1 overall process division
The process of establishing ISO900 1 quality management system is based on PDCA principle (plan: do: implement; Check: check; Action: improvement), usually including four stages. Popularly speaking, it includes what people usually say, "Write what I do, do what I write, remember what I do, and strive for perfection." These four stages are: preparation stage, planning quality management system stage, system operation stage and certification audit stage. The overall completion time is about four months. Different management systems have slightly different requirements for time.
1. 1 preparation stage:
System planning time: about one week.
Enterprises set up a standard implementation team, which is usually the responsibility of the top management of the enterprise. The team members include management representatives, managers at all levels and technical backbones appointed by the top management. The ISO team discussed with the consultant and worked out a draft plan for establishing a quality management system.
1.2 system planning stage
Time: about a month.
This stage includes the process of enterprise investigation, diagnosis, standard training, preparation and revision of system documents, and document release.
1.3 system operation stage
Time: The general management system standard requires running for more than three months.
This stage includes: document training, quality management system operation guidance, internal audit training and guidance, management review training and guidance.
1.4 certification review stage
Time: about half a month.
This stage includes: compliance audit (simulation audit), preparation before certification, on-site audit of certification institutions, closing non-conformity guidance, obtaining certificates and other processes.
On-site audit An independent third-party certification body evaluates the conformity of the enterprise quality management system and standards to determine whether to issue a certification certificate.
2. Focus of each stage.
2. 1 Establish a standard implementation team.
It is best for the bid-passing team to be headed by the general manager of the company, give full play to the leading role required for the establishment of the system, and realize "strategizing and winning thousands of miles".
The main function of the management representative is to be fully responsible for ISO900 1 related matters on behalf of the general manager, especially the deputy general manager in charge of business. On the one hand, he is familiar with the operation of various departments in the organization, on the other hand, he has enough power and influence in management decision-making.
2.2 investigation
Time: 1 ~ 2 days, enterprises with many departments and complicated processes will need more time accordingly.
Investigation is the basis of establishing quality management system. Its purpose is to understand the management situation of the enterprise, find out the gap with the standard, modify the draft plan for establishing the quality management system, and form the final implementation plan.
Before the investigation, the enterprise shall collect the information related to the above contents, including the description of the enterprise's organization (figure), working system, operating rules, inspection rules, working record list and record form style in use, technical manual, equipment account, list of measuring instruments, applicable laws, regulations and national standards, etc.
During the investigation, the consulting team comprehensively and carefully investigated and understood the organizational structure, responsibilities, authority, management process, production process, quality management status, equipment management status and employee quality status of the enterprise. After fully understanding the company's basic situation, communicate with the company's top management to clarify the company's development direction and ideas, organizational structure, planning framework of management system, etc.
According to the enterprise's situation, the research work generally takes 1 ~ 2 days, and enterprises with many departments and complicated processes will need more time.
? 2.3 Training
The training is divided into three parts: A, standard training B, document training C, internal audit and management review training.
2.3. 1 standard training
Time: It will take about two to three days.
This training is aimed at ISO900 1 standard. The training contents include the development history of ISO9000 series standards, eight principles of quality management, ISO900 1 standard, etc. The purpose of this training is to enable enterprise leaders, managers and employees at all levels to have a profound understanding and mastery of the contents of the standards, and to use them flexibly on this basis, establish a quality management system in combination with the actual situation of enterprises, implement and improve it, and give full play to its role.
Before training, the enterprise should make a training plan to determine the training time, place and participants. For the purpose of training, the participants should at least include middle-level and above leaders (senior managers must attend), and it is best for all employees to attend.
Document training
The training was conducted by the consultant after the release of the system documents. The purpose of this training is to familiarize internal auditors with the contents of system documents, know what specific work they have in the system, guide internal auditors how to follow these documents, what records need to be formed, and the problems that should be paid attention to in the implementation process. Then, the internal auditor will conduct necessary training for the personnel of the department, so that relevant personnel can understand the requirements of the system documents and implement them. This kind of training can be carried out by the enterprise at an appropriate time and place according to the needs.
2.3.3 Training on Internal Audit and Management Review
This training is generally conducted within one and a half months after the release and operation of system documents, aiming at internal auditors. Through training, internal auditors should master the skills and methods of internal audit, find out the problems existing in the system operation and how to deal with them.
