Some standard content:
GB/T19023—1996
This standard is equivalent to ISO10013:1995 "Guide to the Preparation of Quality Manuals". Appendix A, Appendix B, Appendix C and Appendix D of this standard are all indicative appendices. This standard is proposed and managed by the National Technical Committee for Standardization of Quality Management and Quality Assurance (CSBTS/TC151). This standard was drafted by the China Institute of Standardization and Information Classification and Coding. Drafting units of this standard: China Institute of Standardization and Information Classification and Coding, China National Accreditation Committee for Quality System Certification Bodies, China New Era Quality System Certification Center, 708 Institute of China Aerospace Industry Corporation. The main drafters of this standard: Li Tienan, Chen Zhitian, Li Renliang, Xu Yougang, Cao Chun, Zhang Zhizhen, Bo Yumin, Yu Dan GB/T19023—1996
ISO Foreword
ISO (International Organization for Standardization) is a worldwide federation composed of national standardization bodies (ISO member bodies). The work of formulating international standards is usually completed by ISO's technical committees. If a member group is interested in a project established by a technical committee, it has the right to participate in the work of the committee. International organizations (official or unofficial) that maintain contact with ISD may also participate in the relevant work. In the field of electrotechnical standardization, ISO maintains a close cooperative relationship with the International Electrotechnical Commission (IEC). The draft international standard adopted by the technical committee is submitted to the member groups for voting. It must obtain the approval of at least 75% of the member groups participating in the voting before it can be officially published as an international standard. International Standard ISO10013 was developed by the ISO/TC176/SC3 International Organization for Standardization Technical Committee on Quality Management and Quality Assurance Supporting Technical Subcommittee.
Appendix A, Appendix B, Appendix C, and Appendix D of this standard are for reference only. GB/T 19023—1996
The ISO9000 family of international standards includes requirements for quality systems that enable consistent interpretation, development, implementation and application of quality management and quality assurance. The ISO9000 family of international standards requires the development and implementation of a documented quality system, including the preparation of a quality manual. GB/T6583-1994 "Quality Management and Quality Assurance Terms" idt ISO8402:1994) defines quality manual as: a document that states the quality policy of an organization and describes its quality system. The quality manual may cover all activities of an organization or selected parts of its activities. For example, specific requirements may be specified according to the product or service, process, contract requirements, government regulations or the nature of the organization itself. It is important that the requirements and content of the quality system and quality manual should reflect the quality standards that are expected to be met. This standard provides guidance for the preparation of quality manuals
1 Scope
National Standard of the People's Republic of China
Guidelines for developing
qualitymanuals
GB/T19023-1996
dt ISO 10013:1995
This standard provides guidance for the development, preparation and control of quality manuals, which users can tailor according to their specific needs. The most complete quality manual will reflect the documented quality system procedures required by the ISO 9000 family of standards. This standard does not cover detailed work instructions, quality plans, work manuals and other quality system related documents (see Appendix A and C). Note: This standard can also be used for the preparation of quality manuals for quality system standards other than the ISO D family of standards. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. At the time of publication of this standard, the versions shown are valid. All standards will be revised, and parties using this standard should explore the possibility of using the latest versions of the following standards. GB/T6583-1994 Quality Principles and Quality Assurance Terms (idtISO&402:1994) 3 Definitions
This standard adopts the definitions in GB/T6583-1991. 4 Quality System Documents
Appendix A gives a typical quality system document hierarchy. In any organization, the order in which these documents are prepared depends on the specific circumstances of the organization. Generally, the organization's quality policy and objectives should be formulated first. 4.1 Documented quality system procedures
Documented quality system procedures shall form the basis for the overall planning and management of activities that affect quality. According to the ISO 9000 family of standards, these documented procedures shall include all applicable elements of the quality system standard, describe the roles, authorities and relationships of personnel involved in the management, execution, verification and review of quality-related activities to a level of detail sufficient to adequately control the activities involved, and describe how the various activities are accomplished, the documents used and the controls applied (see Annex A). 4.1.1 Scope of procedures
Each documented procedure shall cover a logically separate part of the quality system, such as a complete quality system requirement or part thereof, or a group of interrelated activities related to more than one quality system element. The number of documented procedures, the content of each procedure and its format and presentation are determined by the user of this standard and are generally reflective of the complexity of the facility, the composition of the organization and the characteristics of the business. Documented quality system procedures shall not involve purely technical details, which are usually specified in the work instructions of the entity.
4.1.2 Unified approach
Each documented procedure shall have a consistent structure and format so that users are familiar with the unified approach for each requirement and enhance the ability to systematically meet the requirements of the standard. Approved by the State Administration of Technical Supervision on April 4, 1996 and implemented on October 1, 1996
4.2 Quality Manual
CB/T 19023: 1996
The quality manual shall include or reference the documented quality system procedures compiled for the overall planning and management of activities affecting quality within the organization. The quality manual shall cover all applicable elements of the quality system standards required by the organization and shall appropriately address the same control content mentioned in 4.1+. In some cases, the relevant documented quality system procedures may be the same as certain chapters in the quality manual, but usually a certain degree of tailoring is required to ensure that only the documented procedures (or chapters therein) that are appropriate to the specific quality manual being compiled are selected. Chapter 7 describes the content of the quality manual in detail. If necessary, documented procedures related to the quality system that are not covered in the selected quality system standard but are necessary for appropriate control of activities should be added to the quality manual or cited as a reference (see Appendix 13).
