality is referred to as "fitness for use" or "fitness for purpose" or "customer satisfaction" or "conformance to the requirements".  Since these represent only certain facets of quality, fuller explanations are usually required that eventually lead to the concept defined above.
  

ISO 8402_1994,
2.1 Quality

• Totality of characteristics of a entity that bear on its ability to satisfy stated and implied needs.
• NOTE 1.  In a contractual environment, or in a regulated environment, such as the nuclear safety field, needs are specified, whereas in other environments, implied needs should be identified and defined.
• NOTE 2.  In many instances, needs can change with time; this implies a periodic review of requirements for quality.
• NOTE 3.  Needs are usually translated into characteristics with specified criteria (see requirements for quality).  Needs may include, for example, aspects of performance, usability, dependability (availability, reliability, maintainability), safety, environment (see requirements of society), economics and aesthetics.
• NOTE 4.  The term "quality" should not be used as a single term to express a degree of excellence in a comparative sense, nor should it be used in a quantitative sense for technical evaluations.  To express these meanings, a qualifying adjective should be used.  For example, use can be made of the following terms: a) "relative quality" where entities are ranked on a relative basis in the degree of excellence or comparative sense (not to be confused with grade); b) "quality level" in a quantitative sense (as used in acceptance sampling) and "quality measure" where precise technical evaluations are carried out.
• NOTE 5.  The achievement of satisfactory quality involves all stages of the quality loop as a whole.  The contributions to quality of these various stages are sometimes identified separately for emphasis; for example, quality due to product design, quality due to conformance, quality due to product support throughout its lifetime.
• NOTE 6.  In some references, quality is referred to as "fitness for use" or "fitness for purposes" or "customer satisfaction" or "conformance to the requirements".  These represent only certain facets of quality, as defined above.
  

1.1 Entity (item)

• That which can be individually described and considered.
• NOTE.  An entity may be, for example: an activity or a process; a product; an organization, a system or a person; or any combination thereof.
  

ISO 9000_2000,
3.1.1 Quality

• Degree to which a set of inherent characteristics fulfils requirements.
• NOTE 1.  The term "quality" can be used with adjectives such as poor, good or excellent.
• NOTE 2.  "Inherent", as opposed to "assigned", means existing in something, especially as a permanent characteristic.
  

3.1.2 Requirement

• Need or expectation that is stated, generally implied or obligatory.
• NOTE 1.  "Generally implied" means that it is custom or common practice for the organization, its customers and other interested parties, that the need or expectation under consideration is implied.
• NOTE 2.  A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement.
• NOTE 3.  A specified requirement is one which is stated, for example, in a document.
• NOTE 4.  Requirements can be generated by different interested parties.
  

3.5.1 Characteristic

• Distinguishing feature
• NOTE 1.  A characteristic can be inherent or assigned.
• NOTE 2.  A characteristic can be qualitative or quantitative.
• NOTE 3.  There are various classes of characteristic, such as the following: physical (e.g. mechanical, electrical, chemical or biological characteristics); sensory (e.g. related to smell, touch, taste, sight, hearing); temporal (e.g. punctuality, reliability, available); ergonomic (e.g. physiological characteristic, or related to human safety); functional (e.g. maximum speed of an aircraft).
  

CNS 12680_2008 = ISO 9000_2005,
3.1.1 品質(Quality)

• 一組固有的特性滿足要求之程度。(Degree to which a set of inherent characteristics fulfils requirements.)
• 備考1：「品質」可用形容詞如差、好或優來修飾。(NOTE 1.  The term "quality" can be used with adjectives such as poor, good or excellent.)
• 備考2：「固有的」（其反面是指定的）意指現存於事物中本來就有的，特別是永久性的特性。(NOTE 2.  "Inherent", as opposed to "assigned", means existing in something, especially as a permanent characteristic.)
  

