How to write quality system documents
A. the role of quality system documents
1. The quality system document determines the assignment of responsibilities and the procedures of activities, and is the "regulation" within the enterprise.
L- Give the best and most practical methods to achieve quality objectives. The compilation and use of documents is a dynamic and high value-added activity;
L—— Clear responsibilities and authorities, handle interfaces well, and make the quality system an organic whole, with clear responsibilities and coordination;
L—— "What should be said must be said, and what is said must be done", and the document becomes the organization's laws and regulations, and the expected purpose is achieved through careful implementation.
2. Quality system documents are the basis of quality system audit.
L— The proving process has been determined and optimized;
L- the provisions of the certification documents have been effectively implemented;
Proof that the document is under use control.
3. Quality system documents are the basis for enterprises to carry out internal training.
L- documents are used as teaching materials for training all employees;
L-Seek an appropriate balance between document content, skills and training content;
4. Quality system documents provide a basis for quality system improvement.
L— Determine the improvements needed in the working process according to the documents;
L—— When the quality improvement results are incorporated into documents and become standardized procedures, these results can be effectively consolidated.
2. The level of quality system documents
The first floor: quality manual
Layer 2: program files
The third layer: operation guidance documents, which are usually divided into:
N grade)
N Technical third-layer documents (such as product standards, raw material inspection procedures, sampling standards, technical drawings, process operation instructions, process cards, equipment operation procedures, etc.). )
Foreign documents
Level 4: Quality Record Form
Three. Basic requirements for writing quality system documents
A) systematic
L Plan the document structure of the quality system, covering the requirements and regulations of ISO900 1 all relevant elements;
L tools: quality system document list and departmental responsibility allocation table.
B) compliance
L should meet the requirements of ISO9000 standard clauses;
L should be in line with the actual situation of the business process of this enterprise. Specific control requirements should be based on meeting the needs of enterprises, rather than the stricter the better, in a word: moderate.
L Achieve a unique understanding by being clear, accurate, comprehensive, simple and to the point, and ensure that the provisions of all documents are fully achieved in practical work;
coordinate
L documents should be coordinated with each other to avoid inconsistency. As for the overall structure of writing a specific document, we should closely follow the purpose and scope of the document and try not to describe activities outside the scope of the document.
L All provisions of system documents shall be coordinated with other management regulations, technical standards and specifications of the company;
L The interfaces of each process should be handled carefully to avoid disharmony or unclear responsibilities.
4. Requirements for writing quality system documents
A) Clear responsibilities and affirmative tone (avoid using words such as "general", "basic", "possible" and "possible");
B) Clear structure, concise writing and consistent writing style. ;
C) Compiling all kinds of documents according to the principle of "the easiest to understand";
Verb (abbreviation for verb) The general content of a file.
A) Name and serial number of the document;
B) Controlled status, version number and distribution number
C) Preparation, review and approval;
D) effective date;
Compilation of quality manual of intransitive verbs
A) General structure of quality manual:
L cover
-Name of the company;
-Manual title;
—Document number, manual version, controlled chapter and distribution number;
-The signatures of the drafters and approvers and the effective date;
I issued a decree.
—Explain in concise language that the quality manual of our company is compiled according to the selected standards and approved for publication and implementation. The order issued must be described as the top manager of the company and must be signed by name and date.
L manual description (scope of application)
-Applicable products;
-the organizational field or region where products are produced;
-Standards on which the manual is based;
L manual catalogue
-Lists the chapter titles contained in the manual.
L revision page
-Explain the revision of all parts of the manual in the form of revision records.
L Definition section (if necessary)
-First, use the definitions of terms in national standards;
-Define specific terms and concepts.
L Organization Overview (Foreword Page)
-Company name, main products;
-Business situation, main background, history and scale, etc. ;
—Location and communication method.
—Organization chart
L organization's quality policy and objectives
-the organization's quality policy and quality objectives;
-Signature of the Supreme Leader.
L supporting information appendix
For example: list of program documents
The numbering methods are Appendix A and Appendix B, which shall be postponed accordingly.
