Quality Management System (QMS) refers to the management system that directs and controls an organization in terms of quality . The quality management system is a systematic quality management model established within the organization that is necessary to achieve quality goals, and is a strategic decision of the organization.
It combines resources and processes , system management with process management methods , selects a number of system elements to combine according to the characteristics of the enterprise , generally includes process components related to management activities, resource provision, product realization, and measurement, analysis and improvement activities . It can be understood as covering the requirements of planning, implementation, monitoring, correction and improvement activities in the whole process from the determination of customer needs, design and development, production, inspection, sales, and delivery, generally in a documented manner, as an organization's internal quality management requirements.
professional
Chief Quality Officer, Quality Engineer
standard
In response to the requirements of the quality management system, the Quality Management and Quality Assurance Technical Committee of the International Organization for Standardization has formulated the ISO9000 family of standards to apply to organizations of different types, products, scales and natures. This type of standard consists of several interrelated or supplementary individual Standards, among which the well-known one is ISO9001 "Quality Management System Requirements", the requirements it puts forward are supplements to product requirements, and have been revised several times. On the basis of this standard, different industries have formulated corresponding technical specifications, such as IATF 16949 "Special Requirements for the Application of ISO9001:2015 in the Organization of Automobile Production Parts and Maintenance Parts", ISO 13485 "Requirements for Medical Device Quality Management System for Regulations" "wait.
The ISO9001:2015 standard is one of the quality management series standards formulated by the Quality System Subcommittee of the ISO (International Organization for Standardization)/TC176/SC2 Quality Management and Quality Assurance Technical Committee.
2008 Edition: Quality Management Principles
The eight quality management principles are the guiding principles used by top leaders to lead the organization to improve performance, and are the basis of the ISO9000 family of standards, including:
(1) focus on customers;
(2) Leadership;
(3) full participation;
(4) Process method ;
(5) A systematic approach to management;
(6) Continuous improvement ;
(7) Fact-based decision-making methods;
(8) Mutually beneficial relationship with suppliers.
The 2015 version of quality management system: quality management principles include the following seven aspects .
(1) focus on customers;
(2) Leadership;
(3) Active participation of all staff;
(4) Process method;
(5) improvement;
(6) Evidence-based decision-making;
(7) Relationship management.
implement
Purchasing Standards
Quality Management System
Before you are ready to implement, you need a standard. You need to understand and understand.
Refer to related literature and software
There are many quality publications and software tools to help you understand, implement and register a quality management system.
Form a team and develop a strategy
You organize and plan the full implementation of the system by developing strategy with top management. Responsibility for the quality management system rests with senior management , so senior managers need to be involved when starting to implement the system.
consider training
Whether it is the quality manager or the senior manager who is responsible for implementing the system, it is necessary to raise the overall awareness of ISO9001:2008. Group activities, seminars and training sessions can help.
choose a consultant
You can get advice from a neutral consultant on how to better implement a quality management system. They have rich experience in implementing QMS and ensure that you avoid detours.
select company
The certification company is a third-party organization, such as BSI, DNV, TUV, CQC, etc. It is possible to travel to and effectively audit your company's quality management system, and if standards are met, these bodies will issue a certificate. Selecting a certification company can be a complicated process for various market reasons. Factors considered include: factory experience, geographical scope, price and service level. The key is to find the certification body that best suits your needs.
writing manual
The quality manual is a high-level document that lists your key points for quality management. The what, why and how of implementing a quality management system in business.
create file
Establish procedure documentation to support the quality manual. Clear and concise, list the main points for completing a job, who does it, what it does, how it is done, when it is done, and where it is done.
implementation system
The key to implementation is communication and training. During the implementation phase, all those who execute the program must collect records to prove that: what was stipulated was done, and what was done complied with the regulations.
Pre-audit service
The pre-audit service is usually carried out 6 weeks after the implementation of the system. The goal is to find out which areas failed to meet the standard. This will allow you to consider areas for improvement before the initial review.
Certified
You arrange an initial audit with your certifying body. At this stage the certification body will review your quality management system and recommend whether to issue a certificate.
follow-up review
Once you are certified and have a certificate, you can advertise (subject to usage guidelines) that your business has successfully been certified. You need to continue to implement all quality systems in order to maintain certification. The certification body regularly inspects the implementation of the standard (surveillance audit). The certification is valid for 3 years, and after three years, it needs to be re-evaluated (re-evaluated), and the certification certificate will be replaced if the re-evaluated is qualified.
Planning and Design
The planning and design phase of the quality system is mainly to do a good job in various preparations, including education and training, unified understanding, organization and implementation, and drawing up plans; determining quality policies and formulating quality objectives; current situation investigation and analysis; adjusting organizational structure, allocating resources, etc. .
training awareness
The first level : establish a quality system construction leading group (or committee) with 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 policy and objectives;
3. Decomposition of quality functions by functional department.
The second level is to set up a working team attended by leaders (or representatives) of various functional departments. Its main task is to organize and implement in accordance with the overall plan for system construction.