Note that the content of proprietary information is handled by the organization. 4.2.1 Purpose of the quality manual
Each organization prepares and uses a quality manual to deliver the following (but not limited to): a) communicate the organization's quality policy, procedures and requirements b) describe and implement an effective quality system; c) provide improved control and promote assurance activities; d) provide a documented basis for auditing the quality system; e) ensure the continuity of the quality system and its requirements when circumstances change; train personnel on quality system requirements and their implementation methods; g) demonstrate its quality system to the outside, such as demonstrating compliance with GB/T19001-1994, GB/T19002-1994 or CB/T19003-1994;
Prove that the quality system meets the quality requirements under the contract. 4.2.2 Structure and format
There are no universal requirements for the structure or format of the quality manual, but it should accurately, completely and concisely describe the organization's quality policy, quality objectives and documented procedures that govern it (see Clause 6). One way to ensure that the main issues are properly described and arranged is to map the sections of the quality manual to the quality elements of the underlying quality system standard. Other appropriate approaches may also be used, such as arranging the structure of the quality manual to reflect the characteristics of the organization. NOTE Any quality system elements of the underlying quality system standard that are omitted from the quality manual should be explained for the purpose of clarifying the system and making the assessment.
4.2.3 Format of the quality manual
The quality manual may be:
a) a direct compilation of documented quality system procedures; h) a set of documented quality system procedures; c) a set of documented procedures applicable to a specific facility! t) Multiple copies or multiple layers of documents;
e) Common core document with tailored appendices;) Individual versions or other forms,
B) Various other possible derivative documents depending on the needs of the organization. 4.2.4 Specific application of the quality manual
When the same manual is used for both quality management and quality assurance purposes, it is referred to as the "quality manual", which is the most common. When the organization considers it necessary to distinguish between the manuals in terms of content or purpose, it must ensure that there is no conflict between the manuals describing the same quality system. Any quality manual should clearly define the management responsibilities and explain or reference the procedures of the documented quality system to outline all applicable requirements of the quality system standard selected by the organization. 5 Quality manual preparation process
5.1 Preparation responsibilities
GB/T19023—1996
When management decides to document the quality system in the form of a quality manual, it should first appoint a competent organization authorized by management to be responsible for the coordination work. The organization can be only one person or a group of people from one or more functional departments. If appropriate, the actual preparation work should be completed and controlled by the authorized competent organization, or carried out separately by each functional department. The use of existing documents and reference materials can help identify deficiencies in the quality system that need attention and correction, and can greatly shorten the time required to prepare a quality manual.
If appropriate, the competent organization may take the following steps: a) Determine and list the current applicable quality system policies, objectives and documented procedures, or prepare a corresponding plan; b) Determine the applicable quality system elements based on the selected quality system standard; c) Collect information about the current quality system and practices using various methods such as surveys or interviews; d) Collect additional original documents or reference materials from business units; e) Determine the structure and format of the manual to be compiled; f) Classify existing documents according to the expected structure and format; g) Prepare a draft quality manual using any other method suitable for the organization. 5.2 Use of References
If appropriate, references to currently valid standards or documents available to users of the manual should be made in the manual to avoid excessive length of the manual.
5.3 Accuracy and completeness
The authorized competent body shall be responsible for ensuring the accuracy and completeness of the draft quality manual and for the continuity and content of the document. 6 Quality Manual Approval, Distribution and Control Process 6.1 Final Review and Approval
Before the manual is issued, it shall be reviewed by responsible personnel to ensure that it is clear, accurate, applicable and well-structured. The intended users shall also have the opportunity to assess and comment on the usability of the manual. It shall then be approved for distribution by the management responsible for implementing the quality manual. All texts shall be marked as approved for distribution. Electronic or other manual distribution methods may be used if evidence of approval can be preserved. 6.2 Distribution of the Manual
The approved distribution method for the manual (whether in its entirety or by chapter) shall ensure that all users have appropriate access to the manual. Reasonable distribution and control methods shall be used, for example, texts may be provided to recipients in sequential numbers. Management shall ensure that each user in the organization is familiar with the content of the manual that is relevant to him or her. 6.3 Incorporation of Changes
The method for proposing, preparing, reviewing, controlling, and incorporating changes to the manual shall be specified. This work shall be delegated to the appropriate document control function. The same review and approval process used to prepare the base manual shall also be applied to handling changes. 6.4 Release and Change Control
Document release and change control is essential to ensure that the contents of the manual are properly approved and that the approved contents are easily identifiable. Consideration shall be given to various methods to facilitate the actual implementation of changes. To ensure that each manual is current and valid, appropriate methods shall be used to ensure that each holder of the manual receives all changes and incorporates them into the manual. Tables of contents, individual revision status, or other appropriate methods may be used to ensure that the user holds the approved manual.
6.5 Uncontrolled Text
When no change control is applied to manuals distributed for bidding, customer site use, and other purposes, all such manuals shall be clearly marked as uncontrolled texts.
Note that failure to ensure the implementation of this process may result in the unintended use of outdated texts. 7 Contents of the quality manual
7.1 General
The quality manual should normally include the following contents:
) Title, scope and applicable areas
h) Date
c) Introduction page of the organization and the manual itself
d) The quality policy and objectives of the organization
) Description of the organizational structure, responsibilities and authorities
GB/T 19023—1996
f) Description of the quality system elements and referenced documented quality system procedures; g) Definitions (if necessary);
h) Guidelines for the use of the quality manual (if necessary); [{) Appendix of supporting materials (if necessary). Note: The order of the contents of the quality manual can be determined according to the needs of the user. 7.2 Title, scope and applicable areas
The title and scope of the quality manual should clearly specify the organization to which the manual applies. This chapter of the quality manual should also specify the quality system elements used. To ensure clarity and avoid confusion, the negative method can also be used (such as what the quality manual does not cover and in which occasions it should not be used). Some or all of these contents are also placed in the title. 7.3 Table of Contents
The table of contents of the quality manual should list the titles of each chapter in the manual and the search method. The numbering and classification system of each chapter, section, page number, chart, diagram, illustration and table should be precise and reasonable. 7.4 Introduction page
The introduction page of the quality manual should give basic information about the organization and quality management. The information of the organization should at least include its name, location and general introduction. A brief description of the nature of the business, background, history and scale can also be added.
