Definition of quality management system
Connotation of quality management system
Characteristics of quality management system
Implementation of quality management system
Steps to establish a quality management system
Certification procedure of quality management system
Quality management system
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Definition of quality management system
Any organization needs management. When management is related to quality, it is quality management. Quality management is the coordination activity of commanding and controlling organizations in quality, which usually includes activities such as formulating quality policies and objectives, quality planning, quality control, quality assurance and quality improvement. To achieve the goal of quality management and effectively carry out various quality management activities, we must establish a corresponding management system, which is the quality management system.
Refers to the systematic quality activities established within the enterprise, which are necessary to ensure product quality or quality objectives. It combines several system elements according to the characteristics of enterprises, strengthens the quality management activities from design, development, production, inspection, sales and use, and makes them institutionalized and standardized, which has become the requirements and activity procedures of quality workers in enterprises.
In modern enterprise management, ISO900 1:2000 quality management system is widely adopted by enterprises.
I SO900 1:2000 is one of a series of quality management standards formulated by iso (international organization for standardization) TC 176.
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Connotation of quality management system
The quality management system shall conform to.
In order to effectively implement quality management, we must design, establish, implement and maintain the quality management system. The top management of the organization is responsible for the decision of designing, establishing, implementing and maintaining the quality management system according to ISO900 1 international standards, and is responsible for establishing a reasonable organizational structure and providing appropriate resources; The management representative and the quality functional department are directly responsible for the formulation and implementation of the promotion sequence, the establishment and operation of the process.
The quality management system should be unique.
The design and establishment of quality management system should be combined with the organization's quality objectives, product categories, process characteristics and practical experience. Therefore, different organizations' quality management systems have different characteristics.
The quality management system should be systematic.
Quality management system is a combination of interrelated functions, including: ① organizational structure-reasonable organizational structure and clear responsibilities, authorities and their coordination; (2) Procedures-The documented procedures and work instructions specified in place are the basis of process operation and activities; ③ The effective implementation of the process quality management system is realized by the effective operation of the required processes; ④ Resources-Necessary, sufficient and suitable resources include personnel, funds and facilities. Equipment, materials, energy, technology and methods.
The quality management system should be fully effective.
The operation of the quality management system should be comprehensive and effective, which can not only meet the requirements of internal quality management of the organization, but also meet the contract requirements between the organization and customers, and also meet the requirements of second-party identification, third-party authentication and registration.
The quality management system should be preventive.
The quality management system should be able to take appropriate preventive measures and have certain ability to prevent important quality problems.
The quality management system should be dynamic.
Top management regularly approves internal quality management system audits and conducts management reviews to improve the quality management system; It is also necessary to support quality functional departments (including workshops) to take corrective and preventive measures to improve the process and thus improve the system.
The quality management system should be continuously controlled.
The application process and its activities required by the quality management system should be continuously controlled.
Quality management system needs to be optimized
The organization should comprehensively consider the benefits, costs and risks, and optimize the quality management system through its continuous and effective operation.
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Characteristics of quality management system
(1) It represents a view that modern enterprises or government agencies think about how to really play the role of quality and how to make quality decisions optimally.
(b) It is the basis of in-depth and detailed quality documents.
(3) The quality system is the basis for the effective management of the company's broader quality activities.
(4) The quality system is the basis for improving the main quality activities of the whole company in a planned and step-by-step order.
Any organization needs management. When management is related to quality, it is quality management. Quality management is the coordination activity of commanding and controlling organizations in quality, which usually includes activities such as formulating quality policies and objectives, quality planning, quality control, quality assurance and quality improvement. To achieve the goal of quality management and effectively carry out various quality management activities, we must establish a corresponding management system, which is the quality management system. Can effectively improve the quality.
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Implementation of quality management system
Procurement standard
You need a standard before you are ready to realize it. You need to read and understand.
Refer to related literature and software.
There are many quality publications and software tools that can help you understand, implement and register the quality management system.
Form a team and formulate a strategy
You work with senior management to formulate strategies and organize the overall implementation of the system. The responsibility of quality management system lies with top managers, so top managers need to participate in the implementation of the system.
Consider training
Whether the quality manager or senior manager is responsible for the implementation of the system, it is necessary to improve the overall awareness of ISO 900 1:2000. Group activities, seminars and training courses will help.
