ISO 10015 Quality management — Guidelines for training
质量管理体系-业绩改进指南
质量管理体系-业绩改进指南1ICS 03.120.10A 00 GB中华人民共和国国家标准GB/T 19004-idt ISO 9004:质量管理体系—业绩改进指南Quality management systems — Guidelinesfor performance improvements-XX-XX发布 -XX-XX实施国家质量技术监督局发布目录前言 (4)引言 (5)1 范围 (8)2 引用标准 (8)3 术语和定义 (8)4 质量管理体系 (9)4. 1 体系和过程的管理 (9)4. 2 文件………………………………………………………………………34. 3 质量管理原则的应用 (10)5管理职责………………………………………………………………… (11)5. 1 通用指南 (11)5. 2 相关方的需求和期望 (13)5. 3 质量方针 (15)5. 4 策划 (15)5. 5 职责、权限和沟通 (17)5. 6 管理评审 (18)6 资源管理 (1)46. 1 通用指南 (19)6. 2 人员 (20)6. 3 基础设施 (22)6. 4 工作环境 (22)6. 5 信息 (23)6. 6 供方及合作关系 (23)6.7 自然资源 (24)6.8 财务资源 (24)7 产品实现 (2)57. 1 通用指南 (24)7. 2 与相关方有关的过程 (28)7. 3 设计和开发 (29)7. 4 采购 (32)7.5生产和服务的运作 (34)7. 6 测量和监视装置的控制 (36)8 测量、分析和改进 (36)8. 1 通用指南 (36)8. 2 测量和监视 (37)8. 3 不合格的控6制 (43)8. 4 数据的分析 (43)8. 5 改进 (44)附录A 自我评价指南 (48)B 持续改进的过程 (56)文献目录 (58)7。
质量管理顾客满意组织处理投诉指南
质量管理顾客满意组织处理投诉指南Quality management-Customer satisfaction- Guidelines forcomplaints handling in organizations前言国际标准化组织〔ISO〕是由各国标准化团体〔ISO 成员团体〕组成的世界性联合会。
制定国际标准的工作通常由 ISO 技术委员会完成,各成员团体假设对某技术委员会确立的项目感爱好,均有权参加该委员会的工作。
与ISO保持联系的各国际组织〔官方的或非官方的〕也可参加有关工作。
在电工技术标准方面,ISO 与国际电工委员会〔IEC〕保持紧密合作关系。
国际标准遵照ISO/IEC导那么第2部分的规那么起草。
由技术委员会通过的国际标准草案提交各成员团体表决,需取得至少75%参加表决的成员团体的同意,才能作为国际标准正式公布。
本国际标准中的某些内容有可能涉及一些专利权问题,对此应引起注意。
ISO不负责识别任何如此的专利权问题。
ISO10002是由 ISO/TC176/SC3 质量治理和质量保证技术委员会/支持技术分委员会制定的。
注:ISO10002 是 ISO/DIS10018 标准草案经投票后产生的结果。
引言0.1 概述本国际标准为设立和执行有效的投诉处理程序提供指南。
投诉涉及的范畴包括各种商业和非商业或与电子商务有关的行为,其目的是为组织及其消费者、投诉者以及其他相关人员的投诉提供依据。
从投诉处理过程中获得的信息,能够有效地促进产品和过程的改进,不管组织的规模大小、所处的地理位置和环境如何,如投诉得到了有效的处理,就能提升该组织的声誉。
在全球市场中,本国际标准均能提供同一的处理方式。
因此,本标准的重要性十分突出。
有效并高效地进行投诉处理,能够表达卖方和买方的共同需求。
注:国际标准的全文中,所使用的〝产品〞一词也包含〝服务〞的意思。
按照国际标准提供的程序进行投诉处理,能够提高用户中意度。
假如消费者不中意,鼓舞消费者对产品进行反馈,包括投诉,如此能够保持和提高消费者对产品的信任和支持。
ISO 10015
ISO 10015(4、培训指南)
4.4 提供培训 4.4.1 总则 4.4.2 提供支持 4.4.2.1 培训前支持 4.4.2.2 培训支持 4.4.2.3 培训后支持
ISO 10015(4、培训指南)
4.5 评价培训结果 4.5.1 总则 4.5.2 收集资料并准备评价报告
ISO 10015(5、培训过程的监 视和改进)
为培训需求确定说明(4.2.7)
能力要求清单 能力差距清单 以前培训的结果 纠正措施的要求
将培训目标和 培训需求说明 预期的培训结 果形成文件
培训需求说明 文件
各类组织对ISO 10015 的反应
国内培训机构迅速引进、消化,积极推
广 很多大中型企业解决学习、应用 海尔为中国首先通过ISO 10015 认证
ISO 10015(3、定义)
3.1 能力 competence 在工作中,知识、技能的应用和行为 表现。 3.2 培训 training 提供和开发知识、技能和行为方式以 满足要求的过程。
ISO 10015(4、培训指南)
4.1 培训:四阶段过程 4.1.1 总则 经过策划的、系统的培训过程能够在帮 助组织改进其能力并满足其质量目标方 面作出重要贡献。
开发与管理领域有关培训的第一部国际 标准指南,是适合于各级各类组织的培 训标准。 ISO 10015标准的发布,对于广泛意义上 的组织的培训提供了可以借鉴和规范的 依据指南。
ISO 10015 的作用与意义
ISO 10015 是一个以质量管理为总背景下
的培训指南,是一个有关教育和培训的 总体框架性、规范性标准。 ISO 10015 是ISO 9000 族标准的支持性文 件。 培训过程质量的保证是培训质量保证的 根本。
质量手册翻译中英文对照
质量手册翻译中英文术语表3.1.1质量quality3.1.2要求requirement3.1.3等级grade3.1.4顾客满意customer satisfaction3.1.5能力capability3.2.1体系(系统)system3.2.2管理体系management system3.2.3质量管理体系quality management system 3.2.4质量方针quality policy3.2.5质量目标quality objective3.2.6管理management3.2.7最高管理者top management3.2.8质量管理quality management3.2.9质量策划quality planning3.2.10质量控制quality control3.2.11质量保证quality assurance3.2.12质量改进quality improvement3.2.13持续改进continual improvement3.2.14有效性effectiveness3.2.15效率efficiency3.3.1组织organization3.3.2组织结构organizational structure3.3.3基础设施infrastructure3.3.4工作环境'77ork environment 3.3.5顾客customer3.3.6供方supplier3.3.7相关方interested party3.4.1过程process3.4.2产品product3.4.3项目project3.4.4设计和开发design and development 3.4.5程序procedure3.5.1特性characteristic3.5.2质量特性quality characteristic 3.5.3可信性dependability3.5.4可追溯性traceability3.6.1合格(符合)conformity3.6.2不合格(不符合)nonconformity 3.6.3缺陷defect3.6.4预防措施preventive action3.6.5纠正措施corrective action3.6.6纠正correction3.6.7返工rework3.6.8降级regrade3.6.9返修repair3.6.10报废scrap3.6.11让步concession3.6.12偏离许可deviation permit3.6.13放行release3.7.1信息information3.7.2文件document3.7.3规范specification3.7.4质量手册quality manual3.7.5质量计划quality plan3.7.6记录record3.8.1客观证据objective evidence3.8.3试验test3.8.4验证verification3.8.5确认validation3.8.6鉴定过程qualification process3.8.7评审review3.9.1审核audit3.9.2审核方案audit programme3.9.3审核准则audit criteria3.9.4审核证据audit evidence3.9.5审核发现audit findings3.9.6审核结论audit conclusion3.9.7审核委托方audit client3.9.8受审核方auditee3.9.9审核员auditor3.9.10审核组audit team3.9.11技术专家technical expert3.9.12能力competence3.10.1测量控制体系measurement control system 3.10.2测量过程measurement process3.10.3计量确认metrological confirmation3.10.4测量设备measuring equipment3.10.5计量特性metrological characteristic 3.10.6计量职能metrological function Aaudit3.9.1审计audit client 3.9.7客户审计audit conclusion3.9.6审计结论audit criteria3.9.3审计标准audit evidence3.9.4审计证据audit findings3.9.5audit programme3.9.2审计大纲audit team3.9.10审计团队auditee3.9.8auditor3.9.9Ccapability3.1.5characteristic3.5.1concession3.6.11conformity3.6.1continual improvement3.2.13 correction3.6.6corrective action3.6.5customer 3.3.5customer satisfaction3.1.4 competence3.9.12Ddefect3.6.3dependability 3.5.3design and development3.4.4deviation permit3.6.12document 3.7.2Eeffectiveness 3.2.14efficiency3.2.15Ggrade3.1.3Iinformation3.7.1infrastructure3.3.3inspection3.8.2interested party3.3.7Mmanagement3.2.6management system3.2.2 measurement control system3.10.1 measurement process 3.10.2 measuring equipment 3.10.4 metrological characteristic3.10.5 metrological confirmation3.10.3 metrological function3.10.6Nnonconformity 3.6.2Oobjective evidence3.8.1客观证据organization3.3.1organizational structure3.3.2Ppreventive action3.6.4 procedure3.4.5process3.4.1product3.4.2project3.4.3Qqualification process3.8.6 quality3.1.1quality assurance3.2.11quality characteristic3.5.2 quality control3.2.10quality improvement 3.2.12 quality management3.2.8quality management system3.2.3 quality manual3.7.4quality objective3.2.5quality plan 3.7.5quality planning3.2.9质量计划quality policy3.2.4Rrecord3.7.6记录regrade3.6.8release3.6.13放行repair3.6.9requirement3.1.2review3.8.7rework3.6.7返工Sscrap3.6.10specification 3.7.3supplier 3.3.6供应商system3.2.1系统Ttechnical expert<audit>3.9.11技术出口test3.8.3测试top management3.2.7高层管理traceability3.5.4可塑性Vvalidation3.8.5verification3.8.4验证Wwork environment3.3.4工作环境质量管理体系基础和术语Quality management syst ems--Fundamentals and vocabulary质量管理和质量保证标准第2部分:GB/T19001、GB /T19002和GB/T19003实施通用指南Quality mana gement and quality assurance standards--Part 2:Generic guidelines for the application of GB /T19001、GB/T19002and GB/T19003质量管理和质量保证标准第3部分:GB/T19001在计算机软件开发、供应、安装和维护中的使用指南Qu ality management and quality assurance standard s--Part3:Guidelines for the application of GB/T19001to the development,supply,installa tion and maintenance of computer software质量管理和质量保证标准第4部分:可信性大纲管理指南Quality management and quality assurance s tandards--Part4:Guide to dependability prog ramme management质量管理体系要求Quality management systems--Requirements质量管理体系业绩改进指南Quality management sy stems--Guidelines for performance improvement s质量管理和质量体系要素第2部分:服务指南Quali ty management and quality system elements--Pa rt2:Guidelines for services质量管理和质量体系要素第3部分:流程性材料指南Quality management and quality system elements --Guidelines for processed materials质量管理和质量体系要素第4部分:质量改进指南Q uality management and quality system elements--Guidelines for quality improvement质量管理质量计划指南Quality management--Gui delines for quality plans质量管理项目管理质量指南Quality management--Guidelines to quality in project management 质量管理技术状态管理指南Quality management--Guidelines for configuration management质量体系审核指南审核Guidelines for auditing q uality systems--Part1:Auditing质量体系审核指南质量体系审核员的评定准则Guide lines for auditing quality systems--Part2:Q ualification criteria for quality systems audit ors质量体系审核指南审核工作管理Guidelines for au diting quality systems--Part3:Management of audit programmes测量设备的质量保证要求第一部分:测量设备的计量确认体系Quality assurance requirements for mea suring equipment Part1:Metrological confirmat ion system for measuring equipment测量设备的质量保证第2部分:测量过程控制指南Q uality assurance for measuring equipment--Par t2:Guidelines for control of measurement proc esses质量手册编制指南Guidelines for developing qual ity manuals质量经济性管理指南Guidelines for managing the economics of quality质量管理培训指南Quality management--Guideli nes for trainingEnglish Chinesereceipt(入厂)接受,验收,进货handling搬运packaging包装storage保存protection保护comparison比较identification标识replacement of identification mark标识标志更换maintenance of identification标识的保持records of identification control标识控制记录tender标书normative document标准文件supplemental补充nonconforming product不合格品control of nonconforming product不合格品控制control procedure of nonconforming products不合格品控制程序tendency of nonconformance不合格倾向purchasing采购verification of purchased product采购的产品验证purchasing process采购过程purchasing control procedure采购控制程序purchasing information采购信息reference standard参照标准reference instructions参照细则stockhouse仓库measurement,analysis and improvement测量,分析和改进measurement result测量结果control procedure of monitoring and measuring d evices测量设备控制程序planning策划preservation of product产品保护control procedure for maintenance,replacement and records of product identification产品标识的保持,更换及记录控制程序procedure for product identification and tracea bility产品标识和可追溯性程序conformity of product产品的符合性monitoring and measurement of product产品的监督和测量product plan产品方案control procedure for product preservation产品防护控制程序method of product release产品放行方法conformity of product,product conformity产品符合性product realization产品实现planning of product realization产品实现策划product characteristics产品特性input to product requirements产品要求的输入product status产品状态final acceptance of product产品最后验收procedure程序program documents程序文件continual improvement持续改进procedure for continual improvement of quality management system持续改进质量体系程序adequacy充分性storage location存放地点agency personnel代理人员submission of tenders递交标书adjustment调整,调节statutory and regulatory requirements法律法规要求rework,vt返工repair,vt返修subcontractor分承包方annex附录improvement改进improvement actions改进措施on-the-job training岗位技能培训responsibility of individual department and pos t各部门,各岗位职责change identification更改标记change order number更改单编号process sheets工艺单process specification工艺规程procedure(process card)工艺规程(工艺卡) process characteristics工艺特性Job Description Format工种描述单work environment工作环境impartiality公正性functional requirements功能要求supplier供方supplier evaluation procedure供方评价程序supplier provided special processes供方提供的特殊过程verification at supplier's premises供方现场验证supply chain供应链criteria for supplier selection,evaluation and re-evaluation供应商选择、评估和再评估准则communication沟通customer顾客customer property顾客财产control procedure for customer property顾客财产控制程序customer feedback顾客反馈Customer Service Contact Form顾客服务联系表customer communications顾客沟通customer satisfaction顾客满意statistical analysis of customer satisfaction 顾客满意度统计分析customer complaint顾客投诉identification of customer requirements顾客要求的识别management review管理评审records from management review管理评审记录management review control procedure管理评审控制程序management representative管理者代表management responsibility管理职责specified limits of acceptability规定的可接受界限specified use规定的用途process过程complexity of processes过程的复杂性monitoring and measurement of processes过程的监视和测量operation of process过程的运行status of processes过程的状态process approach过程方法process controls过程控制process control documents过程控制文件process performance过程业绩appropriateness合适性changes to contractor合同的更改contract review control procedure合同评审控制程序internet sales互联网销售environmental conditions环境条件monogram pragram requirements会标纲要要求type of activities活动类型infrastructure基础建设infrastructure基础设施fundamentals and vocabulary基础与词汇control of records记录控制technical specificaion技术规范process trace sheet加工跟踪单monitoring and measurement监视和测量monitoring and measuring device监视和测量装置control of monitoring and measuring devices监视和测量装置控制check method检查方法frequency of checks检查频次calibration status检定状态inspection and test control procedure检验和试验控制程序identification procedure for inspection and tes t status检验和试验状态标识程序inspection witness point检验见证点inspection hold point检验停止点buildings建筑物delivery交付post-delivery activities交付后的活动delivery activities交付活动interface接口acceptance of contract or orders接受合同或定单type of medium介质类型experience经验correction action纠正措施Corrective action response time纠正措施答复时间,纠正措施响应时间management procedure for corrective actions纠正措施管理程序corrective action response times纠正措施响应时间development activity开发活动traceability mark可追溯性标志objectivity客观性Customer Service Log客户服务记录簿control feature控制特性,控制细节control features控制细则periodic assessment of stock库存定期评估justification理由routine例程,惯例,常规质量职能分配表论证范围internal communication内部沟通internal audit内部审核internal