Some standard content:
ICS 03.120.01
National Standard of the People's Republic of China
GB/T19023—2003/IS0/TR10013:2001 replaces GB/T19023—1996
Guidelines for quality management system documentation(IS0/TR 10013:2001, IDT)
2003-04-21 Issued
People's Republic of China
General Logistics Department of Quality Supervision, Inspection and Quarantine
2003-09-01 Implementation
ISO Foreword
Normative references
Terms and definitions
Quality management system documents
Purpose and purpose
Quality policy and quality objectives
Quality manual
Procedure documents
Operation instructions||t t||Quality plan
External documents
Records
Quality management system document preparation process
5.1 Preparation duties
Quality management system document preparation method
5.3 Use of referenced documents
6 Quality management system document approval, release and control process..6.1 Review and approval
6.2 Distribution
6.3 Changes
6.4 Release and change control
5.5 Uncontrolled documents
GB/T 19023-—2003/IS0/TR 10013:2001 Appendix A (Informative Appendix) Typical quality management system document hierarchy Appendix 1 (Informative Appendix)
Example of work instruction format
Signature and reference documents
GB/T 19023—2003/1SO/TR 10D13.2001 This standard is one of the GB/T19000 family standards. The word "shall" in the standard indicates requirements, and "should" serves as a guide.
This standard is equivalent to ISO/TR100132001 Quality Management System Document Guide 3 (English version). This standard replaces GB/T19023-1996 Quality Manual Preparation Guide. Compared with GB/T19023-1996 Quality Manual Preparation Guide, this standard has the following major changes: This standard provides guidance for the establishment and maintenance of quality management system documents. Quality management system documents include not only quality manuals, but also procedure documents, work instructions, forms, quality plans, This standard adopts the terms and definitions in GB/T19000--2000 for documents such as specifications, external documents, and records. This standard adds the terms and definitions of "operation instructions" and "forms". Appendix A and Appendix B of this standard are informative appendices. This standard was proposed and coordinated by the National Technical Committee for Standardization of Quality Management and Quality Assurance (CSBTS/TC151). This standard is initiated by the China Standards Research Center. The drafting units participating in this standard are: China National Accreditation Service for Conformity Assessment, Beijing New Century Quality System Certification Center. The main drafters of this standard are: Yin Xufeng, Gao Yan, Yang Ming, Niu Dongbo, and Xu Yougang. GB/F 19023—2003/IS0/TR 10013:2001ISO Foreword
The International Organization for Standardization (ISO) is a worldwide federation of national standardization bodies (ISO member bodies). The work of preparing international standards is usually done by ISO's technical committees. Each member body has the right to participate in the work of a committee interested in a project determined by a technical committee. International organizations (official or unofficial) that maintain ties with ISO may also participate in the work. ISO maintains a close cooperative relationship with the International Electrotechnical Commission (IEC) in the standardization of electrotechnical technology. International standards are developed in accordance with the rules of Part 3 of the ISO/IEC Directives. The draft international standard adopted by the technical committee is submitted to the member bodies for voting, and at least 75% of the member groups participating in the vote must be approved. Only with the consent of the technical committee can it be officially published as an international standard. When there is a special need, such as the technical committee has collected different information from those who have officially published it as an international standard, the technical committee can decide whether to publish a technical report by a simple majority vote. In terms of nature, technical reports are purely informational and will only be reviewed when the information provided in the technical report is considered outdated or no longer useful. Some of the contents of this technical report may involve some patent issues, which should be noted. ISO is not responsible for identifying any such patent issues.