L description of quality system elements
-Principles for describing the elements of the quality system;
1. meets the requirements of the selected standard;
2. Meet the needs of practical operation.
3. Responsibility implementation
4. Meet the requirements of relevant laws and regulations and contracts.
The elements of the quality system describe the structure and content of each chapter.
Purpose-to clarify the purpose of realizing the requirements of elements.
Scope of application-clarify the activities to which the requirements of the implementation elements apply.
Responsibilities-clarify the responsibilities of the departments or personnel involved in the process of implementing the requirements of the elements.
Implementation Summary—Explain all the principles and requirements of activities required to implement the elements.
Related documents-List all kinds of documents needed to implement the requirements of elements. Including:
Program documents, operating procedures, technical standards and management standards;
Seven. Preparation of program files
The contents described in the 1. program file.
It often includes 5W 1H: why and scope of activities; What to do (what), when (where) and who (who) will do it; What materials, equipment and documents should be used, how to control and record activities, etc.
2. Program file structure (reference):
-Cover.
-Body parts:
-1. Purpose
-2. Scope
-3. Responsibility
-4. Program content
-5. Quality records
6. Supporting documents
-7. Appendix
3. Overview of program documents
N Cover: The cover format of the program document is similar to that of the quality manual.
N text:
Objective: To explain why this activity was carried out.
-Scope: Describe the scope of (product, project, process, activity) ...) Participate in the activity.
-Responsibilities: Explain the management and implementation of activities and the responsibilities of verifiers.
-Procedural content: explain the content and requirements of the activity in detail.
-Supporting documents: list the third-level documents supporting this program.
-Quality records: list the records used or generated by the activities.
-Appendices: Appendices involved in this procedure document are all placed here, numbered as Appendix A and Appendix B, to indicate the extension.
4. Procedure documents explicitly required by ISO 9001:2000:
File control program
Quality record control program
Internal audit control procedure
L nonconforming product control procedure
L Corrective Measures Control Procedure
L preventive measures control procedures
5. Example of program files
Internal quality audit control procedure
1.
Through the implementation of internal quality audit to confirm the conformity and effectiveness of the quality system, in order to continuously improve the system.
2. Scope of application
Applicable to the work audit of all departments covered by the company's quality system.
3. Responsibility
3. 1 The management representative is responsible for planning the internal audit activities and appointing the audit team leader.
3.2 The audit team leader is responsible for formulating the internal quality audit plan and organizing relevant personnel to form an audit team to implement audit activities.
3.3 Each department is responsible for cooperating with the audit team to audit the quality activities of its own department.
4. Working procedures
4. 1 Internal quality audit activity is a regular formal quality management system audit activity of this enterprise, which is held twice a year and once in the first half of the year. The management representative may increase the number of audits according to the following circumstances:
L changes in quality policy and quality objectives
L management organizational change
L the customer has a serious complaint
L there are serious anomalies in the operation of the quality system.
4.2 The audit object is all departments covered by the company's quality system, and the members of the audit team are composed of qualified personnel who have passed the internal quality audit training, and the auditors shall not have a direct responsibility relationship with the audited quality activities.
4.3 Pre-audit preparation
4.3. 1 The management representative plans the internal audit opportunity, and appoints the audit team leader to organize the internal audit team to implement the audit activities.
4.3.2 The audit team is responsible for putting forward the internal quality audit plan one month before the audit and submitting it to the management representative for approval. After approval, the audit team will formally submit the audit plan to relevant departments for preparation two weeks before the audit.
4.3.3 The audit team shall prepare a checklist according to the audit plan and audit the system documents when necessary.
4.4 Audit implementation
4.3. 1 meeting: before the on-site audit activity starts, the audit team will hold a short meeting with the heads of relevant departments to explain and reconfirm the audit items.
Site audit
4.3.2. 1 On-site audit should be conducted in the presence of the person in charge of the audited department, and the audit should be based on the principle of not affecting the work of the audited department as much as possible.
4.3.2.2 auditors should judge the nonconformity by asking questions, observing, randomly checking records, inspecting or testing products, etc. The auditor of 4.3.2.3 system shall judge the nonconformities according to the following rules:
A: Serious non-conformity-quality activities seriously fail to meet the requirements of ISO—9002 standard or may lead to system failure.
B: Minor nonconformity-minor nonconformity meeting the quality system standards.