audit procedure内部审核程序internally controlled standard内控标准internal audit内审results of internal and external audits内外部审核结果competence能力training培训training needs培训需要evaluate评价records of the results of the review评审结果的记录review output评审输出review input评审输入Purchase Requisition请购单authority权限validation确认concession让步human resources人力资源job training of personnel人员岗位培训qualification of personnel人员资格equipment control procedure设备控制程序device type设备类型order of design changes设计更改通知单design and development control procedure设计和开发控制程序design and development设计开发design and development planning设计开发策划control of design and development changes设计开发更改控制design and development review设计开发评审design and development validation设计开发确认design and development outputs设计开发输出design and development inputs设计开发输入design and development verification设计开发验证design validation设计确认design documentation设计文件编制design acceptance criteria设计验收准则design verification设计验证audit program审核大纲conduct of audits审核行为audit criteria审核准则production process control生产过程控制production process control procedure生产过程控制程序production and service provision生产和服务提供control of production and service provision生产和服务提供的控制validation of processes for production and serv ice provision生产和服务提供过程的确认production order生产令identification and traceability识别和可追溯性identification and traceability maintenance and replacement识别和可追溯性维护与替换invalidate使失效market survey市场调研suitability适宜性scope适用范围controlled condition受控状态terms and definitions术语与定义analysis of data数据分析sequence顺序transfer of ownership所有权转移system document体系文件statistical technique统计方法outsource(vt)a process外包过程external source外部来源documents of external origin外来文件outsource,vt外协unique identification唯一的标识maintenance维护Document Change Control文件更改控制Request For Document Change(RDC)文件更改需求单control of documents文件控制documentation requirements文件要求enquiry问询,询价field nonconformity analysis现场不符合分析relevance相关性interaction相互作用detail design详细设计,详图设计,零件设计,施工设计sales department销售部sales contract销售合同checklist校验表,一览表,检查一览表calibration校准submission of action plans行动计划的递交documented procedures形成文件的程序documented statement形成文件的声明performance requirements性能要求licensee responsibilities许可证持有者责任acceptance criteria验收准则verification arrangement验证安排verification results验证结果customer focus以客户为关注点,以客户为焦点awareness意识introduction引言,概述,介绍normative references引用标准application应用visit to user用户访问review of requirements related to the product 有关产品的要求评审competent有能力的effectiveness有效性determination of requirements related to the pr oduct与产品有关的要求的确定customer-related processes与顾客有关的过程preventive action预防措施management procedure for preventive actions预防措施管理程序planned results预期的结果intended use预期的用途procedure for competence,knowledge and trainin g of personnel员工能力,知识和培训程序personnel training procedure员工培训程序supporting services支持性服务functions职能部门responsibility职责assignment of responsibility职责分工workmanship制造工艺manufacturing acceptance criteria制造验收准则quality policy质量方针quality programs质量纲领quality management system质量管理体系quality management system planning质量管理体系策划performance of the quality management system质量管理体系业绩quality plan质量计划quality records质量记录quality objectives质量目标quality audit质量审核quality manual质量手册quality problem handling form质量问题处理单quality requirements质量要求allocation table of quality responsibilities质量职能分配表availability of resources资源的可获得性resource management资源管理allocation of resources资源配置provision of resources资源提供general requirements总要求,一般要求constituent part组成部件organization组织continual improvement of the organization组织的持续改进size of organization组织的规模Organizational Diagram组织机构图final acceptance最终验收work instructions作业指导书。
ISO质量管理体系-基础和术语
2.2.4 相关方
相关方的概念超越了仅关注顾客的范围,考虑所有有关的相关方是重要的。 识别相关方是理解组织环境的过程的组成部分。有关的相关方是指若其需求和期望未能 满足,将对组织持续性产生重大风险的各方。为降低风险,组织需明确向有关的相关方提供 何种必要的结果。 组织的成功有赖于获取、赢得和保持有关的相关方的支持。
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2.4 建立质量管理体系
2.体系建立 ➢ 通过周期性改进,随时间的推移而逐步发展的动态系统; ➢ 正式的质量管理体系为策划、实施、监视和改进质量管理活动的绩效提供了框架。质 量管理体系无需复杂化,而是要准确地反映组织的需求。 ➢ 质量管理体系策划不是一件单的活动,而是一个持续过程,随着组织的学习和环境的 变化而逐渐完善,要考虑组织的所有质量活动。 ➢ 组织定期监视和评价质量管理体系计划的实施及其绩效是重要的。周密考虑的指标有 助于这些监视和评价; ➢ 活动审核是一种评价质量管理体系有效性的方法,目的是识别风险和确定是否满足要 求。为了有效地进行审核,需要收集有形和无形的证据。基于对所收集的证据的分析, 采取纠正和改进措施。知识的增长可能会带来创新,使质量管理体系绩效达到更高的 水平。
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2.3 质量管理原则
4.过程方法 ➢ 只有将活动作为相互关联的连贯系统进行运行的过程来理解和管理时,才能更加有效 和高效地得到一致的、可预知的结果。 ➢ 质量管理体系是由相互关联的过程所组成。理解体系是如何产生结果的,能够使组织 优化其体系和绩效。 ➢ 可能获益: • 提高关注关键过程和改进机会的能力; • 通过协调一致的过程体系、得到一致的、可预知的结果; • 通过过程的有效管理、资源的高效利用及跨职能壁垒的减少,获得最佳绩效; • 使组织能够向相关方提供关于其稳定性、有效性和效率方面的信任;
质量管理体系 英语
质量管理体系英语Quality Management SystemQuality management is a systematic approach to ensuring that an organization's products or services consistently meet or exceed customer requirements. It is a crucial aspect of any successful business, as it helps to improve efficiency, reduce costs, and enhance customer satisfaction. In today's highly competitive business environment, a well-designed and effectively implemented quality management system (QMS) can provide a significant competitive advantage.At the core of a QMS is the recognition that quality is not just the responsibility of the production or service delivery departments, but rather a company-wide effort that involves all employees. A comprehensive QMS should encompass all aspects of the organization, from the design and development of products or services to the delivery and after-sales support. By establishing clear policies, procedures, and processes, a QMS helps to ensure that every step of the operation is carried out in a consistent and efficient manner.One of the key components of a QMS is the establishment of quality objectives and metrics. These objectives should be aligned with the overall business goals and should be measurable, achievable, and time-bound. By regularly monitoring and analyzing these metrics, an organization can identify areas for improvement and take corrective action as needed.Another important aspect of a QMS is the emphasis on continuous improvement. This involves constantly evaluating and refining the processes and procedures to identify and address any inefficiencies or areas of weakness. This can be achieved through regular audits, employee feedback, and the implementation of continuous improvement methodologies such as Lean Six Sigma.Effective communication and employee engagement are also critical to the success of a QMS. By ensuring that all employees understand the importance of quality and their role in maintaining it, organizations can foster a culture of quality awareness and ownership. This can be achieved through training, regular feedback, and recognition programs that celebrate the achievements of individuals and teams.In addition to the internal benefits of a QMS, such as improved efficiency and cost savings, a well-designed system can also enhance an organization's external reputation and competitiveness. Manyindustries, particularly those with stringent regulatory requirements, place a high value on third-party certification of a company's QMS, such as ISO 9001. This certification demonstrates to customers, suppliers, and regulators that the organization is committed to maintaining the highest standards of quality and compliance.Furthermore, a robust QMS can also help organizations to better manage risk and respond to changing market conditions. By having well-documented processes and procedures in place, companies can more easily adapt to new requirements or challenges, and minimize the impact of any disruptions or quality issues.In conclusion, a quality management system is a critical component of any successful business. By establishing clear policies, procedures, and processes, and fostering a culture of continuous improvement and employee engagement, organizations can improve efficiency, reduce costs, and enhance customer satisfaction. As the business landscape continues to evolve, a strong QMS will remain an essential tool for maintaining a competitive edge and ensuring long-term success.。
质量管理体系的标准和指南
质量管理体系的标准和指南质量管理体系(Quality Management System,简称QMS)是指为了满足组织对产品和服务质量的要求,通过一系列的规范、措施和流程,确保质量的可持续改进和提高。
标准和指南在质量管理体系的建立和运行中起到关键的指导作用。
本文将介绍质量管理体系的标准和指南的概念、特点,并对其重要性进行讨论。
一、质量管理体系标准的概念和特点质量管理体系标准是国际标准化组织(ISO)发布的关于质量管理体系的要求和指导性文件,以ISO 9001质量管理体系标准为代表。
质量管理体系标准具有以下几个特点:1. 综合性:质量管理体系标准覆盖了组织内各个环节和流程,包括质量策划、质量控制、质量保证等方面,通过全面、系统地规定要求,帮助组织构建完善的质量管理体系。
2. 全球通用:质量管理体系标准是全球通用的,被广泛应用于各个行业和领域,无论企事业单位还是非营利组织,都可以根据标准建立和实施质量管理体系。
3. 持续改进:质量管理体系标准鼓励组织进行持续改进,通过制定目标、指标和评审等方法,不断推动组织的质量水平提高。
4. 可测量性:质量管理体系标准要求设定可测量的质量目标,并建立相应的度量和评估机制,用于衡量质量管理体系的有效性和改进的效果。
二、质量管理体系指南的概念和作用质量管理体系指南是ISO发布的关于质量管理体系的解释、解决方案和最佳实践的指导性文件,不同于质量管理体系标准的规定性要求。
质量管理体系指南具有以下几个概念和作用:1. 解释和解决方案:质量管理体系指南对质量管理体系标准的要求进行解释和解决方案的提供,帮助组织理解和应用标准要求,解决在实施过程中可能遇到的问题和困难。
2. 最佳实践:质量管理体系指南总结了各个行业和组织在质量管理实践中的最佳经验和做法,供其他组织参考和借鉴,提高质量管理水平。
3. 行动指南:质量管理体系指南提供了针对特定问题和情境的行动指南,帮助组织制定实施策略和具体步骤,推进质量管理体系的建立和运行。
优马克斯系统有限公司质量管理系统手册说明书
Quality Management System ManualQuality Management SystemManualISO 9001:2015Revised 2019-01-25The only valid manual is the master in the OptimaxDocument Management System (DMS). Allexternal/printed copies are not controlled.\s\ M. MandinaAuthorized by President, M. Mandina\s\ P. AuginoIssued by Quality Manager, P. AuginoOptimax Systems, Inc.6367 Dean ParkwayOntario, NY 14519-8939(585) 265-1020 (voice)(585) 265-0752 (fax)DMS101982 2019-01-25TABLE OF CONTENTS PageRevision Record (3)1 Introduction (4)1.1 Optimax History (4)1.2 Optimax Value Proposition (4)1.2.1 Vision (5)1.2.2 Mission (5)1.2.3 Quality Policy (5)1.2.4 Corporate Values (5)2 Purpose (5)3 Scope (5)3.1 Relationship of Core and Support Processes (6)Process Flow Chart (6)4 Context of the Organization (7)5 Leadership (7)5.1 Leadership and Commitment (7)5.1.2 Customer Focus (7)5.2 Quality Policy (7)6 Planning................................................................................................... .. (7)7 Support (8)8 Operation (8)9 Performance and Evaluation (8)10 Improvement (9)Organization Chart (9)QMS Procedure Matrix (10)REVISION RECORDRevision D ate Description Amended By 2006-12-20 System review a nd upgrade Iveta M ay2009-02-05 System review a nd upgrade Anne M arino 2010-05-20 Revised S OCAs and P rimary Q MS Procedures Bob M artin 2012-01-27 Changed bldg. size from 40,000 to 60,000 sg ft. Bob M artin 2012-06-15 Changed Organization Chart Bob M artin 2013-04-23 Updated l ogo a nd O rganization C hart Joe T ipps 2013-08-09 Updated format Tori U the2014-04-28 Updated O wner, U pdated Org. C hart Stacy K elly 2015-02-13 Updated O wner, U pdated Org. C hart Todd AndersonTodd Anderson 2016-04-14 Reviewed f or acceptability. Updated O rg. Chart,Updated Adjust to Act (p.6), Updated QMS Manualfrom D MS100682 t o D MS1019822018-01-19 Rewrite to ISO 9001:2015 Standard and toTodd A nderson incorporate updates.2018-05-21 Added fig. 1 to PDCA layout, moved sect 3.1 to afterTodd Anderson fig.1 to show as part of Sect. 3, added “at a minimumannually by the Management Team” to line 3 of Sect.62018-07-27 1. Renamed the following Procedure names.Todd Anderson Management Responsibility and Planning toLeadership Procedure; Order Acceptance toOrder Acceptance – Prototype, Recurring &LGO Business Units; Corrective and PreventiveAction and Continuous Improvement to CorrectiveAction and Continuous Improvement2. Added Order Acceptance Coat-Only BusinessUnit Procedure3. Updated Quality Policy and Mission4. Renamed Management Team to LeadershipTeam5. Removed Organization Chart and replaced withlink to Organization Chart in People Database.2019-01-25 1. Added 1.2.4, moved Quality Policy to 1.2.3,Todd Anderson Corporate Values to 1.2.42. PDCA Map – Changed Management toLeadership3. 