1SO/TR10013 was prepared by the ISO/TC176/SC3 Technical Committee on Quality Management and Quality Assurance with the support of the Technical Subcommittee. The first edition of IS0/TR10013 replaces TSO 10013.1995 Guide to the preparation of quality manuals. Introduction
GB/T 19023—2003/IS0/TR 10013:200 [ISO5000 family of international standards requires the organization's quality management system to be documented. This International Standard encourages organizations to adopt a process approach to establish and implement a quality management system and improve its effectiveness: In order for an organization to operate effectively, it must identify and manage a number of related activities. The activities that transform inputs into outputs through the use of resources and management can be considered processes. Usually, the output of one process directly forms the input to the next process. The application of a system of processes within an organization, together with the identification and interaction of these processes and their management, can be called a "process approach". The advantage of the process approach is the continuous control of the links between individual processes in the system of processes and the combination and interaction of processes. Organizations can document their quality management systems in a flexible manner. The quality management system documents established by each organization should be sufficient to demonstrate that it has effectively planned, operated, controlled and continuously improved the quality management system and its processes. The quality management system documents may be related to all activities of the organization or selected parts of the activities. For example, the specified requirements depend on the type of product, process, contract requirements, applicable regulations or the organization itself. It is important that the requirements and content of the quality management system documents are adapted to the quality standards to be met. The guidance given in this standard is intended to help organizations document their quality management system. It is not intended to be a contractual, regulatory or certification/registration requirement.
One aspect of a quality management system is quality planning. Quality planning documents may include management and operational planning, the preparation for the application of the quality management system (including organization and process arrangements), and the methods for achieving quality objectives. 1 Scope
GB/T 19023—2003/IS0/TR 10013:200 Guide to quality management system documentation
This standard provides guidance for the establishment and maintenance of quality management system documents. These documents, which are appropriate to the specific needs of the organization, are necessary to ensure an effective quality management system. The use of the guide helps to establish a documented system in accordance with the requirements of the applicable quality management system standard. This standard is not only applicable to the documented quality management system to be established in accordance with the (GI/T19000 family of standards), but also to the documented environmental management system and safety management system. Note: When the procedure is documented, it is usually called a "written procedure" or a documented procedure. 2 Normative references The clauses in the following documents become the clauses of this standard through reference in this standard: For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard, however. The parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version applies to this standard. GB/T19000-2000 Basic Terminology of Quality Management System (ID: TSO9000:2000) 3 Terms and Definitions | |tt||This standard adopts the terms and definitions in GB/T19000 and the following terms and definitions: The quality management system of an organization may use different terms to name its document types.
Work instructions
Detailed description of how the work is to be performed and recorded. Method 1: Work instructions may be documented or not. Note: Work instructions may be detailed written descriptions, flow charts, diagrams, models, technical notes in drawings, specifications, equipment manuals, films, videos, inspection requests, or a combination of these methods. Work instructions should describe any materials, equipment and documents used. If necessary, work instructions may also include acceptance criteria.
Form trm
The nature of the data required by the quality management system. Note: When the form is filled with data, it becomes a record. 4 Quality management system documents
4.1 General
The preparation of quality management system documents is usually consistent with the structure of the organization's processes and/or appropriate quality standards. The organization may use any other method according to its own needs. The quality management system documents can adopt a hierarchical structure from top to bottom. This document structure is conducive to the issuance, maintenance and understanding of documents. Appendix A illustrates a typical hierarchical quality management system document. The hierarchical structure of the document depends on the specific circumstances of the organization. The model of quality management system documents varies depending on the differences in the following aspects of the organization: a) the size of the organization and the type of activities;
GB/T 19023-2003/IS0/TR 10013:2001 h) the complexity of the processes and their interactions; c) the capabilities of the personnel.
Quality management system documents may include definitions. The vocabulary used should be consistent with the usage of terms and definitions in GB/T19000 or common academic standards.
Quality management system documents usually include:
Quality standards and targets:
b) Quality manual;
|Procedure documents:
d) Work instructions;
e) Forms;
Quality plan:
g) Specifications;
External documents:
i) Records,
Quality management system documents can use any type of media, such as hard copy or electronic media. Note: The use of electronic media has the following advantages: a) Relevant personnel can access the same latest information at any time; h) Access and changes are easy to create and control; In the form of printed hard copies, distribution is fast and more controlled; d) Remote access to documents can be achieved;
Work is simple and efficient in document retrieval.