C: Observation items-activities that need to be paid attention to because the execution of program files fails to achieve the expected results.
After the on-site audit in 4.3.2.4, the audit team will hold a summary meeting to exchange and summarize the audit situation.
4.4 Summary meeting:
After the on-site audit, the audit team leader is responsible for convening the members of the audit team and the person in charge of the audited department to hold an audit summary meeting.
A. the audit team leader reports the audit situation;
B. Non-conformities and observation results confirmed by the audited department
C time required for both parties to confirm the correction of nonconformities.
4.5 Implement correction and follow-up verification
4.5. 1 For the problems pointed out in the Non-conformance Report, the person in charge of the responsible department is responsible for organizing the formulation of corresponding corrective and preventive measures according to the Control Procedure for Corrective and Preventive Measures, and recording them in the Non-conformance Report.
4.5.3 Audit team members shall follow up the implementation of corrective measures as planned to verify their effectiveness. Find problems and communicate with department leaders in time.
4.5.4 After the follow-up verification, the audit team leader shall sort out the data and complete the Internal Quality Audit Report, which shall include the complete records of the Nonconformance Report and the Observation Report. And submit it to the management representative for approval.
4.4.5 After the audit is approved, the audit team leader will summarize all the documents and materials of this internal audit and submit them to the document control room for archiving.
5. Relevant documents
5. 1 Control Procedure for Corrective and Preventive Measures
6. Quality records
6. 1 internal quality audit plan
6.2 Internal Quality Audit Report
6.3 non-conformance report
6.4 Observation report
6.5 Internal Audit List
6.6 Distribution Table of Nonconformities
6.7 Meeting sign-in form
Eight. Requirements for compiling the third-level documents
1. shall meet the requirements of Articles 3, 4 and 5;
2. The text format varies according to the nature of the document. When feasible, you can refer to the program file format appropriately;
3. Example:
Warehouse management regulations
Warehouse is the company's material management department, responsible for the storage, protection and reception of raw materials and auxiliary materials. In order to further clarify the responsibilities and authority of warehouse managers, this regulation is formulated, and it is hoped that warehouse managers and related personnel will comply with it.
I. receiving, sending and receiving procedures
(1) The warehouse keeper shall receive the goods according to the incoming bill of lading, check the quantity, model and specifications of the incoming materials, and check whether they are in conformity with the bill of lading, then sign and put them in the warehouse, issue a receipt report and register them.
(2) If the warehouse keeper finds that the incoming materials are wet, colored, drawn yarn, holes, warp and weft discrepancies, and the fabrics are stained, he shall immediately report to the factory director for handling.
2. Classification, storage and protection of raw materials and auxiliary materials
(1) The type and type of cloth shall be clearly specified and stored separately.
(2) Accessories shall be placed by category.
(3) To shelter from the rain, sprinkle water every day to prevent moisture and insects.
(4) Raw materials should be stored in strict areas with obvious signs.
(5) Non-conforming products after inspection shall be classified and stored in the non-conforming area.
(6) The warehouse site should do a good job in environmental sanitation regularly.
Three. Identification of materials
(1) Wareholders should identify different kinds of fabrics and accessories, indicating their names, dates, places of origin, specifications and shrinkage rates.
(2) The logo shall be properly kept to avoid loss and damage.
Four. Distribution program
The warehouse staff should make a room list according to the order, cut out the variety, name and quantity on the requisition list issued by the list, and check and sign it for the requisition staff to sign.
Verb (abbreviation for verb) material inventory and report
At the end of each month, the warehouse personnel shall make an inventory of the cloth and accessories in stock, fill in the monthly report according to the receiving, sending and storing data of this month, and submit it to the company's finance department.
6. Safety precautions must be taken to prevent fire, theft and moisture to ensure the safety of the warehouse.
Nine. Quality record form
1. Need to review whether the records mentioned in the standard at 2 1 must be adopted;
2. Forms should be standardized and unified.
3. The content of the form should be substantial, and the content to be filled in should be targeted.
X number of quality system documents (example):
1. System files are numbered according to the assigned score.
Distribution number: mark the distribution number in the controlled chapter with 0 1, 02, ... and record it in the document distribution record.