3.1.2 要求(Requirement)

• 明示、通常隱含或義務的需求或期望。(Need or expectation that is stated, generally implied or obligatory.)
• 備考1：「通常隱含的」意指用於組織、組織的顧客及其他利害相關者之慣例或一般事務運作中所考量隱含的需求或期望。(NOTE 1.  "Generally implied" means that it is custom or common practice for the organization, its customers and other interested parties, that the need or expectation under consideration is implied.)
• 備考2：可用修飾詞表示特定型態的要求，例如產品要求、品質管理要求、顧客要求。(NOTE 2.  A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement.)
• 備考3：特定要求是一種明白表示的要求，例如在文件中表達者。(NOTE 3.  A specified requirement is one that is stated, for example in a document.)
• 備考4：要求可由不同利害相關者提出。(NOTE 4.  Requirements can be generated by different interested parties.)
• 備考5：ISO/IEC 指令第二部分(2004)地3.12.1 節提供了不同的定義。3.12.1 要求：在一文件之內容中，傳遞某一要予以達成之準則的一種表達方式。若該文件係要求予以遵循者，不允許與其產生偏差。(NOTE 5.  This definition differs from that provided in 3.12.1 of ISO/IEC Directives, Part 2:2004. 3.12.1 Requirement.  Expression in the content of a document conveying criteria to be fulfilled if compliance with the document is to be claimed and from which no deviation is permitted.)
  

3.5.1 特性(Characteristic)

• 可區別的特徵。(Distinguishing feature)
• 備考1：特性可以是固有的或指定的。(NOTE 1.  A characteristic can be inherent or assigned.)
• 備考2：特性可以是定性的或定量的。(NOTE 2.  A characteristic can be qualitative or quantitative.)
• 備考3：有各種類別的特性，諸如：物理的（如：機械的、電的、化學的或生物的特性）；感官的（如：嗅覺、觸覺、味覺、視覺、聽覺）；行為的（如禮貌、誠實、正直）；時間的（如：準時性、可靠性、可用性）；人因工程（如：生理的特性、或有關人身安全的特性）；功能的（如：飛機之最高速度）。(NOTE 3.  There are various classes of characteristic, such as the following: physical (e.g. mechanical, electrical, chemical or biological characteristics); sensory (e.g. related to smell, touch, taste, sight, hearing); behavioral (e.g. courtesy, honesty, veracity); temporal (e.g. punctuality, reliability, availability); ergonomic (e.g. physiological characteristic, or related to human safety); functional (e.g. maximum speed of an aircraft).)
  

ISO 9000_2013-CD,
3.1.2 Quality

• Degree to which a set of inherent characteristics of an object fulfils requirements.
• NOTE 1.  The term "quality" can be used with adjectives such as poor, good or excellent.
• NOTE 2.  "Inherent", as opposed to "assigned", means existing in something, especially as a permanent characteristic.
  

1.1 Object (entity)

• Anything perceivable or conceivable.
• Examples.  Product, process, person, organization, system.
• NOTE 1.  Objects may be material (e.g. an engine, a sheet of paper, a diamond), immaterial (e.g. conversion ratio, a project plan) or imaginal (e.g. a unicorn).
  

3.1.3 Requirement

• Need or expectation that is stated, generally implied or obligatory.
• NOTE 1.  "Generally implied" means that it is a custom or common practice for the organization and other interested parties that the need or expectation under consideration is implied.
• NOTE 2.  A specified requirement is one that is stated, for example in documented information.  (Annex SL Appendix 3, 3.03 of the ISO/IEC Directives Part 2:2012)
• NOTE 3.  A qualifier can be used to denote a specific type of requirement e.g. product requirement, quality management requirement, customer requirement, quality requirement.
• NOTE 4.  Requirements can be generated by different interested parties.
• NOTE 5.  It can be necessary for reaching high customer satisfaction to fulfil an expectation of a customer even if it is neither stated or generally implied or obligatory.
  