Information related to the quality manual itself should include: a) Current version or effective identification, release date, or validity period and modification content b) A brief description of how the quality manual is revised and maintained, such as who reviews the contents of the quality manual, the review cycle, who is authorized to make changes and who approves them, etc.: These contents can also be described in the relevant quality system elements. If appropriate, how to record changes to the procedures should also be specified: c) A brief description of the procedures for identifying the status of the quality manual and controlling its distribution, whether it contains confidential information, is it only for internal use within the organization or can it be used externally: d) Evidence of approval by the person responsible for the contents of the quality manual. 7.5 Quality-based policies and objectives
This section of the quality manual should state the organization's quality policy and objectives, and clearly define the organization's The quality policy should also describe how the quality policy is known and understood by all employees and how it is implemented and maintained at all levels. Specific statements of the quality policy may also be made in the relevant quality system elements. Note: Subsequent chapters or system requirements of the manual may also be used to reflect the implementation of the quality policy and objectives and the connection with the quality objectives and goals. 7.6 Description of organization, responsibilities and authorities
This chapter of the quality manual should give a description of the high-level structure of the organization. It may also include an organizational structure diagram showing responsibilities, authorities and relationships. Detailed descriptions should be given in this chapter or in the referenced system element procedures. Explain the responsibilities, authorities and subordinate relationships of various departments that manage, execute and verify the work that affects quality.
7.7 Quality system elements
The remaining chapters of the quality manual should describe all applicable quality system elements. The division of chapters should be reasonable and should reflect the good coordination of the quality system. The description of the elements can directly include or reference the documented quality system procedures. Each organization's quality system and quality manual are unique. Therefore, this standard does not intend to specify a unified structure format, content or expression method for the description of quality system elements applicable to all (or certain) products, including services. GB/T 19023—1996
Requirements for the quality system elements are given by the ISO 9000 family of standards or other applicable standards selected by the organization. Whenever appropriate, it is recommended that the sequence numbers in the selected standard be consistent when describing the quality system elements. Other sequences or comparison tables may be used if appropriate. After selecting the appropriate standard, each organization should determine the applicable quality system elements and specify how the organization should apply, complete and control each selected element in accordance with the requirements of these requirements in the standard. In order to determine the most appropriate approach for the organization, consideration should be given to: - the nature of the business, workforce and resources; - the focus of quality system documents and quality assurance; - the distinction between policies, procedures and work instructions; and - the media selected for the quality manual.
The final quality manual should reflect the organization's unique approach and actions to meet the requirements specified in the selected quality system standards and quality system elements. The methods and actions taken by the organization to fulfill its commitment to meet the requirements should be clear to the users of the manual (see Appendix C). 7.8 Definitions
If it is considered necessary to have a chapter on definitions in the manual, it should be placed directly after "Scope and Scope of Application". Although it is recommended to use the standard terms and definitions in recognized quality terminology documents or general dictionaries, this chapter in the quality manual should also include definitions of its special terms and concepts. Special attention should be paid to words that have different meanings to different people or words that have specific meanings to specific industries. These definitions should give a complete, unified and clear explanation of the contents of the quality manual. It is recommended to use existing concepts, terms, definitions and standards (such as GB/T 6583-1994) as much as possible.
7. 9 Guidelines for the use of the quality manual
You can consider providing an index, or a comparison table of topics and keywords with chapters or page numbers, or other guidelines for quickly finding the contents of the quality manual and the chapters they are in. It can also include the layout of the quality manual and a brief summary of each chapter. This allows readers to find the content they are concerned about.
7.10 Appendix of supporting information
The quality manual may also include an appendix of supporting information for the quality manual GB/T 19023, 1996
Appendix A
(Suggestive Appendix)
Typical quality system document hierarchy
Quality manual
(Level A)
Documented
Quality system procedures
(Level R)
Other quality documents
(Work instructions, reports, formats, etc.)
(Level)
Note: Any of the document levels may be separated, referenced or combined. Appendix B
(Suggestive Appendix)
Example of the format that can be used for a section of the quality manualOrganization
Issuing department
Policy/reference to policy
Give management requirements.
Introduction and scope
Title/Subject
Approved by
List the purpose, intent, areas covered and not covered. Functions
Propose the department responsible for implementing the document to achieve the purpose. Version
Document content
Directly specify the quality policy and objectives and the standards used
Quality system
Summary of the activities of each functional department required to implement the quality system elements
Detailed working conditions
Title/Subject
Measures and methods to achieve the requirements of the system elements GB/T 19023--1996
Continued Table B
List what needs to be done step by step, and cite references and documents as necessary. Keep the order of arrangement reasonable and indicate any exceptions or special scopes with notes. Consider using a flow chart.
Documents and references
Specify the referenced documents and tables involved in the use of the document, or the data that must be recorded. Give examples, if necessary. Records
Specify the records generated when the document is used, and the location and period of retention of the records. NOTE
1 This format can also be used for documented quality system procedures. 2 The structure and order of the items listed above depend on the needs of the organization. 3 The approval and version of the document should be identified.
NOTE 8: This is only an example; the actual structure should be based on the needs of the user.
4.17 Internal quality audits
The supplier shall establish and maintain procedures for planning and conducting internal quality audits to verify that quality activities and meaningful results are in accordance with the planned arrangements and to determine the effectiveness of the quality system.
Internal quality audits shall be planned based on the actual situation and importance of the activities being audited and shall be conducted by personnel who have no direct responsibility for the activities being audited.
The results of the quality control review should be recorded (see 4.16) and brought to the attention of the responsible personnel in the audited area. For any problems found during the audit, the management personnel responsible for the area should take corrective measures in a timely manner. During the review activities, the implementation and effectiveness of the corrective actions taken shall be verified and recorded (see 4.16).
