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The quality manual is prepared according to the "quality system standard requirements", and the program documents are prepared according to the requirements of the quality manual, wherein: the quality system standard requirements stipulate: document control, record control, internal audit, preventive measures, corrective measures, and nonconforming product control, which must be prepared by the program documents.
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The program file needs to be prepared clearly about the settings, operation, and operation related environment, links, effects, and related precautions of the program.
The compilation of the quality manual should include a preface, table of contents, chapter classification, specific content of each chapter, etc.
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Take the ISO9001 mass system as an example:
1.There are requirements in the terms document requirements:
The quality management system documents must include;
a) Documented quality policy and quality objectives.
b) Quality Manual.
c) Documented procedures required in the Articles.
d) Documents and records required for process action and control.
2.In accordance with the above requirements:
Quality Manual (Level 1) Procedure Document (Level 2) Regulation Method WI (Level 3) Form Records, etc. (Level 4).
a.Compilation of [Quality Manual], bDocumented Programs:
Basic Essentials: Document Control Procedures. Records control procedures. Internal audit procedures.
Non-conformity control procedures. Corrective Action Procedures, Preventive Action Procedures (and Quality Manuals);
Others: can be formulated according to the company's operational requirements.
c.Formulate quality policies and quality objectives.
d.Procedural documents, subordinate documents (prescribed methods, wi, etc.) fAccording to the process control requirements, establish forms & records, etc.
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Personally, I think it depends on what kind of standards you implement. You can apply the standards to your documents according to your company's situation.
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Quality Manual: In order to provide a unified Sakura standard, it can unify the quality management norms of the enterprise, establish working procedures, determine quality standards, quality inspection and quality responsibility.
Program documents: In order to ensure that all department personnel, equipment and materials in the enterprise meet the requirements of the quality management system of the enterprise, it can refine the quality management regulations of the enterprise, improve the business operation process, and improve the quality of work.
Work instructions: In order to ensure that each work meets the quality standards and is completed accurately and according to the plan, it can standardize the various operations of the enterprise and avoid quality accidents caused by improper operation.
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First, the content of the expression is different:
1. The quality manual is a programmatic document, and the provisions of the quality manual in the international standard are: the main document that summarizes, elaborates and guides the practice of the quality system of the quality system, and is a programmatic document that the quality management and quality assurance activities of the enterprise should follow for a long time.
2. The program documents are auxiliary documents, and the quality system program documents make provisions for activities that affect the quality.
1. It is a supporting document for the quality manual.
2. It should contain the requirements and regulations of all elements adopted in the quality system.
3. Each quality system procedure document should be aimed at a logically independent activity in the quality system.
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Prepared by the Operations Department.
The procedure documents are written by the relevant departments, because the procedures of each work are only known to the corresponding departments, and they know what to do, how to do it, and to what extent. However, the operations department has to tell them the requirements and format of the writing. Of course, it is best to hold a publicity and implementation meeting to publicize the preparation requirements and formats before the preparation, so that the prepared documents meet the requirements of the specification.
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Hello! We'll be happy to answer your questions. The quality system includes quality manuals, program documents and job instructions.
The quality manual is a overarching document should be prepared by the quality management office, and the program documents and job instructions are executive documents, involving specific work content, work processes and current positions, which should be prepared by relevant departments (controlled departments), and finally drafted by the quality control office. Of course, before compiling, it is best to hold a publicity meeting to teach the requirements and format of writing, so that the prepared documents can meet the requirements of the standard. I hope mine can help you, dear.
Have a great day<>
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It can be prepared by the organization itself or under the guidance of a training institution.
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1. The work instruction refers to the procedures formulated to ensure the quality of the process.
The term "process" refers to a set of specific activities that are related to each other, and a work instruction is also a program to which it is addressed.
It is a specific operational activity, while a program file describes a systematic quality activity.
Work instructions are sometimes referred to as work instructions, operating specifications, operating procedures, etc.
2. The types of work instructions are:
According to the form of issuance: written work instructions; Oral work instructions; computer-based work instructions; audio-visual work instructions;
According to the content: operation instructions, inspection, testing, installation and other specific processes; Work rules, plans, rules and regulations to guide specific management work, etc.; Guiding standard operating practices for high automation procedures and relatively independent operations.
3. The functions of the work instruction are:
It is the most basic document to guide and ensure the quality of the process; Provide guidance for the development of purely technical quality activities; It is a supporting document for the quality system program document.
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The quality manual tells you what to do, the program file tells you how to do it, and the work instruction book tells you how to do it.
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Hello, whether the program file needs to include a quality manual depends on whether the organization or company you are in has relevant regulations and requirements. If your organization or company has strict requirements for software quality management, it is necessary to include a quality manual in the program file. Quality manuals often include the regulations, standards, and processes of the quality management system, which are important for ensuring software quality and effectively managing software projects.
However, if your organization or the Township Division does not require this, it is up to the developer to decide whether or not to include a quality manual in the program file.
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