The third level is to set up element working groups. According to the division of labor of each functional department, the responsible units for the quality system elements are clarified . For example, "design control" should generally be in charge of the design department, and the "purchasing" element should be in charge of the material procurement department. After the organization and responsibilities are implemented, work plans are formulated at different levels. When formulating work plans, attention should be paid to:
1. The goal should be clear. What tasks are to be accomplished, what are the main problems to be solved, and what goals are to be achieved?
2. To control the process. The main stage of establishing the quality system is to specify the timetable for the completion of tasks
3. To highlight the key points. The focus is mainly on the weak links and the critical few in the system . policy goal
The quality policy requirements are:
1. Coordinate with general policy;
2. Should contain quality objectives;
3. Combined with the characteristics of the organization;
4. Make sure people at all levels understand and stick to it.
research analysis
The purpose of status investigation and analysis is to select system elements reasonably , including:
1. System situation analysis.
2. Analysis of product characteristics.
3. Organizational structure analysis.
4. Whether the production equipment and testing equipment can meet the relevant requirements of the quality system.
5. Analysis of the composition, structure and level of technical, management and operating personnel.
6. Management basic work situation analysis.
Documentation
The preparation content and requirements of quality system documents, from the perspective of quality system construction, should emphasize several issues:
1. System documents should generally be formally formulated after the completion of the first phase of work, and can also be carried out cross-over if necessary. If the preliminary work is not done, directly compiling the system documents will easily lead to systemicity, poor integrity, and deviation from reality;
2. Except for the quality manual that needs to be formulated uniformly, other system documents should be formulated separately by each functional department according to the division of labor, and the draft should be put forward first, and then organized for review, which is conducive to the implementation of future documents;
3. The preparation of quality system documents shall be carried out in conjunction with the assignment of quality functions of the unit. According to the selected quality system requirements, each quality activity (including direct quality activities and indirect quality activities) will be expanded one by one, and the quality function will be assigned to each functional department . Quality activity items and assignments can be expressed in the form of a 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 "quality system document list" should be formulated before compilation, and the current quality manual (if compiled), enterprise standards, rules and regulations, management methods and record forms Collected and compared with quality system elements to identify new, addendum or revised quality system documentation items;
5. In order to improve the preparation efficiency of quality system documents and reduce rework, it is necessary to strengthen the coordination between levels of documents and between documents in the process of document preparation. Even so, a set of quality system documents with good quality has to go through multiple iterations from top to bottom and bottom to top;
6. The key to the preparation of quality system documents is to focus on practical results and not formalities. It should not only meet the ISO9000 family standards in general and in principle, but also conform to the reality of the unit in terms of methods and specific practices.
test run
After the preparation of quality system documents is completed, the quality system will enter the trial operation stage. Its purpose is to test the validity and coordination of the quality system documents through trial operation, and to take improvement measures and corrective measures for the problems exposed, so as to further improve the quality system documents . During the trial operation of the quality system, the following work should be focused on:
1. Targeted publicity and implementation of quality system documents. Make all employees realize that the newly established or improved quality system is a change to the past quality system, and it is to be in line with international standards. To adapt to this change, it is necessary to study and implement the quality system documents carefully;
2. Practice is the sole criterion for testing truth. There will inevitably be some problems in the system documents through the trial operation, and all employees will truthfully reflect the problems and improvement opinions arising from practice to the relevant departments in order to take corrective measures;
3. Coordinate and improve the problems exposed in the trial operation of the system, such as poor system design and incomplete projects;
4. Strengthening information management is not only the need of the system trial operation itself, but also the key to ensure the success of the trial operation. All personnel related to quality activities should do a good job in the collection, analysis, transmission, feedback, processing and archiving of quality information according to the requirements of the system documents .
run efficiently
The ISO9000 family of standards is a quality management and quality assurance standard formulated by the International Organization for Standardization to meet the needs of international economic and technological exchanges and international trade development , and has been adopted by more than 100 countries. In particular, the latest version of ISO9001:2000 quality standard in 2000 has the advantages of wide applicability, strong versatility, and systematic control of quality-related activities. Its core content is "to satisfy customers". The implementation of ISO9000 family standards has been valued by many enterprises, and it has become a "passport" for enterprises to prove their product quality and work quality .