1. The results of the internal quality audit are part of the input to the management review activity 1 (see 4.1.3).
2. GB/T J902] --IS(10011 gives guidance on quality system audits.
LGB/T 19001-ISO 9001:1994J
GB/T19023—1996
Appendix C
(Suggested Appendix)
Example of a quality manual section
Issuing department
4.17. 1 Policy
4.17 Internal quality review
Approving person
1994-1-01
QA 5G7-R
Quality audits should be conducted regularly to verify whether quality-based activities and related results are in accordance with the planned arrangements and to determine the effectiveness of the quality system. 4.17.2 The procedures of the quality manual are applicable to the quality system audit, product audit and production process audit. 4.17.3 Responsibilities
The quality manager is responsible for the content of the procedures in this document and ensures its implementation. 4.17.1 Measures and methods
4.17.4.1 Characteristics of the audit
The quality system requirements specified in the quality manual are the basis for the quality system audit. The objects of the quality system audit are the functions that have a significant impact on product quality. Product quality audits are conducted in accordance with the requirements for finished products. Product quality audits are applicable to products manufactured in series:
Process quality audits are conducted in accordance with the requirements for process results. Process quality audits are applicable to wave soldering and injection molding processes.
4.17. 4. 2 Audit scope and planning
The scope of the audit depends on the importance of the activity under consideration and the degree of understanding of existing or potential problems. The frequency of audits shall be at least; quality system audits once a year; product quality audits twice a year; and process quality audits once a year. The audit plan shall be prepared and documented annually. Checklists shall be prepared as an aid. 4.17.4.3 Auditors
All audits shall be conducted by personnel selected from the quality department. 4.17.4.4 Audit report
An audit report shall be prepared every autumn. The report shall include basic information about the audit object, the requirements used as the basis for the audit, and any nonconformities found that do not meet the requirements. The audit report shall be distributed to the relevant managers. The report on the observations of the quality system audit shall be filled in according to the format of Appendix 9.
4.17.4.5 Decisions and actions
The manager of the relevant department is responsible for ensuring that decisions and actions are made as soon as possible based on the observations received.
4.17.4. 6 Tracking
The quantity department shall track the implementation of the measures through continuous monitoring or by directly tracking the next review. The results of the follow-up shall be documented in the form of an audit report.
4.17.4.7 The results of the physical review of the audit results and the observations of the follow-up shall be submitted to the quality department manager for management review. See Section 4.1 of this manual.
44.17.5 Reference Materials
This chapter of the quality manual is based on the quality system procedure QA123.4\Internal Quality Audit\. 14.17.6 Records
The audit report, including the follow-up records, shall be submitted to the quality department for archiving and preservation in accordance with the quality record procedure for at least 5 years. See Chapter 4.16 of this quality manual. GB/T 19023—1996
Appendix D
(Suggested Appendix)
Bibliography
(1) GB/T 19000,1
11994 (idtISO9000-1:1994), Quality management and quality assurance standards Part 1: Selection and use of guidelines
(2) GB/19001-1994 (idtISO9001:1994), Quality system design, development, production, installation and service quality assurance model
Quality assurance model for production, installation and service (3) GB/T19002-1994 (idt1S0 9002:1994), Quality system (4) GB/T19003-1994 (idtISO90031994), Quality system final inspection and testing quality assurance model 5) GB/T19004.1-1994 (idtISO9004-1:1994), Quality management and quality system elements Part 1: Guide1994), Quality management and quality system elements Part 1: Guidance1994), Quality management and quality system elements Part 1: Guidance10 Appendix of supporting information
The quality manual may also include appendices of supporting information for the quality manual GB/T19023, 1996
Appendix A
(Suggestive Appendix)
Typical quality system document hierarchy
Quality manual
(Level A)
Documented
Quality system procedures
(Level R)
Other quality documents
(Work instructions, reports, formats, etc.)
(Level)
Note: Any of the document levels may be separated, referenced or combined. Appendix B
(Suggestive Appendix)
Example of the format that can be used for a section of the quality manualOrganization
Issuing department
Policy/reference to policy
Give management requirements.
Introduction and scope
Title/Subject
Approved by
List the purpose, intent, areas covered and not covered. Functions
Propose the department responsible for implementing the document to achieve the purpose. Version
Document content
Directly specify the quality policy and objectives and the standards used
Quality system
Summary of the activities of each functional department required to implement the quality system elements
Detailed working conditions
Title/Subject
Measures and methods to achieve the requirements of the system elements GB/T 19023--1996
Continued Table B
List what needs to be done step by step, and cite references and documents as necessary. Keep the order of arrangement reasonable and indicate any exceptions or special scopes with notes. Consider using a flow chart.
Documents and references
Specify the referenced documents and tables involved in the use of the document, or the data that must be recorded. Give examples, if necessary. Records
Specify the records generated when the document is used, and the location and period of retention of the records. NOTE
1 This format can also be used for documented quality system procedures. 2 The structure and order of the items listed above depend on the needs of the organization. 3 The approval and version of the document should be identified.
NOTE 8: This is only an example; the actual structure should be based on the needs of the user.
4.17 Internal quality audits
The supplier shall establish and maintain procedures for planning and conducting internal quality audits to verify that quality activities and meaningful results are in accordance with the planned arrangements and to determine the effectiveness of the quality system.
Internal quality audits shall be planned based on the actual situation and importance of the activities being audited and shall be conducted by personnel who have no direct responsibility for the activities being audited.
The results of the quality control review should be recorded (see 4.16) and brought to the attention of the responsible personnel in the audited area. For any problems found during the audit, the management personnel responsible for the area should take corrective measures in a timely manner. During the review activities, the implementation and effectiveness of the corrective actions taken shall be verified and recorded (see 4.16).
