ISO9001 8.1 运行策划和控制

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8.1 运行策划和控制

为满足产品和服务提供的要求，并实施第6章所确定的措施，组织应通过以下措施对所需的过程（见4.4）进行策划、实施和控制：

a)确定产品和服务的要求

b)建立下列内容的准则：

1）过程；

2）产品和服务的接收。

c)确定所需的资源以使产品和服务符合要求；

d)按准则实施过程控制；

e)在必要的范围和程度上，确定并保持、保留成文信息，以：

1）确信过程已经按策划进行；

2）证实产品和服务符合要求。

策划的输出应适合于组织的运行。

组织应控制策划的变更，评审非预期变更的后果，必要时采取措施减轻不利影响。

组织应确保外包过程受控（见8.4）

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8.1 Operation Planning and Control



To meet the requirements for product and service provision and implement the measures identified in Chapter 6, the organization shall plan, implement, and control the required processes (see 4.4) through the following measures:



a) Determine the requirements for products and services



b) Establish guidelines for:



1) Process;



2) Receipt of products and services.



c) Determine the necessary resources to ensure that products and services meet the requirements;



d) Implement process control according to guidelines;



e) To the necessary extent and extent, determine, maintain, and retain written information to:



1) Ensure that the process has been carried out as planned;



2) Verify that the products and services meet the requirements.



The output of the planning should be suitable for the operation of the organization.



Organizations should control planned changes, review the consequences of unexpected changes, and take measures to mitigate adverse impacts if necessary.



Organizations should ensure that the outsourcing process is controlled (see 8.4)

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本条款已经涵盖生产或服务过程的策划（几乎已经存在，理顺一下即可）、实施（及生产与服务过程的运行）和控制（过程中设备工艺参数控制、产品过程检测、不合格产品控制等）。就制造业而言，包括：

条款a）涉及：

——成品标准（内控标准、出厂检验标准）；

条款b）涉及：

——（生产或加工）工艺标准，包括设备、介质等控制标准；

——原材料（原料、辅料、加工助剂、工程助剂、工程介质等）标准、各种在制品标准；

条款c）涉及：

——生产或加工的输入，，以及启动生产或加工的生产计划等；

条款d）涉及：

——工艺说明书、工艺流程图、操作规程（SOP）、涉及过程管理的程序文件、过程检验计划；

条款e）涉及：

——过程操作记录、产品检测检验记录，不合格处置记录等。

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When establishing the ISO9001 based quality management system, the production process or service process of almost all organizations has been finalized. In order to meet the requirements of this clause, corresponding descriptions can be made in the Quality Manual. Of course, separate production or service realization and process control plans can also be prepared.



This clause already covers the planning (almost existing, just sort it out), implementation (and operation of production and service processes), and control (control of equipment process parameters, product process testing, control of non-conforming products, etc.) of production or service processes. In terms of manufacturing, including:



Clause a) involves:



——Finished product standards (internal control standards, factory inspection standards);



Clause b) involves:



——(Production or processing) process standards, including control standards for equipment, media, etc;



——Standards for raw materials (raw materials, auxiliary materials, processing aids, engineering aids, engineering media, etc.) and various standards for work in progress;



Clause c) involves:



——The input for production or processing includes various raw materials, auxiliary materials, processing aids and other purchasing materials, self-produced engineering media (water, steam, thermal energy or cooling capacity, etc.), energy (electricity, natural gas, heavy oil, etc.), equipment and facilities, competent personnel, testing and inspection instruments, operating and transportation tools, recording methods, communication configurations, and automated office configurations (such as computers), And production plans for initiating production or processing;



Clause d) involves:



——Process instructions, process flow diagrams, operating procedures (SOPs), procedural documents related to process management, and process inspection plans;



Clause e) involves:



——Process operation records, product testing and inspection records, and records of non-conforming disposal.



Other changes include experimental use of raw materials, process change notifications, product formula change notifications, process or final product standard change notifications, production plan change notifications, etc. These change notifications are confirmed and reviewed by relevant responsible personnel before being issued

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whye 发表于 2023-7-25 08:23
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