4.2 Purpose and rolebzxZ.net
Documenting the organization's quality management system can achieve (but not limited to) the following purposes and roles: a) Describing the organization's quality management system:
Providing information to cross-functional teams to help them better understand their relationships;
Communicating management's commitment to quality to employees; e) Helping employees understand their role in the organization, thereby deepening their understanding of the importance of basic work and enabling managers and employees to reach a consensus;
Providing a basis for expected work performance and
explaining how to achieve the specified requirements;
Providing Objective evidence that the process meets the specified requirements: Provide a clear and effective operating framework;
Provide a basis for training new employees and regular retraining of existing employees; k)
Lay the foundation for order and stability in the organization: Achieve consistency of operations by documenting the process; m)
Provide a basis for continuous improvement:
Provide confidence to customers by documenting the system and demonstrate the organization's capabilities to relevant parties;
Provide a clear framework for suppliers;
Provide a basis for quality management system review: Improve the ability to evaluate the effectiveness and continued suitability of the quality management system. 4.3 Quality policy and quality objectives
Quality policy and quality objectives should be documented and may be a separate document or part of a quality register. 2
4.4 Quality Manual
4.4.1 Content
GB/T19023—2003/ISO/TR10013:2001 The quality manual of each organization is unique. This standard allows organizations of all kinds to have flexibility in the structure, format, content or method of expression of the document when documenting their quality management system. For small organizations, it may be appropriate to write a description of the entire quality management system (including all procedure documents established in accordance with the requirements of GB/T19001) in a quality manual. For large, multinational organizations (such as multinational, national or regional), it may be necessary to form corresponding quality manuals at different levels, and the hierarchy of the documents is more complex. The quality manual should include the scope of the quality management system, any details and rationale for deletions, procedure documents or their references, and a description of the quality management system processes and their interactions. Relevant information about the organization, such as name, address and contact information, should also be included in the quality manual. The quality manual may also include additional information such as the organization's business processes, a brief description of the organization's background, history and size. The quality manual should include the content described in 4.4.2 to 4.4.9 (but not necessarily in the same order). 4.4.2 Title and scope
The title and (or) scope of the quality manual should clearly indicate the organization using the manual. The quality manual should reference the quality management system standard on which the quality management system is established.
4. 4. 3 Contents
The content of the quality manual should list the serial number, title and location of each part. 4. 4. 4 Review, approval and revision
The quality manual should clearly indicate the review, approval, revision status and date of the quality manual. When feasible, the nature of the change should be clearly stated in the document or attachment. 4.4.5 Quality policy and quality objectives
If the organization decides to state the quality policy in the quality manual, the quality manual may include a statement of the quality policy and quality objectives. The organization may decide to specify specific indicators for achieving quality objectives in other quality management system documents. The quality policy should include a commitment to meet requirements and continually improve the effectiveness of the quality management system. Quality objectives are usually derived from the organization's quality policy and are achievable. When quality objectives are quantified, objectives become indicators and are generally measurable:
4. 4.6 Organization, responsibilities and authorities
The quality manual should include a description of the organizational structure. Responsibilities, authorities and their relationships can be expressed in the form of organizational charts, flow charts and/or job descriptions. These documents can be directly included in the quality manual or referenced by the quality manual. 4.4.7 Referenced documents
The quality manual should include a list of referenced documents, but these referenced documents are not included in the quality manual. 4.4.8 Description of the quality management system
The quality manual shall describe the quality management system and its implementation. The quality manual shall also include a description of the processes and their interactions. The quality manual shall include or reference procedure documents. The organization shall document its quality management system in a sequence of processes, a structure of adopted standards, or any sequence that is appropriate to the organization. A comparison chart showing the relationship between the adopted standards and the contents of the quality manual can be an effective approach. The quality manual shall reflect the methods used by the organization to achieve its policies and objectives. 4.4.9 Appendix
The manual may include appendices containing supporting information. 4.5 Procedure Documentation
4.5.1 Structure and Format
The structure and format of procedure documents (hard copy or electronic media) shall be specified by the organization through text, flow charts, tables, a combination of these, or any other appropriate means required by the organization. The procedure document shall include the necessary information (see 4.5.2) and shall be uniquely identified. The procedure document may refer to the work instruction, which specifies the method of carrying out the activity. The procedure document usually describes cross-functional activities, while the work instruction usually applies to activities within a function. 4.5.2 Content 4.5.2.1 Title The title shall clearly identify the procedure document. 4.5.2. 2 Purpose