1. The results of the internal quality audit are part of the input to the management review activity 1 (see 4.1.3).
2. GB/T J902] --IS(10011 gives guidance on quality system audits.
LGB/T 19001-ISO 9001:1994J
GB/T19023—1996
Appendix C
(Suggested Appendix)
Example of a quality manual section
Issuing department
4.17. 1 Policy
4.17 Internal quality review
Approving person
1994-1-01
QA 5G7-R
Quality audits should be conducted regularly to verify whether quality-based activities and related results are in accordance with the planned arrangements and to determine the effectiveness of the quality system. 4.17.2 The procedures of the quality manual are applicable to the quality system audit, product audit and production process audit. 4.17.3 Responsibilities
The quality manager is responsible for the content of the procedures in this document and ensures its implementation. 4.17.1 Measures and methods
4.17.4.1 Characteristics of the audit
The quality system requirements specified in the quality manual are the basis for the quality system audit. The objects of the quality system audit are the functions that have a significant impact on product quality. Product quality audits are conducted in accordance with the requirements for finished products. Product quality audits are applicable to products manufactured in series:
Process quality audits are conducted in accordance with the requirements for process results. Process quality audits are applicable to wave soldering and injection molding processes.
4.17. 4. 2 Audit scope and planning
The scope of the audit depends on the importance of the activity under consideration and the degree of understanding of existing or potential problems. The frequency of audits shall be at least; quality system audits once a year; product quality audits twice a year; and process quality audits once a year. The audit plan shall be prepared and documented annually. Checklists shall be prepared as an aid. 4.17.4.3 Auditors
All audits shall be conducted by personnel selected from the quality department. 4.17.4.4 Audit report
An audit report shall be prepared every autumn. The report shall include basic information about the audit object, the requirements used as the basis for the audit, and any nonconformities found that do not meet the requirements. The audit report shall be distributed to the relevant managers. The report on the observations of the quality system audit shall be filled in according to the format of Appendix 9.
4.17.4.5 Decisions and actions
The manager of the relevant department is responsible for ensuring that decisions and actions are made as soon as possible based on the observations received.
4.17.4. 6 Tracking
The quantity department shall track the implementation of the measures through continuous monitoring or by directly tracking the next review. The results of the follow-up shall be documented in the form of an audit report.
4.17.4.7 The results of the physical review of the audit results and the observations of the follow-up shall be submitted to the quality department manager for management review. See Section 4.1 of this manual.
44.17.5 Reference Materials
This chapter of the quality manual is based on the quality system procedure QA123.4\Internal Quality Audit\. 14.17.6 Records
The audit report, including the follow-up records, shall be submitted to the quality department for archiving and preservation in accordance with the quality record procedure for at least 5 years. See Chapter 4.16 of this quality manual. GB/T 19023—1996
Appendix D
(Suggested Appendix)
Bibliography
(1) GB/T 19000,1
11994 (idtISO9000-1:1994), Quality management and quality assurance standards Part 1: Selection and use of guidelines
(2) GB/19001-1994 (idtISO9001:1994), Quality system design, development, production, installation and service quality assurance model
Quality assurance model for production, installation and service (3) GB/T19002-1994 (idt1S0 9002:1994), Quality system (4) GB/T19003-1994 (idtISO90031994), Quality system final inspection and testing quality assurance model 5) GB/T19004.1-1994 (idtISO9004-1:1994), Quality management and quality system elements Part 1: Guide10 Appendix of supporting information
The quality manual may also include appendices of supporting information for the quality manual GB/T19023, 1996
Appendix A
(Suggestive Appendix)
Typical quality system document hierarchy
Quality manual
(Level A)
Documented
Quality system procedures
(Level R)
Other quality documents
(Work instructions, reports, formats, etc.)
(Level)
Note: Any of the document levels may be separated, referenced or combined. Appendix B
(Suggestive Appendix)
Example of the format that can be used for a section of the quality manualOrganization
Issuing department
Policy/reference to policy
Give management requirements.
Introduction and scope
Title/Subject
Approved by
List the purpose, intent, areas covered and not covered. Functions
Propose the department responsible for implementing the document to achieve the purpose. Version
Document content
Directly specify the quality policy and objectives and the standards used
Quality system
Summary of the activities of each functional department required to implement the quality system elements
Detailed working conditions
Title/Subject
Measures and methods to achieve the requirements of the system elements GB/T 19023--1996
Continued Table B
List what needs to be done step by step, and cite references and documents as necessary. Keep the order of arrangement reasonable and indicate any exceptions or special scopes with notes. Consider using a flow chart.
Documents and references
Specify the referenced documents and tables involved in the use of the document, or the data that must be recorded. Give examples, if necessary. Records
Specify the records generated when the document is used, and the location and period of retention of the records. NOTE
1 This format can also be used for documented quality system procedures. 2 The structure and order of the items listed above depend on the needs of the organization. 3 The approval and version of the document should be identified.
NOTE 8: This is only an example; the actual structure should be based on the needs of the user.
4.17 Internal quality audits
The supplier shall establish and maintain procedures for planning and conducting internal quality audits to verify that quality activities and meaningful results are in accordance with the planned arrangements and to determine the effectiveness of the quality system.
Internal quality audits shall be planned based on the actual situation and importance of the activities being audited and shall be conducted by personnel who have no direct responsibility for the activities being audited.
The results of the quality control review should be recorded (see 4.16) and brought to the attention of the responsible personnel in the audited area. For any problems found during the audit, the management personnel responsible for the area should take corrective measures in a timely manner. During the review activities, the implementation and effectiveness of the corrective actions taken shall be verified and recorded (see 4.16).
1. The results of the internal quality audit are part of the input to the management review activity 1 (see 4.1.3).
2. GB/T J902] --IS(10011 gives guidance on quality system audits.
LGB/T 19001-ISO 9001:1994J
GB/T19023—1996
Appendix C
(Suggested Appendix)
Example of a quality manual section
Issuing department
4.17. 1 Policy
4.17 Internal quality review
Approving person
1994-1-01
QA 5G7-R
Quality audits should be conducted regularly to verify whether quality-based activities and related results are in accordance with the planned arrangements and to determine the effectiveness of the quality system. 4.17.2 The procedures of the quality manual are applicable to the quality system audit, product audit and production process audit. 4.17.3 Responsibilities
The quality manager is responsible for the content of the procedures in this document and ensures its implementation. 4.17.1 Measures and methods
4.17.4.1 Characteristics of the audit
The quality system requirements specified in the quality manual are the basis for the quality system audit. The objects of the quality system audit are the functions that have a significant impact on product quality. Product quality audits are conducted in accordance with the requirements for finished products. Product quality audits are applicable to products manufactured in series:
Process quality audits are conducted in accordance with the requirements for process results. Process quality audits are applicable to wave soldering and injection molding processes.