Select a consultant
You can get advice from neutral consultants on how to better implement the quality management system. They have rich experience in implementing QMS, so you can avoid detours.
Select a certification company
Certification companies are third-party organizations, such as BSI. You can effectively review your company's quality management system. If it meets the standards, BSI will issue a certificate. Due to various market reasons, choosing a certification company may be a complicated process. Factors considered include: factory experience, geographical scope, price and service level. The key is to find the certification body that best suits your needs. Looking for BSI, you may stand higher.
Write a quality manual
The quality manual is a high-level document, which should list your quality management points. The contents, ways and methods of implementing quality management system in their enterprises.
Establish supporting documents
Establish program documents supporting the quality manual. Briefly list the main points of completing a job, who, what and how to do it.
Implement your quality management system.
The key to implementation is communication and training. In the implementation stage, all those who carry out the plan should collect records to prove this; What was prescribed was done, and it was done according to the regulations.
Pre-audit service
Pre-audit services are usually carried out 6 weeks after the implementation of the system. The purpose is to find out which aspects are not up to standard. This will enable you to consider the direction of improvement before the initial review.
Obtain certification
You and your certification body arrange a preliminary inspection. At this stage, the certification body will review your quality management system and make suggestions on whether to issue certificates.
Subsequent audit
Once you get the certification and get the certificate, you can publicize the success of your enterprise certification. In order to ensure certification, you need to continue to implement all quality systems. Certification bodies should regularly check the implementation of standards.
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Steps to establish a quality management system
The establishment and improvement of quality system generally go through four stages: the planning and design of quality system, the compilation of quality system documents, the trial operation of quality system and the audit and review of quality system, and each stage can be divided into several specific steps.
Planning and design of quality system
This stage is mainly to do all kinds of preparations, including education and training, unified understanding, organization and implementation, drawing up plans, etc. Determine the quality policy and set the quality objectives; Investigation and analysis of current situation; Adjust the organizational structure and allocate resources.
First, education and training, unified understanding.
The process of establishing and perfecting the quality system is a process from education to education, and it is also a process of improving and unifying understanding. Education and training should be carried out step by step.
The first level is the decision-making level, including party, political and technical (technical) leaders. Main training:
1. By introducing the development of quality management and quality assurance and the experience and lessons of our unit, the urgency and importance of establishing and perfecting the quality system are explained;
2. Through the general introduction of ISO9000 family standards, improve the understanding of establishing quality system according to national (international) standards.
3. By explaining the elements of the quality system (focusing on the overall elements such as "management responsibilities"), the key position and leading role of decision-making leaders in the construction of the quality system are clarified.
The second level is management, focusing on the heads of management, technology and production departments, as well as the staff related to the establishment of quality system.
These two levels of personnel are the backbone of the quality system construction and improvement, and play a connecting role. In order to make them fully receive the training of ISO9000 family standard, the method of combining explanation and discussion can be adopted. The third level is the executive level, that is, the operators related to the whole process of product quality formation. The personnel at this level mainly receive content training related to the quality activities of this post, including the tasks that should be undertaken in quality activities, the authority that should be given to complete the tasks, and the responsibilities that should be borne for quality faults.
Second, organize the implementation and make plans.
Although the construction of quality system involves all departments and employees of an organization, it may be necessary for most units to establish a lean work team. According to the practice of some units, this team can also be divided into three levels.
The first level: set up a quality department construction leading group (or committee) headed by the top manager (factory director, general manager, etc.). ) as the team leader and the quality supervisor as the deputy team leader. Its main tasks include:
1. Overall planning of system construction;
2. Formulate quality policies and objectives;
3. Decomposition of quality functions by functional departments.
The second level, the establishment of a working group attended by leaders (or representatives) of various functional departments. This working group is generally led by the leaders of the quality department and the planning department, and its main task is to organize and implement according to the overall plan of system construction.
The third level: set up a factor working group. According to the division of labor of various functional departments, the responsible units of quality system elements are defined. For example, the design department is generally responsible for "design control" and the material procurement department is responsible for "procurement" elements. After the implementation of the organization and responsibility, the work plan should be formulated at different levels, and attention should be paid to:
1. The goal should be clear. What tasks should be accomplished, what major problems should be solved and what purpose should be achieved?
2. Control the process. The main stage of establishing the quality system should stipulate the timetable for completing the task, the main responsible persons and participants, as well as their division of responsibilities and mutual cooperation.