5.2, Removed “Enabling customer success andemployee prosperity”1 IntroductionOptimax provides quick reliable delivery of precision optical components. Our tag line is “Prototype Optics in one week.” and we have been fulfilling that value proposition for more than 25 years.We are the largest optics manufacturer in the United States. Our products include spherical, aspheric and cylindrical components, prisms, freeforms, coatings, and optical assemblies.Responsiveness is our core value and Optimax empowers employees to use their skills and knowledge for real time decision making. Employees are provided the information and equipment necessary to prioritize workloads for dynam ic production control in an ongoing effort to ensure quality while minimizing process times.While small volume production is our specialty, with lot sizes of 1 to 100 pieces for a wide variety of applications, large volume orders are also supported. Our services include optics for aerospace, astronomy, bio-medical, cinematography, machine vision, metrology, military, process control, pure research, remote sensing and telecom.1.1 Optimax HistoryOptimax was founded in 1991 as a beta site for Opticam technology. Opticam is computer-numerically-controlled (CNC) machining of glass. People have been CNC machining metals for 40 years but Opticam goes beyond conventional technology by processing brittle optical materials to tolerances 100 times tighter. Opticam also significantly reduces the number of manufacturing steps from 14 to 5, thus enabling a quicker, more robust process.In 2015, Optimax had grown to the point that its business model required modification in order to meet the demands of our customers. Larger volume capabilities and laser grade optic manufacturing were the main drivers.In 2016 Optimax formed five Business Units; Prototype, Recurring (Large Volume), LGO (Laser Grade Optics), Coating and Support. Each Business Unit operates with its own management, budget and responsibilities.Today, Optimax has a 55,000 sq. ft. main facility, 3,000 sq. ft. satellite facility and more than 100 opticians machining optical components 3-400mm in diameter. Our customer base is diverse with the largest customer representing less than 20 percent of our business.1.2 Optimax Value PropositionOptimax strives to create value in every process, with every part, for every customer.Optimax takes ownership of each job received and is driven to create value that our customers can leverage to satisfy market needs and build customer success and employee prosperity. Our commitment to high quality, and on-time delivery, whether small or large volume, is more than just a statement. At Optimax, we understand that the value we add to each order goes beyond the unit price. Product performance (over the part’s entire lifespan), quality (number of rejected parts) and risk (on-time delivery) are all factors.1.2.1 Vision“To be the leading global optics provider, building the highest performing teamsand solutions.”1.2.2 Mission“Enabling customer success and employee prosperity.”1.2.3 Quality PolicyOur Quality Policy is made up of three elements, each of which is very important in its own right. In order to be successful, we have to know where we want to be(Vision), how we will get there (Mission) and our strengths (SOCA’s). When linked together, each working with and supporting the other, they create a unity ofpurpose and direction.1.2.4 Corporate ValuesOptimax believes in ethical behavior, free/open communication, good corporate citizenship, charitable giving to advance youth participation in STEM (Science, Technology, Engineering and Mathematics), and leadership in the area of workforce development for Advanced Manufacturers. KIS (Know-How, Innovation, and Speed) are the Optimax sources of competitive advantage.Senior leadership models the behavior expected from all employees. Regular feedback and review is provided to all employees.2 PurposeThis manual describes the framework for the Optimax Quality Management System. It is provided to satisfy the needs of all stakeholders, including regulatory agencies, customers and employees is to understand and to use as a blueprint for improvement to Optimax’s Quality Management System.3 ScopeThe management system described in this manual applies to the prototyping and production of custom optical lenses and assemblies by Optimax Systems, Inc., located in Ontario, NY.At a minimum, the Optimax Quality Management System meets the requirements of the ISO 9001:2015 standard and applicable statutory and government regulations. Some processes are additionally compliant to other standards, as required by particular customers.Optimax manufactures components for its customers to their specifications and is not responsible for the product design or product service. It is Optimax’s practice to assist our customers as early as possible in the order process to ensure manufacturability.3.1 Relationship of Core and Support ProcessesThe production of optical lenses and lens assemblies is managed as an interrelated system that contributes to the effectiveness and efficiency in achieving Optimax objectives and, ultimately, customer satisfaction. Through system monitoring and analysis, Optimax continually improves its quality management system as it strives to exceed customer expectations.4 Context of the OrganizationOptimax has established, documented and implemented a Quality Management System (QMS) in accordance with the requirements of ISO 9001:2015.Optimax has developed a Strategic Planning Initiative to understand external and internal opportunities and risks that may impact the Quality Management System as the companies short and long term vision is developed and deployed.Optimax defined procedures have been written to outline the scope of the QMS.Processes, documents and records, applicable to the Quality Management System are managed to ensure relevant information is readily available and correct.5 Leadership5.1 Leadership and CommitmentThe Optimax Leadership Team provides leadership and commitment to unity of purpose and direction of the organization by creating and maintaining the internal environment in which people are fully involved in achieving the organization's objectives.5.1.2 Customer FocusThe Optimax Leadership Team ensures that customer needs and expectations are determined and achieved with the aim of enhancing customer satisfaction through established processes and procedures.5.2 PolicyThe Optimax Leadership Team is responsible for setting and communicating Optimax policies to all employees. The Quality Policy is also the Company’s Mission Statement.It provides a framework for establishing and reviewing quality objectives. It is included in new employee orientation, training on the QMS and internal auditing.The Leadership Team reviews the quality policy annually to determine its continuing suitability for the company.6 PlanningOptimax has developed a Risk Management Plan. The plan defines those processes critical to the success of the Quality Management System.A Risk Matrix is used to identify and cause action to occur in the event any definedrisk thresholds are reached.Risks are reviewed and revised at a minimum annually by the Leadership Team to ensure they remain applicable.7 SupportThe Optimax Leadership Team ensures employees are competent within their position and are aware of the relevance and importance of their contributions to the achievement of Optimax goals and objectives. Optimax provides mandatory and elective training, and encourages all employees to expand their skills and education.Information is communicated throughout the company to ensure every person is informed of the importance of complying with customer and regulatory requirements as well as the company’s effectiveness in meeting these requirements.Additionally, Optimax provides an environment that enhances the successful fulfillment of customer orders, including a safe and comfortable workspace, maintained building, suitable equipment and technologies, and supporting services.Optimax maintains various databases as repositories for documented information required for customer satisfaction, statutory and regulatory requirements and other stake holders.8 OperationThe requirements of each customer order are identified and reviewed to ensure that they are understood and that the organization has the capability and capacity to meet those requirements. Requirements include customer requirements, statutory and regulatory requirements, and self-imposed requirement of the QMS.Each order is planned, controlled and monitored to ensure conformance to customer requirements and satisfaction. This includes the selection of vendor(s) to provide product or service that will best satisfy the completion and delivery of customers’ orders.Customer supplied materials and equipment receive the same care and control as that which is Optimax owned. This includes the identification and traceability of material and finished products.The control of nonconforming or underperforming processes are documented, reviewed and acted upon through various means including the Strategizer database, Edgy Job database, Communities of Practice as well as through Business Unit and Cell level action groups.Nonconforming product is handled by way of the DMR process. This is also a step off point for continual improvement.9 Performance and EvaluationThe Optimax quality management system monitors, measures and analyzes processes and products against expected results and objectives to ensure that they satisfy requirements. Appropriate corrective and preventive action, and improvement opportunities are implemented based on the analysis of data and information.Optimax employs an internal ISO Team responsible for monitoring implementation of the Quality Management System.Management Review meetings are held annually, at the minimum, to review, evaluate and improve the Quality Management System.10 ImprovementOptimax has a dedicated Continuous Improvement team which leads the overall effort to improve processes and procedures.An employee suggestion program allows for operator involvement in the improvement process.Organization Chart。
《品质内涵全面品质管理与ISO9000品保系统》[1]
品質成本分析已被視為財務控制之管理工具 ,它同時可被用來協助發掘降低成本之機會 。
《品质内涵全面品质管理与ISO9000 品保系统》[1]
1.4 品質成本(續)
美國品管學會將品質成本分為四類: 預防成本(prevention costs) 是指為了預 防不合格品等有關設計及製造之成本。 評估成本(appraisal costs) 或稱鑑定成本 是指有關量測、評估、稽核產品、零件、 及材料是否合乎規格之成本。
《品质内涵全面品质管理与ISO9000 品保系统》[1]
1.1 品質的定義
品質應為顧客現在和未來的需求
品質就是適用,適用就是適合其既定用途 的程度
品質的定義是符合標準,標準的建構來自 顧客的需求及公司全體員工的智慧
戴明博士 裘蘭博士 克勞斯比博士
《品质内涵全面品质管理与ISO9000 品保系统》[1]
因此,TQM 是以品質為中心之企業經 營理念。
《品质内涵全面品质管理与ISO9000 品保系统》[1]
2.3 全面品質管理之內涵(續)
TQM 五大原則: 1. 達成顧客滿意 2. 以產品/服務品質為核心 3. 善用組織人力資源 4. 持續改善 5. 全員參與
《品质内涵全面品质管理与ISO9000 品保系统》[1]
指一個產品/服務之主要 (基本) 操作 特性、功能。例如:電視機之解析度 2.特色 (Features)
指補充一個產品/服務之基本功能的額 外特性 (亦即額外的項目)。例如:有鎖 控之電視機
《品质内涵全面品质管理与ISO9000 品保系统》[1]
1.2 品質的構面(續)
3.可靠性 (Reliability) 在一指定的時間內,一個產品/服務會
ISO10013-2021质量管理体系 文件指南
