Introduction to ISO9001 standard
ISo9000 series standards on quality management and quality assurance. ISO9001 quality system certification refers to the third party (certification body) to audit, evaluate and register the quality system of an enterprise,
Its purpose is to prove that the quality system of an enterprise conforms to the ISO9001 standard through audit, evaluation and post supervision, and to grant certificates to those who meet the requirements of the standard and register them.
ISO is a global non-governmental organization, is a very important organization in the field of international standardization. ISO was founded in 1946. China is a full member of ISO and participates on behalf of China
The national organization of ISO is China's State Bureau of technical supervision (CSBTS). ISO is closely related to the International Electrotechnical Commission (IEC). The national organization of China participating in IEC is also the national quality supervision, inspection and quarantine
General Administration. ISO and IEC also have about 3000 working groups. ISO and IEC formulate and revise 1000 international standards every year.
The main function of ISO is to provide a mechanism for people to formulate international standards and reach consensus. ISO also has liaison with 450 international and regional organizations on standards, especially with the International Telecommunication Union
The three systems of ISO include:
ISO ISO 9001, ISO 14001, ISO 18001 (ISO 45001) system certification, these three system standards are applicable to all walks of life, there are hundreds of thousands of enterprises, service organizations and other organizations in the world have successfully obtained the third-party certification.
ISO9001 certificate content
The name of certification institution, the name of the applicant and the relevant standards passed in the product audit, the validity period of the certificate, the certificate number, the official seal of the certification institution, and the signature of the person in charge of the certification institution, etc.
1. The enterprises certified by ISO9001 system can improve their competitiveness, establish good corporate image and establish a reasonable and standardized quality system;
2. if the enterprise has participated in bidding activities, ISO9001 is mostly used as the threshold of bidding. Even if the tenderee does not specify clearly, ISO certificate can also add points for the enterprise bidding;
3. If the customers of the enterprise need to buy the products of the enterprise in large quantities, they will often ask the enterprise to show the certification.
The qualification for obtaining the certification shall be qualified (such as business license, organization code, relevant national administrative approval qualification or industry qualification), relevant facilities and resources, and normal operation activities. Can provide more than three months of business activity records.
According to the new survey results released by the international organization for Standardization (ISO) in November 2007, as of the end of 2006, 897866 ISO 9001: 2000 certificates have been issued in 170 countries, among which 162259 certificates have been issued in China, accounting for 18% of the total certificates issued, ranking the first in the world. This shows that the 2000 version of the standard has been widely used and attracted the attention of many organizations. China has also become a veritable quality management system certification country.
The process of obtaining certification is usually divided into two stages: the certification consultation stage: after the contract is signed, our company will send consulting teachers to the enterprise to conduct research, determine the enterprise's Certification Intention, help the enterprise to determine the organization and division of responsibilities and authorities, the system coverage, prepare and improve the system documents required for certification, and provide relevant training for enterprise personnel, And guide enterprises to operate according to the requirements of system documents, and help enterprises apply for certification.
Certification audit stage: the auditors sent by the certification agency shall inspect the activities of the enterprise applying for certification in accordance with the certification standards and enterprise system documents. The key point is to verify the situation of the enterprise and prepare certification documents and records. After the inspection, the auditors shall report to the certification agency and issue certificates.
ISO9000 provides a scientific quality management method and means for enterprises, which can improve the level of internal management.
Make the responsibilities of all kinds of personnel in the enterprise clear, avoid passing the buck and reduce the trouble of leaders.
The documented management system makes all quality work knowable, visible and searchable. Through training, employees can understand the importance of quality and the requirements for their work.
Can make the product quality get the fundamental guarantee.
It can reduce the cost of management and loss of enterprises and raise profits.
Provide confidence to customers and potential customers
Improve the image of the enterprise, and increase the strength of competition.
Meet the requirements of market access. The above is the benefit of passing ISO certification. Also, take this opportunity to remind enterprises with this intention. Please handle as soon as possible if necessary, because the normal time of issuing certificate is one month. After all, business opportunities are not waiting for others. It is always good to prepare for the future.
Requirements for ISO9001 certification application
1. Chinese enterprises hold the "business license of enterprise legal person" issued by the administrative department for Industry and commerce; foreign enterprises hold the registration certificate of the relevant departments] institutions.
