The quality system documents are divided into those four levels, and the quality management system d

There are different levels of quality system documents, they are:

Level 1 Quality Manual;

Level 2 Procedural documents;

Level 3 Work instructions (including testing rules and operating procedures);

Level 4 Quality Records (**, Reports, Records, etc.).

The above is to divide the quality system document into four levels, and there are also three levels, which are:

Level 1 Quality Manual;

Level 2 Procedural documents;

The third level of quality documents (including work instructions, **, reports, etc.).

A quality manual is a document that sets out a laboratory's quality policy and describes its quality system. The quality manual should describe the scope of the quality system, the interconnected relationship between the processes, and the control procedures of the documents required by each process, and it stipulates the organizational structure (including responsibilities), procedures, and activity capabilities of the laboratory, i.e., processes and resources. Medical Education Network|Collecting and sorting out it is not only a form of quality system representation, but also a program for the establishment and operation of the quality system, and a programmatic document that the laboratory has followed for a long time.

The main question of what to do, the quality manual is usually used by managers and "users".

Procedural documents are documents that describe the quality activities and specific work procedures of each functional department involved in the implementation of the requirements of the quality system, and should stipulate the detailed rules in the quality activities and specific work procedures of each functional department. The main question of how to do it, for use by the various departments of the agency, is a supporting document. In order to ensure that the planning and operation of the process and activities are effectively organized and continuously and effectively controlled.

The work instruction is a more detailed document for specific staff to use, and is the basis for the implementation of various processes and quality control activities of the technical basis and management documents, mainly based on the implementation of the problem, for the implementation of the document. It is used to guide the operator to complete various quality control activities, mainly for the personal use of the operator.

The quality record is the basis for the confirmation of the operation of the quality system, that is, the objective basis for the effectiveness of the operation of the quality system and the evidence of the completion of an activity. Broadly speaking, quality records can be generated inside the laboratory or from outside the laboratory.

The quality system document is three layers, the first layer is the quality manual, the second layer is the program document, and the third layer is the supporting documents, including job instructions, external documents and internal management documents.

It is divided into one layer: quality manual, two layers: program documents, three layers: work instructions, four layers: records, and some units merge three or four layers of documents and divide them into three layers.

Level 1: Quality Manual.

Layer 2: Program files.

Level 3: Work instructions.

Fourth layer: **, documents, records, books, archives.

The quality management system documents include the following eight categories: quality manuals, procedure documents, work books, product quality standards, testing technical specifications and standard methods, quality plans, quality records, and test reports.

The quality system documents are generally divided into three or four levels, and the laboratory can be specified according to its own monitoring needs and habits.

Legal Analysis: The Pimmin Level 4 document is a directory list.

Legal basis: Article 14 of the Product Quality Law of the People's Republic of China The state implements the enterprise quality system certification system according to the international quality management standards. According to the principle of voluntariness, enterprises can apply for enterprise quality system certification to the certification body recognized by the market supervision and administration department or authorized by the market supervision and administration department.

If it is certified and qualified, the certification body will issue the enterprise quality system certification certificate.

The state refers to the international advanced product standards and technical requirements, and implements the product quality certification system. According to the principle of voluntary, enterprises can apply for product quality certification to the certification body recognized by the market supervision and management department or authorized by the market supervision and management department. If it is certified, the certification body will issue a high-excitation product quality certification certificate, and the enterprise is allowed to use the product quality certification mark on the product or its packaging.

Quality system documentsThe principles of writing include:

1. The quality system document should be systematic and coordinated.

The quality system document should be able to reflect the systemic characteristics of an organization's quality system and respond to the impact on the quality of the product or service.

The control of technical, managerial and personnel factors in the formation process is uniformly regulated. Different documents should be clearly hierarchical, clearly interfaced, reasonably structured, coordinated and reordered, and appropriately selected elements and contents in terms of various levels and document quality.

2. The preparation of quality system documents should meet the requirements of regulations.

A quality system document is an organization that implements quality management.

and guidelines for quality assurance activities.

3. The quality system document should have a high crude value of increased sales.

4. The preparation and application of quality system documents is a process, and the process of loss is a dynamic and high value-added conversion process.

5. The quality system documents should meet the requirements of suitability.

What documents are included in the QMS document? For this problem, the majority of construction people may not be very clear, the following is the construction network to bring about the quality management system documents including the content of the content of the document for reference.

It can be divided according to the needs of its own organization, and is generally divided into two categories: system documents and external documents. Give you the classification of documents from my unit for reference.

File categorization. Administrative Documents:

a) Quality manual (including documented quality policy and quality objectives);

b) program documentation;

c) Departmental work instructions;

d) Other management documents (such as various management systems, job responsibilities, management review reports, internal audit reports and related supporting documents);

e) Records**.

Technical Documents:

a) process documentation;

b) Applicable international, national and industry standards;

c) Service specifications, service provision specifications, quality control specifications, technical standards, inspection specifications, quality plans, management regulations, etc. prepared by the group or department.

External documents: a) Laws, regulations, standards, superior documents from outside the group;

b) Drawings, technical data, contracts, agreements, business documents, safety or quality assurance documents provided by customers or suppliers, etc.

Controlled and non-controlled files.

Documents can be divided into two categories: "controlled" and "uncontrolled":

a) a "controlled" document is a document that is under the control of the Group and in which changes can be implemented, which is a change notification version, which can be traced back to all users when changes are made, and changes are implemented to ensure that it is current;

b) "Uncontrolled" documents refer to external documents, group system documents that do not require change control (including documents for bidding, off-site use by customers and other special issuances, production plans, monthly quality reports, season-related operation documents and other documents that are automatically invalidated when they expire with timeliness).

Controlled documents shall be stamped with a "controlled" seal and shall be registered for distribution and marked with a distribution number. Non-controlled documents are issued after approval by authorized personnel, and are only for issuance registration, without a distribution number. When the group's controlled documents are issued as non-controlled documents (e.g. bidding, off-site use by customers), they should be stamped with the "uncontrolled" seal.

The form of the file.

Documents can be in any form or type of medium, such as paper, hard copy, electronic**, etc.