Quality management systems — Guidancefor documented informationBS ISO 10013:2021National forewordThis British Standard is the UK implementation of ISO 10013:2021. Itsupersedes PD ISO/TR 10013:2001, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee QS/1, Quality management and quality assurance procedures.A list of organizations represented on this committee can be obtained on request to its committee manager.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.© The British Standards Institution 2021 Published by BSI Standards Limited 2021ISBN 978 0 539 01891 2ICS 03.100.70; 03.120.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2021.Amendments/corrigenda issued since publicationDate Text affected BRITISH STANDARD© ISO 2021Quality management systems — Guidance for documented informationSystèmes de management de la qualité — Recommandations pour les informations documentéesINTERNATIONAL STANDARD ISO10013First edition 2021-03-09Reference numberISO 10013:2021(E)BS ISO 10013:2021ISO 10013:2021(E)ii © ISO 2021 – All rights reservedCOPYRIGHT PROTECTED DOCUMENT© ISO 2021, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.ISO copyright office Ch. de Blandonnet 8 • CP 401CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11Fax +41 22 749 09 47copyright@ BS ISO 10013:2021ISO 10013:2021Foreword ........................................................................................................................................................................................................................................iv Introduction ..................................................................................................................................................................................................................................v 1 Scope (12)Normative references (13)Terms and definitions .....................................................................................................................................................................................14 Documented information ............................................................................................................................................................................24.1 General ...........................................................................................................................................................................................................24.1.1 Structure .................................................................................................................................................................................24.1.2 Definitions .............................................................................................................................................................................24.1.3 Content .....................................................................................................................................................................................24.1.4 Purpose ....................................................................................................................................................................................34.1.5 Benefits ....................................................................................................................................................................................34.2 Documented information to be maintained ..................................................................................................................44.2.1 Scope of the quality management system ..................................................................................................44.2.2 Quality policy ......................................................................................................................................................................44.2.3 Quality objectives ............................................................................................................................................................44.2.4 Information that the organization determined necessary to support the operation of the quality management system and its processes ...........................................54.3 Documented information to be retained .. (95)Creating and updating documented information ..............................................................................................................95.1 Implementation ......................................................................................................................................................................................95.1.1 General ......................................................................................................................................................................................95.1.2 Use of references ...........................................................................................................................................................105.1.3 Responsibility for creation of documented information ............................................................105.1.4 Identification and description ...........................................................................................................................105.1.5 Format and media ........................................................................................................................................................105.1.6 Review and approval .................................................................................................................................................115.2 Control of documented information ..................................................................................................................................115.2.1 Availability ..........................................................................................................................................................................115.2.2 Protection ............................................................................................................................................................................115.2.3 Distribution, access, retrieval and use .......................................................................................................115.2.4 Storage and preservation ......................................................................................................................................115.2.5 Updating documented information and control of changes ...................................................115.2.6 Retention and disposition .....................................................................................................................................12Annex A (informative) Examples of documented information structures .................................................................13Bibliography .............................................................................................................................................................................................................................14© ISO 2021 – All rights reserved iiiContents Page BS ISO 10013:2021BS ISO 10013:2021ISO 10013:2021ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see /directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see /patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso. org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 3, Supporting technologies.This first edition of ISO 10013 cancels and replaces ISO/TR 10013:2001, which has been technically revised. The main changes compared with ISO/TR 10013:2001 are as follows:— it has been aligned with the new structure and requirements of ISO 9001:2015, notably the documentation requirements;— the original hierarchy of documentation is no longer used but left open for the user.Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at /members.html.iv© ISO 2021 – All rights reservedBS ISO 10013:2021ISO 10013:2021 IntroductionISO 9001 requires an organization to maintain and retain documented information to support the operation of its processes and to have confidence that the processes are being carried out as planned. Documented information is information required to be controlled and maintained by an organization and the medium on which it is contained. Documented information can be used to communicate, to provide objective evidence or for sharing knowledge.Documented information enables the knowledge and experiences of the organization to be preserved and can generate value to support the improvement of products or services.This document provides guidance for the development and maintenance of documented information. The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. It is applicable to all organizations, regardless of size, complexity or business model. Its aim is to increase an organization’s awareness of its duties and commitment in fulfilling the needs and expectations of its customers and interested parties, and in achieving satisfaction with its products and services.It is important to consider the context of the organization, including the legal and regulatory framework, needs and expectations of interested parties, risks and opportunities, and strategic direction of the organization, when an organization plans what documented information to maintain and retain for its quality management system. While the adoption of a quality management system is strategic, this also applies to its documented information.Documented information can relate to an organization’s total activities or to a selected part of those activities, e.g. specified requirements depending upon the nature of products and services, processes, contractual requirements, statutory and regulatory requirements, the context of the organization itself. It is important that the content of the documented information also conforms to the requirements of the standards they intend to satisfy, e.g. sector-specific requirements. Organizations have been moving from paper-based systems to electronic media in the last two decades. ISO 9001has reflected this change, replacing terminology such as “documentation, quality manual, documented procedures, and records” with “documented information.” This guidance document uses the word “documented information” to refer to information that needs to be controlled by the organization and “documents” to refer to information. It also uses the word “document” as a verb in a few places.ISO management system standards use a high-level structure to encourage the use of integrated management systems. This guidance document by its design and scope is focused on the quality management system and uses terminology from ISO 9000:2015. However, nothing prohibits its use in other management system standards.In the previous version of this document, a hierarchy of documentation, such as a quality manual, procedures, work instructions and forms/checklists, was suggested as a way of documenting the quality management system. This document does not prescribe a particular hierarchy but reflects the ability of electronic media to organize itself in a multitude of ways. It is important to realize that while a quality manual is not required, it can still be useful, and many sector-specific standards still require “quality manuals and documented procedures”.© ISO 2021 – All rights reserved vThis page deliberately left blankBS ISO 10013:2021 INTERNATIONAL STANDARD ISO 10013:2021Quality management systems — Guidance for documented information1 ScopeThis document gives guidance for the development and maintenance of the documented information necessary to support an effective quality management system, tailored to the specific needs of the organization.This document can also be used to support other management systems, e.g. environmental or occupational health and safety management systems.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2015, Quality management systems — Fundamentals and vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000:2015 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses:— ISO Online browsing platform: available at https:///obp— IEC Electropedia: available at /3.1work instructiondetailed description of how to perform tasksEXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations thereof.Note 1 to entry: Work instructions can be documented.Note 2 to entry: Work instructions describe any materials, equipment and documented information to be used. When relevant, work instructions include acceptance criteria.3.2formdocumented information to be maintained and used to record data required by the quality management systemNote 1 to entry: A form becomes documented information to be retained (i.e. a record) when data are entered.