3. Get to the point. The focus is mainly on the weak links and key minorities in the system. This minority may be one or several elements, or it may be some activities in elements.
Three, determine the quality policy, formulate quality objectives
Quality policy embodies an organization's pursuit of quality and its commitment to customers, and it is the guideline of employees' quality behavior and the direction of quality work. The requirements for formulating the quality policy are:
1. Coordinate with major policies;
2. Quality objectives should be included;
3. Combining the characteristics of the organization;
4. Ensure that people at all levels can understand and stick to it.
Four. Investigation and analysis of current situation
The purpose of current situation investigation and analysis is to reasonably select system elements, including:
1. system analysis. That is, analyze the quality system of the organization, so as to select the elements of the quality system according to the quality system.
2. Analysis of product characteristics. In other words, analyze technical strength, users, product safety characteristics, etc. To determine the degree of adoption of elements.
3. Organizational structure analysis. Whether the management organization of the organization meets the needs of the quality system. Establish an organizational structure that is compatible with the quality system, and establish the affiliation and contact information between institutions.
4. Production equipment and testing equipment can meet the relevant requirements of the quality system.
5. Composition, structure and level analysis of technical, management and operating personnel.
6. Analysis of basic management. Namely standardization, metrology, quality responsibility system, quality education and quality information analysis.
The above contents can be compared with the requirements of quality system elements specified in the standard.
Verb (abbreviation for verb) adjusts organizational structure and allocates resources.
Because there are other kinds of management besides quality management in an organization. Due to the historical evolution, most organizational structures have not set corresponding functional departments according to the objective law of quality formation. After completing the implementation of quality system elements and developing into corresponding quality activities, the corresponding work responsibilities and authorities in the activities must be assigned to each functional department. On the one hand, it is an objective quality activity, on the other hand, it is an artificial functional department. Generally speaking, a quality functional department can be responsible for or participate in multiple quality activities, but don't let multiple functional departments be responsible for a quality activity. At present, the responsibilities and functions of the existing functional departments of Chinese enterprises for quality management activities are generally unsatisfactory, and should be strengthened as a whole. In the process of activities, there must be corresponding hardware, software and personnel involved, and appropriate deployment and enrichment according to needs.
Compilation of quality system documents
From the perspective of quality system construction, the contents and requirements of quality system documents should emphasize several issues:
1. System documents shall generally be formally formulated after the completion of the first stage work, and may be crossed if necessary. If the preliminary work is not done well, directly compiling the system documents is prone to the disadvantages of being systematic, incomplete and divorced from reality.
2. Except for the quality manual, other system documents should be formulated by the centralized functional department according to the division of labor, and the draft should be put forward first, and then the audit should be organized, which is conducive to the implementation of the documents in the future.
3. The preparation of quality system documents should be combined with the distribution of quality functions of the unit. According to the requirements of the selected quality system, quality activities (including direct quality activities and indirect quality activities) are carried out one by one, and the distribution of quality functions is implemented in various functional departments. The quality activity items and distribution can be expressed in the form of matrix diagram, and the quality function matrix diagram can also be attached to the quality manual as an attachment.
4. In order to coordinate and unify the compiled quality system documents, a "List of Quality System Documents" should be compiled before compilation, and the existing quality manuals (if compiled), enterprise standards, rules and regulations, management methods, record forms, etc. should be collected together and compared with the quality system elements to determine the items of newly compiled, added or revised quality system documents.
5. In order to improve the efficiency of writing quality system documents and reduce rework, the coordination between documents at different levels and between documents should be strengthened in the process of writing documents. Nevertheless, a set of quality system documents should be repeated from top to bottom and from bottom to top.
6. The key to writing quality system documents is practicality rather than formalization. It is necessary to conform to the ISO9000 family standard in general and principle, and to conform to the reality of the unit in terms of methods and specific practices.
Trial operation of quality system
After the quality system documents are compiled, the quality system will enter the trial operation stage. Its purpose is to test the effectiveness and coordination of quality system documents through trial operation, and take improvement measures and corrective measures for the exposed problems, so as to further improve the quality system documents. During the trial operation of the quality system, we should focus on the following work:
1. Publicize the quality system documents in a targeted manner. Make all employees realize that the newly established or improved quality system is a change from the previous quality system and is in line with international standards. In order to adapt to this change, we must seriously study and implement the quality system documents.