Relevant experts believe that "Standard Implementation" provides a scientific guide for enterprises to improve management, improve product and service quality, and at the same time find a "common language" for enterprises to enter the international market. With China's accession to the WTO, all walks of life will accelerate the process of international standardization, and "standard implementation" has become more urgent. Undoubtedly, "Standard Implementation" is not a panacea and cannot cure all diseases, but through "Standard Implementation", the quality awareness and management awareness of all employees of the enterprise have been enhanced, and various management responsibilities and work procedures have been clarified to promote the company's The management work has shifted from "rule of man" to "rule of law". It has truly achieved that someone is responsible for everything, there are rules to follow, everything is well-documented, and everything is supervised, realizing "prevention first " ; Clarified the responsibilities and authority of each department and all employees, prevented and controlled the occurrence of unqualified, and reduced the cost of enterprise quality management; through regular organization of quality inspection and quality audit activities, it is possible to discover and find out in time the management activities and service quality. The existing problems and weak links in the field were effectively corrected, which improved the overall management level and quality monitoring ability of the enterprise, and laid the foundation for the enterprise to implement comprehensive scientific management; implemented the "people-oriented" principle and comprehensively improved the business of employees . Skills and comprehensive quality have laid a solid foundation for the long-term development of the company ; around "customer satisfaction", we will deal with customer complaints or opinions in a timely and serious manner, continuously meet customer needs and expectations, win customer trust, improve customer satisfaction, and enhance the social status of the company image and market competitiveness .
Audit review
Quality system audits are often more important in the initial stages of system establishment. At this stage, the focus of the quality system audit is mainly to verify and confirm the applicability and effectiveness of the system documents.
1. The main contents of audit and review generally include:
(1) Whether the specified quality policy and quality objectives are feasible;
(2) Whether the system documents cover all the main quality activities, and whether the interface between each document is clear ;
(3) Whether the organizational structure can meet the needs of the quality system operation, and whether the quality responsibilities of each department and each post 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 the system documents, and how is the implementation.
2. The characteristics of the system audit at this stage are:
(1) The system audit during normal operation of the system focuses on compliance, and in the trial operation stage, it is usually carried out by combining compliance and applicability;
(2) In order to expose the problems as much as possible in the trial operation stage, in addition to organizing the audit team to conduct formal audits, the majority of employees should also participate and encourage them to discover and raise problems through the practice of trial operation;
(3) After the completion of each stage of trial operation, an audit should be formally arranged in order to correct the problems found in time, and some major problems can also be audited in a timely manner according to the needs;
(4) During the trial operation, all elements shall be reviewed and covered;
(5) Fully consider the guarantee effect on the product;
(6) On the basis of internal audit, the top management organizes a system review.
It should be emphasized that the quality system is perfected through continuous improvement. After the quality system enters normal operation, various means such as internal audit and management review must be adopted to maintain and continuously improve the quality system.
certification process
Apply
1.1. The applicant submits a formal application form which should be signed by its authorized representative. The application or its attachments should include:
1) A brief profile of the applicant, such as the nature, name, address, legal status, and relevant human and technical resources of the organization;
2) The scope of products or services covered by the application for certification;
3) A copy of the business license of the legal person, and a copy of the qualification certificate and production license if necessary;
4) List of consulting agencies and consultants;
5) National product quality supervision and inspection situation;
6) general information about the quality system and activities;
7) The applicant agrees to abide by the certification requirements and provide the information needed for evaluation;
8) Explanation of other referenced documents of standards applicable to the proposed certification system.
1.2. The certification center provides relevant public documents according to the applicant's needs.
1.3. From the date of receipt of the applicant's application materials, the certification center will make a decision to accept, reject or accept after improvement within 30 days after the contract review, and notify the entrusting party (audited party). To ensure that the:
A. The requirements for certification are clearly defined, documented and understood;
B. Differences in understanding between the certification authority and the applicant are resolved;
C. For the scope of certification applied by the applicant, the operating site and some special requirements, such as the language used by the applicant, the certification body has the ability to implement certification;
D. The certification center requires the auditee to supplement materials and explanations when necessary.
1.4. Both parties sign the "Quality System Certification Contract".
When a specific certification plan or certification requirements need to be explained, the representative of the certification center is responsible for explaining according to the documents recognized by the accreditation body and releasing them to relevant parties.
1.5. The information received will be used for the preparation of on-site audit assessment. The Certification Center promises to keep it confidential and keep it safe.
Prepare
2.1. Before the on-site audit, the documented quality system established by the applicant's ISO9000 standard should run for 3 months , and submit the quality manual and required related documents to the certification center at least 2 months in advance.
2.2. The certification center is going to set up an audit team, appoint a full-time auditor or audit team leader to review the quality manual as part of the formal audit, fill out the "Quality Manual Review Form" after the review to notify the auditee, and keep the records.
2.3. The certification center shall be prepared to negotiate with the auditee to determine the audit date and consider necessary management arrangements after the document review is passed. 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 appoints a qualified audit team, determines the audit team leader, and forms an audit team to carry out on-site audit on behalf of the certification center.