© ISO 2021 – All rights reserved 1BS ISO 10013:2021ISO 10013:20213.3workflowseries of activities necessary to complete a taskNote 1 to entry: A workflow that is partially or completely carried out without manual interference can be referred to as an “automated workflow”.Note 2 to entry: Workflows can be documented.4 Documented information4.1 General4.1.1 StructureDocumented information can be structured and created in many ways based on the needs of the organization and other factors such as leadership, intended results of the management system, context (including statutory and regulatory requirements) and interested parties.The structure of the documented information used in the quality management system can be described in a hierarchy. This structure facilitates the distribution, maintenance and understanding of the documented information. Electronic systems provide additional choices for structuring documented information. Annex A illustrates examples of documented information structures. Smaller organizations may choose a simplified documented information structure to meet their needs.The type and extent of the documented information needed for the quality management system should be based on an analysis of processes and can differ from one organization to another due to, for example:a) the size of the organization and type of activities;b) the complexity of processes and their interactions;c) the maturity of the quality management system;d) risks and opportunities;e) the competence of persons;f) statutory and regulatory requirements;g) customer and other interested party requirements;h) the need for evidence of results achieved;i) the need to support accessibility and retrievability remotely.4.1.2 DefinitionsDocumented information can include definitions. To enhance comprehension, the organization should consider using vocabulary that is in accordance with standard terms and definitions which are referenced in ISO 9000, in general dictionary usage or which can be specific to the organization. An organization's quality management system may use different terminology for the defined types of documented information.4.1.3 ContentAn organization’s documented information should include the following:a) the scope of the quality management system (see 4.2.1);2 © ISO 2021 – All rights reservedb) a quality policy (see 4.2.2);c) quality objectives (see 4.2.3);d) information that the organization determined necessary to support the operation of the quality management system and its processes, including, as applicable:1) a quality manual (see 4.2.4.2);2) organizational charts (see 4.2.4.3);3) process maps, process flow charts and/or process descriptions (see 4.2.4.4);4) procedures and work instructions (see 4.2.4.5);5) automated workflows (see 4.2.4.6);6) product and service specifications (see 4.2.4.7);7) internal and external communications (see 4.2.4.8);8) plans, schedules and lists (see 4.2.4.9);9) forms and checklists (see 4.2.4.10);10) documented information of external origin (see 4.2.4.11);e) documented information to be retained (i.e. records) for providing evidence of results achieved (see 4.3).Documented information can be in any type of media, such as paper, electronic, photograph or physical sample.NOTE The advantages of electronic media are, for example:— easier access to relevant versions including access from remote locations;— easier control of changes, including the withdrawal of obsolete documented information;— immediate and controlled distribution;— retrievability and retention versus paper or other physical media.4.1.4 PurposeThe purpose of having documented information for an organization includes:a) communication of information;b) evidence of achieving results or activities performed;c) knowledge sharing;d) knowledge preservation;e) describing the quality management system of the organization.4.1.5 BenefitsThe benefits of having documented information for an organization include:a) demonstrating compliance with statutory and regulatory requirements:© ISO 2021 – All rights reserved 3b) providing information for cross-functional groups so that they can better understand interrelationships;c) communicating the organization’s commitment to quality to relevant interested parties;d) helping persons to understand their role within the organization, thus providing a basis for expectations of work performance;e) facilitating mutual understanding between different levels in the organization;f) providing objective evidence that specified requirements have been achieved;g) addressing risks and opportunities to improve organizational performance, product or service conformity, and customer satisfaction;h) providing organizational knowledge, including the basis for competency and training for persons and other relevant interested parties;i) stating how things are to be done to consistently meet specified requirements, thus promoting controlled conditions and providing a basis for continual improvement;j) demonstrating to interested parties the capabilities within the organization, thus providing confidence;k) providing requirements for external providers;l) providing a basis for auditing and evaluating the effectiveness and continuing suitability of the quality management system.4.2 Documented information to be maintained4.2.1 Scope of the quality management systemThe scope of the quality management system should be documented based on the organization’s determination of the boundaries and applicability of the quality management system. The scope of a management system can include the whole of the organization, specific and identified functions of the organization, specific and identified sections of the organization, or one or more functions across a group of organizations. The scope should state the types of products and services covered and, if required, provide justification for any requirement of the relevant quality standard that the organization determines is not applicable to the scope of its quality management system. The scope of the quality management system should be based on the nature of the organization’s products and services, their operational processes, issues raised in establishing the context of the organization and relevant requirements from interested parties, the results of risk-based thinking, commercial considerations, and contractual, statutory and regulatory requirements.4.2.2 Quality policyThe quality policy helps an organization engage its people in the culture of quality of the organization. It should be aligned with the organization’s strategic direction, mission and vision. It provides a verifiable commitment to quality to relevant interested parties.An organization can have other policies besides the quality policy relating to the quality management system.4.2.3 Quality objectivesQuality objectives should reflect the results to be achieved by the organization with respect to its strategic direction, quality policy, risks and opportunities, and applicable requirements to the quality management system.4 © ISO 2021 – All rights reserved4.2.4 Information that the organization determined necessary to support the operation of the quality management system and its processes4.2.4.1 GeneralThe organization should determine the type and extent of documented information necessary to support the operation of its processes, the formats to be used and the media for communicating with users. The organization may decide what terms it uses for its documented information. While terms such as “procedures”, “work instructions” and “quality manual” are used in this document, the organization is not obliged to adopt such terminology.4.2.4.2 Quality manualThere are many ways in which an organization can document its quality management system. Organizations can choose to use a quality manual, or a quality manual can be mandated by the organization’s external requirements. A quality manual is unique to each organization. It can provide the structure, format, content or method of presentation for documenting the quality management system and its processes for all types of organizations.A small organization can find it appropriate to include the description of its entire quality management system within a single manual, including all the documented information it maintains. Large, multinational organizations can need manuals at different levels (e.g. the global, national or regional level) and a more complex hierarchy of documented information. If the organization chooses to implement a quality manual, it may include documented procedures or a reference to them, and a description of the processes of the quality management system and their interactions. Information about the organization, such as name, location, context and means of communication including relevant specific terms and definitions, should be included in the quality manual. Additional information such as its line of business, a brief description of its background, history and size may also be included.The quality manual can provide a description of the quality management system and its implementation in the organization. Descriptions of the processes and their interactions or a reference to them should be included in the manual. The processes of the organization should be designed to meet the overall objectives of the organization, its policies, context, and relevant expectations of interested parties. In large organizations, the processes can link the functional areas of the organization (see Annex A). The organization should document its specific quality management system following the sequence of the flow of the processes or any sequencing appropriate to the organization. Cross-referencing between the selected standard and the processes of the organization can be useful. The sequence and interaction of the processes within the quality management system can be documented using a process map. NOTE 1 Manuals are also referred to as “quality manual”, “policy manual”, “reference manual”, “procedure manual” or any other suitable title.NOTE 2 Although ISO 9001:2015 does not require a quality manual, some sector-specific standards do.4.2.4.3 Organizational chartsOrganizational charts are often graphical depictions of the roles, responsibilities and authorities within an organization. They can illustrate how roles, responsibilities and authorities flow through the organization and how different people or groups of people interact within the organization.4.2.4.4 Process maps, process flow charts and/or process descriptionsA process map identifies the processes and visually describes the sequence and interaction of the processes in the organization. The processes can be further described using flow charts.A process flow chart is a visual description of the process or procedure. It shows the process steps an organization performs, what triggers the process or procedure (i.e. start of the process and its input)© ISO 2021 – All rights reserved 5and what is the final step of the process or its output. Some process flow chart formats document the input and output for each process step, the control points and the related acceptance criteria.A process description is a textual description of the process. It explains the process steps in words. Process owners should be identified for quality management system processes. Process owners are usually assigned by top management and given the authority and responsibility for a process from start to finish, and therefore should understand their role and be competent in the process. This is especially important since processes can cut across functional or departmental boundaries.4.2.4.5 Procedures and work instructionsThe structure and format of documented procedures should be defined by the organization either through text, flow charts, automated workflows, tables, a combination of the above or any other suitable method according to the needs of the organization. A procedure generally answers questions such as who, what, when, where and with what resources. Documented procedures should contain the information necessary to properly carry out the activities that comprise the process and reference any requirements to retain documented information and should be uniquely identified.The level of detail can vary depending on the complexity of the activities, risks and opportunities, the methods used, and the levels of competency of people that is necessary to perform the activities. Irrespective of the level of detail, the following aspects should be