The procedure document shall specify its purpose,
4.5.2.3 Scope
The procedure document shall describe its scope, including applicable and inapplicable situations. 4.5.2.4 Responsibilities and authorities
The procedure document shall clearly define the responsibilities and authorities of personnel and/or management functional departments, and their interrelationships in the processes and activities described by the procedure. This may be clarified by means of flow charts and textual descriptions. 4.5.2.5 Description of activities
The level of detail in the description of an activity depends on the complexity of the activity, the methods used, and the level of skills and training required for the personnel performing the activity. Regardless of the level of detail, when applicable, the description of the activity shall be clearly defined. The description of activities should consider the following aspects: a) Identify the needs of the organization and its customers and suppliers: describe the process in the form of a verbal description and/or a flow chart related to the required activities; clarify what is done, who or which function does it, why, when, where and how it is done; c) Describe process control and control of identified activities; clarify the resources (people, training, equipment and materials) required to complete the activities: f) Identify the documents related to the required activities; clarify the inputs and outputs of the process; h) Identify the measurements to be performed. The organization may decide whether it is more appropriate to describe some of the above in the work instructions. 4.5.2.6 Records
Records of activities covered should be specified in this or other relevant parts of the procedure document. The forms used for these records should be specified, where applicable, and the methods for completing, filing and maintaining records should be specified. 4.5.2.7 Appendices
Appendices should be included in the procedure document, which contain supporting information such as charts, flow charts and tables. 4.5.3 Review, approval and revision
The status and period of review and approval and revision of the procedure document should be specified. 4.5.4 Identification of changes
When feasible, the nature of the changes should be specified in the document and its annexes. 4.6 Work Instructions
4.6.1 Structure and Format
Work instructions should be developed and maintained for all activities that would have an adverse effect without them. Work instructions can be developed and presented in a variety of ways: Work instructions should include a title and a unique identifier (this content is described in 4.6.4). The structure, format and level of detail of the work instructions should be appropriate to the needs of the organization's personnel responsible for use, and depend on the complexity of the activities, the methods used, the training for implementation, and the skills and qualifications of the personnel. The structure of the work instructions may be different from the procedure documents. Work instructions may be included in or referenced by the procedure documents. 4
4.6.2 Content
GB/T 19023—2003/1S0/TR 10013:200 Work instructions should be related to the activities described. The level of detail of the work instructions should be sufficient to control the activities. Training can reduce the need for detailed work instructions if the relevant personnel have been provided with the necessary information to carry out the work accurately. 4.6.3 Types of work instructions
Although there is no requirement for the structure and format of work instructions, work instructions usually describe the purpose and scope of the work and its objectives, and refer to relevant procedural documents: Whatever the format or combination, the work instructions should be consistent with the sequence of the work and accurately reflect the requirements and related activities. To avoid confusion and uncertainty, the format or structure of work instructions should be defined and maintained consistently. Examples of work instructions are given in Annex B. 4.6.4 Review, approval and revision
The organization shall provide clear evidence of the review and approval of work instructions and the status and date of revision. 4.6.5 Records
Where applicable, the records specified in the work instructions shall be specified in this section or other relevant sections: The minimum records required are specified in GB/T 19001. The work instructions shall specify the method of filling in, filing and maintaining records, and where applicable, the form to be used for these records.
4.6.6 Identification of changes
Where practicable, the nature of the change shall be clearly stated in the document or in an associated attachment. 4.7 Forms
Forms are developed and maintained to record relevant data to demonstrate that the requirements of the quality management system have been met. The forms shall include a title, identification number, revision status and date: The forms shall be referenced or attached to the quality management system, procedure documents and/or work instructions.
4.8 Quality plan
The quality plan is an integral part of the quality management system documents. The quality plan only needs to reference the quality management system documents to explain how they apply to the specific situation, clearly define how the organization will meet the specific requirements involved in the specific product process, project or contract, and document the scope of the quality plan. The quality plan may include specific procedures, work instructions and/or records. 4.9 Specifications
Specifications are documents that state requirements. Since specifications are completely dependent on the product or organization, the standard does not further discuss specifications.