2. Modify the status
"Revision number/version number", where the version number is represented by "A, B, C ..." and the revision number is represented by "0-4". For example, 1/A represents the first revision of version A, and the version will be changed after the fifth revision (if there are major revisions, the version will be changed in advance).
Main features and requirements of ISO900 1:2000: 2000 standard
Quality is an eternal topic in social production and life, and it is also one of the themes of global economic development in this century. With the development of the times, the progress of science and technology, and the deepening of human cognition of objective things, quality is constantly given new life and mission. Nowadays, the integration of national economies and the deepening of global trade, as well as the increasingly perfect pursuit of quality by members of society, have brought huge development space for ISO9000 family standards.
The ISO9000 series standard of version 1987 comes from the British standard BS5750. In order to popularize this effective management method in the field of quality management, the experts of the International Organization for Standardization (ISO) and its member countries have made fruitful efforts and hard work, and produced the first edition of ISO9000 series standards in 1987, which has become the basic international standard to measure the quality management activities of enterprises.
Since then, the ISO9000 family standard, as a global bestseller, has gradually spread in Europe, America, Asia and even the world. This quality management model has injected new vitality into enterprise management, brought quality credibility to world trade and provided evaluation basis for quality management system. At the same time, with the global economic integration, the improvement of objective cognition and the needs of the standard itself, it has been continuously developed and improved. From the evolution of ISO9000 series standards, it can be seen that ISO900 1, version 1987, from the perspective of self-assurance, pays more attention to internal quality management and quality assurance. 1994 version of ISO900 1 standard contains the requirements of users, regulations and quality assurance through 20 quality management system elements: 2000 version of ISO900 1 standard keeps pace with the times in standard concept and standard purpose, and the concept of process method, consideration of customer demand and continuous improvement run through the whole standard, which makes the quality of the organization.
With the popularization of ISO9000 family standards and the increase of standard users, the excessive number of standards in ISO9000 family standards, the difficulty of applying standards in different economic and technical fields and the effectiveness of quality management system have become the focus of general attention in the use of standards. In order to solve the problems existing in the use of the 1994 version of the standard, consider the future development of the standard, and fully meet the needs of customers, ISO/TC 176 conducted a written survey on the users of120 and 197 who adopted the ISO9000 family standard all over the world, and solicited the opinions of standard users. The written opinions also include the willingness to revise the standards, the respective characteristics and relationships of ISO900 1 and ISO9004 standards, and the relationship between quality management system standards and environmental management system standards. After five years, on February 5, 2000,16,5438+08 was officially promulgated and implemented by the International Organization for Standardization. ISO9000, ISO900 1, ISO9004 and ISO 190 165438 constitute the core standards of the new ISO9000 family standard.
Compared with the 1994 version, the 2000 version of ISO900 1 standard has obvious changes in structure, content and concept. The new version of the standard adopts the organization mode of quality management system based on process, which is completely different from the organization mode of ISO900 1 Edition 1994 based on 20 elements. The process-based structural model is more practical than the factor-based structural model, and it is used more in today's management activities. The use of process mode has achieved the purpose of unifying the PDCA cycle contents in ISO900 1 and ISO 1400 1 in 2000. All the 20 elements of ISO900 1 in 1994 are included in the new standard. In terms of changes, the new ISO900 1 standard mainly has the following characteristics:
First of all, the standard has wide applicability.
As a general quality management system standard, ISO900 1:2000: 2000 can be applied to all kinds of organizations, regardless of the type of organization.
Influence and limitation of scale, economic and technological activities or professional scope, and types of products provided. This feature of the standard can be manifested in four aspects:
1, any organization's quality management system should consider four important components: first, management responsibilities, including policies, objectives, management commitments, responsibilities and authority, planning, customer needs, quality management system and management review; Secondly, resource management, including human resources, information resources, facilities and equipment and working environment; The third is process management, including customer demand conversion, design, procurement, product production and service provision; The fourth is measurement, analysis and improvement, including information evaluation, internal audit of quality management system, product monitoring and measurement, process monitoring and measurement, nonconforming product control, continuous improvement, corrective and preventive measures, etc. Four important components of the quality management system are reflected in the classification of new standard terms.