A. Members of the audit team shall be national registered auditors;
B. Hire professional technical experts to assist in the review when necessary;
C. Names of audit team members and experts.
The certification center will notify the auditee in advance and remind the auditee if there is any objection to the assigned auditors and experts. If there may be a conflict of interest between the above personnel and the auditee, the auditee has the right to request replacement of personnel, but must obtain the approval of the certification center.
2.5. The certification center formally appoints the audit team, prepares the audit plan, and the audit plan and date should be agreed by the auditee. If necessary, arrange an initial visit to the auditee before preparing the audit plan, inspect the site, and understand the special requirements.
On-site audit
The audit is based on the certification standards selected by the auditee, and the quality system of the auditee is audited within the scope of products determined in the contract. The main procedures are:
3.1. Hold the first meeting:
A. Introduce the members of the audit team and their division of labor;
B. Clear audit purpose, based on documents and scope;
C. Explain the audit method, confirm the audit plan and the issues that need to be clarified.
3.2. Implement on-site audit.
Collect evidence and write a non-conformity report for the non-conformity items. The principles for evaluating the types of non-conformity items are:
A. Serious non-conformities mainly refer to: the quality system does not conform to the requirements of the agreed quality system standards or documents; non-conformities that cause systemic and regional serious failures or non-conformities that can cause serious consequences can directly lead to unqualified product quality;
B. Minor (or general) non-conformity items mainly refer to: isolated human errors; non-conformities that do not have serious consequences due to occasional non-compliance with documents, and non-conformities that will not have a significant impact on the system, etc.
3.3. The audit team writes the audit report to make audit conclusions, and there are three types of audit conclusions:
1) If there is no or only a small amount of general non-conformity, it may be recommended to pass the certification;
2) If there are multiple serious non-conformities that cannot be corrected in a short period of time, it is recommended not to pass the certification;
3) If there are individual serious nonconformities that may be corrected in the short term, it is recommended to postpone the certification.
3.4. Notify the auditee of the audit situation and conclusions to the auditee.
3.5. Hold the final meeting, read out the audit report, and the auditee confirms the audit results.
3.6. The certification center tracks the effect of corrective measures taken by the auditee on the non-conformities.
Certification Approval
4.1. The certification center will review and approve the audit conclusions and notify the auditee within one month after the on-site audit, no later than two months, and include them in the post-certification supervision and management.
4.2. The certification center is responsible for registering and issuing certification certificates approved by the general manager of the certification center after passing the certification, and publishing the list of quality system certification registration units on designated publications.
The scope of publication and announcement includes: the list of qualified enterprises and corresponding information (product range, quality assurance mode standard, approval date, certificate number, etc.).
4.3. For enterprises that cannot be approved for certification, the certification center must give a formal notice, explaining the reasons for the failure, and the enterprise will not be able to accept the application again until at least 6 months later.
scope standard
5.1. If a certified enterprise needs to expand or reduce the scope of system certification, the certified party shall submit a written application and propose a quality manual corresponding to the expansion or reduction of the certification scope. For the scope of certification contract, if the scope of certification needs to be reduced, the procedures for changing the original contract shall be handled. During the on-site audit, it will be responsible for auditing the relevant elements, departments and production workshops of the expanded certification scope, and the specific implementation will be carried out in accordance with the "Quality System Certification (Audit) Implementation and Control Procedures". After the audit is passed, the certification certificate will be replaced. The scope of coverage will be changed in the certificate, and the date of renewal will be indicated, but the validity period of the certificate will remain unchanged.
5.2. When the certified enterprise needs to change the system certification standard (mainly refers to the certification standard changed from GB/T19002-1994idtISO9002:1994 to GB/T19001-1994idtISO9001 or GB/T19003-1994idtISO9003:1994 to GB/T19002-1994idtISO9002:1994) must be The certified party submits a written application and provides a quality manual that is compatible with the certification standards. On-site auditors review the elements of certification standard changes and related departments. The specific implementation is carried out in accordance with the "Quality System Certification (Audit) Implementation and Control Procedures". The validity period remains unchanged.
maintenance improvement
"Continuous improvement" is the spirit of the quality management system. It refers to the cyclical activities that enhance the ability to meet requirements. It requires the organization to continuously seek opportunities for improvement to improve the characteristics of products and improve the effectiveness and effectiveness of the processes used to produce or deliver products. efficiency. Improvement measures can be daily improvement activities or major improvement projects. The organization shall plan and manage the following five activities to continuously improve the effectiveness of the quality management system.
a) Review the quality policy: the organization can motivate employees to make continuous efforts and create an atmosphere and environment for continuous improvement by updating and implementing a new quality policy;
b) Review the quality objectives and clarify the direction of improvement;
c) Conduct data analysis and internal audit analysis on the status of the existing process (including existing and potential nonconformities), determine improvement plans, and continuously seek opportunities for improvement;
d) implement corrective and preventive actions and other applicable actions to achieve continual improvement;
e) Organizational management review.