4.10 External Documents
The organization shall clearly identify external documents in the quality management system documents and control them. External documents include customer drawings, specifications, legal and regulatory requirements, standards, regulations and maintenance manuals. 4.11 Records
Quality management system records shall state the results obtained or provide evidence to show that the activities specified in the procedures and work instructions have been carried out. Records shall be able to show that the requirements of the quality management system and the specified requirements of the product have been met. The responsibility for records shall be stated in the quality management system documents. NOTE: Since records cannot be changed, revision control is not normally applied to them. 5. Preparation process of quality management system documents
5.1 Responsibilities for preparation
The quality management system documents should be organized by the personnel responsible for the processes and activities. This will help employees to deepen their understanding of the necessary requirements and give employees a sense of participation and responsibility. The evaluation and use of existing documents and referenced documents will significantly shorten the preparation time of quality management system documents. At the same time, it will also help to identify deficiencies in the quality management system so that they can be remedied and corrected. 5.2 Preparation method of quality management system documents
An organization that is about to or is implementing a quality management system should: a) identify the processes required to effectively implement the quality management system; b) understand the interactions between these processes; c) document these processes to the extent necessary to ensure their effective operation and control. The amount of documentation required for a quality management system depends on the analysis of the process, and the process should not be determined by the documents: the order in which quality management system documents are prepared does not necessarily have to be carried out from top to bottom according to the hierarchical structure shown in Appendix A, because the quality manual is usually completed after the procedure documents and work instructions are completed. Examples of basic activities for writing quality management system documents are given below (when applicable): 1) Determine the applicable quality management system documentation requirements based on the selected quality management system standard; h)
Collect data on the existing quality management system and processes through various means, such as questionnaires and interviews; List existing applicable quality management system documents and analyze these documents to determine their applicability; d)
Train those involved in document preparation in document preparation and the applicable quality management system standard or other selected criteria; e
Seek and obtain other source documents or reference documents from operating departments; f)
Determine the structure and format of the document to be prepared; Prepare a flow chart covering all processes applicable to the quality management system; h)
Analyze the flow chart to identify possible improvements and implement these improvements; Confirm these documents through trial operation;
) Complete the quality management system documents within the organization using other appropriate methods; k) Review and approve the documents before release. 5.3 Use of referenced documents
Where appropriate, in order to limit the size of the document, reference may be made to existing recognized documents that are available to the quality management system or users:
When referencing documents, avoid specifying the revision status of the referenced document to avoid making the reference invalid due to the revision of the referenced document. 6 Approval, release and control process of quality management system documents 6.1 Review and approval
Before release, the document should be reviewed by authorized personnel to ensure that it is clear, accurate, sufficient and appropriately structured. The users of the document should also have the opportunity to evaluate and comment on the applicability of the document and whether it reflects the actual situation. The release of the document should be approved by the management responsible for its implementation. Each document should have evidence of authorized release. The organization should retain evidence of document approval 6.2 Distribution
The method of distributing documents by authorized personnel should ensure that all persons who need the document can obtain the correct version of the applicable document. The correct distribution and control of documents can be assisted by methods such as the use of serial numbers for each copy of the document received by the recipient. The distribution of quality registers and quality plans may involve external personnel (such as customers, certification bodies and regulatory authorities). 6.3 Changes
The process for proposing, implementing, evaluating, controlling and incorporating changes to the document history should be specified. The process for document updates should be subject to the same review and approval process as the original document.
6.4 Release and change control
The release and change control of documents is necessary to ensure that the content of the document is approved by authorized personnel and has a clear approval mark. Various methods can be used to implement the change process of the document. The organization should establish a process to ensure that the documents used are applicable. In some cases, the applicable document used may not be the latest revised document. The latest revised document should replace the modified document, and a document list that indicates the revision status of the document can be used to ensure that the user is using the approved and correct version of the document. The organization should consider recording the history of document changes to meet legal and regulatory requirements and (or) the need for knowledge accumulation. 6.5 Uncontrolled Documents
Documents used for bidding, off-site use by customers, and other special releases are not required to be controlled for changes. Such documents should be clearly marked as uncontrolled documents.
Note: If such documents are not effectively controlled, it may lead to the mistake of invalidating the documents.
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