4.17. 4. 2 Audit scope and planning
The scope of the audit depends on the importance of the activity under consideration and the degree of understanding of existing or potential problems. The frequency of audits shall be at least; quality system audits once a year; product quality audits twice a year; and process quality audits once a year. The audit plan shall be prepared and documented annually. Checklists shall be prepared as an aid. 4.17.4.3 Auditors
All audits shall be conducted by personnel selected from the quality department. 4.17.4.4 Audit report
An audit report shall be prepared every autumn. The report shall include basic information about the audit object, the requirements used as the basis for the audit, and any nonconformities found that do not meet the requirements. The audit report shall be distributed to the relevant managers. The report on the observations of the quality system audit shall be filled in according to the format of Appendix 9.
4.17.4.5 Decisions and actions
The manager of the relevant department is responsible for ensuring that decisions and actions are made as soon as possible based on the observations received.
4.17.4. 6 Tracking
The quantity department shall track the implementation of the measures through continuous monitoring or by directly tracking the next review. The results of the follow-up shall be documented in the form of an audit report.
4.17.4.7 The results of the physical review of the audit results and the observations of the follow-up shall be submitted to the quality department manager for management review. See Section 4.1 of this manual.
44.17.5 Reference Materials
This chapter of the quality manual is based on the quality system procedure QA123.4\Internal Quality Audit\. 14.17.6 Records
The audit report, including the follow-up records, shall be submitted to the quality department for archiving and preservation in accordance with the quality record procedure for at least 5 years. See Chapter 4.16 of this quality manual. GB/T 19023—1996
Appendix D
(Suggested Appendix)
Bibliography
(1) GB/T 19000,1
11994 (idtISO9000-1:1994), Quality management and quality assurance standards Part 1: Selection and use of guidelines
(2) GB/19001-1994 (idtISO9001:1994), Quality system design, development, production, installation and service quality assurance model
Quality assurance model for production, installation and service (3) GB/T19002-1994 (idt1S0 9002:1994), Quality system (4) GB/T19003-1994 (idtISO90031994), Quality system final inspection and testing quality assurance model 5) GB/T19004.1-1994 (idtISO9004-1:1994), Quality management and quality system elements Part 1: GuideReports, forms, etc.)
(Tanou)
Note: Any of the following documents may be separated, referenced or combined. Appendix B
(Informative Appendix)
Example of the format that may be used for a section of the quality manualOrganization
Issuing department
Policy/reference to policy
Give management requirements.
Format and scope
Title/subject
Approving person
List the purpose, intent, areas covered and not covered.Responsibility
Propose the department responsible for implementing the document to achieve the purpose. Version
Document content
Describe the quality policy and objectives specified and the standards used
Quality system
Summary of the activities of each functional department required to implement the quality system elements
Detailed working conditions
Title/subject
Measures and methods to meet the requirements of the system elements GB/T 19023--1996
Continued Table B
List the things to be done step by step, and cite references if necessary. Keep a reasonable order and indicate any exceptions or special scopes with notes. Consider using a flow chart.
Documents and references
Specify the reference documents and tables involved in the use of this document, or the data that must be recorded. Give examples if necessary. Records
Specify the records generated when using this document and the storage location and retention period of the records. NOTE
1 This format can also be used to form a documented quality system procedure. 2 The structure and order of the items listed above shall be determined by the organization's needs. 3 The approval and version of the document shall be identified.
NOTE 8 This is only an example; the actual structure shall be determined by the needs of the user.
4.17 Internal quality audits
The supplier shall establish and maintain a documented procedure for planning and conducting internal quality audits to verify that quality activities and meaningful results conform to the planned arrangements and to determine the effectiveness of the quality system.
Internal quality audits shall be scheduled based on the actual situation and importance of the audited activities and shall be conducted by personnel who have no direct responsibility for the audited activities.
The results of the quality audits shall be recorded (see 4.16) and brought to the attention of the responsible personnel in the audited area. For any problems found during the audit, the management responsible for the area shall take timely corrective actions. During the review activities, the implementation and effectiveness of the corrective actions taken shall be verified and recorded (see 4.16).
1. The results of the internal quality audit are part of the input to the management review activity 1 (see 4.1.3).
2. GB/T J902] --IS(10011 gives guidance on quality system audits.
LGB/T 19001-ISO 9001:1994J
GB/T19023—1996bzxZ.net
Appendix C
(Suggested Appendix)
Example of a quality manual section
Issuing department
4.17. 1 Policy
4.17 Internal quality review
Approving person
1994-1-01
QA 5G7-R
Quality audits should be conducted regularly to verify whether quality-based activities and related results are in accordance with the planned arrangements and to determine the effectiveness of the quality system. 4.17.2 The procedures of the quality manual are applicable to the quality system audit, product audit and production process audit. 4.17.3 Responsibilities
The quality manager is responsible for the content of the procedures in this document and ensures its implementation. 4.17.1 Measures and methods
4.17.4.1 Characteristics of the audit
The quality system requirements specified in the quality manual are the basis for the quality system audit. The objects of the quality system audit are the functions that have a significant impact on product quality. Product quality audits are conducted in accordance with the requirements for finished products. Product quality audits are applicable to products manufactured in series:
Process quality audits are conducted in accordance with the requirements for process results. Process quality audits are applicable to wave soldering and injection molding processes.