2. the product quality is stable and can be produced in normal batch. Quality stability refers to the continuous spot check of products over one year. Products produced in small quantities cannot represent the stability of product quality, and must be formally completed
Enterprises that batch produce products can be qualified to apply for certification.
3. the products meet the national standards, industry standards and supplementary technical requirements, or meet the standards confirmed by the competent department of standardization administration under the State Council. The standard referred to here refers to a national standard with an international level or
Industry standards. Whether the products meet the standards shall be verified by sampling by the inspection institutions confirmed and approved by the state quality and Technology Supervision Bureau.
4. the quality system established by the production enterprise meets the requirements of quality assurance standards in gb/t19000-iso9000 family, and establishes the applicable quality standard system,
And make it work effectively.
ISO9001 certified materials
1. certification materials for the application organization to have independent legal qualifications (such as the valid business license and organization code certificate recently inspected annually)
2. license, qualification certificate, etc. within the validity period (copy)
3. production process flow chart / working process diagram or working principle diagram
4. product profile for application for certification (including information on technology, output, use, quality, sales, etc.)
5. product standard list and laws and regulations related to product / process
6. Other relevant information
ISO9001 certification process
. Identify and diagnose the original quality system of the enterprise;
. Establish ISO9001 implementation organization;
O set goals and incentives;
. Personnel at all levels should receive necessary training of management awareness and quality awareness;
O ISO 9001 standard knowledge training;
. Quality system compilation;
. Large scale publicity, training, release and trial operation of quality system;
. Management training;
. Internal auditors are trained;
. Several internal quality system audits;
. Management review based on internal audit;
. Perfect and improve the quality control system;
. Apply for certification;
. Certification company audit;
. On site audit;
. Corrective actions;
O registration and certification;
. Perfect after-sales service.
ISO9001 certification fee
At present, the price of ISO9001 certification consulting agency on the market is about 8000 yuan. Of course, the actual cost is also affected by other factors, as follows: first, the number of personnel. Certification companies need to arrange the audit time according to the number of personnel when they carry out certification, which leads to the longer audit time for organizations with more personnel, This also means that the higher the audit cost of certification bodies, the higher the natural price. According to the relevant regulations, for every 100 more people, the number of people will increase by one level, the audit fees of foreign certification bodies will increase by 4000 yuan, and that of domestic institutions will increase by 1500 yuan. The amount of ISO9001 certification training cost mainly depends on the company's training requirements. The higher the demand, the higher the price. According to the actual situation of the organization, to enable the company's personnel to truly master and use the ISO9001 standard, the cost is generally more than 20000 yuan.
The data related to ISO9001 certification are mainly assisted by training companies, and the cost is more than 12000 yuan. The company just wants to get ISO9001 certification, does not need to carry out system training, the cost of more than 4000 other necessary expenses: staff travel expenses, instrument school preparation costs, these are based on the actual situation, generally different. In short, to achieve ISO9001 certification, the general cost is about 8000 yuan. The specific price needs to be determined according to the company's geographical location, industry and scale. The number of people in the company is a factor that affects the price. If it is an enterprise with 60 people, the certification fee may reach more than 12000 yuan, so it depends on the specific situation.
According to the requirements of ISO9001 standard, the ISO standard system must be operated within the enterprise for three months before applying for certification in the fourth month.
But because the original management level of each enterprise is different, the time to transform into ISO9001 quality system is different. From the past experience, it can be divided into two situations
(1) fast certification enterprises: generally, it takes one month. Of course, the cycle of doing ISO mostly depends on the implementation of the enterprise, the degree of cooperation with the implementation, and whether there are significant changes in the organizational structure and related product range in the process of implementation.
(2) Enterprises fully implementing ISO certification standards: it takes about 3-6 months. It takes about three months to compile the training documents, and then it takes about one month to revise the organization documents
During the month of operation. Generally, it takes about one month to apply for certification, conduct on-site audit, pass certification and issue certificates.
For many sales-oriented enterprises, manufacturing enterprises, or production-oriented enterprises, we need to control and clearly understand all aspects of the enterprise's qualification or image. With the development of business or the competition in all directions, many enterprises have to keep pace with each other
Competition needs to improve the image of the enterprise or meet the development position of the enterprise, so we need to apply for ISO certification, enterprises have the qualification to bid or participate in market cooperation in order to better obtain market recognition.