The maintenance of the system always follows the "PDCA" operation mode.
Classification
First-party audits , also known as internal audits, are used for internal purposes by the organization itself or on behalf of the organization and can be used as the basis for the organization's self-declaration of conformity. Internal audit is a quality system certification audit of the quality management system.
The role of internal audit is as follows:
(1) According to the requirements and standards of the quality management system, inspect the activities and processes, and evaluate the procedures and management systems and the requirements of corresponding laws and regulations.
(2) Verify whether the organization's own quality management system requirements are continuously and effectively implemented and maintained.
(3) Evaluate the effectiveness and efficiency of the manager's decision-making, quality policy and objectives, the organization's own regulations, and contract requirements.
(4) As an important management tool, timely discover problems, take corrective or preventive measures, and provide information for continuous improvement.
(5) Promote product quality improvement, continuous customer satisfaction and compliance with regulatory requirements and continuous improvement of the quality management system.
For internal audits, the organization shall prepare corresponding procedural documents, which shall include the planning of audit programs, requirements of auditors, implementation of audits, assurance of audit independence, responsibilities for recording results and reporting to managers, and tracking of corrective measures. Verification, recording and reporting requirements are clearly defined.
Second-party audits are conducted by the organization's customer or by others on behalf of the customer.
The role of the second party audit:
(1) When there is an intention to establish a contractual relationship, conduct a preliminary evaluation of the supplier.
(2) In the case of a contractual relationship, verify that the supplier's quality management system continues to meet the specified requirements and is functioning.
(3) As one of the basis for formulating and adjusting the list of qualified suppliers.
(4) Communicate the consensus on quality requirements between the supply and demand sides.
Third-party audits are conducted by external independent auditing services. Such organizations are usually accredited, providing certification or registration in compliance with (eg ISO9001) requirements.
The role of third-party audits:
(1) Determine whether the quality management system requirements meet the specified requirements.
(2) Determine whether the current quality management system is effective in achieving the specified quality objectives.
(3) Determine whether the quality management system of the auditee can be certified/registered.
management steps
The establishment and improvement of a quality system generally involves four stages : planning and design of the quality system, preparation of quality system documents, trial operation of the quality system, audit and review of the quality system, and each stage can be divided into several specific steps.
Planning and design
This stage is mainly to do various preparatory work, including education and training, unifying understanding, organizing implementation, drawing up plans; determining quality policy, formulating quality objectives; current situation investigation and analysis; adjusting organizational structure, allocating resources, etc.
1. Unified understanding of education and training
The process of establishing and improving the quality system starts with education and ends with education. It is also a process of raising awareness and unifying awareness. Education and training should be carried out step by step.
The first level is the decision-making level, including party, government, and technical (technical) leadership. Main training:
1. Explain the urgency and importance of establishing and improving the quality system by introducing the development of quality management and quality assurance and the experience and lessons of the unit;
2. Through the general introduction of the ISO9000 family of standards, improve the awareness of establishing quality systems according to national (international) standards.
3. Through the explanation of the elements of the quality system (the focus should be on general elements such as "management responsibilities"), the key position and leading role of decision-making leaders in the construction of the quality system will be clarified.
The second level is the management, focusing on the heads of the management, technology and production departments, as well as the staff related to the establishment of the quality system.
The personnel at these two levels are the backbone of the construction and improvement of the quality system, and play a link between the past and the future. To enable them to fully accept the training on the relevant content of the ISO9000 family of standards, the method can be combined with explanation and discussion.
The third level is the executive level, that is, the operators related to the whole process of product quality formation.
For this level of personnel, the main training is related to the quality activities of the post, including the tasks to be undertaken in the quality activities, the authority to be granted to complete the tasks, and the responsibilities that should be borne for quality errors.
2. Organize and implement the proposed plan
Although the construction of the quality system involves all departments and all employees of an organization, for most units, it may be necessary to set up a capable working team. According to the practice of some units, this team can also be divided into three levels.
The first level: establish a leading group (or committee) for the construction of the quality department with 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 policy and objectives;
3. Decomposition of quality intelligence by functional department.
The second level is to set up a working team 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 it in accordance with the overall plan for system construction.
The third level: set up element working group. According to the division of labor of each functional department, the responsible units for the quality system elements are clarified. For example, "design control" should generally be in charge of the design department, and the "purchasing" element should be in charge of the material procurement department. After the organization and responsibilities are implemented, work plans are formulated at different levels. When formulating work plans, attention should be paid to:
1. The goal should be clear. What tasks are to be accomplished, what are the main problems to be solved, and what goals are to be achieved.
2. To control the process. The main stage of establishing a quality system is to specify the timetable for completing tasks, the main responsible persons and participants, as well as their division of responsibilities and mutual collaboration.