2. Practice is the only criterion for testing truth. Through trial operation, there are bound to be some problems in the system documents, and all employees will truthfully reflect the problems in practice and suggestions for improvement to the relevant departments so as to take corrective measures.
3. Coordinate and improve the problems exposed in the trial operation of the system, such as imperfect system design and incomplete projects.
4. Strengthening information management is not only the need of system debugging itself, but also the key to ensure the success of debugging. All personnel related to quality activities shall collect, analyze, transmit, feedback, process and file quality information according to the requirements of system documents.
Audit and review of quality system
Quality system audit is often more important in the initial stage of system establishment. At this stage, the focus of quality system audit is mainly to verify and confirm the applicability and effectiveness of system documents.
1. The main contents of audit and review generally include:
Whether the quality policy and quality objectives specified in (1) are feasible;
(2) Whether the system documents cover all major quality activities and whether the interfaces between the documents are clear;
(3) Whether the organizational structure can meet the needs of the operation of the quality system, and whether the quality responsibilities of various departments and positions are clear;
(4) Whether the selection of quality system elements is reasonable;
(5) Whether the specified quality records can play a witness role.
(6) Whether all employees have developed the habit of operating or working according to system documents, and how is the implementation.
2. The characteristics of system audit at this stage are:
(1) During the normal operation of the system, the system audit focuses on compliance, and in the trial operation stage, compliance and applicability are usually combined;
(2) In order to expose the problems in the trial operation stage as much as possible, in addition to organizing an audit team to conduct a formal audit, employees should also participate and encourage them to find and raise problems through the trial operation practice;
(3) After the trial operation of each stage, an audit should be arranged formally in order to correct the problems found in time, and some major problems can also be organized in time according to the needs;
(4) In the trial operation, all elements should be audited and covered again;
(5) Give full consideration to the protection of products;
(6) On the basis of internal audit, top management shall organize system review.
It should be emphasized that the quality system is improved through continuous improvement. After the quality system enters normal operation, various means such as internal audit and management review should still be taken to maintain and continuously improve the quality system.
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Certification procedure of quality management system
1. Application for quality system certification:
1. 1. The applicant shall submit a formal application signed by its authorized representative. The application or its annexes shall include:
1) Brief introduction of the applicant, such as the nature, name, address, legal status, relevant human and technical resources, etc.
2) Scope of products or services for which certification is applied.
3) Copy of business license of legal person, and provide copy of qualification certificate and production license when necessary.
4) List of consulting institutions and consultants.
5) The latest national product quality supervision and inspection.
6) General information about the quality system and activities.
7) The applicant agrees to comply with the certification requirements and provide the information required for the evaluation.
8) Description of other standard reference documents applicable to the proposed certification system.
1.2. The certification center shall provide relevant public documents according to the needs of the applicant.
1.3. The certification center shall make a decision of accepting, rejecting or accepting after improvement within 30 days after contract review from the date of receiving the application materials of the applicant, and notify the entrusting party (audited party). Ensure that:
The requirements for certification are clearly defined, recorded and understood;
B. The differences of understanding between the certification center and the applicant are resolved;
C. Certification institutions have the ability to certify the scope of certification, business premises and some special requirements, such as the language used by the applicant;
D when necessary, the certification center requires the auditee to supplement the information and explanations.
1.4. Both parties sign the "Quality System Certification Contract".
When a specific certification plan or certification requirement needs to be explained, the representative of the certification center is responsible for explaining it according to the documents approved by the accreditation body and releasing it to the relevant parties.
1.5. The information received will be used to prepare the on-site audit evaluation. The certification center promises confidentiality and safekeeping.
2. Preparation before on-site audit
2. 1. Before the on-site audit, the documented quality system established by the applicant's ISO9000 standard shall run for 3 months, and the quality manual and required related documents shall be submitted to the certification center at least 2 months in advance.
2.2. The Certification Center will set up an audit team and appoint a full-time auditor or audit team leader to audit the quality manual as part of the formal audit. After the review, fill in the Quality Manual Review Form and notify the auditee, and keep records.
2.3. The Certification Center shall be prepared to negotiate with the auditee to determine the audit date, and consider the necessary management arrangements after the documents are reviewed and approved. Before the initial audit, the auditee shall provide at least one implementation record of internal quality audit and management review.