2. The term "product" used in the standard has a double meaning. The term "product" can refer to tangible physical products or "services".
3. The organization adopts this standard to establish a quality management system, the main purpose of which is to show that the organization has the ability to continuously provide products that meet the needs of customers and the requirements of relevant laws and regulations, and to ensure that the trust of customers is enhanced through the effective operation of the quality management system.
4. The content and requirements of the standard clauses use clear language and terminology, which fully reflects the characteristics of various quality management activities and reduces the difficulty of understanding and applying the standard clauses.
Second, the compatibility between ISO9000 series standards and ISO 14000 series standards has been significantly improved.
The new ISO900 1 standard can be more compatible with ISO14001:1996 environmental management system standard, which is a very important customer demand in the process of standard implementation. This demand exists in the existing and expected way. To improve the compatibility between ISO9000 series standards and ISO 14000 series standards, we can look at the structure, quality management system mode, standard content, language and terminology of the new ISO900 1 standard. When an organization's management activities and management system adopt the standards of two systems, there are management system elements that can be used and meet the standards of ISO900 1 and ISO 1400 1. In the management and control of product/service quality, environmental factors and environmental impact, process model and PDCA cycle method can be better combined to play a role. Meeting the requirements of relevant laws and regulations, the needs of customers and the interests of social interest groups has become the common goal of the two series of standards. Monitoring, measurement, analysis and improvement, as necessary measures of management activities, are put forward in the same way in two series of standards, which is more conducive to the operation of management system and improve its effectiveness.
Another compatibility feature of the new ISO900 1 standard is that it provides convenience for users of ISO 900 1994, ISO9002 and ISO9003. Comparing the standard elements of ISO 900 1994 with those of ISO900 1 2000, it can be seen that the 20 quality management system elements of ISO900 1 994 are completely contained in the new standard terms and contents. Users of the standard 1994 version only need to classify and partially adjust the contents and requirements of their quality management system when they switch to the new version.
Third, the choice and requirements of standard terms.
One of the principles of adopting standards is to meet all the requirements of standards, which is a basic feature of standardization activities. Obviously, if the organization's products and product realization processes are within the quality range, its quality management system should meet all the requirements of ISO900 1:2000: 2000 standard. However, due to the differences in organizational functions, the objective characteristics of products and the scope of application of standards, in the process of adopting standards, no matter whether the organization brings all or part of its products and product realization process into the management scope of the quality management system, it may find that the standard terms are not applicable. Therefore, the ISO900 1:2000: 2000 standard gives the possibility of deleting inapplicable standard clauses and requirements through the 1.2 "Standard Scope of Application" clause. This means that in the process of adopting new standards, organizations can choose standard terms and requirements according to the requirements and scope of application of their quality management system, and delete inapplicable standard terms. The quality management system requirements mentioned here refer to the adoption of standards for selected products and product realization processes; Scope of application refers to the situation that all or part of the product and product realization process adopt standards. Whether the organization accepts or rejects the terms and requirements of the standard, the results of adopting the standard should show that the quality management system of the organization meets the standard. The declaration of conformity of the standard can be completed by organizing self-declaration, second-party evaluation or third-party certification. Therefore, the new version of the standard limits the deletion of standard clauses to the content of Chapter 7 "Product Realization". At the same time, when deleting the contents of Chapter 7 of the standard, we should also consider whether it will bring difficulties to the organization's ability, responsibility, product provision and product realization.
Fourth, effectively solve the operability of quality management system documents.
Users of version 1994 feel the same way: to establish a quality calendar system according to the standard requirements, at least 17 program files and 18 or more quality records need to be generated; The compilation of these program documents or quality records brings too much documentation workload to the organization; Some documents or records deviate from the organization's characteristics and management reality more or less; The use and management of quality management system documents has become an increasingly heavy burden; There are more and more phenomena of document formatting in quality management system. These phenomena in the use of standards reduce the effectiveness and practicability of quality management system documents. The 2000 edition of ISO900 1 standard has two important purposes in quality management system documents: to establish a simple file format suitable for organizations of different sizes; The quantity and content of documents are more in line with the expected results of organizational process activities.