3. To highlight the key points. The focus is mainly on the weak links and the critical few in the system. This minority may be one or several elements, or some activities among the elements.
3. Determine the quality policy and formulate quality objectives
The quality policy embodies an organization's pursuit of quality and commitment to customers, and is the code of conduct for employees and the direction of quality work. The requirements for formulating a quality policy are:
1. Coordinate with general policy;
2. Should contain quality objectives;
3. Combined with the characteristics of the organization;
4. Make sure people at all levels understand and stick to it.
3. Current Situation Survey and Analysis
The purpose of status investigation and analysis is to select system elements reasonably, including:
1. System situation analysis. That is to analyze the quality system situation of the organization in order to select the requirements of the quality system elements according to the quality system situation.
2. Analysis of product characteristics. That is to analyze the product's technology-intensive degree, use object, product security features , etc., to determine the degree of adoption of elements.
3. Organizational structure analysis. Whether the organization's management structure meets the needs of the quality system. An organizational structure compatible with the quality system shall be established and the affiliation and contact methods among various institutions shall be established.
4. Whether the production equipment and testing equipment can meet the relevant requirements of the quality system.
5. Analysis of the composition, structure and level of technical, management and operating personnel.
6. Management basic work situation analysis. That is, the analysis of standardization, measurement, quality responsibility system, quality education and quality information.
The above content can be compared with the quality system element requirements stipulated in the standard for comparative analysis.
4. Adjust the organizational structure and allocate resources
In addition to quality management, there are other kinds of management in an organization. Due to the history of organizational structure, most of the corresponding functional departments are not set up according to the objective laws of quality. Therefore, after completing the implementation of quality system elements and launching corresponding quality activities, the corresponding job responsibilities and authorities in the activities must be assigned to various functional departments. On the one hand, it is an objective quality activity, and on the other hand, it is an artificial existing functional department. Generally speaking, a quality functional department can be responsible for or participate in multiple quality activities, but do not let one Quality activities are undertaken by multiple functional departments. The responsibilities and roles played by the existing functional departments of Chinese enterprises in quality management activities are generally not ideal, and should be strengthened in general. In the process of carrying out activities, corresponding hardware, software and staffing must be involved, and appropriate deployment and enrichment should be carried out according to needs.
Related Laws
Chapter 1 General Provisions
Article 1 In order to deal with certification and accreditation appeals and complaints in a timely, accurate and fair manner, and to protect the legitimate rights and interests of the parties concerned, these measures are formulated in accordance with relevant national laws and regulations and the functions of the National Certification and Accreditation Administration Commission (hereinafter referred to as the Certification and Accreditation Administration Commission) entrusted by the State Council. .
Article 2 Any organization or individual who believes that the conduct of certification and accreditation institutions, personnel or certified organizations violates laws and regulations shall have the right to appeal and complain to CNCA in accordance with these Measures.
Article 3 The handling of appeals and complaints shall follow the following principles:
(1) Based on facts and based on laws and regulations;
(2) The principle of protecting the legitimate rights and interests of the parties;
(3) Principles of legality and rationality;
(4) Principles of openness, fairness and impartiality;
(5) Efficient and economical principles.
Article 4 The Policy and Legal Affairs Department of CNCA (hereinafter referred to as the Legal Department) is responsible for uniformly accepting certification and accreditation appeals and complaints, and organizing the investigation and punishment of major certification and accreditation violations.
Article 5 Appeals and complaints that belong to general violations of certification and accreditation shall be transferred by the legal department to relevant business supervision departments for handling; for appeals and complaints that are major certification and accreditation violations or illegal acts, the legal department shall organize relevant business supervision departments to set up cases for handling Working group review process.
Chapter II Complaint Handling Procedures
Article 6 If the parties have objections to the decision of the relevant certification and accreditation agency, they shall appeal to the agency that made the decision, and if they still have objections to the handling results, they may appeal to the CNCA.
If the party believes that the conduct of the certification and accreditation agency has seriously violated its own legitimate rights and interests, it may also directly lodge a complaint with the CNCA.
Article 7 The parties concerned who file a complaint with CNCA shall meet the following conditions:
(1) There is a clear respondent;
(2) There are specific appeal requests, facts and reasons;
(3) It belongs to the scope of certification and accreditation work.
Article 8 The appeal of the parties shall be in written form, in duplicate, and shall specify the following items:
(1) The name, address, telephone number, and postal code of the party concerned (if the party concerned is a natural person, the name, address, telephone number, and postal code should be specified);
(2) The name, address, telephone number, and zip code of the respondent;
(3) The requirements, reasons and relevant factual basis of the appeal.
Article 9 Where a party entrusts an agent to appeal, it shall submit a power of attorney to CNCA.