2.4. The certification center shall designate a qualified audit team, determine the audit team leader, and form an audit team to conduct on-site audit on behalf of the certification center.
A members of the audit team shall be national registered auditors.
B. when necessary, hire professional technical experts to assist in the audit.
C. review the names of team members and experts.
The certification center shall notify the auditee in advance and remind the auditee whether there is any objection to the designated auditors and experts. If there may be a conflict of interest between the above-mentioned personnel and the auditee, the auditee has the right to request the replacement of personnel, but it must obtain the consent of the certification center.
2.5. The Certification Center formally appoints an audit team to prepare the audit plan. The audit plan and date shall be agreed by the auditee. If necessary, an initial visit to the auditee should be arranged before the audit plan is prepared to inspect the site and understand the special requirements.
3. On-site audit:
According to the certification standard selected by the auditee, the quality system of the auditee shall be audited within the product range specified in the contract. The main procedures are as follows:
3. 1. Convene the first meeting:
A. introduce the members of the audit team and their division of labor.
B clarify the purpose of the audit according to the documents and scope.
C. Explain the audit method and confirm the audit plan and the problems that need to be clarified.
3.2. Conduct on-site audit.
Collect evidence and write non-conformance report for nonconformities. The principles for evaluating nonconformity types are:
A. Serious nonconformity mainly means that the quality system does not meet the requirements of the agreed quality system standards or documents; Non-conformities that lead to serious systematic and regional failures or may lead to serious consequences will directly lead to unqualified product quality.
B minor (or general) nonconformity mainly refers to: isolated human error; Occasionally, the document is not complied with, which leads to serious consequences and non-conformity, but it will not have an important impact on the system.
3.3. The audit team prepares the audit report and makes the audit conclusion. There are three kinds of audit conclusions:
1) does not exist or has only a small amount of general nonconformity, so it can be recommended to pass the certification.
2) If many serious nonconformities cannot be corrected in a short time, it is recommended not to pass the certification.
3) If there are some serious nonconformities that may be corrected in a short time, it is suggested to postpone the certification.
3.4. Inform the auditee of the audit situation and conclusions.
3.5. Hold the last meeting, read the audit report, and the auditee will confirm the audit results.
3.6. The Certification Center tracks the effect of corrective measures taken by the auditee for nonconformities.
4. Certification and approval
4. 1. The certification center shall examine and approve the audit conclusion, and notify the auditee within one month and two months at the latest after the on-site audit, which shall be included in the supervision and management after certification.
4.2. The certification center is responsible for registering and issuing the certification certificate approved by the general manager of the certification center after passing the certification, and publishing the list of quality system certification registration units in the designated publications.
The scope of the announcement includes: the list of certified qualified enterprises and corresponding information (product scope, quality assurance model standard, approval date, certificate number, etc.). ).
4.3. For the enterprise that cannot approve the certification, the certification center shall issue a formal notice explaining the reasons for not approving it. It takes at least 6 months for the enterprise to reapply.
5. Expand and narrow the scope of certification and change the certification standards.
5. 1 If the certified enterprise needs to expand or narrow the scope of system certification, the licensee shall submit a written application and a corresponding quality manual to expand or narrow the scope of certification. After examination and acceptance, the contract management department shall sign a contract to expand the scope of certification, and if it is necessary to narrow the scope of certification, it shall go through the formalities for changing the original contract. During on-site audit, be responsible for auditing relevant elements, departments and production workshops, expanding the scope of certification, and the specific implementation shall be carried out in accordance with the Quality System Certification (Audit) Implementation Control Procedure. After the approval, the certification certificate shall be replaced, the coverage shall be changed in the certificate, and the replacement date shall be indicated, but the validity period of the certificate shall remain unchanged.
5.2 When the certified enterprise needs to change the system certification standard (mainly referring to that the certification standard is changed from GB/T/KOOC-0/9002-/KOOC-0/994 IDT ISO 9002:/KOOC-0/994 to GB/T/KOOC-0/900/KOOC-0). Kloc-0/9003-1994 IDT ISO 9003:1994 is changed to GB/T. The on-site auditor shall review the elements of certification standard change and relevant departments according to the Procedure for Implementation and Control of Quality System Certification (Auditing). After the approval, the certification certificate shall be replaced, the certification standard shall be changed, and the renewal date shall be indicated, but the validity period of the certificate shall remain unchanged.