ISO9001 is one of the core standards of a quality management system included in the ISO9000 family of standards. The ISO 9000 family standard is a concept proposed by the International Organization for Standardization (ISO) in 1994 and refers to the international standard established by ISO/Tc 176 (International Organization for Standardization Quality Management and Quality Assurance Technical Committee).
The benefits of certification
The company's ISO9001 certification can bring the following benefits:
- Emphasis on the customer-centered concept, clarifying the company's ability to acquire and understand customer requirements through various means, determine customer requirements, meet customer requirements through the operation of various processes in the system, and even exceed customer requirements, and obtain through customer satisfaction measurement The customer satisfaction process feels to continuously improve the company's position in the customer's mind and enhance customer confidence;
- Clearly require the top management of the company to directly participate in the quality management system activities, and develop quality policies and quality objectives at all levels from the company level. The top management can judge the performance of the quality management system by timely obtaining the achievement of quality objectives, and participate directly in the regular The management review masters the overall status of the entire quality system, and takes timely measures for the inadequacies of the system to ensure the adequacy of resources from the company level;
- Clarify the responsibilities and interrelationships of each function and level of personnel, and clarify the competency requirements of various personnel from the aspects of education, training, skills and experience to ensure that they are competent and participate in the establishment of the entire quality system through full participation. , operation and maintenance activities to ensure the smooth operation of all aspects of the company;
- Clearly control all links that may result in non-conforming products, isolate and dispose of the resulting non-conforming products, and through institutionalized data analysis, find the root cause of the unqualified products, and prevent non-conformities through corrective or preventive measures. Recurring, thereby continuously reducing the cost of bad quality incurred by the company, and continuously improving the effectiveness and efficiency of the quality management system through other continuous improvement activities, thereby achieving continuous reduction of company costs and continuous growth of profits;
- Substitute a cumbersome second-party factory review through a single third-party registration review. Third-party professional audits can reveal the company's problems in a deeper level, and supervise the company's personnel in accordance with the company's quality management system specifications through regular supervision and audit. To carry out work;
- Obtaining quality system certification is a stepping stone to obtain customer qualifications and enter the international market. It is also an important basis for enterprises to carry out supply chain management.
Scope of application
The ISO 9001:2015 standard is the basis for enterprises to apply for certification. It is clear in the scope of application of the standard that this standard is applicable to all walks of life and does not limit the size of the enterprise. Internationally certified companies involve all walks of life in the national economy.
Apply for certification conditions
Organizations applying for certification must have the following basic conditions:
(1) An organization with independent legal personality or authorized by an independent legal entity;
(2) Establish a documented quality management system in accordance with the requirements of the ISO9001:2015 standard;
(3) It has been operated for more than three months in accordance with the documented system, and at least one management review and internal quality system audit has been carried out in accordance with the requirements of the document before the certification audit;
ISO Essence
Quality is controlled by people. As long as it is a person, it is inevitable to make mistakes of one kind or another. So how to prevent mistakes, make fewer mistakes, or try not to give you the opportunity to make mistakes, this is the essence of the ISO9000 family of standards. Preventive measures are an important improvement activity. It is spontaneous, active, and advanced. It can be said that the ability of the organization to take preventive measures is the performance of management strength. Some organizations have reviewed it for five years and there is no single record of preventive measures.
Of course, the ISO 9000 family standard is based on the customer's point of view. The customer wants the company to have the ability to prevent problems, so this is a consideration for the customer to choose the supplier.
The standard requires organizations to establish documented preventive procedures, and many organizations combine this procedure with corrective action procedures, especially for small and medium-sized businesses. The organization should establish mechanisms to reward precautionary measures and address the problems found:
In the practice of ISO9001 certification audit, many customers are often found to be able to self-discover some problems, such as internal audit, assessment, inspection, return, complaints, etc., and some measures have been taken, but many of these measures are going through the process, on the matter, Only corrected the failure. After the event, there are often instances of recurrence. Such as the surface of the injection molded parts oil problem. Clause 8.5.2 of the ISO 9001 standard sets clear requirements for corrective actions. I found the problem, not only to improve, but also to improve effectively. If you invest resources to solve the problem, you should solve it thoroughly. To solve the problem effectively is to eliminate the cause of the problem.
The problems we need to solve are usually influential to the organization. Of course, there is a problem that affects the size. Because of the time it takes to analyze and solve the problem, it usually takes time, so the organization should take strong measures to control or eliminate the non-conforming product/service itself. This is called "correction."
The organization should set a goal (to what extent) to take corrective action, preferably with a timetable. The standard requires recording the development, tracking, results, and acceptance of corrective actions. The management of corrective actions should be documented. The organization should also consider the economic benefits of taking measures. It should not invest one million to solve a problem of damage of only ten dollars. The recurrence of the problem is probable. If it can be correctly predicted, it would be better.
Since the original system of the organization is an organic whole, when we take strong measures, we must consider whether these measures will affect the original system and prevent unexpected problems. 100% problem solving is just an ideal state. In the process of development of enterprises, the problem is not solved. Just like our body.