Article 10 CNCA shall, within 7 working days from the date of receipt of the appeal letter, make the following dispositions:
(1) The appeal shall be accepted if it complies with the provisions of these Measures;
(2) If the appeal does not comply with the regulations, the appellant shall be notified in writing and the reasons for not accepting it shall be informed.
Article 11 The following appeals shall not be accepted or shall be terminated:
(1) The case has been accepted or handled by a court, arbitration institution or other administrative agency;
(2) The parties cannot prove that their rights and interests have been violated;
(3) It does not belong to the scope of certification and accreditation work.
Article 12 After the CNCA accepts the appeal of the parties, the undertaker shall fill in the registration form for registering the appeal case and attach relevant materials at the same time.
Article 13 After the CNCA accepts the appeal case, it shall send the copy of the appeal letter to the respondent within 5 working days, and the respondent shall submit the statement of defense and relevant evidence within 5 days after receiving the copy of the appeal letter.
Article 14 The parties concerned shall provide evidence for their own complaints, collect evidence on their own or convene relevant parties for investigation, and the relevant parties shall cooperate.
Article 15 CNCA may entrust relevant certification and accreditation agencies to assist in investigation and evidence collection, and the entrusted certification and accreditation agencies shall provide assistance.
Article 16 If the CNCA deems that identification or testing is necessary for specialized issues, it may submit it to a statutory identification or testing agency agreed by the parties, or a statutory identification or testing agency designated by the CNCA and agreed by the parties. identification, detection. Appraisal or testing expenses shall be paid in advance by the complainant or the respondent, and the expenses shall be borne by the responsible party when the processing is completed.
Article 17 If the appeal case raised by the parties is subject to negotiation, settlement or mediation, a mediation statement shall be prepared.
Article 18 The mediation letter shall state the appeal request and the result of the parties' agreement. The mediation statement shall be signed by the undertaker, stamped with the seal of CNCA and delivered to the parties.
Article 19 CNCA shall make a handling decision within three months from the date of accepting the appeal of the party concerned.
If it is necessary to extend the processing period due to special circumstances, it shall be reported to the competent leader of CNCA for approval. Article 20 For the violations of the respondent, CNCA may make decisions such as circular criticism, suspension of relevant qualifications, etc.
Article 21 The State Certification and Accreditation Administration shall transfer the illegal acts of the respondent to the local quality inspection administrative department for handling. The local quality inspection administrative department shall promptly report the investigation and punishment to the Certification and Accreditation Administration.
Chapter III Complaint Handling Procedures
Article 22 Complaints to CNCA shall include the following matters:
(1) There is a clear respondent;
(2) There are specific complaint facts;
(3) Contact information with the complainant.
Article 23 After receiving the complaint, the Legal Department of CNCA shall conduct preliminary verification. The following complaints will not be accepted or will be terminated:
(1) The case has been accepted or handled by a court, arbitration institution or other administrative agency;
(2) The facts of the complaint are inconclusive, insufficient or inconsistent with the facts;
(3) It does not belong to the scope of certification and accreditation work.
Article 24 If the complaint meets the conditions for filing a case, it shall fill out the registration form for filing a complaint case, and accept the case in accordance with the provisions of Article 5 of these Measures.
Article 25 CNCA may entrust accreditation agencies or local quality inspection administrative departments to handle the complaints received. The institution or department that accepts the entrustment shall report the handling results to the Legal Department of the CNCA in a timely manner.
Article 26 To handle a complaint case, if the CNCA deems it necessary to collect evidence, it may collect evidence by itself or organize personnel to conduct investigations on the spot in accordance with the provisions of laws, administrative regulations and rules, and relevant parties shall cooperate and truthfully provide relevant evidence .
Article 27 CNCA shall make a decision within three months from the date of filing the case.
Article 28 For the violations of the respondent, CNCA may make decisions such as circular criticism, suspension of relevant qualifications, etc.
Article 29 The CNCA will transfer the illegal behavior of the respondent to the local quality inspection administrative department for handling. The local quality inspection administrative department shall promptly report the investigation and punishment to the Certification and Accreditation Administration.
Article 30 After handling the complaint case, if there is a clear complainant, the undertaker shall inform the complainant of the handling result
Chapter IV Supervision and Management of Appeals and Complaints
Article 31 The legal department shall regularly check the handling of appeals and complaint cases, and correct any problems found in a timely manner.
Article 32 CNCA shall establish and improve the management system for appeals and complaint files. Within 7 days after the appeal and complaint case is closed, the undertaker shall transfer the appeal and complaint files to the legal department.
The storage period of the archives can be determined according to the appeal, the importance of the complaint and the retention value.
Article 33 CNCA shall establish an information statistical system for appeals and complaint handling.
Article 34 The staff responsible for handling appeals and complaints shall recuse themselves if they have a direct interest in the appeals or complaints.
Article 35 The staff responsible for handling appeals and complaints shall be responsible for keeping confidential any non-public information related to appeals and complaints.