4.17. 4. 2 Audit scope and planning
The scope of the audit depends on the importance of the activity under consideration and the degree of understanding of existing or potential problems. The frequency of audits shall be at least; quality system audits once a year; product quality audits twice a year; and process quality audits once a year. The audit plan shall be prepared and documented annually. Checklists shall be prepared as an aid. 4.17.4.3 Auditors
All audits shall be conducted by personnel selected from the quality department. 4.17.4.4 Audit report
An audit report shall be prepared every autumn. The report shall include basic information about the audit object, the requirements used as the basis for the audit, and any nonconformities found that do not meet the requirements. The audit report shall be distributed to the relevant managers. The report on the observations of the quality system audit shall be filled in according to the format of Appendix 9.
4.17.4.5 Decisions and actions
The manager of the relevant department is responsible for ensuring that decisions and actions are made as soon as possible based on the observations received.
4.17.4. 6 Tracking
The quantity department shall track the implementation of the measures through continuous monitoring or by directly tracking the next review. The results of the follow-up shall be documented in the form of an audit report.
4.17.4.7 The results of the physical review of the audit results and the observations of the follow-up shall be submitted to the quality department manager for management review. See Section 4.1 of this manual.
44.17.5 Reference Materials
This chapter of the quality manual is based on the quality system procedure QA123.4\Internal Quality Audit\. 14.17.6 Records
The audit report, including the follow-up records, shall be submitted to the quality department for archiving and preservation in accordance with the quality record procedure for at least 5 years. See Chapter 4.16 of this quality manual. GB/T 19023—1996
Appendix D
(Suggested Appendix)
Bibliography
(1) GB/T 19000,1
11994 (idtISO9000-1:1994), Quality management and quality assurance standards Part 1: Selection and use of guidelines
(2) GB/19001-1994 (idtISO9001:1994), Quality system design, development, production, installation and service quality assurance model
Quality assurance model for production, installation and service (3) GB/T19002-1994 (idt1S0 9002:1994), Quality system (4) GB/T19003-1994 (idtISO90031994), Quality system final inspection and testing quality assurance model 5) GB/T19004.1-1994 (idtISO9004-1:1994), Quality management and quality system elements Part 1: GuideReports, forms, etc.)
(Tanou)
Note: Any of the following documents may be separated, referenced or combined. Appendix B
(Informative Appendix)
Example of the format that may be used for a section of the quality manualOrganization
Issuing department
Policy/reference to policy
Give management requirements.
Format and scope
Title/subject
Approving person
List the purpose, intent, areas covered and not covered.Responsibility
Propose the department responsible for implementing the document to achieve the purpose. Version
Document content
Describe the quality policy and objectives specified and the standards used
Quality system
Summary of the activities of each functional department required to implement the quality system elements
Detailed working conditions
Title/subject
Measures and methods to meet the requirements of the system elements GB/T 19023--1996
Continued Table B
List the things to be done step by step, and cite references if necessary. Keep a reasonable order and indicate any exceptions or special scopes with notes. Consider using a flow chart.
Documents and references
Specify the reference documents and tables involved in the use of this document, or the data that must be recorded. Give examples if necessary. Records
Specify the records generated when using this document and the storage location and retention period of the records. NOTE
1 This format can also be used to form a documented quality system procedure. 2 The structure and order of the items listed above shall be determined by the organization's needs. 3 The approval and version of the document shall be identified.
NOTE 8 This is only an example; the actual structure shall be determined by the needs of the user.
4.17 Internal quality audits
The supplier shall establish and maintain a documented procedure for planning and conducting internal quality audits to verify that quality activities and meaningful results conform to the planned arrangements and to determine the effectiveness of the quality system.
Internal quality audits shall be scheduled based on the actual situation and importance of the audited activities and shall be conducted by personnel who have no direct responsibility for the audited activities.
The results of the quality audits shall be recorded (see 4.16) and brought to the attention of the responsible personnel in the audited area. For any problems found during the audit, the management responsible for the area shall take timely corrective actions. During the review activities, the implementation and effectiveness of the corrective actions taken shall be verified and recorded (see 4.16).
1. The results of the internal quality audit are part of the input to the management review activity 1 (see 4.1.3).
2. GB/T J902] --IS(10011 gives guidance on quality system audits.
LGB/T 19001-ISO 9001:1994J
GB/T19023—1996
Appendix C
(Suggested Appendix)
Example of a quality manual section
Issuing department
4.17. 1 Policy
4.17 Internal quality review
Approving person
1994-1-01
QA 5G7-R
Quality audits should be conducted regularly to verify whether quality-based activities and related results are in accordance with the planned arrangements and to determine the effectiveness of the quality system. 4.17.2 The procedures of the quality manual are applicable to the quality system audit, product audit and production process audit. 4.17.3 Responsibilities
The quality manager is responsible for the content of the procedures in this document and ensures its implementation. 4.17.1 Measures and methods
4.17.4.1 Characteristics of the audit
The quality system requirements specified in the quality manual are the basis for the quality system audit. The objects of the quality system audit are the functions that have a significant impact on product quality. Product quality audits are conducted in accordance with the requirements for finished products. Product quality audits are applicable to products manufactured in series:
Process quality audits are conducted in accordance with the requirements for process results. Process quality audits are applicable to wave soldering and injection molding processes.
4.17. 4. 2 Audit scope and planning
The scope of the audit depends on the importance of the activity under consideration and the degree of understanding of existing or potential problems. The frequency of audits shall be at least; quality system audits once a year; product quality audits twice a year; and process quality audits once a year. The audit plan shall be prepared and documented annually. Checklists shall be prepared as an aid. 4.17.4.3 Auditors
All audits shall be conducted by personnel selected from the quality department. 4.17.4.4 Audit report
An audit report shall be prepared every autumn. The report shall include basic information about the audit object, the requirements used as the basis for the audit, and any nonconformities found that do not meet the requirements. The audit report shall be distributed to the relevant managers. The report on the observations of the quality system audit shall be filled in according to the format of Appendix 9.
4.17.4.5 Decisions and actions
The manager of the relevant department is responsible for ensuring that decisions and actions are made as soon as possible based on the observations received.