considered, as applicable:— defining the needs of the organization and its relevant interested parties;— describing the process(es) in terms of text, or other methods (e.g. flow charts, photos, videos) related to the required activities;— describing what is to be done, by whom or by which organizational function, why, when and where;— describing process controls and controls of the identified activities;— addressing risks and opportunities in a process as it affects the overall objectives of the organization;— defining the resources needed for the activities (e.g. in terms of people, infrastructure and materials);— defining the appropriate internal and external documented information related to the required activities;— defining the inputs required and outputs expected of these interrelated or interacting activities;— defining the measurements to be taken and the criteria to apply to ensure the effective operation and control of these processes.Documented procedures should refer to related work instructions that define how an activity is performed. Documented procedures generally describe activities that can cross different functions, while work instructions generally apply to tasks within one function. The organization can decide that some of the above information is more appropriate in a work instruction. Documented work instructions should be developed and maintained when the expected outcomes of the activity would be adversely affected by lack of such instructions. There are many ways to prepare and present instructions, therefore the organization should determine the most effective way to fulfil its purposes.The structure, format and level of detail used in the work instructions should be tailored to the needs of the persons performing the activities and also depend on their skills and qualifications, the training undertaken, the complexity of the work, risks and opportunities, and the methods used. The structure of the work instructions can vary from that of documented procedures. Work instructions can be contained in various forms of media and languages as appropriate.The work instructions can be included or referenced in the documented procedures.6 © ISO 2021 – All rights reserved。
质量管理体系基础和术语
ICS 03.120.10A 00中华人民共和国国家标准GB/T19000—2008/ISO9000: 2005代替GB/T19000—2000质量管理体系基础和术语Quality management systems—Fundamentals and vocabulary(ISO9000:2005,IDT)2008-10-29发布 2009-05-01实施中华人民共和国国家质量监督检验检疫总局中国国家标准化管理委员会发布目次前言 (ⅱ)引言 (ⅲ)1 范围 (1)2 质量管理体系基础 (1)2.1 质量管理体系的理论说明 (1)2.2 质量管理体系要求与产品要求...........................................................................(1 )2.3 质量管理体系方法 (2)2.4 过程方法 (2)2.5 质量方针和质量目标 (2)2.6 最高管理者在质量管理体系中的作用..................................................................(3 )2.7 文件............................................................................................................(4 )2.8 质量管理体系评价 (4)2.9 持续改进…………………………………………………………………………………………( 5 )2.10 统计技术的作用…………………………………………………………………………………( 5 )2.11 质量管理体系与其他管理体系的关注点………………………………………………………( 6 )2.12 质量管理体系与优秀模式之间的关系…………………………………………………………( 6 )3 术语和定义…………………………………………………………………………………………( 6 )3.1 有关质量的术语…………………………………………………………………………………( 7 )3.2 有关管理的术语…………………………………………………………………………………( 8 )3.3 有关组织的术语…………………………………………………………………………………( 10)3.4 有关过程和产品的术语…………………………………………………………………………( 11)3.5 有关特性的术语…………………………………………………………………………………( 12)3.6 有关合格(符合)的术语…………………………………………………………………………( 13)3.7 有关文件的术语…………………………………………………………………………………( 15)3.8 有关检查的术语…………………………………………………………………………………( 16)3.9 有关审核的术语…………………………………………………………………………………( 17)3.10 有关测量过程质量管理的术语…………………………………………………………………( 19)附录A(资料性附录)定义标准中的术语所使用的方法……………………………………………( 21)文献目录…………………………………………………………………………………………………( 30)英文字首索引……………………………………………………………………………………………( 31)前言本标准等同采用ISO9000:2005《质量管理体系基础和术语》。
质量管理和质量保证标准第1部分-选择和使用指南(GB-T19000.1-1994)
质量管理和质量保证标准第1部分:选择和使用指南Quality management and quality assurancestandards-Part1:Guidelines for selection and useGB/T19000.1-1994前言本标准等同采用ISO9000-1:1994《质量管理和质量保证标准第1部分:选择和使用指南》,代替GB/T19000-92-ISO9000:1987。
本标准直接沿用“ISO9000族”术语,因其有专门定义。
但在国内“ISO9000族”与“GB/T19000族”同义。
所谓GB/T19000族是指由全国质量管理和质量保证标准化技术委员会(CSBTS/TC151)归口的,按等同原则由ISO9000族国际标准转化而成的所有国家标准。
本标准的附录A是标准的附录;本标准的附录B、附录C、附录D、附录E都是提示的附录。
本标准由CSBTS/TC151全国质量管理和质量保证标准化技术委员会提出并归口。
本标准由CSBTS/TC151/SC2全国质量管理和质量保证标准化技术委员会质量体系分技术委员会负责起草。
本标准起草单位:机械科学研究院、中国标准化与信息分类编码研究所、中国人民大学、航天工业总公司708所、国家烟草工业总公司。
本标准主要起草人:蒋鸿章、李仁良、杨文士、张志珍、周韵笙、徐有刚、秦前浩。
ISO前言ISO(国际标准化组织)是由各国标准化团体(ISO成员团体)组成的世界性的联合会。
制定国际标准的工作通常由ISO的技术委员会完成,各成员团体若对某技术委员会确立的项目感兴趣,均有权参加该委员会的工作。
与ISO保持联系的各国际组织(官方的或非官方的)也可参加有关工作。
在电工技术标准化方面,ISO与国际电工委员会(IEC)保持密切合作关系。
由技术委员会通过的国际标准草案提交各成员团体表决,需取得至少75%参加表决的成员团体的同意,才能作为国际标准正式发布。
国际标准ISO9000-1是由ISO/TC176/SC2国际标准化组织质量管理和质量保证技术委员会质量体系分委员会制定的。
品质治理名词及英文缩写
品质治理名词(中英文对照) QA: Quality Assurance 品质保证QC: Quality Control 品质操纵 QE=品质工程师(Quality Engineer)QE: Quality Engineering 品质工程 MSA: Measurement System Analysis 量测系统QFD: Quality Function Design 品质性能展开分析Quality 质量 LCL: Lower Control limit 管制下限 Quality manual 品质手册 Control plan 管制打算 Quality policy 品质政策 Correction 纠正Range 全距 Cost down 降低本钱 Record 记录 CS: customer Sevice 客户中心 Reflow 回流 Data 数据 Reject 拒收 Data Collection 数据搜集 Repair 返修 Description 描述 Repeatability 再现性 Device 装置Reproducibility 再生性 Digital 数字 Requirement 要求 Do 执行Residual 误差 DOE: Design of Experiments 实验设计 Response 响应Environmental 环境 Responsibilities 职责 Equipment 设备 Review 评审 FMEA: Failure Mode and Effect analysis 失效模Rework 返工式与成效分析 Rolled yield 直通率 FA: Failure Analysis 坏品分析 sample 抽样,样本 FQA: Final Quality Assurance 最终品质保证 Scrap 报废FQC: Final Quality control 最终品质操纵 SOP: Standard Operation Procedure 标准作业 Gauge system 量测系统书 Grade 品级 SPC: Statistical Process Control 统计制程管制 Inductance 电感Specification 规格 Improvement 改善 SQA: Source(Supplier) Quality Assurance 供给 Inspection 查验商品质保证 IPQC: In Process Quality Control 制程品质操纵 Taguchi-method 田口方式 IQC: Incoming Quality Control 来料品质操纵 TQC: Total Quality Control 全面品质操纵 ISO: International Organization for TQM: Total Quality Management 全面品质治理 Standardization 国际标准组织Traceability 追溯 LQC: Line Quality Control 生产线品质操纵 UCL: Upper Control Limit 管制上限 LSL: Lower Size Limit 规格下限 USL: Upper Size Limit 规格上限 Materials 物料 Validation 确认Measurement 量测 Variable 计量值 Occurrence 发生率 Verification验证 Operation Instruction 作业指导书 Version 版本 Organization组织 QCC Quality Control Circle 品质圈/QC小组 Parameter 参数PDCA Plan Do Check Action 打算执行检查 Parts 零件总结 Pulse 脉冲 Consumer electronics 消费性电子产品 Policy 方针Communication 通信类产品 Procedure 流程 Core value (核心价值)Process 进程 Love 爱心 Product 产品 Confidence 信心 Production 生产 Decision 决心 Program 方案 Corporate culture (公司文化) Projects 项目 Integration 融合Responsibility 责任 RMA Return Material Audit 退料认可 Progress进步 7QCTools 7 Quality Control Tools 品管七大手法 QC quality control 品质治理人员通用之件类 FQC final quality control 终点品质管制人员 ECN Engineering Change Notice 工程变更通知 IPQC in process quality control 制程中的品质管(供给商) 制人员 ECO Engineering Change Order 工程改动要求 OQC output quality control最终出货物质管制人(客户) 员 PCN Process Change Notice 工序改动通知 IQC incoming quality control 进料品质管制人员 PMP Product Management Plan 生产管制打算 TQC total quality control 全面质量治理 SIP Standard Inspection Procedure 制程查验标 POC passage quality control 段检人员准程序 QA quality assurance 质量保证人员SOP Standard Operation Procedure 制造作业 OQA output quality assurance 出货质量保证人标准员 IS Inspection Specification 成品查验标准 QE quality engineering 品质工程人员 BOM Bill Of Material 物料清单 FAI first article inspection 新品首件检查 PS Package Specification 包装标准 FAA first article assurance 首件确认 SPEC Specification 规格 CP capability index 能力指数 DWG Drawing 图面SSQA standardized supplier quality audit 合格系统文件类供给商品质评估 ES Engineering Standard 工程标准 FMEA failure model effectiveness analysis 失效IWS International Workman Standard 工艺标准 ISO International Standardization Organization 模式分析 AQL Acceptable Quality Level 运作类允收品质国际标准化组织水准 GS General Specification 一样规格 S/S Sample size 抽样查验样本大小部类 ACC Accept 允收 PMC Production & Material Control 生产和物料 REE Reject 拒收操纵 CR Critical 极严峻的 PCC Product control center 生产管制中心 MAJ Major 要紧的 PPC Production Plan Control 生产打算操纵 MIN Minor 轻微的 MC Material Control 物料操纵Q/R/S Quality/Reliability/Service 品质/靠得住度/DCC Document Control Center 资料操纵中心效劳 QE Quality Engineering 品质工程(部) P/N Part Number 料号 QA Quality Assurance 品质保证处 L/N Lot Number 批号 QC Quality Control 品质管制(课) AOD Accept On Deviation 特采 PD Product Department 生产部 UAI Use As It 特采LAB Laboratory 实验室 FPIR First Piece Inspection Report 首件检查报IE Industrial Engineering 工业工程告 R&D Research & Design 设计开发部 PPM Percent Per Million 百万分之一 SPC Statistical Process Control 统计制程管制 SQC Statistical Quality Control 统计品质管制 GRR Gauge Reproducibility & Repeatability 量具之再制性及重测性判定量靠得住与否 DIM Dimension 尺寸 DIA Diameter 直径QIT Quality Improvement Team 品质改善小组 ZD Zero Defect 零缺点 QI Quality Improvement 品质改善品质部相关职位的工作职责: QP Quality Policy 目标方针 1 职位名称(IPQC)、 OQC、 FQC 、IQC TQM Total Quality Management 全面品质治理直属上级 QC组长工作内容: 9) 每日按期抽查组员填写的报表是不是真实(每三-每日工作:四小时一次); 1) 参与保护、监督质量体系的运行、组织和治理10) 每日下班前审核QC的相关记录,并做出处内部质量审核工作;理决定; 2) 依照查验打算完成当日首件、巡检、综检11) 如有新产品生产,跟踪其品质情形,并汇总出货检工作任务;给QE; 3) 确认生产单位的自检记录; 12) 学习产品查验标准,并教育组员利用之; 4) 按SIP及相应流程对待检产品进行查验,查验13) 教育新进员工,并使之达到上岗;前和查验进程中认真查对产品代码、名称,填14) 每日按期稽察生产现场的生产纪律执行情写况,并将其结果报上级;查验记录,并提交QC组长; 15) 每日搜集数据,对组员进行考核分析; 5) 汇总、存档各项质检记录及相关资料; 16) 提报加班要求和追踪组员加班情形; 6) 为纠正质量问题,有权临时停止现场生产,并17) 协助质量主管完成其它质量治理体系方面的当即向上级报告;工作。
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Reference number ISO 10015:1999(E)©ISO 1999INTERNATIONAL STANDARD ISO 10015First edition 1999-12-15Quality management —Guidelines for trainingManagement de la qualité—Lignes directrices pour la formationCopyright International Organization for Standardization Provided by IHS under license with ISO--`,,```,,,,````-`-`,,`,,`,`,,`---ISO10015:1999(E)PDF disclaimerThis PDF file may contain embedded typefaces.In accordance with Adobe's licensing policy,this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing.In downloading this file,parties accept therein the responsibility of not infringing Adobe's licensing policy.The ISO Central Secretariat accepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file;the PDF-creation parameters were optimized for printing.Every care has been taken to ensure that the file is suitable for use by ISO member bodies.In the unlikely event that a problem relating to it is found,please inform the Central Secretariat at the address given below.©ISO1999All rights reserved.Unless otherwise specified,no part of this publication may be reproduced or utilized in any form or by any means,electronic or mechanical,including photocopying and microfilm,without permission in writing from either ISO at the address below or ISO's member body in the country of the requester.ISO copyright officeCase postale56·CH-1211Geneva20Tel.+41227490111Fax+41227341079E-mail copyright@iso.chWeb www.iso.chPrinted in Switzerland--`,,```,,,,````-`-`,,`,,`,`,,`---ii©ISO1999–All rights reserved Copyright International Organization for StandardizationProvided by IHS under license with ISOISO 10015:1999(E)ContentsPageForeword (iv)Introduction.................................................................................................................................................................v 1Scope..............................................................................................................................................................12Normative reference......................................................................................................................................13Terms and definitions ...................................................................................................................................14Guidelines for training ..................................................................................................................................24.1Training:A four-stage process....................................................................................................................24.2Defining training needs.................................................................................................................................34.3Designing and planning training..................................................................................................................44.4Providing for the training..............................................................................................................................74.5Evaluating training outcomes......................................................................................................................85Monitoring and improving the training process.........................................................................................85.1General............................................................................................................................................................85.2Validation of the training process (9)Annex A (informative)Tables (10)--`,,```,,,,````-`-`,,`,,`,`,,`---ISO10015:1999(E)ForewordISO(the International Organization for Standardization)is a worldwide federation of national standards bodies(ISO member bodies).The work of preparing International Standards is normally carried out through ISO technical committees.Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee.International organizations,governmental and non-governmental,in liaison with ISO,also take part in the work.ISO collaborates closely with the International Electrotechnical Commission(IEC)on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives,Part3.Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least75%of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights.ISO shall not be held responsible for identifying any or all such patent rights.International Standard ISO10015was prepared by Technical Committee ISO/TC176,Quality management and quality assurance,Subcommittee SC3,Supporting technologies.Annex A of this International Standard is for information only.--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 10015:1999(E)IntroductionThe Quality management principles underlying the ISO 9000family of standards (of which the ISO 10000series form a part)emphasize the importance of human resource management and the need for appropriate training.They recognize that customers are likely to both respect and value an organization’s commitment to its human resources and its ability to demonstrate the strategy used to improve the competence of its personnel.Personnel at all levels should be trained to meet the organization's commitment to supply products of a required quality in a rapidly changing market place where customer requirements and expectations are increasing continuously.This International Standard provides guidelines to assist organizations and their personnel when addressing issues related to training.It may be applied whenever guidance is required to interpret references to “education“and “training“within the ISO 9000family of quality assurance and quality management standards.Any references to “training“in this document includes all types of education and training.An organization’s objectives for continual improvement,including the performance of its personnel ,might be affected by a number of internal and external factors including changes in markets,technology,innovation,and the requirements of customers and other stakeholders.Such changes may require an organization to analyse its competence-related needs.Figure 1illustrates how training could be selected as an effective means of addressing these needs.Figure 1—Improving quality by training--`,,```,,,,````-`-`,,`,,`,`,,`---ISO10015:1999(E)The role of this International Standard is to provide guidance that can help an organization to identify and analyse training needs,design and plan the training,provide for the training,evaluate training outcomes,and monitor and improve the training process in order to achieve its objectives.It emphasizes the contribution of training to continual improvement and is intended to help organizations make their training a more effective and efficient investment. --`,,```,,,,````-`-`,,`,,`,`,,`---INTERNATIONAL STANDARD ISO10015:1999(E) Quality management—Guidelines for training1ScopeThese guidelines cover the development,implementation,maintenance,and improvement of strategies and systems for training that affect the quality of the products supplied by an organization.This International Standard applies to all types of organizations.It is not intended for use in contracts,regulations,or for certification.It does not add to,change,or otherwise modify requirements for the ISO9000series.This International Standard is not intended to be used by training providers delivering services to other organizations.NOTE The main source of reference for training providers should be ISO9004-2:1991,Quality management and quality system elements—Part2:Guidelines for services,until superseded by ISO9004:2000.Training providers may use this International Standard when addressing the training needs of their own personnel.2Normative referenceThe following normative document contains provisions which,through reference in this text,constitute provisions of this International Standard.For dated references,subsequent amendments to,or revisions of,any of this publication do not apply.However,parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below.For undated references,the latest edition of the normative document referred to applies.Members of ISO and IEC maintain registers of currently valid International Standards.ISO8402,Quality management and quality assurance—Vocabulary1).3Terms and definitionsFor the purposes of this International Standard,the terms and definitions given in ISO8402and the following apply.3.1competenceapplication of knowledge,skills,and behaviours in performance3.2trainingprocess to provide and develop knowledge,skills and behaviours to meet requirements 1)To be revised as ISO9000:2000.--` , , ` ` ` , , , , ` ` ` ` -` -` , , ` , , ` , ` , , ` ---ISO10015:1999(E)4Guidelines for training4.1Training:A four-stage process4.1.1GeneralA planned and systematic training process can make an important contribution in helping an organization to improve its capabilities and to meet its quality objectives.This training process is illustrated in the training cycle diagram shown in Figure2.To increase the readability of this International Standard and to distinguish clearly between guidance and use of the process model to describe the guidance,the process model appears in Tables A.1to A.5in annex A.For selecting and implementing training to close the gaps between required and existing competence, management should monitor the following stages:a)defining training needs;b)designing and planning training;c)providing for the training;d)evaluating the outcome of training.As illustrated,the output of one stage will provide the input for the following stage.Figure2—Training cycle4.1.2Purchase of training-related products and servicesIt should be the responsibility of the management to decide if and when the external or internal purchasing and resourcing of products and services related to any of the four stages of the training process,and its monitoring, should occur(see Tables A.1to A.5).For example,some organizations might find it beneficial to use external expertise to carry out an analysis of its training needs.--`,,```,,,,````-`-`,,`,,`,`,,`---ISO10015:1999(E)4.1.3Involvement of personnelAppropriate involvement of the personnel whose competence is being developed,as part of the training process, may result in those personnel feeling a greater sense of ownership of the process,resulting in their assuming more responsibility for ensuring its success.4.2Defining training needs4.2.1GeneralThe training process should be initiated after a needs analysis of the organization has been conducted and competence-related issues have been recorded,as depicted in Figure1in the Introduction.The organization should define the competence needed for each task that affects the quality of products,assess the competence of the personnel to perform the task,and develop plans to close any competence gaps that may exist.The definition should be based on an analysis of present and expected needs of the organization compared with the existing competence of its personnel.The purpose of this stage should be to:a)define the gaps between the existing and required competence;b)define the training needed by employees whose existing competence does not match the competencerequired for the tasks;andc)document specified training needs.The analysis of the gaps between existing and required competence should be conducted to determine whether the gaps can be closed by training or whether other actions might be necessary(see Table A.1).4.2.2Defining the needs of the organizationThe organization’s quality and training policies,quality management requirements,resource management and process design should be considered when initiating training,as an input to4.2,to ensure that the required training will be directed toward satisfying the organization’s needs.4.2.3Defining and analysing competence requirementsCompetence requirements should be documented.This documentation can be periodically reviewed or as necessary when work assignments are made and performance is assessed.The definition of an organization’s future needs relative to its strategic goals and quality objectives,including the required competence of its personnel,may be derived from a variety of internal and external sources,such as:¾organizational or technological change that affects work processes or impacts on the nature of products supplied by the organization;--`,,```,,,,````-`-`,,`,,`,`,,`---¾data recorded from past or current training processes;¾the organization’s appraisal of the competence of the personnel to perform specified tasks;¾turnover or seasonal fluctuation records involving temporary personnel;¾internal or external certification needed for the performance of specific tasks;ISO10015:1999(E)¾requests from employees identifying opportunities for personal development which contribute to the organization’s objectives;¾the result of process reviews and corrective actions due to customer complaints or reports of nonconformities;¾legislation,regulations,standards and directives affecting the organization,its activities and resources;and¾market research identifying or anticipating new customer requirements.4.2.4Reviewing competenceA regular review should be conducted of documents that indicate the competence required for every process and the records that list the competence of every employee.Methods used for reviewing competence might include the following:¾interviews/questionnaire with employees,supervisors,managers;¾observations;¾group discussions;and¾inputs from subject matter experts.The review is related to task requirements and task performance.4.2.5Defining competence gapsA comparison of the existing competencies with those required should be made to define and record the competence gaps.4.2.6Identifying solutions to close the competence gapsThe solutions to close the competence gaps could be found through training or other actions of the organization, such as redesigning processes,recruitment of fully trained personnel,outsourcing,improving other resources,job rotation or modifying work procedures.4.2.7Defining the specification for training needsWhen a training solution is selected to close the competence gaps,training needs should be specified and documented.The specification for training needs should document the objectives and the expected outcomes of the training.The input to the specification for training needs should be provided by the list of competence requirements found in 4.2.3,the results of previous training,and current competence gaps and requests for corrective action.This document should become part of the training plan specification and should include a record of the organization’s objectives which will be considered as inputs for designing and planning training and for monitoring the training process.4.3Designing and planning training4.3.1GeneralThe design and plan stage provides the basis for the training plan specification.