Chapter V Supplementary Provisions
Article 36 The term "appeal" in these Measures refers to the objection raised by the parties concerned when they are directly affected by the decision made by the relevant certification and accreditation agency.
The term “complaint” in these Measures refers to the report by any organization or individual that the relevant certification and accreditation institutions, personnel or certified organizations have violations of laws and regulations.
The certification and accreditation institutions referred to in these Measures refer to accreditation/registration institutions, certification institutions, certification consulting institutions, certification training institutions, and related testing and inspection institutions engaged in certification and accreditation work.
Article 37 The Measures shall be interpreted by CNCA.
Article 38 These Measures shall come into force on the date of promulgation.
build process
The establishment of a quality management system by an enterprise should be based on the correct quality management guiding ideology, guided by scientific quality management principles, expressed in the quality management manual, through scientific evaluation of the quality management system, and through continuous evaluation and revision. , re-evaluation and re-correction are completed. Generally go through the following steps:
1. Establish the guiding ideology for enterprises to establish a quality management system. The quality management system is a subsystem of the entire management system of an enterprise, and its establishment goals must conform to the strategic goals of enterprise development and become the guarantee for the successful development of the enterprise.
2. Clarify the specific functions and system structure of the enterprise to establish the quality management system. Under the guidance of the correct guiding ideology, use the "quality ring" tool to analyze and determine the scope of functions of the enterprise to establish the quality management system. When applying "quality ring" analysis, it is necessary to analyze the process of product quality generation, formation and realization according to the characteristics of the enterprise's products, find out all links that may affect product quality, and study and determine the quality function of each link.
3. Establish the enterprise quality management manual in the form of documents. A company's quality management manual consists of documents that clarify the company's quality policy and describe its quality management system. The quality management manual involves all the activities of the enterprise related to quality management, and its title and scope reflect its application field. In general, the enterprise quality management manual includes or involves quality policy; personnel responsibilities, authorities and interrelationships affecting the management, implementation, verification or review of quality; quality management system procedures and instructions; regulations on manual review, modification and control and so on.
4. Evaluate the quality management system that has been operated in practice. The purpose of the evaluation is to determine whether the enterprise's quality activities and related results conform to the planned arrangements, and whether these arrangements have achieved the expected goals. The evaluation method is carried out by reviewing the elements that make up the quality management system. According to different audit purposes, there are two types of quality management system audits: internal audits and external audits.
5. Further improve the quality management system according to the evaluation results. The main purpose of an enterprise's quality management system evaluation is to provide a basis for the improvement of the enterprise's quality management system. Practice has proved that whether the product quality of an enterprise can satisfy customers and bring benefits to the enterprise depends on the effectiveness and operating efficiency of the quality management system established by the enterprise.
Authenticity query
ISO9001 certification certificate authenticity query method
Method 1: Check through the official website of the certification body, the fastest
Method 2: Inquire through the website of the National Certification and Accreditation Administration Commission. Since the certificate data on the website of the Certification and Accreditation Administration is regularly reported by the certification bodies, there may be delays.
Inquiry path: Open the official website of CNCA→Inquiry Area→Certification Inquiry→Management System and Voluntary Product Certification Public Inquiry
Auditor
Personnel engaged in the audit activities of ISO9001 quality management system certification. Divided into internal auditors (internal quality auditors) and external auditors (national registered auditors).
Internal auditor refers to a qualification that has obtained the internal quality management system audit after training and passing the assessment of ISO standards. Generally, it is trained and assessed by an institution with ISO-related system consulting qualifications recognized by the National Certification and Accreditation Administration. serve. It is only applicable to the internal audit of the enterprise (unit), familiar with the operation process of the enterprise and the authority of management responsibilities, and can be competent for a basic means and requirements of the quality management system for the self-improvement and self-management of the enterprise itself. It is responsible for the internal management review and inspection. Omissions, supervision, and responsibility for proposing rectification plans.
Relative to internal auditors are national registered auditors (also known as external auditors). Those who are engaged in third-party audits in the name of certification companies can directly go to each company for audits. The national registration system is implemented for external auditors. They need to participate in the external auditor training and obtain the external auditor training certificate before they can participate in the national quarterly audit. After passing the final unified examination, you can apply for registration as a national registered auditor of the quality management system. This kind of qualification needs to go through a more rigorous training examination and internship period, that is, the cumulative review time reaches a certain amount. And it needs to be linked to a certification body with certification qualifications recognized by the National Accreditation Committee, which can be divided into part-time and full-time.
Generally, enterprises carry out system certification, and first organize internal auditors to audit their own enterprises to determine whether the system operation is effective, and rectify the unqualified and weak links found in the audit, and then the certification agency sends an audit team to audit the enterprise. To obtain certification.
Transfer from: Quality Management System_Baidu Encyclopedia