3.6.1 Characteristic

• Distinguishing feature.
• NOTE 1.  A characteristic can be inherent or assigned.
• NOTE 2.  A characteristic can be qualitative or quantitative.
• NOTE 3.  There are various classes of characteristic, such as following: a) physical (e.g. mechanical, electrical, chemical or biological characteristics); b) sensory (e.g. related to smell, touch, taste, sight, hearing); c) behavioural (e.g. courtesy, honesty, veracity); temporal (e.g. punctuality, reliability, availability); d) ergonomic (e.g. physiological characteristic, or related to human safety); e) functional (e.g. maximum speed of an aircraft).
  

3.1.4 Quality requirement

• Requirement related to quality.
  

3.6.2 Quality characteristic

• Inherent characteristic of an object related to a requirement.
• NOTE 1.  Inherent means existing in something, especially as a permanent characteristic.
• NOTE 2.  A characteristic assigned to an object (e.g. the price of an object) is not a quality characteristic of that object.
  

美國品質學會對於品質的定義：American Society for Quality (ASQ) - Quality Glossary - Q

• A subjective term for which each person or sector has its own definition.
• In technical usage, quality can have two meanings: 1. the characteristics of a product or service that bear on its ability to satisfy stated or implied needs. 2. a product or service free of deficiencies.
• According to Joseph Juran, quality means "fitness for use," according to Philip Crosby, it means "conformance to requirements."
  

英國品質學會對於品質的定義：Chartered Quality Institute (CQI), U.K.

• Quality: a degree of excellence: the extent to which something is fit for its purpose.
• Product or service quality: conformance with requirements, freedom from defects or contamination, or simply a degree of customer satisfaction.
• (quality management) the totality of characteristics of a product or service that bears on its ability to satisfy stated and implied needs.
  

醫療與健康照護對於品質的定義：Six areas or dimensions of quality health care or health system

• effective, delivering health care that is adherent to an evidence base and results in improved health outcomes for individuals and communities, based on need;
• efficient, delivering health care in a manner which maximizes resource use and avoids waste;
• accessible, delivering health care that is timely, geographically reasonable, and providing in a setting where skills and resources are appropriate to medical need;
• acceptable/patient-centered, delivering health care which takes into account the preferences and aspirations of individual service users and the culture of their communities;
• equitable, delivering health care which does not vary in quality because personal characteristics such as gener, race, ethnicity, geographical location, or socioeconomic stattus;
• safet, delivering health care which minimizes risks and harm to service users.
  

其他關於品質的定義(Others):

• (manufacturing) a measure of excellence or a state of being free from defects, deficiencies and significant variations.  It is brought about by strict and consistent commitment to certain standards that achieve uniformity of a product in order to satisfy specific customer or user requirements. (from business dictionary website)
• the customer's perception of the value of the suppliers' work output.
• (medical) error-free, value-added care and service that meets and/or exceeds both the needs and legitimate expectations of those served as well as those within the Medical Center.
• the properties of products and/or services that are valued by the customer.
• (Navy Medicine) delivering products and services to our customers which are faster, better, cheaper and newer.
• Reducing the variation around the target.
• Doing the right things rights, at the first time, and always.
• Satisfy the ever-changing needs of our customers, vendors and employees, with value added products and services emphasizing a continuous commitment to satisfaction through an ongoing process of education, communication, evaluation and constant improvement.
• Meeting the customer's needs in a way that exceeds the customer's expectations.
• (Joseph Juran) fitness for use.
• (Armand Feigenbaum) a customer determination based upon a customer's actual experience with a product or service, measured against his or her requirements-stated or unstated, conscious or merely sensed, technically operational or entirely subjective-and always representing a moving target in a competitive market.
• (Peter Senge et al) a transformation in the way we think and work together, in what we value and reward, and in the way we measure success.  All of us collaborate to design and operate a seamless value-adding system that incorporates quality control, customer service, process improvement, supplier relationships, and good relations with the communities we serve and in which we operate - all optimizing for a common purpose.