©ISO 1999–All rights reserved5This stage includes:a)design and planning of actions which should be taken to address the competence gaps identified in 4.2.5;and b)definition of the criteria for evaluating the training outcomes and monitoring the training process (see 4.5,clause 5and Table A .2).4.3.2Defining the constraintsRelevant items which constrain the training process should be determined and listed.These might include:¾regulatory requirements imposed by laws;¾the policy requirements,including those relating to human resources,imposed by the organization;¾financial considerations;¾timing and scheduling requirements;¾the availability,motivation and ability of the individuals to be trained ;¾factors such as the availability of in-house resources to perform the training,or the availability of reputable training providers;and¾constraints on any other available resources.The list of constraints should be used in the selection of training methods (4.3.3)and training provider (4.3.5)and for the development of a training plan specification (4.3.4).4.3.3Training methods and criteria for selectionPotential training methods to meet the training needs should be listed.The appropriate form of training will depend on the listed resources,constraints and objectives.Training methods might include:¾courses and workshops on or off site;¾apprenticeships;¾on-the-job coaching and counselling;¾self-training ;and ¾distance learning.Criteria for selection of the appropriate methods,or combination of methods,should be defined and documented.These may include:¾date and location;¾facilities;¾cost;Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---6©ISO 1999–All rights reserved¾training objectives;¾target group of trainees (e.g.current or planned professional position,specific expertise and/or experience,maximum number of participants);¾duration of training and sequence of implementation;and ¾forms of assessment,evaluation and certification.4.3.4Training plan specificationA training plan specification should be established in order to negotiate with a potential training provider the provisions of specific training processes,e.g.delivery of specific training content.A training plan specification is appropriate in order to establish a clear understanding of the organization’s needs,the training requirements,and the training objectives that define what the trainees will be able to achieve as a result of the training.Training objectives should be based on the expected competence developed in the specification for training needs in order to ensure the effective delivery of training and to create clear and open communication.The specification should consider the following:a)the organization’s objectives and requirements;b)specification for training needs;c)training objectives;d)trainees (target groups or target personnel);e)training methods and outline of content;f)schedule of requirements,such as duration,dates and significant milestones;g)resource requirements,such as training materials and staff;h)financial requirements;i)criteria and methods developed for the evaluation of training outcomes to measure the following:¾satisfaction of the trainee,¾trainee’s acquisition of knowledge,skills and behaviours,¾trainee’s on-the-job performance,¾satisfaction of the trainee’s management,¾impact on the trainee’s organization,and¾procedures for monitoring the training process (see clause 5).4.3.5Selecting a training providerAny potential internal or external training provider should be subject to critical examination before being selected to provide the training.This examination may include the provider's written information (e.g.catalogues,leaflets)and evaluation reports.Examination should be based on the training plan specification and the identified constraints.Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---©ISO 1999–All rights reserved7The selection should be recorded in an agreement or formal contract establishing ownership ,roles and responsibilities for the training process.4.4Providing for the training4.4.1GeneralIt is the responsibility of the training provider to carry out all the activities specified for the delivery of the training in the training plan specification.However,as well as providing the resources necessary to secure the services of the training provider,the role of the organization in supporting and facilitating the training might include:¾supporting both the trainer and the trainee;and ¾monitoring the quality of the training delivered.NOTEA trainer is a person who applies a training method.The organization may support the training provider in monitoring the provision of training (see clause 5).The success of these activities is affected by the effectiveness of the interactions between the organization,the training provider and the trainee.The purpose of the following subclauses is to provide guidance on how the organization might carry out these activities (see Table A .3).4.4.2Providing support 4.4.2.1Pretraining supportPretraining support may include such activities as:¾briefing the training provider with relevant information (see 4.2);¾briefing the trainee on the nature of the training and the competence gaps it is intended to close;and ¾enabling contact to be made between the trainer and trainee.4.4.2.2Training supportTraining support may include such activities as:¾providing relevant tools,equipment,documentation,software or accommodation to the trainee and/or trainer;¾providing relevant and adequate opportunities for the trainee to apply the competence being developed;and ¾giving feedback on task performance as requested by the trainer and/or trainee.4.4.2.3End-of-training supportEnd-of-training support may include such activities as:¾receiving feedback information from the trainee;¾receiving feedback information from the trainer;and¾providing feedback information to managers and to the personnel involved in the training process.Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---8©ISO 1999–All rights reserved4.5Evaluating training outcomes4.5.1GeneralThe purpose of the evaluation is to confirm that both organizational and training objectives have been met,i.e.training has been effective.The inputs for the evaluation of training outcomes are the specifications for training needs and for the training plan,and the records from the delivery of training.The results of training often cannot be fully analysed and validated until the trainee can be observed and tested on the job.Within a specified time period after the trainee has completed the training,the management of the organization should ensure that an evaluation takes place to verify the level of competence achieved.Evaluations should be carried out on both a short-term and long-term basis:¾in the short term,trainee feedback information should be obtained on the training methods,resources used,and knowledge and skills gained as a result of the training;and¾in the long term,trainee job performance and productivity improvement should be assessed.The evaluation should be conducted on the basis of established criteria (see 4.3.4).The evaluation process should include the collection of data and the preparation of an evaluation report which also provides an input to the monitoring process (see Table A .4).4.5.2Collecting data and preparing an evaluation reportAn evaluation report might include the following:¾specification for training needs;¾evaluation criteria and description of sources,methods and schedule for evaluation;¾analysis of data collected and interpretation of the results;¾review of training costs;and¾conclusions and recommendations for improvement.The occurrence of nonconformities may require procedures for corrective action.The completion of training should be documented in the training records.5Monitoring and improving the training process5.1GeneralThe main purpose of monitoring is to ensure that the training process,as part of the organization’s quality system,is being managed and implemented as required so as to provide objective evidence that the process is effective in meeting the organization’s training requirements.Monitoring involves reviewing the entire training process at each of the four stages (see Figure 2).Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---©ISO 1999–All rights reserved9Monitoring should be conducted by competent personnel in accordance with the organization’s documented procedures.Where possible,such personnel should be independent of the functions in which they are directly involved.Methods for monitoring might include:consultation,observation,and data collection.Methods should have been decided during the training plan specification stage (see 4.3.4).Monitoring is a valuable tool for enhancing the effectiveness of the training process (see Table A.5).5.2Validation of the training processInputs for monitoring might include all the records from all stages in the training process.Based on these records,a review of the different stages can be performed to detect nonconformity issues for corrective and preventive actions.Such inputs can be collected on an on-going basis to provide the basis of validating the training process,and for making recommendations for improvement.If the procedures are followed and the specified requirements met,then the personnel competence records should be up-dated to reflect this additional qualification.If the procedures are not followed and the requirements are met,then the procedures should be revised and the personnel competence records should be up-dated to reflect this additional qualification.If the procedures are followed and the requirements not met,then corrective action may be needed to improve the training process or develop an appropriate non-training solution.Overall,the review of the training process should identify any further opportunities for improving the effectiveness of any stage of the training process.Appropriate records should be maintained of the various monitoring and evaluation activities conducted,the results obtained,and the actions planned.Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---10©ISO 1999–All rights reservedAnnex A (informative)TablesTable A.1—Defining training needs (4.2)InputsProcess Outputs Record Defining organization’s needs (4.2.2)Quality policy Training policyQuality management requirements Resources management Process designConsider all inputs when initiating trainingDecision to initiate training processDecision to initiate training processDefining and analysing competence requirements (4.2.3)Organizational or technological change that affects work processes or impacts on the nature of products supplied by the organization Data recorded from past or current training processesOrganization’s appraisal of the competence of the personnel to perform specified tasks Turnover or seasonal fluctuation records involving temporary personnelInternal or external certification needed for the performance of specific tasksRequests from employees identifying opportunities for personal development contributes to organization’s objectivesResult of process reviews and corrective actions due to customer complaints or nonconformities reportsLegislation,regulations,standards,anddirectives affecting the organization,its activities and resourcesMarket research identifying or anticipating new customer requirements Document competence requirementsCompetence requirements List of competence requirementsReviewing competence (4.2.4)Competence recordsData on task requirements and task performance from:—interviews/questionnaire with employees,supervisors,managers —observations —group discussion—input from subject matter expertsReview existing competenceKnowledge of existingcompetenceList of existing competenceCopyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---。