ISO9001-8.5 .1

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8.5.1生产和服务提供的控制

组织应在受控条件下进行生产和服务提供。

适用时，受控条件应包括：

a) 可获得成文信息，以规定以下内容：

1）拟生产的产品、提供的服务或进行活动的特性；

2）拟获得的结果。

b) 可获得和使用适宜的监视和测量资源；

c) 在适当阶段实施监视和测量活动，以验证是否符合过程或输出的控制准则以及产品和服务的接收准则；

d) 为过程的运行使用适宜的基础设施，并保持适宜的环境；

e) 配备胜任的人员，包括所要求的资格；

f) 若输出结果不能由后续的监测和测量加以验证，应对生产和服务提供过程实现策划结果的能力进行确认，并定期再确认；

g) 采取措施防止人为错误；

h) 实施放行、交付和交付后的活动

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8.5.1 Control of production and service provision



Organizations should conduct production and service provision under controlled conditions.



When applicable, controlled conditions should include:



a) Written information can be obtained to specify the following:



1) The characteristics of the products to be produced, services to be provided, or activities to be carried out;



2) Intended results.



b) Availability and use of appropriate monitoring and measurement resources;



c) Implement monitoring and measurement activities at appropriate stages to verify compliance with process or output control criteria and product and service acceptance criteria;



d) Use appropriate infrastructure for the operation of the process and maintain a suitable environment;



e) Equip competent personnel, including the required qualifications;



f) If the output results cannot be verified by subsequent monitoring and measurement, the ability of the production and service provision process to achieve the planned results should be confirmed and regularly reconfirmed;



g) Take measures to prevent human error;



h) Implement release, delivery, and post delivery activities

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组织必须依照相关的国内外标准、规范与指南，对相关的设施设备、原材料、工艺参数以及人员素质（资质）等做出详细的规定，并通过全程性的监视与测量计划的实施，确保全程受控，从而为最终输出符合法定或规定要求提供保证、有法律约束力的保证。

“采取措施防止人为错误”是新版ISO9001:2015标准的要求，与同前述的风险与机遇管理要求那样，反映出“站在体系之外看影响体系有效实施的非体系本身因素”这一先进的质量管理理念。人不是机器或计算机程序，由于年龄、身体状况、性别、地域习惯、情绪、疾病等原因，必然会导致不可预见性的操作失误、检查失误、判断失误与处置失误，从而影响其职责范围内质量管理过程输出的符合性，为此组织应在综合分析评判断的基础上，采取减少人为失误发生可能性的措施，诸如：

——限制人员工作时间，避免长时间连续工作；

——提供符合人体需要的工作环境，诸如温度、湿度、噪声、照明、洁净度等；

——提供充分的培训与指导，包括激励机制，激发员工质量管理技能与意识，特别是意识；

——尽量采用自动化的设备与装备，包括自动报警装置；

——关键信息录入的双人制；

——通过适当的醒目标识标志来提醒；

——设置防呆性互锁装置；

——设置视频监视系统

——轮岗，换班前充分清楚的交代；

——建立清洁、有序、不拥挤、产品标识清楚醒目的现场工序环境等

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The organization must make detailed regulations on relevant facilities, equipment, raw materials, process parameters, and personnel quality (qualifications) in accordance with relevant domestic and foreign standards, specifications, and guidelines. Through the implementation of a comprehensive monitoring and measurement plan, it is ensured that the entire process is controlled, thereby providing a guarantee and legally binding guarantee for the final output to meet legal or regulatory requirements.



Taking measures to prevent human error "is a requirement of the new version of ISO9001:2015 standard, which, like the risk and opportunity management requirements mentioned earlier, reflects the advanced quality management concept of" looking at non system factors that affect the effective implementation of the system from outside the system ". Human beings are not machines or computer programs. Due to factors such as age, physical condition, gender, regional habits, emotions, and diseases, unpredictable operational errors, inspection errors, judgment errors, and handling errors will inevitably occur, which will affect the compliance of the quality management process output within their scope of responsibility. Therefore, based on comprehensive analysis and evaluation, organizations should take measures to reduce the possibility of human errors, such as:



——Limit personnel's working hours and avoid prolonged continuous work;



——Provide a working environment that meets the needs of the human body, such as temperature, humidity, noise, lighting, cleanliness, etc;



——Provide sufficient training and guidance, including incentive mechanisms, to stimulate employees' quality management skills and awareness, especially awareness;



——Try to use automated equipment and equipment, including automatic alarm devices;



——Double person system for key information input;



——Reminder through appropriate eye-catching signage;



——Set up anti fooling interlocking devices;



——Set up video surveillance system



——Shift, fully and clearly explain before changing shifts;



——Establish a clean, orderly, non crowded, and clearly labeled on-site process environment.



The above measures should become a part of the corresponding documents at all levels of the organization's quality management system and be subject to daily management