Based on the above two aspects, the new standard simplifies the requirements of quality management system documents. Regarding the requirements of the quality manual, clause 4.2. 1b) indicates that the contents of the manual can be determined according to the management requirements of the organization. Article 4.2.2 indicates that the contents of the quality manual required by the standard are the scope of application of the quality management system, the requirements of the standard and the reasons for deletion, the program documents used or quoted in the quality management system, and the contents describing the interrelationships and functions among the processes included in the quality management system. For the requirements of relevant program files, the program files required in 4.2. 1c) include: file control program files required in 4.2.3, record control program files required in 4.2.4, internal audit program files required in 8.2.2, nonconforming product control program files required in 8.3, and 8.5.2. For the requirements of quality records, the standard puts forward 2 1 quality records of quality management system in different clauses. These records are: management review records; Records of education, training, skills and experience of members of the organization; Records used to prove that the product meets the requirements and the product realization process; Records reflecting the review results of product requirements and measures taken; Design and develop input records; Records reflecting the evaluation results of design and development and the measures taken; Records reflecting the verification results of design and development and the measures taken; Records reflecting the confirmation results of design and development and the measures taken; Records reflecting the examination and approval results of design and development and the measures taken; Records reflecting the results of supplier evaluation and self-evaluation; Records reflecting process confirmation when monitoring and measurement fail to achieve verification effect; Establish records with unique identification for traceable products; Customer property management and use records; Records reflecting the calibration and verification of measuring equipment when there is no measurement benchmark; Calibration and verification records of measuring equipment; Records reflecting internal audit defects of the quality management system; Records proving product symbol standards and contract requirements; Records of corrective measures taken for nonconforming products; Records reflecting corrective results and records of preventive activities.
Simplification of quality management system documents enables organizations to build quality management system in a more flexible and effective way, and also enables organizations to fully demonstrate their effective planning, operation and control of the process, as well as the effectiveness and continuous improvement of the quality management system with the least document requirements.
Looking at the contents of ISO900 1 standard in 2000 edition, we can find that the standard highlights four requirements: process identification, control of influencing factors, continuous improvement and effectiveness of system operation. In the quality management system based on process mode, the first problem is to effectively identify the processes protected by the quality management system. As a prerequisite, the standard clause 0.2 process method expresses the basic characteristics of the process, and the standard clause 4. 1a) puts forward the requirements for identifying the processes included in the quality management system.
It is worth mentioning that the contents to be considered in process identification include: the scope of application of the quality management system, the functions and objectives of the organization, the structure of the organization and the quality management activities. The characteristics to be considered are: the process is accompanied by input and output; A process can be composed of one or more activities, which can achieve the same goal but have different functions.
The process can be divided into coarse and fine, and the process of coarse division includes several fine processes. There is no specific requirement for the thickness of process division in the standard, but the requirement for effective control of processes put forward by the standard will make the detailed division of processes better reflect the advantages of process division.
Because the process contains many factors that affect the quality of products or services, the standard puts forward requirements for the management and control of influencing factors in the process from different clauses. Including the control of documents and records, the management of policies and objectives, the management of resources, responsibilities and authority, the management of internal and external information of the organization, the management of product formation process and service provision process, the control of product quality performance and requirements, and the control of factors affecting product quality.
The standard puts forward the requirement of continuous improvement of quality management system in clause 8.5. 1, which involves all aspects of quality management system. Such as the quality policy and objectives, internal quality management system audit and management review, quality control in the process of product realization and control of influencing factors of product quality, customer demand and requirements of relevant laws and regulations, etc. A key link of continuous improvement activities is to consider customer needs from the existing and expected perspectives, which requires organizations to have the ability to predict future needs in quality management activities. The purpose of continuous improvement of quality management system is to keep the quality management system timely and effective, and at the same time, to organize and prove its ability to continuously provide products that meet customer requirements and relevant laws and regulations. This is also an important content emphasized by ISO900 1 2000. The ultimate goal of the standard is to change the requirements of the quality management system model, streamline the quality management system documents and delete inappropriate terms and requirements. Once an organization decides to adopt the standard of 2000 ISO900 1 to establish a quality management system in its quality management activities, it must ensure the timely effectiveness of the quality management system.