4.17.4. 6 Tracking
The quantity department shall track the implementation of the measures through continuous monitoring or by directly tracking the next review. The results of the follow-up shall be documented in the form of an audit report.
4.17.4.7 The results of the physical review of the audit results and the observations of the follow-up shall be submitted to the quality department manager for management review. See Section 4.1 of this manual.
44.17.5 Reference Materials
This chapter of the quality manual is based on the quality system procedure QA123.4\Internal Quality Audit\. 14.17.6 Records
The audit report, including the follow-up records, shall be submitted to the quality department for archiving and preservation in accordance with the quality record procedure for at least 5 years. See Chapter 4.16 of this quality manual. GB/T 19023—1996
Appendix D
(Suggested Appendix)
Bibliography
(1) GB/T 19000,1
11994 (idtISO9000-1:1994), Quality management and quality assurance standards Part 1: Selection and use of guidelines
(2) GB/19001-1994 (idtISO9001:1994), Quality system design, development, production, installation and service quality assurance model
Quality assurance model for production, installation and service (3) GB/T19002-1994 (idt1S0 9002:1994), Quality system (4) GB/T19003-1994 (idtISO90031994), Quality system final inspection and testing quality assurance model 5) GB/T19004.1-1994 (idtISO9004-1:1994), Quality management and quality system elements Part 1: Guide16) and bring the issues found during the audit to the attention of the personnel responsible for the area under audit. For any issues found during the audit, the management personnel responsible for the area should take corrective measures in a timely manner. During the review activities, the implementation and effectiveness of the corrective actions taken shall be verified and recorded (see 4.16).
1. The results of the internal quality audit are part of the input to the management review activity 1 (see 4.1.3).
2. GB/T J902] --IS(10011 gives guidance on quality system audits.
LGB/T 19001-ISO 9001:1994J
GB/T19023—1996
Appendix C
(Suggested Appendix)
Example of a quality manual section
Issuing department
4.17. 1 Policy
4.17 Internal quality review
Approving person
1994-1-01
QA 5G7-R
Quality audits should be conducted regularly to verify whether quality-based activities and related results are in accordance with the planned arrangements and to determine the effectiveness of the quality system. 4.17.2 The procedures of the quality manual are applicable to the quality system audit, product audit and production process audit. 4.17.3 Responsibilities
The quality manager is responsible for the content of the procedures in this document and ensures its implementation. 4.17.1 Measures and methods
4.17.4.1 Characteristics of the audit
The quality system requirements specified in the quality manual are the basis for the quality system audit. The objects of the quality system audit are the functions that have a significant impact on product quality. Product quality audits are conducted in accordance with the requirements for finished products. Product quality audits are applicable to products manufactured in series:
Process quality audits are conducted in accordance with the requirements for process results. Process quality audits are applicable to wave soldering and injection molding processes.
4.17. 4. 2 Audit scope and planning
The scope of the audit depends on the importance of the activity under consideration and the degree of understanding of existing or potential problems. The frequency of audits shall be at least; quality system audits once a year; product quality audits twice a year; and process quality audits once a year. The audit plan shall be prepared and documented annually. Checklists shall be prepared as an aid. 4.17.4.3 Auditors
All audits shall be conducted by personnel selected from the quality department. 4.17.4.4 Audit report
An audit report shall be prepared every autumn. The report shall include basic information about the audit object, the requirements used as the basis for the audit, and any nonconformities found that do not meet the requirements. The audit report shall be distributed to the relevant managers. The report on the observations of the quality system audit shall be filled in according to the format of Appendix 9.
4.17.4.5 Decisions and actions
The manager of the relevant department is responsible for ensuring that decisions and actions are made as soon as possible based on the observations received.
4.17.4. 6 Tracking
The quantity department shall track the implementation of the measures through continuous monitoring or by directly tracking the next review. The results of the follow-up shall be documented in the form of an audit report.
4.17.4.7 The results of the physical review of the audit results and the observations of the follow-up shall be submitted to the quality department manager for management review. See Section 4.1 of this manual.
44.17.5 Reference Materials
This chapter of the quality manual is based on the quality system procedure QA123.4\Internal Quality Audit\. 14.17.6 Records
The audit report, including the follow-up records, shall be submitted to the quality department for archiving and preservation in accordance with the quality record procedure for at least 5 years. See Chapter 4.16 of this quality manual. GB/T 19023—1996
Appendix D
(Suggested Appendix)
Bibliography
(1) GB/T 19000,1
11994 (idtISO9000-1:1994), Quality management and quality assurance standards Part 1: Selection and use of guidelines
(2) GB/19001-1994 (idtISO9001:1994), Quality system design, development, production, installation and service quality assurance model
Quality assurance model for production, installation and service (3) GB/T19002-1994 (idt1S0 9002:1994), Quality system (4) GB/T19003-1994 (idtISO90031994), Quality system final inspection and testing quality assurance model 5) GB/T19004.1-1994 (idtISO9004-1:1994), Quality management and quality system elements Part 1: Guide16) and bring the issues found during the audit to the attention of the personnel responsible for the area under audit. For any issues found during the audit, the management personnel responsible for the area should take corrective measures in a timely manner. During the review activities, the implementation and effectiveness of the corrective actions taken shall be verified and recorded (see 4.16).
1. The results of the internal quality audit are part of the input to the management review activity 1 (see 4.1.3).
2. GB/T J902] --IS(10011 gives guidance on quality system audits.
LGB/T 19001-ISO 9001:1994J
GB/T19023—1996
Appendix C
(Suggested Appendix)
Example of a quality manual section
Issuing department
4.17. 1 Policy
4.17 Internal quality review
Approving person
1994-1-01
QA 5G7-R
Quality audits should be conducted regularly to verify whether quality-based activities and related results are in accordance with the planned arrangements and to determine the effectiveness of the quality system. 4.17.2 The procedures of the quality manual are applicable to the quality system audit, product audit and production process audit. 4.17.3 Resp
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