The internal auditor plays an important role in the quality management system, and its main duty is to check the operation of the quality management system, to find possible problems in the process involved in the system, to evaluate the compliance of the implementation and planning of the system, to determine the content of improvement, and to realize the self-improvement function of the quality management system.
2.4 Preparation, revision and release of system documents
Time: about a month.
"O900/KLOC-0" quality management system is systematic, follows PDCA management mode and is supported by documents. The formation of documents is not an end, but a value-added activity, and its value lies in communicating ideas and unifying actions.
Before writing documents, necessary preparatory activities should be done, including the division of labor among team members, and relevant information such as existing management documents, processes, standards, laws and regulations should be collected according to the division of labor. On this basis, the advisory group will guide the preparation of system documents.
After the first draft of the document is completed, the consulting team will discuss the contents of the document with the managers of all departments of the company to make the document more operable. The revised system documents were promulgated and implemented after being approved by the company leaders, and the actual operation stage of the system was carried out.
2.5 Internal audit:
Time: The system runs for about one and a half months, which takes about two to three days.
The internal audit shall be conducted by the consultant team under the guidance of the internal auditor. Through internal audit, internal auditors can master the skills and methods of internal audit and train professionals in quality management for the company; Through internal audit, the possible problems and loopholes in the process of enterprise quality management system are found, and targeted corrective/preventive measures are taken to improve and improve the process capability of quality management system.
2.6 Management review:
Time: about 20 days after the end of internal audit.
Management review is usually presided over by the general manager. Its purpose is to evaluate the adequacy, suitability and effectiveness of the quality management system, find out the weak links, take corrective, corrective and preventive measures, and continuously improve and perfect the quality management system according to the internal audit result report, work reports of various departments, customer feedback, process performance, corrective/preventive measures and improvement suggestions.
2.7 Compliance audit (simulation audit):
The consultant will organize a mock audit before the audit of the certification body, conduct a comprehensive audit of the enterprise before the certification according to the audit procedures of the certification body, and put forward rectification opinions on the problems arising from the audit. Through the compliance audit, the employees of the enterprise will be familiar with the audit procedures, feel the audit atmosphere, avoid the problems caused by tension, and strive to successfully pass the on-site certification audit at one time.
2.8 Certification preparation:
This work includes selecting a third-party certification body, drawing up a plan to meet the audit, mobilizing the audit, explaining the matters needing attention in the audit, and ensuring the best mental outlook to meet the audit.
2.9 on-site audit
According to the plan formulated by the certification audit team, actively cooperate with the audit work of the audit team, make logistical arrangements and equip accompanying personnel to ensure the smooth progress of the certification audit.
2. 10 Close nonconforming items
As professional auditors in the quality management system, members of the audit team will always find problems in the operation of the system, and putting forward these problems will help improve the quality management system, which is also the significance of third-party audit. The nonconformities found by the audit team need to be corrected by the enterprise, and necessary corrective measures should be taken according to the reasons to prevent similar problems from happening again. After the measures taken are completed, the enterprise needs to provide relevant evidence to the audit team to prove the rationality and completion of the measures, thus indicating that the nonconformities have been closed. The audit team can only submit audit materials to the certification center after the unqualified closure.
2. 1 1 get the certificate
After the audit results of the audit team are reviewed and approved by the Technical Expert Committee of the Certification Center, the Certification Center will issue certificates to the enterprise to prove that the enterprise quality management system has been established, implemented and improved.
The above are the stages and key processes needed to establish a quality management system. These stages and processes are formulated according to the PDCA principle in management, which is very scientific. We can instill ISO900 management ideas and theories into the actual quality management work of enterprises step by step and penetrate into everyone's thoughts. Compared with the establishment of an effective quality management system, each stage and process is essential, and each stage and process is a step. If every step is enlightenment and experience, step by step, you will eventually feel suddenly enlightened. If enterprises can follow the requirements of each process in a down-to-earth manner, the gains will be immeasurable. On the contrary, if you just go into battle lightly and go through the motions, the effect will be greatly reduced, and even some stages or steps will be omitted in pursuit of speed, which will have a negative impact in serious cases.
It should also be pointed out that it is not the purpose to obtain the certification certificate through certification audit. Maintaining the management system for a long time, constantly discovering problems through various inspection tools such as internal audit and management review, persisting in continuous improvement, constantly improving the management system and keeping pace with the times are the eternal goals of the enterprise.